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.
[en] 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).
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Urban, Philip
Abizaid, Alexandre
Banning, Adrian
Bartorelli, Antonio L.
Baux, Ana Cebrian
Dzavik, Vladimir
Ellis, Stephen
Gao, Runlin
Holmes, David
Jeong, Myung Ho
Legrand, Victor ; Université de Liège - ULiège > Département des sciences cliniques > Cardiologie
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.
Publication date :
2011
Journal title :
Journal of the American College of Cardiology
ISSN :
0735-1097
eISSN :
1558-3597
Publisher :
Elsevier, Netherlands
Volume :
57
Issue :
13
Pages :
1445-54
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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