Limus Eluted From A Durable Versus ERodable Stent Coating (LEADERS)

• Major adverse cardiac events (MACE) within 9 months in the overall population defined as
• composite of cardiac death,
• myocardial infarction (Q-wave and Non-Q wave)
• justified target vessel revascularization

• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Cardiac death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Cardiac death
• All deaths [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• Myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Angiographic and clinical stent thrombosis. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• In-stent and in-segment binary restenosis rate as assessed by QCA. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  In-stent and in-segment binary restenosis rate as assessed by QCA.
• In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA
• In-segment percent diameter stenosis (%DS). [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  In-segment percent diameter stenosis (%DS) as assessed by QCA
• In-stent and in-segment late luminal loss [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  In-stent and in-segment late luminal loss as assessed by QCA
• Device success, lesion success and procedural success. [ Time Frame: at implant ] [ Designated as safety issue: No ]
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Cardiac death [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 4 year ] [ Designated as safety issue: No ]
  Cardiac death
• Cardiac death [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  Cardiac death
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 4 year ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• Major adverse cardiac events (MACE) in the overall population according to the ARC definitions. [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  Major adverse cardiac events (MACE) in the overall population defined as composite of cardiac death,myocardial infarction (Q-wave and Non-Q wave)justified target vessel revascularization and Justified and non-justified target lesion revascularization (TLR)
• All deaths [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• All deaths [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  All deaths (cardiac and non-cardiac)
• Myocardial infarction [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Myocardial infarction (Q-wave and NQWMI)
• Angiographic and clinical stent thrombosis. [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 9 month ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis
• Angiographic and clinical stent thrombosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  Angiographic and clinical stent thrombosis

• Justified and non-justified target lesion revascularization (TLR)at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• Justified and non-justified target vessel revascularization (TVR)at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• Composite of cardiac death, myocardial infarction (Q wave and Non-Q wave), or justified target vessel revascularization at 30 days, 6 months, 1, 2, 3, 4 and 5 years.
• Target Vessel Failure (TVF) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• Cardiac death at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• All deaths (cardiac and non-cardiac) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• Myocardial infarction (Q-wave and NQWMI) at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• Angiographic and clinical stent thrombosis at 30 days, 6 months, 9 months, 1, 2, 3, 4 and 5 years.
• In-stent and in-segment binary restenosis rate as assessed by QCA at 9 months after stent implantation.
• In-stent and in-segment minimal luminal diameter (MLD) as assessed by QCA at 9 months after stent implantation.
• In-segment percent diameter stenosis (%DS) as assessed by QCA at 9 months after stent implantation.
• In-stent and in-segment late luminal loss as assessed by QCA at 9 months.
• Device success, lesion success and procedural success.

The purpose of this study is to compare the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a non-inferiority trial.

Compare the safety and efficacy of the BioMatrix Flex (Biolimus A9-Eluting) stent system with the Cypher SELECT (Sirolimus-Eluting) stent system in a prospective, multi-center, randomized, controlled, non-inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice.

• Coronary Disease
• Coronary Stenosis

• Active Comparator: BioMatrix Flex stent
  Biolimus A9 coated stent with biodegradable polymer
  Intervention: Device: Coronary stent placement
• Active Comparator: Cypher Select stent
  Sirolimus coated stent with durable polymer
  Intervention: Device: Coronary stent placement

• Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P. Biolimus-eluting stent with biodegradable polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. Epub 2008 Aug 31.
• Garg S, Sarno G, Serruys PW, de Vries T, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, Di Mario C, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Jüni P, Windecker S. The twelve-month outcomes of a biolimus eluting stent with a biodegradable polymer compared with a sirolimus eluting stent with a durable polymer. EuroIntervention. 2010 Jun;6(2):233-9.
• Sarno G, Garg S, Onuma Y, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, Eerdmans P, Garcia-Garcia HM, van Es GA, Goedhart D, de Vries T, Jüni P, Meier B, Windecker S, Serruys P. The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial). Am J Cardiol. 2010 Feb 15;105(4):475-9. Epub 2010 Jan 5.
• Wykrzykowska JJ, Serruys PW, Onuma Y, de Vries T, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S. Impact of vessel size on angiographic and clinical outcomes of revascularization with biolimus-eluting stent with biodegradable polymer and sirolimus-eluting stent with durable polymer the LEADERS trial substudy. JACC Cardiovasc Interv. 2009 Sep;2(9):861-70.
• Wykrzykowska JJ, Räber L, de Vries T, Bressers M, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Regar E, Jüni P, Windecker S, Serruys PW. Biolimus-eluting biodegradable polymer versus sirolimus-eluting permanent polymer stent performance in long lesions: results from the LEADERS multicentre trial substudy. EuroIntervention. 2009 Aug;5(3):310-7.
• Stefanini GG, Kalesan B, Pilgrim T, Räber L, Onuma Y, Silber S, Serruys PW, Meier B, Jüni P, Windecker S. Impact of sex on clinical and angiographic outcomes among patients undergoing revascularization with drug-eluting stents. JACC Cardiovasc Interv. 2012 Mar;5(3):301-10.
• Gutiérrez-Chico JL, Jüni P, García-García HM, Regar E, Nüesch E, Borgia F, van der Giessen WJ, Davies S, van Geuns RJ, Secco GG, Meis S, Windecker S, Serruys PW, di Mario C. Long-term tissue coverage of a biodegradable polylactide polymer-coated biolimus-eluting stent: comparative sequential assessment with optical coherence tomography until complete resorption of the polymer. Am Heart J. 2011 Nov;162(5):922-31. Epub 2011 Oct 7.
• Stefanini GG, Kalesan B, Serruys PW, Heg D, Buszman P, Linke A, Ischinger T, Klauss V, Eberli F, Wijns W, Morice MC, Di Mario C, Corti R, Antoni D, Sohn HY, Eerdmans P, van Es GA, Meier B, Windecker S, Jüni P. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial. Lancet. 2011 Dec 3;378(9807):1940-8. Epub 2011 Nov 8.
• Klauss V, Serruys PW, Pilgrim T, Buszman P, Linke A, Ischinger T, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, van Geuns RJ, van Es GA, Kalesan B, Wenaweser P, Jüni P, Windecker S. 2-year clinical follow-up from the randomized comparison of biolimus-eluting stents with biodegradable polymer and sirolimus-eluting stents with durable polymer in routine clinical practice. JACC Cardiovasc Interv. 2011 Aug;4(8):887-95.
• Gutiérrez-Chico JL, Regar E, Nüesch E, Okamura T, Wykrzykowska J, di Mario C, Windecker S, van Es GA, Gobbens P, Jüni P, Serruys PW. Delayed coverage in malapposed and side-branch struts with respect to well-apposed struts in drug-eluting stents: in vivo assessment with optical coherence tomography. Circulation. 2011 Aug 2;124(5):612-23. Epub 2011 Jul 18.
• Wykrzykowska JJ, Garg S, Onuma Y, de Vries T, Goedhart D, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. Circ Cardiovasc Interv. 2011 Feb 1;4(1):47-56. Epub 2011 Jan 4.
• Wykrzykowska JJ, Garg S, Girasis C, de Vries T, Morel MA, van Es GA, Buszman P, Linke A, Ischinger T, Klauss V, Corti R, Eberli F, Wijns W, Morice MC, di Mario C, van Geuns RJ, Juni P, Windecker S, Serruys PW. Value of the SYNTAX score for risk assessment in the all-comers population of the randomized multicenter LEADERS (Limus Eluted from A Durable versus ERodable Stent coating) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):272-7.

Inclusion Criteria:

• Age >= 18 years;
• Symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation myocardial infarction and ST-elevation myocardial infarction;
• Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft from 2.25 to 3.5 mm in diameter that can be covered with one or multiple stents;
• No limitation on the number of treated lesions, and vessels, and lesion length

Exclusion Criteria:

• Pregnancy;
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Sirolimus, Biolimus or contrast material;
• Inability to provide informed consent;
• Currently participating in another trial before reaching first endpoint;
• Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the perisurgical period