Stent Thrombosis and Bleeding Complications After Implantation of Sirolimus-Eluting Coronary Stents in an Unselected Worldwide Population

• Published in: Journal of the American College of Cardiology Vol. 57; no. 13; pp. 1445 - 1454
• Main Authors: Urban, Philip, MD, Abizaid, Alexandre, MD, Banning, Adrian, MD, Bartorelli, Antonio L., MD, Baux, Ana Cebrian, PhD, Džavík, Vladimír, MD, Ellis, Stephen, MD, Gao, Runlin, MD, Holmes, David, MD, Jeong, Myung Ho, MD, Legrand, Victor, MD, Neumann, Franz-Josef, MD, Nyakern, Maria, PhD, Spaulding, Christian, MD, Worthley, Stephen, MD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 29.03.2011
• Subjects: antithrombotic therapy; bleeding complication; Cardiovascular; coronary stent; drug-eluting stent; Internal Medicine; sirolimus-eluting stent; stent thrombosis; SES; myocardial infarction; sirolimus-eluting stent(s); drug-eluting stent(s); dual antiplatelet therapy; percutaneous coronary intervention; ESC; MACE; MB; major bleeding; stent thrombosis; bleeding complication; MI; acute coronary syndrome(s); DAPT; ST; drug-eluting stent; sirolimus-eluting stent; antithrombotic therapy; major adverse cardiac event(s); ACS; DES; European Society of Cardiology; PCI; coronary stent
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2010.11.028

Objectives The aim of this study was to ascertain the 1-year incidence of stent thrombosis (ST) and major bleeding (MB) in a large, unselected population treated with sirolimus-eluting stents (SES). Background Stent thrombosis and MB are major potential complications of drug-eluting stent implantation. Their relative incidence and predisposing factors among large populations treated worldwide are unclear. Methods The SES were implanted in 15,147 patients who were entered in a multinational registry. We analyzed the incidence of: 1) definite and probable ST as defined by the Academic Research Consortium; and 2) MB, with the STEEPLE (Safety and efficacy of Enoxaparin in PCI) definition, together with their relation to dual antiplatelet therapy (DAPT) and to 1-year clinical outcomes. Results The mean age of the sample was 62 ± 11 years, 30.4% were diabetic, 10% had a Charlson comorbidity index ≥3, and 44% presented with acute coronary syndrome or myocardial infarction. At 1 year, the reported compliance with DAPT as recommended by the European Society of Cardiology guidelines was 86.3%. Adverse event rates were: ST 1.0%, MB 1.0%, mortality 1.7%, myocardial infarction 1.9%, and target lesion revascularization 2.3%. Multivariate analysis identified 9 correlates of ST and 4 correlates of MB. Advanced age and a high Charlson index were associated with an increased risk of both ST and MB. After ST, the 7-day and 1-year all-cause mortality was 30% and 35%, respectively, versus 1.5% and 10% after MB. Only 2 of 13,749 patients (0.015%) experienced both MB and ST during the entire 1-year follow-up period. Conclusions In this worldwide population treated with ≥1 SES, the reported compliance with DAPT was good, and the incidence of ST and MB was low. Stent thrombosis and MB very rarely occurred in the same patient. (The e-SELECT Registry: a Multicenter Post-Market Surveillance; NCT00438919 )