Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry.

Journal article

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).

Authors: Urban, P; Abizaid, A; Banning, A; Bartorelli, A; Baux, A

• Journal: Journal of the American College of Cardiology
• Volume: 57
• Issue: 13
• Pages: 1445-1454
• Publication date: 2011-03-01
• DOI: 10.1016/j.jacc.2010.11.028
• EISSN: 1558-3597
• ISSN: 0735-1097
• Language: English
• Keywords: Age Factors; Platelet Aggregation Inhibitors; Middle Aged; e-SELECT Investigators; Humans; Acute Coronary Syndrome; Male; Female; Multivariate Analysis; Drug-Eluting Stents; Myocardial Revascularization; Follow-Up Studies; Coronary Thrombosis; Myocardial Infarction; Hemorrhage; Sirolimus; Comorbidity; Registries