Angina, Chronic Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia, Stent Thrombosis, Vascular Disease
Conditions
Keywords
Drug eluting stents, Stents, Angioplasty
Brief summary
The objectives of this post-marketing surveillance, conducted in Japan, is to know the frequency, type and degree of device malfunction, to assure the safety of the medical device, and to collect information on evaluation of the efficacy and safety.
Detailed description
The surveillance is to be conducted in accordance with the Japanese Ministerial Ordinance concerning the Standards for Postmarketing Surveillance and Tests of Medical Devices.
Interventions
DEVICEXIENCE V / PROMUS stent
Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Only XIENCE V stent(s)or PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Exclusion criteria
* Neither XIENCE V stent(s) nor PROMUS stent(s) is (are) implanted in the coronary vasculature during the index procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Post Procedure to 1 Year | Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise&fall in cardiac biomarkers * Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Diameter Stenosis (%DS) | Baseline | Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). |
| Acute Gain | On day 0 after procedure | The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD). |
| Late Loss | On day 0 after procedure | Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\]. |
| Net Gain | On day 0 after procedure | Net Gain = Acute Gain - Late Loss, paired analysis only. |
| Acute Success | On day 0 (Immediately post-index procedure) | Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: * Stent was successfully delivered to the intended location * Stent was successfully deployed at the intended location * Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure. |
| Number of Participants With Target Lesion Revascularization (TLR) | Post Procedure to 1 Year | Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent. |
| Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) | Post Procedure to 1 Year | All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. |
| Number of Participants With Myocardial Infarctions (MI) | Post Procedure to 1 Year | Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. |
| Number of Participants With Adverse Events Related to Anti-platelet Medication | From post-procedure to 1 year | — |
| Number of Participants With Cardiac Death and All MI | Post Procedure to 1 Year | Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. |
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) | Post Procedure to 1 Year | — |
| Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR | Post Procedure to 1 Year | — |
| Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) | Post Procedure to 1 Year | — |
| Number of Participants With All Deaths and All MI | Post Procedure to 1 Year | — |
| Number of Participants With All Deaths, All MI and All Revascularization | Post Procedure to 1 Year | — |
| Number of Participants With All Deaths, TVMI and TLR | Post Procedure to 1 Year | — |
| Number of Participants With All Deaths, TVMI and CI-TLR | Post Procedure to 1 Year | — |
| Number of Participants With Target Vessel Revascularization (TVR) | Post Procedure to 1 Year | Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. |
Countries
Japan
Participant flow
Recruitment details
A total of 2010 patients were registered. Of which 1 patient was excluded from this analysis. Therefore, 2009 patients (1,159 patients treated with XIENCE V; 850 patients treated with PROMUS) were included in the analysis.
Pre-assignment details
Study has excluded those patients who were treated with stents other than CoCr-EES (XIENCE V or PROMUS), or underwent concomitant treatment of a graft vessel. Patients were invited to enroll in the study after apparently successful per-cutaneous coronary intervention (PCI).
Participants by arm
| Arm | Count |
|---|---|
| XIENCE V / PROMUS Stent Only the patients treated with the XIENCE V / PROMUS stent during the index procedure will be analyzed.
XIENCE V / PROMUS stent: Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure. | 2,009 |
| Total | 2,009 |
Baseline characteristics
| Characteristic | XIENCE V / PROMUS Stent |
|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 10.1 |
| Region of Enrollment Japan | 2009 participants |
| Sex: Female, Male Female | 481 Participants |
| Sex: Female, Male Male | 1528 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 184 / 2,009 |
| other Total, other adverse events | 116 / 2,009 |
| serious Total, serious adverse events | 910 / 2,009 |
Outcome results
Primary
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise&fall in cardiac biomarkers * Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite Stent Thrombosis | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Probable Stent Thrombosis | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Possible Stent Thrombosis | 5 participants |
Primary
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise&fall in cardiac biomarkers * Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: Post Procedure to 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite Stent Thrombosis | 6 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Probable Stent Thrombosis | 2 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Possible Stent Thrombosis | 6 participants |
Primary
Number of Participants With Stent Thrombosis (ST) as Per ARC Definition
Definite ST occurred by either angiographic/pathologic confirmation of ST. Angiographic confirmation:The presence of a thrombus that originates in the stent/in the segment 5mm proximal/distal to the stent&presence of at least 1 of the following criteria within 48-hours: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes * Typical rise&fall in cardiac biomarkers * Non-occlusive &occlusive thrombus Pathological confirmation:Evidence of recent thrombus within the stent determined at autopsy/via examination of tissue retrieved following thrombectomy. Probable ST may occur due to: * Unexplained death within first 30 days * Irrespective of the time after the index procedure,any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST&in the absence of any other obvious cause. Possible ST occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up
Time frame: From 2 years to 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Definite Stent Thrombosis | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Probable Stent Thrombosis | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Stent Thrombosis (ST) as Per ARC Definition | Possible Stent Thrombosis | 4 participants |
Secondary
Acute Gain
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time frame: On day 0 after procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Acute Gain | In-stent (n=1845 lesions) | 1.769 millimeters |
| XIENCE V / PROMUS Stent | Acute Gain | In-segment (n=1846 lesions) | 1.409 millimeters |
Secondary
Acute Success
Acute Success: Procedural Success (Subject Level Analysis): Stent implant procedure was considered successful when all of the following criteria were met: * Stent was successfully delivered to the intended location * Stent was successfully deployed at the intended location * Stent delivery system was withdrawn without any issue Stent implantation procedure was considered successful in 99.94% of the stents. There was no stent adjudicated as procedure failure.
Time frame: On day 0 (Immediately post-index procedure)
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Acute Success | Success | 99.94 percentage of stents |
| XIENCE V / PROMUS Stent | Acute Success | Unknown | 0.06 percentage of stents |
Secondary
Late Loss
Proximal and distal late loss was calculated by \[post-procedure minimum lumen diameter (MLD)\] - \[MLD at 8 months\].
Time frame: On day 0 after procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Late Loss | In-stent (n=1303 lesions) | 0.219 millimeters |
| XIENCE V / PROMUS Stent | Late Loss | Proximal (n=1086 lesions) | 0.152 millimeters |
| XIENCE V / PROMUS Stent | Late Loss | Distal (n=1298 lesions) | 0.034 millimeters |
| XIENCE V / PROMUS Stent | Late Loss | In-segment (n=1308 lesions) | 0.128 millimeters |
Secondary
Net Gain
Net Gain = Acute Gain - Late Loss, paired analysis only.
Time frame: On day 0 after procedure
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Net Gain | In-stent (n=1300 lesions) | 1.536 millimeters |
| XIENCE V / PROMUS Stent | Net Gain | In-segment (n=1305 lesions) | 1.269 millimeters |
Secondary
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 4 years to 5 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Abnormal Non-Cardiac Lab Value/Test | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Allergic Reaction | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Bleeding | 3 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cardiac | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cancer/Tumor | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Gastro-intestinal | 2 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | General/Musculoskeletal/Connective | 2 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Genito-urinary and renal disorder | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Neurological/Psychiatric disorders | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Vascular | 0 participants |
Secondary
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From post-procedure to 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Abnormal Non-Cardiac Lab Value/Test | 13 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Allergic Reaction | 10 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Bleeding | 32 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cardiac | 3 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cancer/Tumor | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Gastro-intestinal | 4 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | General/Musculoskeletal/Connective | 7 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Genito-urinary and renal disorder | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Neurological/Psychiatric disorders | 3 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Vascular | 4 participants |
Secondary
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 1 year to 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Genito-urinary and renal disorder | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cardiac | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Abnormal Non-Cardiac Lab Value/Test | 2 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Allergic Reaction | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Bleeding | 5 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cancer/Tumor | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Gastro-intestinal | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | General/Musculoskeletal/Connective | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Neurological/Psychiatric disorders | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Vascular | 0 participants |
Secondary
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 2 years to 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Abnormal Non-Cardiac Lab Value/Test | 2 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Allergic Reaction | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Bleeding | 3 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cardiac | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cancer/Tumor | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Gastro-intestinal | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | General/Musculoskeletal/Connective | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Genito-urinary and renal disorder | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Neurological/Psychiatric disorders | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Vascular | 0 participants |
Secondary
Number of Participants With Adverse Events Related to Anti-platelet Medication
Time frame: From 3 years to 4 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Abnormal Non-Cardiac Lab Value/Test | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Allergic Reaction | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Bleeding | 9 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cardiac | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Cancer/Tumor | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Gastro-intestinal | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | General/Musculoskeletal/Connective | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Genito-urinary and renal disorder | 0 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Neurological/Psychiatric disorders | 1 participants |
| XIENCE V / PROMUS Stent | Number of Participants With Adverse Events Related to Anti-platelet Medication | Vascular | 2 participants |
Secondary
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, All MI and All Revascularization | 449 participants |
Secondary
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, All MI and All Revascularization | 508 participants |
Secondary
Number of Participants With All Deaths, All MI and All Revascularization
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, All MI and All Revascularization | 345 participants |
Secondary
Number of Participants With All Deaths and All MI
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths and All MI | 105 participants |
Secondary
Number of Participants With All Deaths and All MI
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths and All MI | 134 participants |
Secondary
Number of Participants With All Deaths and All MI
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths and All MI | 61 participants |
Secondary
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and CI-TLR | 196 participants |
Secondary
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and CI-TLR | 113 participants |
Secondary
Number of Participants With All Deaths, TVMI and CI-TLR
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and CI-TLR | 161 participants |
Secondary
Number of Participants With All Deaths, TVMI and TLR
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and TLR | 214 participants |
Secondary
Number of Participants With All Deaths, TVMI and TLR
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and TLR | 176 participants |
Secondary
Number of Participants With All Deaths, TVMI and TLR
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With All Deaths, TVMI and TLR | 126 participants |
Secondary
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: From 2 years to 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) | 109 participants |
Secondary
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) | 47 participants |
Secondary
Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death)
All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in subjects with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. • Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. • Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. • Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: From 1 to 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Any Death (Cardiac Death, Vascular Death, or Non-cardiovascular Death) | 80 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) | 87 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) | 120 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR)
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Lesion Revascularization (CI-TLR) | 133 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) | 122 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) | 163 participants |
Secondary
Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR)
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, All MI and Clinically-indicated Target Vessel Revascularization (CI-TVR) | 184 participants |
Secondary
Number of Participants With Cardiac Death and All MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death and All MI | 31 participants |
Secondary
Number of Participants With Cardiac Death and All MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death and All MI | 51 participants |
Secondary
Number of Participants With Cardiac Death and All MI
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death and All MI | 56 participants |
Secondary
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR | 96 participants |
Secondary
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR | 125 participants |
Secondary
Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Cardiac Death, Target Vessel Myocardial Infarction (TVMI) and TLR | 140 participants |
Secondary
Number of Participants With Myocardial Infarctions (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: From 2 years to 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Myocardial Infarctions (MI) | 33 participants |
Secondary
Number of Participants With Myocardial Infarctions (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Myocardial Infarctions (MI) | 17 participants |
Secondary
Number of Participants With Myocardial Infarctions (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Time frame: From 1 year to 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Myocardial Infarctions (MI) | 30 participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Lesion Revascularization (TLR) | 72 participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: From 2 years to 3 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Lesion Revascularization (TLR) | 104 participants |
Secondary
Number of Participants With Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: From 1 year to 2 years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Lesion Revascularization (TLR) | 92 participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: From 2 Years to 3 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Vessel Revascularization (TVR) | 168 participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: Post Procedure to 1 Year
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Vessel Revascularization (TVR) | 113 participants |
Secondary
Number of Participants With Target Vessel Revascularization (TVR)
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: From 1 Year to 2 Years
Population: The number of participants analyzed includes subjects who had available follow up data at that time frame.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XIENCE V / PROMUS Stent | Number of Participants With Target Vessel Revascularization (TVR) | 146 participants |
Secondary
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: Baseline
Population: Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Percent Diameter Stenosis (%DS) | 69.6 Percent Diameter stenosis | Standard Deviation 15.4 |
Secondary
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: At 8 months
Population: Eight-month follow-up angiograms for 1,309 lesions in 1,085 patients were assessed by the core laboratory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Percent Diameter Stenosis (%DS) | 26.1 Percent Diameter stenosis | Standard Deviation 14.5 |
Secondary
Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: On day 0 after procedure
Population: Pre-procedure and immediate post-procedure angiograms were available from all of the analysis population of 2,009 patients (2,647 lesions), of which 1,850 lesions in 1548 patients were assessed by the core laboratory.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XIENCE V / PROMUS Stent | Percent Diameter Stenosis (%DS) | 23.6 Percent Diameter stenosis | Standard Deviation 10.7 |