| 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. | 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 | Posted | | Number | | Percentage of participants | | 12-months post-procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | | | | In the CYPHER® ELITE™ arm the TLF rate was 5.36% (23/429) compared with 2.78% (6/216) in the CYPHER® Bx VELOCITY® arm, a difference in rates of 2.58%, upper limit of 95% two sided confidence interval of 5.55%. | Difference between TLF rates | 2.58 | | | 1-Sided | 95 | | 5.55 | | | | Yes |
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| 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. | ITT: All randomized participants regardless whether they received the intervention | Posted | | Number | | Percentage of success | | At procedure | Lesions | Participants | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | Intent to Treat population. | Posted | | Number | | Percentage of success | | At procedure | Devices | Participants | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | Intent to Treat population. | Posted | | Number | | Percentage of success | | At procedure | Devices | Participants | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | | Posted | | Number | | Percentage of participants | | At procedure during hospital stay | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post-procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | All randomized participants with lesions of more than 1 vessel and were followed for 12 months | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | All randomized participants who had diabetes and were followed up for 12 months. | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | All randomized participants who had 12 months follow-up and documented specific events | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| Secondary | Percentage of Participants Who Died | Death incidences include both Cardiac and non-cardiac death. | All randomized participants who had 12 months follow-up and documented specific events | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| Secondary | Percentage of Participants Who Experienced Any Myocardial Infarction (MI) | Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events. | All randomized participants who had 12 months follow-up and documented specific events | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| Secondary | Percentage of Participants Who Experienced Stroke | The stroke definition includes both hemorrhagic and non-hemorrhagic strokes. | All randomized participants who had 12 months follow-up and documented specific events | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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:
- DEFINITE - Angiographic or pathologic confirmation;
- 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;
- 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. | 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 | Posted | | Number | | Percentage of participants | | 12 months post procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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. | Posted | | Number | | Percentage of participants | | 0-30 days post-procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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| 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. | 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 | Posted | | Number | | Percentage of participants | | 31-360 days post-procedure | | | | ID | Title | Description |
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| OG000 | ELITE™ | CYPHER® ELITE™ Sirolimus-Eluting Stent System. | | OG001 | CYPHER® | CYPHER® Bx VELOCITY® Sirolimus-eluting Stent System |
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