LIMUS ELUTED FROM A DURABLE VERSUS ERODABLE STENT COATING

INTERVENTION: Product Name: BioMatrix III DES System Product Code: BioMatrix III stent Pharmaceutical Form: INN or Proposed INN: BIOLIMUS Concentration unit: µg microgram(s) Concentration type: range Concentration number: 133‐454 Trade Name: Cypher Select Product Name: Cypher Sirolimus‐Eluting Coronary Stent Pharmaceutical Form: INN or Proposed INN: SIROLIMUS CAS Number: 53123889 Concentration unit: µg microgram(s) Concentration type: range Concentration number: 140‐479 CONDITION: Coronary heart disease PRIMARY OUTCOME: Main Objective: The objective of the present study is to compare the safety and efficacy of the BioMatrixTM III Stent (Biolimus‐eluting) with the CypherTM (Sirolimus‐eluting) stent in a prospective, multicenter, randomized, controlled, non‐inferiority trial in patients undergoing percutaneous coronary intervention in routine clinical practice. Primary end point(s): The primary outcome is major adverse cardiac events (MACE) defined as a composite of cardiac death, myocardial infarction (Q‐wave and non‐Q wave), or justified target vessel revascularization (TVR) within 9 months.; ; Endpoint of the Angiographic Study; The principal endpoint of the angiographic study in the pre‐specified group of patients undergoing repeat angiography at nine months after stent implantation is in‐stent percent diameter stenosis (% DS). ; Secondary Objective: At 30 d, 6 mo, 9 mo, 1, 2, 3, 4 & 5 yr: ; Justified/non‐justified target lesion revascularization (TLR) and target vessel revascularization (TVR) ; Composite of cardiac death, myocardial infarction, justified TVR; Target Vessel Failure; Cardiac/Non cardiac death; MI; Angiographic and clinical stent thrombosis; ; By QCA analysis at 9 mo: ; in‐stent and in‐segment binary restenosis rate ; in‐stent and in‐segment minimal luminal diameter; in‐segment percent diameter stenosis ; in‐stent and in‐segment late luminal loss ; ; Device success: <20% residual stenosis (by QCA), using the study device; Lesion success: <20% residual stenosis (by QCA), using any PCI method; Procedural success: < 20% residual stenosis (by QCA) using any PCI method, without death, MI, or TVR INCLUSION CRITERIA: 1. Age = 18 years 2. 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 3. Presence of one or more coronary artery stenoses >50% in a native coronary artery or a saphenous bypass graft in a vessel with a reference diameter ranging from 2.25 to 4.0 mm which can be covered with one or multiple stents 4. No limitation to the number of treated lesions, number of vessels or lesion length but according to the randomization group. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range