Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)

• All Death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Myocardial infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Composite of death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Composite of cardiac death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
• Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
• Stent thrombosis (ARC criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
• In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. [ Time Frame: at 3 days in average ] [ Designated as safety issue: No ]
  At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)
• All death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• All death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Myocardial infarction (MI) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• Myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• Composite of death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• Composite of cardiac death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
• Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
• Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
• Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
• Stent thrombosis (ARC criteria) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

• All Death [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Cardiac death [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Myocardial infarction (MI) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Composite of death or MI [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Composite of cardiac death or MI [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: No ]
• Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: No ]
• Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• Stent thrombosis (ARC criteria) [ Time Frame: 30 days, 6 months, and 1 year ] [ Designated as safety issue: Yes ]
• In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
• Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay. [ Time Frame: at 30 days ] [ Designated as safety issue: No ]

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation for long coronary lesions.

Following angiography, patients with significant diameter stenosis >50% and lesion length (> 25mm) requiring single or multiple long-stent placement (total stent length>28mm) by visual estimation and eligible for LONG-DES IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.

• Device: Cypher
  Sirolimus-eluting stent
  Other Name: Sirolimus-eluting stent
• Device: Endeavor Resolute
  Zotarolimus-eluting Stent
  Other Name: Zotarolimus-eluting Stent

• Active Comparator: Cypher
  Sirolimus-eluting stent
  Intervention: Device: Cypher
• Active Comparator: Endeavor Resolute
  Zotarolimus-eluting Stent
  Intervention: Device: Endeavor Resolute

Inclusion Criteria:

• The patient must be at least 18 years of age.
• Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
• Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
• The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

• Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
• An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
• Acute ST-segment-elevation MI or cardiogenic shock
• Terminal illness with life expectancy <1 year
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted)
• Patients with EF<30%.
• Serum creatinine level >=3.0mg/dL or dependence on dialysis.
• Patients with left main stem stenosis (>50% by visual estimate).

• CardioVascular Research Foundation, Korea
• Medtronic