Coronary Artery Disease, Coronary Atherosclerosis
Conditions
Keywords
Atherosclerosis, de novo native coronary lesion
Brief summary
The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.
Detailed description
A prospective, single-blind, randomized, multicenter, two arm study. The objective of this study is to show similar (non-inferior) safety and effectiveness between CYPHER® ELITE™ and CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems in a prospective, multi-center, randomized clinical study for the treatment of de novo native coronary lesions.
Interventions
DEVICECYPHER® ELITE™ Sirolimus-Eluting Stent System
Drug eluting stent
DEVICECYPHER® Bx VELOCITY® Sirolimus-eluting Stent System
Drug eluting stent
Sponsors
Cordis US Corp.
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
* Subjects with de novo atherosclerotic CAD in 1 or 2 vessels; * The subject must be \>/= 18 years of age; * Female of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment; * Diagnosis of angina pectoris as defined by stable angina pectoris Canadian Cardiovascular Society Classification (Class I, II, III) OR non-ST segment elevation acute coronary syndrome (Braunwald Classification B&C) OR non-ST segment elevation myocardial infarction \>/= 48 hours from the time of study index procedure OR asymptomatic subjects with a positive stress test; * Treatment of \</= two lesions in one or two major coronary arteries (1 target lesion in each of 2 vessels or 2 target lesions in 1 vessel); * Target vessel diameter must be \>/= 2.25mm and \</= 4.0 in diameter (visual estimate); * Target lesion stenosis is \> 50% and \< 100% (visual estimate); * Target lesion length \<30mm (for each target lesion(s)) with a total implanted stent length \< 66mm. Additional stents can be used to treat dissections, etc,: however, these must be the same stent to which the subject has been randomized in the study. * Subject or Legally Authorized Representative must provide written informed consent prior to the procedure using a form that is approved by the Institutional Review Board/Independent Ethics Committee.
Exclusion criteria
* ST Segment Elevation Myocardial Infarction (STEMI) within 30 days of the study index procedure; * Unprotected left main coronary disease with \>/= 50% stenosis; * Total coronary occlusion or TIMI grade 0 or 1 in the target vessel; * Angiographic evidence of thrombus within target lesion(s); * Calcified target lesion(s) which cannot be, in the investigator's opinion, successfully pre-dilated; * Bifurcation disease involving a side branch \>/= 2 mm in diameter; * Prior stent within 5 mm of target lesion(s); * Ostial target lesion(s); * Target lesion(s) within a coronary bypass graft (e.g., saphenous vein or arterial graft); * Documented left ventricular ejection fraction \</= 25%; * Impaired renal function (creatinine \> 250 μmol/L or \> 2.5 mg/dl) at the time of treatment; * Pretreatment with devices other than conventional balloon angioplasty; * Significant angulation in the target vessel that, in the Investigator's opinion, may preclude stent delivery and deployment; * Subject previously treated with brachytherapy; * Recipient of heart transplant; * Subject with a life expectancy less than 12 months; * Known allergies to the following: aspirin, clopidogrel bisulfate and ticlopidine, heparin, stainless steel, contrast agent (that cannot be managed medically), or sirolimus that cannot be managed medically; * Any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study; * Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints; * In the Investigator's opinion, the lesion is not suitable for stenting; * Known bleeding or hypercoagulable disorder; * Known or suspected active infection at the time of the study procedures; * Subject is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser; * Subject has had major surgical or interventional procedures unrelated to this study within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experienced Target Lesion Failure (TLF) | 12-months post-procedure | The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Device Success - Protocol Definition | At procedure | Device success is defined as achievement of a final residual diameter stenosis of \<50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included. |
| Percentage of Device Success - All CYPHER® Stents Included | At procedure | Device success is defined as achievement of a final residual diameter stenosis of \<50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was \<50%. Non-study CYPHER® Stents were also included. |
| Percentage of Participants Who Achieved Procedure Success | At procedure during hospital stay | Procedure success is defined as achievement of a final diameter stenosis of \< 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay. |
| Percentage of Participants Who Experienced Target Lesion Revascularization (TLR) | 12 months post-procedure | TLR is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA. |
| Percentage of Participants Who Experienced Target Vessel Revascularization (TVR) | 12 months post procedure | TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA. |
| Percentage of Participants Who Experienced Target Vessel Failure (TVF) | 12 months post procedure | Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure. |
| Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE) | 12 months post procedure | MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization. |
| Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF) | 12 months post procedure | A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure. |
| Percentage of Lesion Success | At procedure | Lesion success is defined as the attainment of \< 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method. |
| Percentage of Participants Who Experienced Bleeding Complications | 12 months post procedure | Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and Protocol definitions. |
| Percentage of Participants Who Died | 12 months post procedure | Death incidences include both Cardiac and non-cardiac death. |
| Percentage of Participants Who Experienced Any Myocardial Infarction (MI) | 12 months post procedure | Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events. |
| Percentage of Participants Who Experienced Stroke | 12 months post procedure | The stroke definition includes both hemorrhagic and non-hemorrhagic strokes. |
| Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition) | 12 months post procedure | Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring \> 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel. |
| Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 12 months post procedure | Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following: 1. DEFINITE - Angiographic or pathologic confirmation; 2. PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; 3. POSSIBLE - Any unexplained death \> 30 days. ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. |
| Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0-30 days post-procedure | Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis. |
| Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 31-360 days post-procedure | Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis. |
| Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF) | 12 months post procedure | A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ELITE™ CYPHER® ELITE™ Sirolimus-Eluting Stent System. | 452 |
| CYPHER® CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System | 226 |
| Total | 678 |
Baseline characteristics
| Characteristic | ELITE™ | CYPHER® | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 200 Participants | 89 Participants | 289 Participants |
| Age, Categorical Between 18 and 65 years | 252 Participants | 137 Participants | 389 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 10.5 | 62.2 years STANDARD_DEVIATION 10.5 | 62.8 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 4 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 421 Participants | 218 Participants | 639 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 14 Participants |
| Patients with Family History of Coronary Artery (CAD) Family History of Coronary Artery (CAD) | 255 participants | 137 participants | 392 participants |
| Patients with Family History of Coronary Artery (CAD) Without Family History of Coronary Artery (CAD) | 197 participants | 89 participants | 286 participants |
| Patients with History of Diabetes Mellitus History of Diabetes Mellitus | 144 participants | 69 participants | 213 participants |
| Patients with History of Diabetes Mellitus Without History of Diabetes Mellitus | 308 participants | 157 participants | 465 participants |
| Patients with History of Hyperlipidemia History of Hyperlipidemia | 388 participants | 188 participants | 576 participants |
| Patients with History of Hyperlipidemia Without History of Hyperlipidemia | 64 participants | 38 participants | 102 participants |
| Patients with History of Hypertension History of Hypertension | 360 participants | 178 participants | 538 participants |
| Patients with History of Hypertension Without History of Hypertension | 92 participants | 48 participants | 140 participants |
| Patients with History of Previous Coronary Artery Bypass Graft (CABG) History of Previous CABG | 48 participants | 21 participants | 69 participants |
| Patients with History of Previous Coronary Artery Bypass Graft (CABG) Without History of Previous CABG | 404 participants | 205 participants | 609 participants |
| Patients with History of Previous Percutaneous Coronary Intervention (PCI) History of Previous PCI | 145 participants | 69 participants | 214 participants |
| Patients with History of Previous Percutaneous Coronary Intervention (PCI) Without History of Previous PCI | 307 participants | 157 participants | 464 participants |
| Race American Indian or Alaska Native | 2 participants | 0 participants | 2 participants |
| Race Asian | 11 participants | 3 participants | 14 participants |
| Race Black or African American | 33 participants | 20 participants | 53 participants |
| Race Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants |
| Race Other | 3 participants | 0 participants | 3 participants |
| Race White | 403 participants | 203 participants | 606 participants |
| Region of Enrollment United States | 452 participants | 226 participants | 678 participants |
| Sex: Female, Male Female | 138 Participants | 74 Participants | 212 Participants |
| Sex: Female, Male Male | 314 Participants | 152 Participants | 466 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 227 / 452 | 125 / 226 |
| serious Total, serious adverse events | 3 / 452 | 1 / 226 |
Outcome results
Primary
Percentage of Participants Who Experienced Target Lesion Failure (TLF)
The primary endpoint for this study is the percentage of participants who experienced Target Lesion Failure (TLF) during the 12 months post-procedure. A TLF event is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
Time frame: 12-months post-procedure
Population: Event-specific adjusted intent to treat (ITT) population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Target Lesion Failure (TLF) | 5.36 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Target Lesion Failure (TLF) | 2.78 Percentage of participants |
Comparison: Sample sizes of 1,061 from the ELITE™ group and 531 from the CYPHER® group were planned to achieve 90 percent power at a 2.5 percent significance level using an one-sided equivalence test, assuming a 10 percent TLF rate in each group and the maximum allowable rate difference between the groups being 5 percent. The total sample size was increased to 1,770 patients to account for an approximately 90 percent compliance to clinical follow-up.
Secondary
Percentage of Device Success - All CYPHER® Stents Included
Device success is defined as achievement of a final residual diameter stenosis of \<50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. All CYPHER® Stents were included if the final residual stenosis was \<50%. Non-study CYPHER® Stents were also included.
Time frame: At procedure
Population: Intent to Treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Device Success - All CYPHER® Stents Included | 95.7 Percentage of success |
| CYPHER® | Percentage of Device Success - All CYPHER® Stents Included | 95.1 Percentage of success |
p-value: 0.72495% CI: [-2.2, 4.2]Fisher Exact
Secondary
Percentage of Device Success - Protocol Definition
Device success is defined as achievement of a final residual diameter stenosis of \<50 percent (by QCA), using the assigned device only. If QCA was not available, the visual estimate of diameter stenosis was used. Device success was based on the following two measurements. Protocol definition: Only protocol-defined study stents were included.
Time frame: At procedure
Population: Intent to Treat population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Device Success - Protocol Definition | 95.7 Percentage of success |
| CYPHER® | Percentage of Device Success - Protocol Definition | 82.0 Percentage of success |
p-value: <0.00195% CI: [9.2, 18.9]Fisher Exact
Secondary
Percentage of Lesion Success
Lesion success is defined as the attainment of \< 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.
Time frame: At procedure
Population: ITT: All randomized participants regardless whether they received the intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Lesion Success | 99.6 Percentage of success |
| CYPHER® | Percentage of Lesion Success | 100.0 Percentage of success |
p-value: 0.54995% CI: [-1.3, 1]Fisher Exact
Secondary
Percentage of Participants Who Achieved Procedure Success
Procedure success is defined as achievement of a final diameter stenosis of \< 50 percent (by QCA) using any percutaneous method, without the occurrence of death, Myocardial Infarction (MI), or repeat revascularization of the target lesion during the hospital stay.
Time frame: At procedure during hospital stay
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Achieved Procedure Success | 97.3 Percentage of participants |
| CYPHER® | Percentage of Participants Who Achieved Procedure Success | 98.7 Percentage of participants |
p-value: 0.40795% CI: [-3.5, 1.4]Fisher Exact
Secondary
Percentage of Participants Who Died
Death incidences include both Cardiac and non-cardiac death.
Time frame: 12 months post procedure
Population: All randomized participants who had 12 months follow-up and documented specific events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Died | 0.70 Percentage of participants |
| CYPHER® | Percentage of Participants Who Died | 0.46 Percentage of participants |
p-value: 195% CI: [-1.92, 1.63]Fisher Exact
Secondary
Percentage of Participants Who Experienced Any Myocardial Infarction (MI)
Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.
Time frame: 12 months post procedure
Population: All randomized participants who had 12 months follow-up and documented specific events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Any Myocardial Infarction (MI) | 2.80 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Any Myocardial Infarction (MI) | 2.31 Percentage of participants |
p-value: 0.80195% CI: [-2.73, 2.91]Fisher Exact
Secondary
Percentage of Participants Who Experienced Bleeding Complications
Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and Protocol definitions.
Time frame: 12 months post procedure
Population: All randomized participants who had 12 months follow-up and documented specific events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Bleeding Complications | 13.08 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Bleeding Complications | 12.84 Percentage of participants |
p-value: 195% CI: [-5.61, 5.43]Fisher Exact
Secondary
Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.
Time frame: 0-30 days post-procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.22 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Early Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.00 Percentage of participants |
Secondary
Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.
Time frame: 31-360 days post-procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.7 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Late Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.46 Percentage of participants |
Secondary
Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE)
MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.
Time frame: 12 months post procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE) | 6.29 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Major Adverse Cardiac Events (MACE) | 3.70 Percentage of participants |
p-value: 0.295% CI: [-1.35, 5.85]Fisher Exact
Secondary
Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition)
Academic Research Consortium (ARC) defines STENT THROMBOSIS as consisting of the following: 1. DEFINITE - Angiographic or pathologic confirmation; 2. PROBABLE - Any unexplained death within the first 30 days or Any MI (related to documented acute ischemia and without another obvious cause) in the territory of the stent; 3. POSSIBLE - Any unexplained death \> 30 days. ARC Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points.
Time frame: 12 months post procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.93 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Stent Thrombosis (Academic Research Consortium (ARC) Definition) | 0.46 Percentage of participants |
p-value: 0.66895% CI: [-1.72, 1.96]Fisher Exact
Secondary
Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition)
Protocol defined Stent thrombosis include both Early and Late Thrombosis. Early thrombosis is defined as composite thirty-day ischemic endpoint including death, Q-wave MI, or subabrupt closure requiring revascularization. Late thrombosis is defined as myocardial infarction occurring \> 30 days after the index procedure and attributable to the target vessel with angiographic documentation (site-reported or by qualitative coronary angiography) of thrombus or total occlusion at the target site and freedom from an interim revascularization of the target vessel.
Time frame: 12 months post procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented specific events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition) | 0.47 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Stent Thrombosis (Protocol Definition) | 0.46 Percentage of participants |
p-value: 195% CI: [-2.14, 1.28]Fisher Exact
Secondary
Percentage of Participants Who Experienced Stroke
The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.
Time frame: 12 months post procedure
Population: All randomized participants who had 12 months follow-up and documented specific events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Stroke | 0.47 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Stroke | 1.39 Percentage of participants |
p-value: 0.34195% CI: [-3.56, 0.6]Fisher Exact
Secondary
Percentage of Participants Who Experienced Target Lesion Revascularization (TLR)
TLR is defined as any clinically-driven repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic electrocardiogram (ECG) changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.
Time frame: 12 months post-procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Target Lesion Revascularization (TLR) | 3.50 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Target Lesion Revascularization (TLR) | 1.39 Percentage of participants |
p-value: 0.20395% CI: [-0.84, 4.48]Fisher Exact
Secondary
Percentage of Participants Who Experienced Target Vessel Failure (TVF)
Target Vessel failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
Time frame: 12 months post procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Target Vessel Failure (TVF) | 6.99 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Target Vessel Failure (TVF) | 4.17 Percentage of participants |
p-value: 0.16695% CI: [-1.28, 6.26]Fisher Exact
Secondary
Percentage of Participants Who Experienced Target Vessel Revascularization (TVR)
TVR is defined as any clinically driven repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. Clinically-driven revascularizations are those in which the patient has a positive functional study, ischemic ECG changes at rest in a distribution consistent with the target vessel, or ischemic symptoms, and an in-lesion diameter stenosis 50 percent by QCA.
Time frame: 12 months post procedure
Population: Event specific adjusted ITT population: All randomized participants excluding those with follow-up less than 330 days and without documented events during the 360 days post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Experienced Target Vessel Revascularization (TVR) | 5.13 Percentage of participants |
| CYPHER® | Percentage of Participants Who Experienced Target Vessel Revascularization (TVR) | 2.78 Percentage of participants |
p-value: 0.2295% CI: [-1.24, 5.28]Fisher Exact
Secondary
Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF)
A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
Time frame: 12 months post procedure
Population: All randomized participants who had diabetes and were followed up for 12 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF) | 6.67 Percentage of participants |
| CYPHER® | Percentage of Participants Who Had Diabetes and Experienced Target Lesion Failure (TLF) | 1.49 Percentage of participants |
p-value: 0.1795% CI: [-2.03, 10.83]Fisher Exact
Secondary
Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF)
A Target Lesion Failure is defined as clinically-driven target lesion revascularization, target vessel myocardial infarction, or cardiac death that could not be clearly attributed to a vessel other than the target vessel at 12 months post-procedure.
Time frame: 12 months post procedure
Population: All randomized participants with lesions of more than 1 vessel and were followed for 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ELITE™ | Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF) | 14.89 Percentage of participants |
| CYPHER® | Percentage of Participants Who Had Lesions of More Than 1 Vessel and Experienced Target Lesion Failure (TLF) | 3.33 Percentage of participants |
p-value: 0.1495% CI: [-3.73, 24.64]Fisher Exact