Coronary Artery Disease
Conditions
Keywords
drug-eluting stents, DES, atherosclerotic
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions. This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels (workhorse). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).
Detailed description
The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies (March 2008). During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis. The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.
Interventions
DEVICEPROMUS Coronary Stent System
PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS \[XIENCE V\] stent).
DRUGAspirin
Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
DRUGThienopyridine
Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must be at least 18 years of age * Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed * For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed * Patient is eligible for percutaneous coronary intervention (PCI) * Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris * Patient is an acceptable candidate for coronary artery bypass grafting (CABG) * Patient has a left ventricular ejection fraction (LVEF) \>=30% as measured within 30 days prior to enrollment * Patient is willing to comply with all protocol-required follow-up evaluations Angiographic Inclusion Criteria (visual estimate): \- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) \>=2.50 mm and \<=4.25 mm. Target lesion length must measure (by visual estimate) \<=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis \>=50% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow \>1.
Exclusion criteria
* Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI) * Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows. * Patients are excluded if any of the following criteria are met at time of the index procedure. * If creatine kinase-myoglobin band (CK-MB) \>2× upper limit of normal (ULN), the patient is excluded regardless of CK Total. * If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is \>2× ULN. * If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure. * Troponin \>1× ULN with at least one of the following. * Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, \>1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block \[LBBB\]); * Development of pathological Q waves in the ECG; or * Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient. * Patient has received an organ transplant or is on a waiting list for an organ transplant * Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure * Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus) * Patient is receiving chronic (\>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome * Patient has platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3 * Patient has white blood cell (WBC) count \<3,000 cells/mm3 * Patient has documented or suspected liver disease, including laboratory evidence of hepatitis * Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance \<50 ml/min by the Cockcroft Gault formula, or \[(140-age)\*lean body weight (in kg)\]/\[plasma creatinine (mg/dl)\*72\]) * Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions * Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol * Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure * Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure * Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure * Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement * Planned PCI or CABG after index procedure * Patient previously treated at any time with coronary intravascular brachytherapy * Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated * Patient has active peptic ulcer or active gastrointestinal (GI) bleeding * Patient has one of the following. * Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months * Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.) * Planned procedure that may cause non-compliance with protocol or confound data interpretation * Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint * Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure * Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.) * Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential) * Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Failure (TLF) | 12-month post index procedure | Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 30 days | TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF. |
| Myocardial Infarction (MI) Related to the Target Vessel | 30 days | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal |
| All Cause Mortality | 30 days | — |
| Cardiac Death Related to the Target Vessel | 30 days | Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded |
| Non-cardiac Death | 30 Days | Defined as a death not due to cardiac causes (see definition of cardiac death above) |
| Cardiac Death or Myocardial Infarction (MI) | 30 days | Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above |
| Target Lesion Failure (TLF) | 30 days | TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel. |
| Target Lesion Revascularization (TLR) | 30 days | Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. |
| Target Vessel Revascularization (TVR) | 30 days | Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion. |
| Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 24 hours | DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days). |
| Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 30 days | See above for definitions of MI and TVR |
| Clinical Procedural Success | In hospital | Defined as mean lesion diameter stenosis \<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death |
| Acute Technical Success | Acute-At time of index procedure | Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent |
| All Death or Myocardial Infarction (MI) | 30 days | Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal |
Countries
Australia, Austria, Belgium, Denmark, Finland, France, Germany, Japan, Latvia, Malaysia, Netherlands, New Zealand, Poland, Portugal, Singapore, United Kingdom, United States
Participant flow
Recruitment details
Enrollment of 1,532 patients was planned; 1,530 patients (762 PROMUS and 768 PROMUS Element) were enrolled and randomized at 132 clinical sites from January 27, 2009 to September 4, 2009. Of these, 788 patients were from the USA, 562 from Europe, 124 from Japan, and 56 from the Asia-Pacific region excluding Japan.
Participants by arm
| Arm | Count |
|---|---|
| PROMUS Participants randomized to treatment with PROMUS everolimus-eluting stent (control device) | 762 |
| PROMUS Element Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device) | 768 |
| Total | 1,530 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 8 | 10 |
| Overall Study | Incarcerated | 0 | 1 |
| Overall Study | Missed 12-month visit | 21 | 21 |
| Overall Study | Withdrawal by Subject | 6 | 1 |
Baseline characteristics
| Characteristic | PROMUS | PROMUS Element | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 349 Participants | 391 Participants | 740 Participants |
| Age, Categorical Between 18 and 65 years | 413 Participants | 377 Participants | 790 Participants |
| Age, Continuous | 63.11 years STANDARD_DEVIATION 10.28 | 63.99 years STANDARD_DEVIATION 10.27 | 63.55 years STANDARD_DEVIATION 10.28 |
| Cardiac History Congestive Heart Failure | 50 Participant | 57 Participant | 107 Participant |
| Cardiac History Previous Coronary Artery Bypass Graft (CABG) | 40 Participant | 45 Participant | 85 Participant |
| Cardiac History Previous Myocardial Infarction (MI) | 160 Participant | 160 Participant | 320 Participant |
| Cardiac History Previous Percutaneous Coronary Intervention (PCI) | 247 Participant | 238 Participant | 485 Participant |
| Cardiac History Silent Ischemia | 143 Participant | 128 Participant | 271 Participant |
| Cardiac History Stable Angina | 463 Participant | 474 Participant | 937 Participant |
| Cardiac History Unstable Angina | 188 Participant | 185 Participant | 373 Participant |
| Cardiac History-Ejection Fraction | 59.04 Percent Ejection Fraction STANDARD_DEVIATION 9.54 | 59.53 Percent Ejection Fraction STANDARD_DEVIATION 10.07 | 59.29 Percent Ejection Fraction STANDARD_DEVIATION 9.81 |
| Cardiac Risk Factor Family History of Coronary Artery Disease | 401 Participant | 392 Participant | 793 Participant |
| Cardiac Risk Factor Hyperlipidemia Requiring Medication | 579 Participant | 598 Participant | 1177 Participant |
| Cardiac Risk Factor Hypertension Requiring Medication | 558 Participant | 544 Participant | 1102 Participant |
| Cardiac Risk Factor Medically Treated Diabetes | 191 Participant | 169 Participant | 360 Participant |
| Cardiac Risk Factor Smoking, Ever | 448 Participant | 493 Participant | 941 Participant |
| Comorbidities History of Cerebrovascular Accident | 23 Participants | 27 Participants | 50 Participants |
| Comorbidities History of Gastrointestinal Bleeding | 8 Participants | 10 Participants | 18 Participants |
| Comorbidities History of Peripheral Vascular Disease | 66 Participants | 70 Participants | 136 Participants |
| Comorbidities History of Renal Disease | 23 Participants | 26 Participants | 49 Participants |
| Comorbidities History of Transient Ischemic Attack | 13 Participants | 31 Participants | 44 Participants |
| Lesion Characteristic: Lesion Location Distal | 72 Lesions | 84 Lesions | 156 Lesions |
| Lesion Characteristic: Lesion Location Mid | 401 Lesions | 387 Lesions | 788 Lesions |
| Lesion Characteristic: Lesion Location Ostial | 30 Lesions | 33 Lesions | 63 Lesions |
| Lesion Characteristic: Lesion Location Proximal | 338 Lesions | 348 Lesions | 686 Lesions |
| Lesion Characteristic-Percent Diameter Stenosis | 71.90 Percent Diameter Stenosis STANDARD_DEVIATION 11.47 | 71.81 Percent Diameter Stenosis STANDARD_DEVIATION 11.46 | 71.86 Percent Diameter Stenosis STANDARD_DEVIATION 11.46 |
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 0 | 0 Lesion | 0 Lesion | 0 Lesion |
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 1 | 6 Lesion | 5 Lesion | 11 Lesion |
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 2 | 27 Lesion | 29 Lesion | 56 Lesion |
| Lesion Characteristic - Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow TIMI 3 | 808 Lesion | 818 Lesion | 1626 Lesion |
| Lesion Characteristics > 45 Degree Bend | 142 Lesions | 148 Lesions | 290 Lesions |
| Lesion Characteristics > 90 Degree Bend | 18 Lesions | 13 Lesions | 31 Lesions |
| Lesion Characteristics Bifurcation | 62 Lesions | 78 Lesions | 140 Lesions |
| Lesion Characteristics Calcification, any | 236 Lesions | 238 Lesions | 474 Lesions |
| Lesion Characteristics Eccentric Lesion | 454 Lesions | 477 Lesions | 931 Lesions |
| Lesion Characteristics Lesion Length | 12.50 Millimeters STANDARD_DEVIATION 5.51 | 12.95 Millimeters STANDARD_DEVIATION 5.74 | 12.72 Millimeters STANDARD_DEVIATION 5.63 |
| Lesion Characteristics Minimum Lumen Diameter | 0.74 Millimeters STANDARD_DEVIATION 0.34 | 0.75 Millimeters STANDARD_DEVIATION 0.35 | 0.75 Millimeters STANDARD_DEVIATION 0.34 |
| Lesion Characteristics Reference Vessel Diameter | 2.63 Millimeters STANDARD_DEVIATION 0.49 | 2.67 Millimeters STANDARD_DEVIATION 0.49 | 2.65 Millimeters STANDARD_DEVIATION 0.49 |
| Lesion Characteristics Tortuosity, any | 62 Lesions | 72 Lesions | 134 Lesions |
| Lesion Characteristics Total Occlusion | 6 Lesions | 5 Lesions | 11 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type A | 82 Lesions | 72 Lesions | 154 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B1 | 225 Lesions | 223 Lesions | 448 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type B2 | 361 Lesions | 378 Lesions | 739 Lesions |
| Lesion Characteristics: American College of Cardiology (ACC)/American Heart Association (AHA) Class Type C | 173 Lesions | 179 Lesions | 352 Lesions |
| Lesion Characteristic: Target Lesion Vessel Left Anterior Descending Artery | 354 Lesion | 357 Lesion | 711 Lesion |
| Lesion Characteristic: Target Lesion Vessel Left Circumflex Artery | 219 Lesion | 222 Lesion | 441 Lesion |
| Lesion Characteristic: Target Lesion Vessel Right Coronary Artery | 268 Lesion | 273 Lesion | 541 Lesion |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 participant | 3 participant | 7 participant |
| Race/Ethnicity, Customized Asian | 68 participant | 75 participant | 143 participant |
| Race/Ethnicity, Customized Black of African heritage | 21 participant | 18 participant | 39 participant |
| Race/Ethnicity, Customized Caucasian | 644 participant | 650 participant | 1294 participant |
| Race/Ethnicity, Customized Hispanic or Latino | 15 participant | 13 participant | 28 participant |
| Race/Ethnicity, Customized Maori | 0 participant | 1 participant | 1 participant |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 4 participant | 3 participant | 7 participant |
| Race/Ethnicity, Customized Not Disclosed | 6 participant | 5 participant | 11 participant |
| Race/Ethnicity, Customized Other | 1 participant | 4 participant | 5 participant |
| Region of Enrollment Europe | 276 participants | 286 participants | 562 participants |
| Region of Enrollment Japan | 61 participants | 63 participants | 124 participants |
| Region of Enrollment Pacifica | 29 participants | 27 participants | 56 participants |
| Region of Enrollment United States | 396 participants | 392 participants | 788 participants |
| Sex: Female, Male Female | 220 Participants | 218 Participants | 438 Participants |
| Sex: Female, Male Male | 542 Participants | 550 Participants | 1092 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 190 / 762 | 197 / 768 |
| serious Total, serious adverse events | 237 / 762 | 238 / 768 |
Outcome results
Primary
Target Lesion Failure (TLF)
Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time frame: 12-month post index procedure
Population: The primary analysis set for the non-inferiority testing of the primary endpoint, 12-month TLF, is the per-protocol analysis set. All randomized participants who received their assigned treatment are included in the per-protocol analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Failure (TLF) | 2.9 percentage of participants |
| PROMUS Element | Target Lesion Failure (TLF) | 3.4 percentage of participants |
Comparison: Study had 89% statistical power to demonstrate non-inferiority for target lesion failure (TLF, accounting for an expected 1-year attrition rate of 5%), assuming a 1-year TLF rate of 5.5% for both stents.p-value: 0.001Farrington-Manning test
Secondary
Acute Technical Success
Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent
Time frame: Acute-At time of index procedure
Population: Analysis was intention to treat (all patients in the study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Acute Technical Success | 98.8 percentage of stents |
| PROMUS Element | Acute Technical Success | 99.4 percentage of stents |
Secondary
All Cause Mortality
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Cause Mortality | 1.2 percentage of participants |
| PROMUS Element | All Cause Mortality | 1.3 percentage of participants |
Secondary
All Cause Mortality
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Cause Mortality | 0.5 percentage of participants |
| PROMUS Element | All Cause Mortality | 0.8 percentage of participants |
Secondary
All Cause Mortality
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Cause Mortality | 0.1 percentage of patients |
| PROMUS Element | All Cause Mortality | 0.1 percentage of patients |
Secondary
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Death or Myocardial Infarction (MI) | 3.0 percentage of participants |
| PROMUS Element | All Death or Myocardial Infarction (MI) | 2.4 percentage of participants |
Secondary
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Death or Myocardial Infarction (MI) | 1.4 percentage of participants |
| PROMUS Element | All Death or Myocardial Infarction (MI) | 0.8 percentage of participants |
Secondary
All Death or Myocardial Infarction (MI)
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | All Death or Myocardial Infarction (MI) | 2.0 percentage of participants |
| PROMUS Element | All Death or Myocardial Infarction (MI) | 1.7 percentage of participants |
Secondary
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death or Myocardial Infarction (MI) | 1.8 percentage of participants |
| PROMUS Element | Cardiac Death or Myocardial Infarction (MI) | 1.4 percentage of participants |
Secondary
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death or Myocardial Infarction (MI) | 2.5 percentage of participants |
| PROMUS Element | Cardiac Death or Myocardial Infarction (MI) | 2.0 percentage of participants |
Secondary
Cardiac Death or Myocardial Infarction (MI)
Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death or Myocardial Infarction (MI) | 1.4 percentage of participants |
| PROMUS Element | Cardiac Death or Myocardial Infarction (MI) | 0.8 percentage of participants |
Secondary
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death Related to the Target Vessel | 0.1 percentage of participants |
| PROMUS Element | Cardiac Death Related to the Target Vessel | 0.5 percentage of participants |
Secondary
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death Related to the Target Vessel | 0.0 percentage of participants |
| PROMUS Element | Cardiac Death Related to the Target Vessel | 0.1 percentage of participants |
Secondary
Cardiac Death Related to the Target Vessel
Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Cardiac Death Related to the Target Vessel | 0.4 percentage of participants |
| PROMUS Element | Cardiac Death Related to the Target Vessel | 0.8 percentage of participants |
Secondary
Clinical Procedural Success
Defined as mean lesion diameter stenosis \<30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death
Time frame: In hospital
Population: Analysis was intention to treat (all patients in study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Clinical Procedural Success | 98.2 percentage of participants |
| PROMUS Element | Clinical Procedural Success | 98.3 percentage of participants |
Secondary
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 4.9 percentage of participants |
| PROMUS Element | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 5.0 percentage of participants |
Secondary
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 1.6 percentage of participants |
| PROMUS Element | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 0.9 percentage of participants |
Secondary
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
See above for definitions of MI and TVR.
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 2.4 percentage of participants |
| PROMUS Element | Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR) | 2.4 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: >24 hr-30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.3 percentage of participants |
| PROMUS Element | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.0 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: >30 days-1 year
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.0 percentage of participants |
| PROMUS Element | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.3 percentage of participants |
Secondary
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: \>24 hours to 30 days post; late ST: \>30 days to 1 year post; Very late ST: \>1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days).
Time frame: 24 hours
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.1 percentage of participants |
| PROMUS Element | Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition | 0.1 percentage of participants |
Secondary
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Myocardial Infarction (MI) Related to the Target Vessel | 1.4 percentage of participants |
| PROMUS Element | Myocardial Infarction (MI) Related to the Target Vessel | 0.7 percentage of participants |
Secondary
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Myocardial Infarction (MI) Related to the Target Vessel | 1.4 percentage of participants |
| PROMUS Element | Myocardial Infarction (MI) Related to the Target Vessel | 0.7 percentage of participants |
Secondary
Myocardial Infarction (MI) Related to the Target Vessel
Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) \>3x normal (peri-percutaneous coronary intervention \[PCI\]) or \>2x normal (spontaneous) with elevated CK-MB, or troponin \>3x normal (peri-PCI) or \>2x normal (spontaneous) plus one of the following: ECG changes indicating new ischemia (new ST-T changes/left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar criteria for MI post bypass graft surgery, with CK-MB or troponin \>5x normal
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Myocardial Infarction (MI) Related to the Target Vessel | 1.3 percentage of participants |
| PROMUS Element | Myocardial Infarction (MI) Related to the Target Vessel | 0.7 percentage of participants |
Secondary
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Time frame: 30 Days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Non-cardiac Death | 0.0 percentage of participants |
| PROMUS Element | Non-cardiac Death | 0.0 percentage of participants |
Secondary
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Non-cardiac Death | 0.5 percentage of participants |
| PROMUS Element | Non-cardiac Death | 0.4 percentage of participants |
Secondary
Non-cardiac Death
Defined as a death not due to cardiac causes (see definition of cardiac death above)
Time frame: 6 Months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Non-cardiac Death | 0.1 percentage of participants |
| PROMUS Element | Non-cardiac Death | 0.3 percentage of participants |
Secondary
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Failure (TLF) | 1.4 Percentage of participants |
| PROMUS Element | Target Lesion Failure (TLF) | 0.9 Percentage of participants |
Secondary
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Failure (TLF) | 3.2 percentage of participants |
| PROMUS Element | Target Lesion Failure (TLF) | 3.5 percentage of participants |
Secondary
Target Lesion Failure (TLF)
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Failure (TLF) | 1.9 percentage of participants |
| PROMUS Element | Target Lesion Failure (TLF) | 1.7 percentage of participants |
Secondary
Target Lesion Revascularization (TLR)
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Revascularization (TLR) | 1.9 percentage of participants |
| PROMUS Element | Target Lesion Revascularization (TLR) | 1.9 percentage of participants |
Secondary
Target Lesion Revascularization (TLR)
TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Revascularization (TLR) | 1.1 percentage of participants |
| PROMUS Element | Target Lesion Revascularization (TLR) | 0.5 percentage of participants |
Secondary
Target Lesion Revascularization (TLR)
Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Lesion Revascularization (TLR) | 0.8 percentage of participants |
| PROMUS Element | Target Lesion Revascularization (TLR) | 0.1 percentage of participants |
Secondary
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Failure (TVF) | 2.0 percentage of participants |
| PROMUS Element | Target Vessel Failure (TVF) | 1.8 percentage of participants |
Secondary
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Failure (TVF) | 1.4 percentage of participants |
| PROMUS Element | Target Vessel Failure (TVF) | 0.9 percentage of participants |
Secondary
Target Vessel Failure (TVF)
TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Failure (TVF) | 4.0 percentage of participants |
| PROMUS Element | Target Vessel Failure (TVF) | 4.2 percentage of participants |
Secondary
Target Vessel Revascularization (TVR)
Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time frame: 30 days
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Revascularization (TVR) | 0.8 percentage of participants |
| PROMUS Element | Target Vessel Revascularization (TVR) | 0.1 percentage of participants |
Secondary
Target Vessel Revascularization (TVR)
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time frame: 12 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Revascularization (TVR) | 2.9 percentage of participants |
| PROMUS Element | Target Vessel Revascularization (TVR) | 2.7 percentage of participants |
Secondary
Target Vessel Revascularization (TVR)
TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.
Time frame: 6 months
Population: Analysis was intention to treat; all patients in the study underwent clinical follow up to provide the information needed for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PROMUS | Target Vessel Revascularization (TVR) | 1.2 percentage of participants |
| PROMUS Element | Target Vessel Revascularization (TVR) | 0.7 percentage of participants |