Severe Aortic Stenosis
Conditions
Keywords
Valvular Heart Disease, Critical Aortic Stenosis, Severe Aortic Stenosis, High Risk, Aortic Valve Replacement
Brief summary
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or very high risk for aortic valve surgery.
Interventions
Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
Surgical Aortic Valve Replacement (SAVR)
Sponsors
Medtronic Cardiovascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Extreme Risk Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days. * High Risk Surgical Only: Subject must have comorbidities such that one cardiologist and two cardiac surgeons agree that predicted risk of operative mortality is ≥15% (and predicted operative mortality or serious, irreversible morbidity risk of \< 50%) at 30 days. * Subject has senile degenerative aortic valve stenosis with: mean gradient \> 40 mmHg, or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram, or simultaneous pressure recordings at cardiac catheterization (either resting or dobutamine stress), AND an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤ 0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization * Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater. * The subject or the subject's legal representative has been informed of the nature of the trial, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site. * The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
Clinical * Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment. * Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the intended treatment. (High Risk Surgical Only: Including bare metal stents. Additionally, any drug eluting stents placed within 6 months prior to the index procedure.) * Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \<50,000 cells/mm3), history of bleeding diathesis or coagulopathy. * Untreated clinically significant coronary artery disease requiring revascularization. * Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. * Need for emergency surgery for any reason. * Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20% as measured by resting echocardiogram. * Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA). * End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min. * Active Gastrointestinal (GI) bleeding within the past 3 months. * A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: * Aspirin * Heparin (HIT/HITTS) * Bivalirudin (Extreme Risk Only) * Nitinol (titanium or nickel) * Ticlopidine and clopidogrel * Contrast media * Ongoing sepsis, including active endocarditis. * Subject refuses a blood transfusion. * Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions. * Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent. * Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). * Currently participating in an investigational drug or another device trial. * Symptomatic carotid or vertebral artery disease. * Subject has been offered surgical aortic valve replacement but declined. (High Risk Surgical Only) Anatomical * Native aortic annulus size \< 18 mm or \> 29 mm per the baseline diagnostic imaging. * Pre-existing prosthetic heart valve any position. * Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation (3-4+)). * Moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation. * Moderate to severe mitral stenosis. * Hypertrophic obstructive cardiomyopathy. * New or untreated echocardiographic evidence of intracardiac mass, thrombus or vegetation. * Severe basal septal hypertrophy with an outflow gradient. * Aortic root angulation (angle between plane of aortic valve annulus and horizontal plane/vertebrae) \> 70° (for femoral and left subclavian/axillary access) and \> 30° (for right subclavian/axillary access). * Ascending aorta diameter \> 43 mm if the aortic annulus diameter is 23-29 mm; ascending aorta diameter \> 40 mm if the aortic annulus diameter is 20-23 mm; or an ascending aorta diameter \> 34 mm if the aortic annulus diameter is 18-20 mm. * Congenital bicuspid or unicuspid valve verified by echocardiography. * Sinus of valsalva anatomy that would prevent adequate coronary perfusion. Vascular \- Transarterial access not able to accommodate an 18Fr sheath.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 1 year | All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day, 6 month, 1 year, 2 year | MACCE is defined as a composite of: * All Cause Mortality * Myocardial infarction (MI) * All Stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| The Occurrence of Individual MACCE Components | 30 day, 6 month, 1 year, 2 year | Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) |
| Major Adverse Events (MAEs) | 30 day, 6 month, 1 year, 2 year | MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism |
| Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day, 6 month, 1 year, 2 year | — |
| Change in NYHA Class | 30 day, 6 month, 1 year, 2 year | Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. |
| Change in Distance Walked During 6-Minute Walk Test (6MWT) | 30 day, 1 year | Change in distance walked during 6MWT from baseline |
| Ratio of Days Alive Out of Hospital Versus Total Days Alive | 1 year | — |
| Quality of Life (QoL) Change | 30 day, 6 month, 1 year, 2 year | QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state. |
| Echocardiographic Assessment of Valve Performance | 30 day, 6 month, 1 year, 2 year | Using the following measures: \- Effective Orifice Area (EOA) |
| Aortic Valve Hospitalizations | 30 day, 6 month, 1 year, 2 year | — |
| Cardiovascular Deaths and Valve Related Deaths | 30 day, 6 month, 1 year, 2 year | — |
| Strokes and Transient Ischemic Attacks (TIAs) | 30 day, 6 month, 1 year, 2 year | Strokes (of any severity) and TIAs |
| Index Procedure Related MAEs | Procedure | — |
| Length of Index Procedure Hospital Stay | Number of days from admission to discharge | — |
| Device Success | Number of days from admission to discharge | Medtronic CoreValve® System subjects only. Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location |
| Procedural Success | Number of days from admission to discharge | Medtronic CoreValve® System subjects only. Defined as device success and absence of in-hospital MACCE. |
| Prosthetic Valve Dysfunction (PVD) | 30 day, 6 month, 1 year, 2 year | PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25 |
Countries
United States
Participant flow
Recruitment details
Between Feb 17, 2011 and Aug 23, 2013, 656 subjects were enrolled into the CoreValve US Pivotal Trial Extreme Risk study at 41 of the 43 activated centers in the United States. Between February 2, 2011 and July 23, 2013, 797 subjects were enrolled into the CoreValve US Pivotal Trial High Risk study at 45 centers in the United States.
Pre-assignment details
The first 3 successfully enrolled and implanted iliofemoral subjects at each implanting site, inclusive of both the High Risk Surgical and Extreme Risk patient populations were considered roll-in subjects, and were automatically assigned to undergo Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI).
Participants by arm
| Arm | Count |
|---|---|
| Extreme Risk: TAVI Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access | 489 |
| Extreme Risk: TAVI Non-Iliofemoral Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access | 150 |
| High Risk: TAVI High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) | 391 |
| High Risk: SAVR High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR) | 359 |
| Total | 1,389 |
Baseline characteristics
| Characteristic | Total | High Risk: SAVR | High Risk: TAVI | Extreme Risk: TAVI Non-Iliofemoral | Extreme Risk: TAVI Iliofemoral |
|---|---|---|---|---|---|
| Age, Continuous | 83.0 years STANDARD_DEVIATION 7.6 | 83.3 years STANDARD_DEVIATION 6.4 | 83.2 years STANDARD_DEVIATION 7.1 | 81.3 years STANDARD_DEVIATION 7.4 | 83.2 years STANDARD_DEVIATION 8.7 |
| Body Surface Area | 1.8 m^2 STANDARD_DEVIATION 0.2 | 1.9 m^2 STANDARD_DEVIATION 0.2 | 1.8 m^2 STANDARD_DEVIATION 0.2 | 1.8 m^2 STANDARD_DEVIATION 0.2 | 1.8 m^2 STANDARD_DEVIATION 0.3 |
| Logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) | 20.3 % STANDARD_DEVIATION 15.1 | 18.8 % STANDARD_DEVIATION 13.2 | 17.7 % STANDARD_DEVIATION 13 | 22.9 % STANDARD_DEVIATION 15.9 | 22.6 % STANDARD_DEVIATION 17.1 |
| NYHA Classification NYHA I | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| NYHA Classification NYHA II | 156 participants | 47 participants | 57 participants | 12 participants | 40 participants |
| NYHA Classification NYHA III | 916 participants | 250 participants | 255 participants | 98 participants | 313 participants |
| NYHA Classification NYHA IV | 317 participants | 62 participants | 79 participants | 40 participants | 136 participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 4 participants | 1 participants | 0 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized Black or African American | 38 participants | 11 participants | 3 participants | 5 participants | 19 participants |
| Race/Ethnicity, Customized More than one race | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 4 participants | 2 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 1341 participants | 343 participants | 387 participants | 143 participants | 468 participants |
| Sex: Female, Male Female | 692 Participants | 171 Participants | 184 Participants | 82 Participants | 255 Participants |
| Sex: Female, Male Male | 697 Participants | 188 Participants | 207 Participants | 68 Participants | 234 Participants |
| Society of Thoracic Surgeons (STS) Risk Score | 8.8 % risk of mortality or morbidity STANDARD_DEVIATION 4.7 | 7.5 % risk of mortality or morbidity STANDARD_DEVIATION 3.3 | 7.3 % risk of mortality or morbidity STANDARD_DEVIATION 3 | 10.7 % risk of mortality or morbidity STANDARD_DEVIATION 5.7 | 10.3 % risk of mortality or morbidity STANDARD_DEVIATION 5.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 440 / 489 | 139 / 150 | 355 / 390 | 320 / 357 |
| serious Total, serious adverse events | 452 / 489 | 142 / 150 | 346 / 390 | 324 / 357 |
Outcome results
Primary
Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality
All-cause Death or Major Stroke (Extreme Risk- Medtronic CoreValve® System); All-cause Mortality (High Risk Surgical- Medtronic CoreValve® System vs. Surgical Valve)
Time frame: 1 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 26.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 39.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 14.1 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Extreme Risk: All-cause Death or Major Stroke; High Risk Surgical: All-cause Mortality | 18.9 percentage of participants, Kaplan-Meier |
Comparison: TAVR with the Medtronic CoreValve System meets the Performance Goal in the 12 month rate of all-cause mortality or major stroke H0: = πMCS TAVI ≥ 43.0% HA: = πMCS TAVI \< 43.0% In the above expressions πMCS TAVI denotes the rate of all-cause mortality or major stroke during a fixed follow-up of 1 year.p-value: <0.000195% CI: [22.3, 30.1]z-test, 1 sided
Comparison: No performance goal created, only descriptive statistics are provided.
p-value: <0.0001z-test, 1 sided
Secondary
Aortic Valve Hospitalizations
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Aortic Valve Hospitalizations | 30 day | 6.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Aortic Valve Hospitalizations | 6 month | 16.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Aortic Valve Hospitalizations | 1 year | 21.9 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Aortic Valve Hospitalizations | 2 year | 29.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Aortic Valve Hospitalizations | 6 month | 18.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Aortic Valve Hospitalizations | 1 year | 21.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Aortic Valve Hospitalizations | 2 year | 27.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Aortic Valve Hospitalizations | 30 day | 8.7 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Aortic Valve Hospitalizations | 1 year | 16.5 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Aortic Valve Hospitalizations | 6 month | 13.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Aortic Valve Hospitalizations | 2 year | 24.2 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Aortic Valve Hospitalizations | 30 day | 3.9 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Aortic Valve Hospitalizations | 2 year | 18.2 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Aortic Valve Hospitalizations | 6 month | 9.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Aortic Valve Hospitalizations | 30 day | 5.2 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Aortic Valve Hospitalizations | 1 year | 14.0 percentage of participants, Kaplan-Meier |
Secondary
Cardiovascular Deaths and Valve Related Deaths
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 1 year Cardiovascular Deaths | 18.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 1 year Valve Related Deaths | 5.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 2 year Valve Related Deaths | 6.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 6 month Cardiovascular Deaths | 15.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 30 Day Valve Related Deaths | 2.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 30 day Cardiovascular Deaths | 8.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 2 year Cardiovascular Deaths | 26.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 6 month Valve Related Deaths | 4.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 30 Day Valve Related Deaths | 2.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 30 day Cardiovascular Deaths | 11.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 1 year Valve Related Deaths | 5.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 1 year Cardiovascular Deaths | 28.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 2 year Valve Related Deaths | 7.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 6 month Valve Related Deaths | 4.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 2 year Cardiovascular Deaths | 35.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Cardiovascular Deaths and Valve Related Deaths | 6 month Cardiovascular Deaths | 23.6 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 1 year Cardiovascular Deaths | 10.6 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 30 day Cardiovascular Deaths | 3.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 30 Day Valve Related Deaths | 2.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 6 month Cardiovascular Deaths | 7.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 6 month Valve Related Deaths | 3.6 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 1 year Valve Related Deaths | 5.6 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 2 year Cardiovascular Deaths | 15.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Cardiovascular Deaths and Valve Related Deaths | 2 year Valve Related Deaths | 6.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 6 month Cardiovascular Deaths | 10.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 30 Day Valve Related Deaths | 0.6 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 2 year Valve Related Deaths | 4.2 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 2 year Cardiovascular Deaths | 19.4 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 30 day Cardiovascular Deaths | 4.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 6 month Valve Related Deaths | 1.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 1 year Cardiovascular Deaths | 12.9 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Cardiovascular Deaths and Valve Related Deaths | 1 year Valve Related Deaths | 2.2 percentage of participants, Kaplan-Meier |
Secondary
Change in Distance Walked During 6-Minute Walk Test (6MWT)
Change in distance walked during 6MWT from baseline
Time frame: 30 day, 1 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 1 year | 13.9 meters | Standard Deviation 140.4 |
| Extreme Risk: TAVI Iliofemoral | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 30 day | 19.6 meters | Standard Deviation 109.1 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 1 year | 22.2 meters | Standard Deviation 136.2 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 30 day | 13.3 meters | Standard Deviation 110 |
| High Risk: TAVI | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 30 day | 25.8 meters | Standard Deviation 105.5 |
| High Risk: TAVI | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 1 year | 27.0 meters | Standard Deviation 114.3 |
| High Risk: SAVR | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 30 day | -6.9 meters | Standard Deviation 89.8 |
| High Risk: SAVR | Change in Distance Walked During 6-Minute Walk Test (6MWT) | 1 year | 24.0 meters | Standard Deviation 111.8 |
Secondary
Change in NYHA Class
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Change in NYHA Class | 30 day | -1.3 average classification level change | Standard Deviation 0.9 |
| Extreme Risk: TAVI Iliofemoral | Change in NYHA Class | 6 month | -1.6 average classification level change | Standard Deviation 0.9 |
| Extreme Risk: TAVI Iliofemoral | Change in NYHA Class | 1 year | -1.6 average classification level change | Standard Deviation 0.9 |
| Extreme Risk: TAVI Iliofemoral | Change in NYHA Class | 2 year | -1.6 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in NYHA Class | 6 month | -1.4 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in NYHA Class | 1 year | -1.4 average classification level change | Standard Deviation 0.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in NYHA Class | 2 year | -1.4 average classification level change | Standard Deviation 0.7 |
| Extreme Risk: TAVI Non-Iliofemoral | Change in NYHA Class | 30 day | -1.0 average classification level change | Standard Deviation 0.8 |
| High Risk: TAVI | Change in NYHA Class | 1 year | -1.5 average classification level change | Standard Deviation 0.8 |
| High Risk: TAVI | Change in NYHA Class | 6 month | -1.5 average classification level change | Standard Deviation 0.8 |
| High Risk: TAVI | Change in NYHA Class | 2 year | -1.5 average classification level change | Standard Deviation 0.8 |
| High Risk: TAVI | Change in NYHA Class | 30 day | -1.3 average classification level change | Standard Deviation 0.8 |
| High Risk: SAVR | Change in NYHA Class | 2 year | -1.5 average classification level change | Standard Deviation 0.9 |
| High Risk: SAVR | Change in NYHA Class | 6 month | -1.4 average classification level change | Standard Deviation 0.8 |
| High Risk: SAVR | Change in NYHA Class | 30 day | -1.0 average classification level change | Standard Deviation 0.9 |
| High Risk: SAVR | Change in NYHA Class | 1 year | -1.5 average classification level change | Standard Deviation 0.8 |
Comparison: Change in NYHA classification from baseline to 1 year from secondary objective #5. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.p-value: <0.0001t-test, 2 sided
Comparison: Change in NYHA classification from baseline to 1 year: TAVR vs. SAVR from secondary objective #5. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean number of classification improvements in NYHA from baseline to 1 year.p-value: <0.0001t-test, 1 sided
Secondary
Conduction Disturbance Requiring Permanent Pacemaker Implantation
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 21.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 24.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 26.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 2 year | 28.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 20.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 21.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 2 year | 22.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 16.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 22.5 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 21.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 2 year | 25.8 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 20.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 2 year | 12.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 6 month | 9.9 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 30 day | 7.1 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Conduction Disturbance Requiring Permanent Pacemaker Implantation | 1 year | 11.6 percentage of participants, Kaplan-Meier |
Secondary
Device Success
Medtronic CoreValve® System subjects only. Defined as: * Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system, * Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function), * Intended performance of the prosthetic valve (aortic valve area \> 1.2 cm2 for 26, 29 and 31mm valves, ≥ 0.9 cm2 for 23mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient \< 20 mmHg or peak velocity \< 3 m/sec, without moderate or severe prosthetic valve aortic regurgitation) * Only one valve implanted in the proper anatomical location
Time frame: Number of days from admission to discharge
Population: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for device success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Device Success | 84.6 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Device Success | 88.7 percentage of participants |
| High Risk: TAVI | Device Success | 86.8 percentage of participants |
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measures: \- Transvalvular Mean Gradient
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Mean Gradient | 8.68 mmHg | Standard Deviation 4.16 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Mean Gradient | 9.10 mmHg | Standard Deviation 3.89 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Mean Gradient | 8.86 mmHg | Standard Deviation 4.09 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Mean Gradient | 8.70 mmHg | Standard Deviation 4.22 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Mean Gradient | 9.42 mmHg | Standard Deviation 5.6 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Mean Gradient | 9.46 mmHg | Standard Deviation 5.65 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Mean Gradient | 9.24 mmHg | Standard Deviation 5.35 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Mean Gradient | 9.74 mmHg | Standard Deviation 5.82 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Mean Gradient | 9.09 mmHg | Standard Deviation 3.49 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Mean Gradient | 9.08 mmHg | Standard Deviation 4.08 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Mean Gradient | 8.47 mmHg | Standard Deviation 3.76 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Mean Gradient | 8.88 mmHg | Standard Deviation 3.86 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Mean Gradient | 12.05 mmHg | Standard Deviation 6.32 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Mean Gradient | 12.12 mmHg | Standard Deviation 6.31 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Mean Gradient | 11.72 mmHg | Standard Deviation 5.7 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Mean Gradient | 12.44 mmHg | Standard Deviation 7.36 |
Comparison: Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.p-value: <0.0001t-test, 2 sided
Comparison: Transvalvular Mean Gradient:~Change in transvalvular mean gradient from baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level of 0.05 the hypotheses: H0: μ MCS TAVR ≤ μ SAVR -15 HA: μ MCS TAVR \> μ SAVR -15 In the above expression μ MCS TAVR and μ SAVR denoted the mean improvements in mean gradient from Baseline to 1 year measured in mmHg.p-value: <0.0001t-test, 1 sided
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measures: \- Effective Orifice Area (EOA)
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day EOA | 1.86 cm^2 | Standard Deviation 0.56 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month EOA | 1.88 cm^2 | Standard Deviation 0.55 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year EOA | 1.88 cm^2 | Standard Deviation 0.54 |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year EOA | 1.86 cm^2 | Standard Deviation 0.55 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month EOA | 1.85 cm^2 | Standard Deviation 0.51 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year EOA | 1.85 cm^2 | Standard Deviation 0.51 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year EOA | 1.83 cm^2 | Standard Deviation 0.58 |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day EOA | 1.82 cm^2 | Standard Deviation 0.64 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year EOA | 1.91 cm^2 | Standard Deviation 0.52 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month EOA | 1.91 cm^2 | Standard Deviation 0.53 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year EOA | 1.87 cm^2 | Standard Deviation 0.48 |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day EOA | 1.94 cm^2 | Standard Deviation 0.56 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year EOA | 1.51 cm^2 | Standard Deviation 0.43 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month EOA | 1.56 cm^2 | Standard Deviation 0.49 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day EOA | 1.60 cm^2 | Standard Deviation 0.51 |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year EOA | 1.57 cm^2 | Standard Deviation 0.49 |
Comparison: EOA:~Change in effective orifice area from Baseline to 1 year from secondary objective #9. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.p-value: <0.0001t-test, 2 sided
Comparison: EOA:~Change in effective orifice area from Baseline to 1 year: TAVR vs.SAVR from secondary objective #9. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -0.375 HA: µ MCS TAVR \> µ SAVR -0.375 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in effective orifice area from Baseline to 1 year measured in cm2.p-value: <0.0001t-test, 1 sided
Secondary
Echocardiographic Assessment of Valve Performance
Using the following measure: \- Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - None | 31.0 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Trivial | 40.6 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 14.1 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 0.0 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 31.5 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 9.1 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 6.4 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Trivial | 32.7 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Moderate | 6.7 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 1.2 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 19.9 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Mild | 36.1 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Trivial | 33.5 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Severe | 0.0 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 36.5 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 43.0 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Trivial | 26.3 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 9.8 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 0.3 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 21.5 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - None | 35.3 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 39.0 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Moderate | 4.4 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 1.2 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 33.3 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Trivial | 36.6 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 19.0 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Severe | 0.0 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 0.0 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 20.7 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Trivial | 27.1 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 2.4 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 4.2 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 10.7 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Trivial | 36.8 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 34.7 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 35.4 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 1.7 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Trivial | 33.9 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Mild | 23.5 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 29.0 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 12.2 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Trivial | 41.4 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 36.4 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 8.1 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 1.9 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 21.6 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Trivial | 37.2 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 29.7 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 10.0 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 1.6 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 28.3 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Trivial | 35.7 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 6.7 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 0.3 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - None | 32.8 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Trivial | 27.0 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Mild | 32.0 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Moderate | 6.6 percentage of participants |
| High Risk: TAVI | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Severe | 1.6 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Severe | 0.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Moderate | 1.6 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Moderate | 1.1 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - None | 58.5 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Mild | 9.8 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- Trivial | 28.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Trivial | 23.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Trivial | 27.3 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 6 month Total Aortic Regurgitation- None | 60.6 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Severe | 0.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- None | 65.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Mild | 13.1 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Moderate | 1.3 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Mild | 8.8 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 30 day Total Aortic Regurgitation- Mild | 10.7 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Moderate | 0.9 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Trivial | 21.7 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- None | 68.1 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 2 year Total Aortic Regurgitation - Severe | 0.0 percentage of participants |
| High Risk: SAVR | Echocardiographic Assessment of Valve Performance | 1 year Total Aortic Regurgitation- Severe | 0.4 percentage of participants |
Secondary
Index Procedure Related MAEs
Time frame: Procedure
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Index Procedure Related MAEs | 53.5 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Index Procedure Related MAEs | 68.9 percentage of participants |
| High Risk: TAVI | Index Procedure Related MAEs | 52.6 percentage of participants |
| High Risk: SAVR | Index Procedure Related MAEs | 49.9 percentage of participants |
Secondary
Length of Index Procedure Hospital Stay
Time frame: Number of days from admission to discharge
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Length of Index Procedure Hospital Stay | 9.2 days | Standard Deviation 8.1 |
| Extreme Risk: TAVI Non-Iliofemoral | Length of Index Procedure Hospital Stay | 11.2 days | Standard Deviation 8.9 |
| High Risk: TAVI | Length of Index Procedure Hospital Stay | 8.0 days | Standard Deviation 6.8 |
| High Risk: SAVR | Length of Index Procedure Hospital Stay | 12.5 days | Standard Deviation 10.7 |
Secondary
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
MACCE is defined as a composite of: * All Cause Mortality * Myocardial infarction (MI) * All Stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 12.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 22.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 29.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 2 Year | 42.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 34.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 41.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 2 Year | 51.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 17.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 20.5 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 15.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 2 Year | 29.7 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 7.7 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 2 Year | 38.6 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 6 month | 21.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 30 day | 10.3 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) | 1 year | 27.0 percentage of participants, Kaplan-Meier |
Comparison: Powered Secondary Hypothesis: TAVR with the Medtronic CoreValve System was superior to SAVR in binary rate of MACCE at 30 days or hospital discharge, whichever was longer:~H0: πMCS TAVR = πSAVR HA: πMCS TAVR \< πSAVR In the above expression πMCS TAVR and πSAVR denoted rates of MACCE at 30 days or hospital discharge, whichever was longer.~Assumptions:~1:1 treatment allocation ratio One-sided alpha=0.025 SAVR = 20.0% MCS TAVI = 12.1% Power = \>80%p-value: 0.1033Kaplan-Meier Point Estimate
Secondary
Major Adverse Events (MAEs)
MAEs Include: * MACCE * Acute Kidney Injury * Cardiac Tamponade * Prosthetic Valve Dysfunction * Cardiogenic Shock * Valve Endocarditis * Life-Threatening, Disabling or Major Bleeding * Major Vascular Complication * Cardiac Perforation * Device Migration/Valve Embolism
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Major Adverse Events (MAEs) | 30 day | 54.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Events (MAEs) | 6 month | 60.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Events (MAEs) | 2 year | 71.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Major Adverse Events (MAEs) | 1 year | 63.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Events (MAEs) | 6 month | 76.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Events (MAEs) | 2 year | 84.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Events (MAEs) | 1 year | 80.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Major Adverse Events (MAEs) | 30 day | 69.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Events (MAEs) | 30 day | 52.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Events (MAEs) | 2 year | 66.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Events (MAEs) | 1 year | 60.1 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Major Adverse Events (MAEs) | 6 month | 58.6 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Events (MAEs) | 2 year | 66.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Events (MAEs) | 30 day | 50.2 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Events (MAEs) | 6 month | 76.4 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Major Adverse Events (MAEs) | 1 year | 59.8 percentage of participants, Kaplan-Meier |
Secondary
Procedural Success
Medtronic CoreValve® System subjects only. Defined as device success and absence of in-hospital MACCE.
Time frame: Number of days from admission to discharge
Population: Participant Population= Consisted of all subjects with a TAVR index procedure who were evaluable for procedural success.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Procedural Success | 77.5 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Procedural Success | 77.5 percentage of participants |
| High Risk: TAVI | Procedural Success | 81.3 percentage of participants |
Secondary
Prosthetic Valve Dysfunction (PVD)
PVD was defined according to VARC I using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total AR reported as moderate or severe was considered PVD. AS was defined as significant stenosis and considered PVD if one of the following was met: * Peak velocity \>4 m/s * Mean gradient \>35 mmHg * EOA \< 0.8 cm2 * TVIV1 / TVIV2 \< 0.25
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with a valve implanted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 2.3 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 23.5 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 3.1 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 26.1 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 3.5 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 27.0 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Stenosis | 3.9 percentage of participants |
| Extreme Risk: TAVI Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Regurgitation | 27.8 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 19.6 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 6.1 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 16.9 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Regurgitation | 19.6 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Stenosis | 6.8 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 18.2 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 6.1 percentage of participants |
| Extreme Risk: TAVI Non-Iliofemoral | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 6.1 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Stenosis | 5.4 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 3.8 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 17.2 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 4.9 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 17.9 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Regurgitation | 19.7 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 3.1 percentage of participants |
| High Risk: TAVI | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 13.6 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Stenosis | 6.5 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 6 month Aortic Regurgitation | 2.3 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Regurgitation | 1.7 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 30 day Aortic Stenosis | 4.8 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Stenosis | 8.2 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Regurgitation | 2.8 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 2 year Aortic Stenosis | 9.3 percentage of participants |
| High Risk: SAVR | Prosthetic Valve Dysfunction (PVD) | 1 year Aortic Regurgitation | 2.8 percentage of participants |
Secondary
Quality of Life (QoL) Change
QoL summary score change from baseline using the following measures: * Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * 12 Item Short Form Health Survey (SF-12): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. * European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 2 year KCCQ - Overall | 25.2 units on a scale | Standard Deviation 27.2 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 6 month EQ-5D | 0.09 units on a scale | Standard Deviation 0.22 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Physical | 5.2 units on a scale | Standard Deviation 11.3 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 30 day EQ-5D | 0.09 units on a scale | Standard Deviation 0.29 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 20.2 units on a scale | Standard Deviation 28 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ-Overall | 27.9 units on a scale | Standard Deviation 27.1 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 2 year SF-12 - Physical | 4.0 units on a scale | Standard Deviation 11.2 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 1 year EQ-5D | 0.06 units on a scale | Standard Deviation 0.25 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 2 year SF-12 - Mental | 3.8 units on a scale | Standard Deviation 15.3 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 20.8 units on a scale | Standard Deviation 26.8 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Physical | 5.9 units on a scale | Standard Deviation 10.4 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Mental | 3.7 units on a scale | Standard Deviation 14.2 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 24.2 units on a scale | Standard Deviation 28.9 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Physical | 5.5 units on a scale | Standard Deviation 10.8 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Mental | 4.6 units on a scale | Standard Deviation 13.6 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 22.2 units on a scale | Standard Deviation 26.1 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 2 year KCCQ - Clinical | 18.8 units on a scale | Standard Deviation 26.1 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Mental | 5.2 units on a scale | Standard Deviation 13.7 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ-Overall | 27.4 units on a scale | Standard Deviation 27 |
| Extreme Risk: TAVI Iliofemoral | Quality of Life (QoL) Change | 2 year EQ-5D | 0.04 units on a scale | Standard Deviation 0.25 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 17.5 units on a scale | Standard Deviation 26.6 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 1 year EQ-5D | 0.05 units on a scale | Standard Deviation 0.25 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 2 year SF-12 - Mental | 2.2 units on a scale | Standard Deviation 14.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 2 year KCCQ - Overall | 14.9 units on a scale | Standard Deviation 29.5 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Physical | 1.9 units on a scale | Standard Deviation 10.4 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 2 year KCCQ - Clinical | 11.6 units on a scale | Standard Deviation 26.9 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 2 year SF-12 - Physical | 1.9 units on a scale | Standard Deviation 11.9 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Physical | 4.5 units on a scale | Standard Deviation 8.9 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 30 day SF-12-Mental | -1.7 units on a scale | Standard Deviation 16.2 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 6 month SF-12-Mental | 4.4 units on a scale | Standard Deviation 13.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 6.8 units on a scale | Standard Deviation 32 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 6 month EQ-5D | 0.05 units on a scale | Standard Deviation 0.21 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 6 month KCCQ-Overall | 23.1 units on a scale | Standard Deviation 28.3 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ-Overall | 21.9 units on a scale | Standard Deviation 26.8 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 30 day EQ-5D | 0.00 units on a scale | Standard Deviation 0.3 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 7.9 units on a scale | Standard Deviation 33.5 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 18.1 units on a scale | Standard Deviation 24.9 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Physical | 4.6 units on a scale | Standard Deviation 10 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 2 year EQ-5D | 0.03 units on a scale | Standard Deviation 0.26 |
| Extreme Risk: TAVI Non-Iliofemoral | Quality of Life (QoL) Change | 1 year SF-12-Mental | 2.4 units on a scale | Standard Deviation 14.3 |
| High Risk: TAVI | Quality of Life (QoL) Change | 30 day SF-12-Mental | 2.6 units on a scale | Standard Deviation 13.1 |
| High Risk: TAVI | Quality of Life (QoL) Change | 30 day EQ-5D | 0.04 units on a scale | Standard Deviation 0.24 |
| High Risk: TAVI | Quality of Life (QoL) Change | 6 month KCCQ-Overall | 24.8 units on a scale | Standard Deviation 26.9 |
| High Risk: TAVI | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 18.6 units on a scale | Standard Deviation 25.7 |
| High Risk: TAVI | Quality of Life (QoL) Change | 6 month SF-12-Physical | 6.3 units on a scale | Standard Deviation 11 |
| High Risk: TAVI | Quality of Life (QoL) Change | 6 month SF-12-Mental | 4.6 units on a scale | Standard Deviation 11.8 |
| High Risk: TAVI | Quality of Life (QoL) Change | 6 month EQ-5D | 0.05 units on a scale | Standard Deviation 0.22 |
| High Risk: TAVI | Quality of Life (QoL) Change | 1 year KCCQ-Overall | 23.2 units on a scale | Standard Deviation 25.4 |
| High Risk: TAVI | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 16.7 units on a scale | Standard Deviation 25.5 |
| High Risk: TAVI | Quality of Life (QoL) Change | 1 year SF-12-Physical | 6.0 units on a scale | Standard Deviation 11.5 |
| High Risk: TAVI | Quality of Life (QoL) Change | 1 year SF-12-Mental | 4.5 units on a scale | Standard Deviation 11.8 |
| High Risk: TAVI | Quality of Life (QoL) Change | 1 year EQ-5D | 0.04 units on a scale | Standard Deviation 0.19 |
| High Risk: TAVI | Quality of Life (QoL) Change | 2 year KCCQ - Overall | 22.2 units on a scale | Standard Deviation 26.5 |
| High Risk: TAVI | Quality of Life (QoL) Change | 2 year KCCQ - Clinical | 14.6 units on a scale | Standard Deviation 26 |
| High Risk: TAVI | Quality of Life (QoL) Change | 2 year SF-12 - Physical | 5.0 units on a scale | Standard Deviation 12.1 |
| High Risk: TAVI | Quality of Life (QoL) Change | 2 year SF-12 - Mental | 3.6 units on a scale | Standard Deviation 13 |
| High Risk: TAVI | Quality of Life (QoL) Change | 2 year EQ-5D | -0.01 units on a scale | Standard Deviation 0.24 |
| High Risk: TAVI | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 19.0 units on a scale | Standard Deviation 29.4 |
| High Risk: TAVI | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 14.7 units on a scale | Standard Deviation 28.6 |
| High Risk: TAVI | Quality of Life (QoL) Change | 30 day SF-12-Physical | 4.9 units on a scale | Standard Deviation 10.2 |
| High Risk: SAVR | Quality of Life (QoL) Change | 2 year SF-12 - Mental | 1.7 units on a scale | Standard Deviation 13 |
| High Risk: SAVR | Quality of Life (QoL) Change | 1 year SF-12-Mental | 3.2 units on a scale | Standard Deviation 12.1 |
| High Risk: SAVR | Quality of Life (QoL) Change | 1 year SF-12-Physical | 5.3 units on a scale | Standard Deviation 10.3 |
| High Risk: SAVR | Quality of Life (QoL) Change | 30 day SF-12-Physical | -0.0 units on a scale | Standard Deviation 10.1 |
| High Risk: SAVR | Quality of Life (QoL) Change | 2 year EQ-5D | -0.01 units on a scale | Standard Deviation 0.21 |
| High Risk: SAVR | Quality of Life (QoL) Change | 1 year KCCQ- Clinical | 15.2 units on a scale | Standard Deviation 26 |
| High Risk: SAVR | Quality of Life (QoL) Change | 1 year KCCQ-Overall | 21.8 units on a scale | Standard Deviation 26.5 |
| High Risk: SAVR | Quality of Life (QoL) Change | 6 month KCCQ-Overall | 22.9 units on a scale | Standard Deviation 26.4 |
| High Risk: SAVR | Quality of Life (QoL) Change | 30 day KCCQ- Overall | 4.3 units on a scale | Standard Deviation 28.1 |
| High Risk: SAVR | Quality of Life (QoL) Change | 6 month EQ-5D | 0.04 units on a scale | Standard Deviation 0.17 |
| High Risk: SAVR | Quality of Life (QoL) Change | 6 month SF-12-Mental | 2.6 units on a scale | Standard Deviation 13.1 |
| High Risk: SAVR | Quality of Life (QoL) Change | 30 day EQ-5D | -0.07 units on a scale | Standard Deviation 0.26 |
| High Risk: SAVR | Quality of Life (QoL) Change | 30 day KCCQ- Clinical | 2.7 units on a scale | Standard Deviation 27.1 |
| High Risk: SAVR | Quality of Life (QoL) Change | 6 month SF-12-Physical | 6.2 units on a scale | Standard Deviation 9.9 |
| High Risk: SAVR | Quality of Life (QoL) Change | 2 year KCCQ - Clinical | 12.6 units on a scale | Standard Deviation 25.8 |
| High Risk: SAVR | Quality of Life (QoL) Change | 6 month KCCQ- Clinical | 17.7 units on a scale | Standard Deviation 25.7 |
| High Risk: SAVR | Quality of Life (QoL) Change | 2 year SF-12 - Physical | 4.3 units on a scale | Standard Deviation 10.2 |
| High Risk: SAVR | Quality of Life (QoL) Change | 2 year KCCQ - Overall | 18.7 units on a scale | Standard Deviation 25.6 |
| High Risk: SAVR | Quality of Life (QoL) Change | 1 year EQ-5D | 0.01 units on a scale | Standard Deviation 0.19 |
| High Risk: SAVR | Quality of Life (QoL) Change | 30 day SF-12-Mental | -2.5 units on a scale | Standard Deviation 13.4 |
Comparison: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year from secondary objective #8. The paired t-test will be used to test the null hypothesis that the mean paired difference is zero versus the two-sided alternative that the mean is not zero.p-value: <0.0001t-test, 2 sided
Comparison: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to 1 year: TAVR vs. SAVR from secondary objective #8. The one-sided two-sample t-test was used to test non-inferiority at a level 0.05 the hypotheses:~H0: µ MCS TAVR ≤ µ SAVR -5 HA: µ MCS TAVR \> µ SAVR -5 In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the KCCQ score from baseline to 1 year.p-value: 0.0063t-test, 1 sided
Comparison: Change in SF-12 Physical Summary Scale from baseline to 30 days: TAVR vs. SAVR from secondary objective #8. The two-sided two-sample t-test was used to test at a level 0.05 the hypotheses:~H0: µ MCS TAVR = µ SAVR HA: µ MCS TAVR ≠ µ SAVR In the above expression µ MCS TAVR and µ SAVR denoted the mean improvements in the SF-12 Physical Summary Scale from baseline to 30 days.p-value: <0.0001t-test, 2 sided
Secondary
Ratio of Days Alive Out of Hospital Versus Total Days Alive
Time frame: 1 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 0.86 ratio of days alive and out of hospital | Standard Deviation 0.28 |
| Extreme Risk: TAVI Non-Iliofemoral | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 0.81 ratio of days alive and out of hospital | Standard Deviation 0.31 |
| High Risk: TAVI | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 0.92 ratio of days alive and out of hospital | Standard Deviation 0.2 |
| High Risk: SAVR | Ratio of Days Alive Out of Hospital Versus Total Days Alive | 0.89 ratio of days alive and out of hospital | Standard Deviation 0.23 |
Secondary
Strokes and Transient Ischemic Attacks (TIAs)
Strokes (of any severity) and TIAs
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day | 4.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month | 6.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year | 8.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 2 year | 10.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 6 month | 14.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 1 year | 15.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 2 year | 19.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | Strokes and Transient Ischemic Attacks (TIAs) | 30 day | 10.2 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Strokes and Transient Ischemic Attacks (TIAs) | 1 year | 10.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Strokes and Transient Ischemic Attacks (TIAs) | 6 month | 8.4 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Strokes and Transient Ischemic Attacks (TIAs) | 2 year | 13.2 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | Strokes and Transient Ischemic Attacks (TIAs) | 30 day | 5.7 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Strokes and Transient Ischemic Attacks (TIAs) | 2 year | 17.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Strokes and Transient Ischemic Attacks (TIAs) | 6 month | 10.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Strokes and Transient Ischemic Attacks (TIAs) | 30 day | 6.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | Strokes and Transient Ischemic Attacks (TIAs) | 1 year | 14.1 percentage of participants, Kaplan-Meier |
Secondary
The Occurrence of Individual MACCE Components
Individual MACCE Components Include: * All Cause Mortality * MI * All stroke * Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time frame: 30 day, 6 month, 1 year, 2 year
Population: Participant Population= Consisted of all subjects with an attempted implant procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 2 year All Cause Mortality | 36.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 8.4 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 1 year MI | 2.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Reintervention | 1.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Stroke | 7.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Stroke | 4.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Reintervention | 1.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 2 year Stroke | 8.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 18.6 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 6 month MI | 1.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 2 year Reintervention | 1.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 2 year MI | 2.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Stroke | 5.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 30 day MI | 1.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Reintervention | 1.5 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Iliofemoral | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 24.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day MI | 2.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 36.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 28.7 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Reintervention | 1.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 2 year Reintervention | 1.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year MI | 2.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 2 year Stroke | 16.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 2 year MI | 3.2 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Stroke | 12.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 1 year Stroke | 13.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month MI | 2.1 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Stroke | 8.8 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 6 month Reintervention | 0.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.0 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 11.3 percentage of participants, Kaplan-Meier |
| Extreme Risk: TAVI Non-Iliofemoral | The Occurrence of Individual MACCE Components | 2 year All Cause Mortality | 44.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 30 day MI | 0.8 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 3.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 30 day Stroke | 4.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.8 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 9.0 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 6 month MI | 1.6 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 6 month Stroke | 7.3 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 6 month Reintervention | 1.0 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 14.1 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 1 year MI | 1.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 1 year Stroke | 8.7 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 1 year Reintervention | 2.2 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 2 year All Cause Mortality | 22.2 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 2 year MI | 1.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 2 year Stroke | 10.9 percentage of participants, Kaplan-Meier |
| High Risk: TAVI | The Occurrence of Individual MACCE Components | 2 year Reintervention | 2.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 6 month Reintervention | 0.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 6 month Stroke | 9.9 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 30 day All Cause Mortality | 4.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 2 year All Cause Mortality | 28.6 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 6 month MI | 1.1 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 6 month All Cause Mortality | 14.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 30 day Stroke | 6.2 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 2 year MI | 2.3 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 30 day Reintervention | 0.0 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 30 day MI | 0.8 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 2 year Reintervention | 0.4 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 1 year Stroke | 12.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 1 year MI | 1.5 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 1 year All Cause Mortality | 18.9 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 2 year Stroke | 16.6 percentage of participants, Kaplan-Meier |
| High Risk: SAVR | The Occurrence of Individual MACCE Components | 1 year Reintervention | 0.0 percentage of participants, Kaplan-Meier |