title: Two-year safety and effectiveness of sirolimus-eluting stents (from a prospective registry).
abstract: Uncertainty exists about the long-term safety and efficacy outcomes of sirolimus-eluting stents (SESs) in unselected patients. The present study was performed to evaluate the safety and efficacy of the SES in treatment of patients with coronary artery disease in an unselected population. Over a 2-year period, 1,504 consecutive patients undergoing percutaneous coronary intervention with ≥1 SES were enrolled. The primary end point was the occurrence of target vessel failure (TVF; a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization). An independent clinical event committee adjudicated all adverse events up to 2-year follow-up. Dual antiplatelet therapy was recommended for ≥1 year throughout the study period. Mean age was 65 ± 11 years; 75% were men, and 34% were diabetics. SESs were implanted for off-label indications in 86% of cases. TVF rates were 3.3%, 6.9%, 11.5%, and 15.5% at 30-day, 6-month, 1-year, and 2-year follow-ups, respectively. The 2-year cumulative rate of definite/probable stent thrombosis was 0.9%; 0.2% was very late thrombosis, occurring from 1 year to 2 years. Patients off dual antiplatelet therapy at 6 months had a significantly increased rate of subsequent death from noncardiac causes. Patients off dual antiplatelet therapy at 1 year had a significantly decreased rate of subsequent clinically driven target lesion revascularization. In conclusion, use of SESs in unselected patients with coronary artery disease was associated with a low TVF rate at 2 years with an acceptable incidence of stent thrombosis.
authors.affiliation: Cardiovascular Research Foundation, New York, New York, USA.
authors.forename: Bimmer E
authors.initials: BE
authors.lastname: Claessen
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.forename: Eric A
authors.initials: EA
authors.lastname: Heller
authors.forename: Giora
authors.initials: G
authors.lastname: Weisz
authors.forename: George
authors.initials: G
authors.lastname: Syros
authors.forename: Gary S
authors.initials: GS
authors.lastname: Mintz
authors.forename: Theresa
authors.initials: T
authors.lastname: Franklin-Bond
authors.forename: Irene
authors.initials: I
authors.lastname: Apostolidou
authors.forename: Jose P S
authors.initials: JP
authors.lastname: Henriques
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: George D
authors.initials: GD
authors.lastname: Dangas
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003324:Coronary Artery Disease / Q000150:complications / Q000628:therapy*; D048909:Diabetes Complications / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D020123:Sirolimus