Trial Outcomes & Findings for Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems (NCT NCT00715884)

Study Comparing the CYPHER® ELITE™ to the CYPHER® Bx VELOCITY® Sirolimus-Eluting Stent Systems

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.

Lesion success is defined as the attainment of \< 50 percent residual stenosis (by Quantitative Coronary Angiography (QCA)) using any percutaneous method.

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.

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.

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.

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.

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.

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.

MAJOR ADVERSE CARDIAC EVENTS (MACE) consists of death, myocardial infarction, emergent bypass surgery, and target lesion revascularization.

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.

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.

Bleeding complications include any bleeding events defined by THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI), Global Strategies for Opening Occluded Coronary Arteries (GUSTO), and "Protocol" definitions.

Death incidences include both Cardiac and non-cardiac death.

Myocardial Infarction includes both Q-wave and WHO Non-Q Wave Myocardial Infarction events.

The stroke definition includes both hemorrhagic and non-hemorrhagic strokes.

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.

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.

Those ARC stent thromboses occurred between 0 and 30 days post-procedure are early stent thrombosis.

Those ARC stent thromboses occurred between 31 to 360 days post-procedure are late stent thrombosis.