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 OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:57

Article

Urban, Philip¹  Abizaid, Alexandre²  Banning, Adrian³  Bartorelli, Antonio L.⁴  Baux, Ana Cebrian⁵  Dzavik, Vladimir⁶  Ellis, Stephen⁷  Gao, Runlin^8,9  Holmes, David¹⁰  Jeong, Myung Ho¹¹  Legrand, Victor¹²  Neumann, Franz-Josef¹³  Nyakern, Maria⁵  Spaulding, Christian^14,15  Worthley, Stephen¹⁶ 

[1] La Tour Hosp, CH-1217 Geneva, Switzerland

[2] Inst Dante Pazzanese Cardiol, Sao Paulo, Brazil

[3] John Radcliffe Hosp, Oxford OX3 9DU, England

[4] Univ Milan, Ctr Cardiol Monzino, IRCCS, Milan, Italy

[5] Cordis Clin Res Europe, Waterloo, Belgium

[6] Univ Hlth Network, Peter Munk Cardiac Ctr, Toronto, ON, Canada

[7] Cleveland Clin Fdn, Cleveland, OH 44195 USA

[8] Cardiovasc Inst, Beijing, Peoples R China

[9] Fu Wai Hosp, Beijing, Peoples R China

[10] Mayo Clin, Rochester, MN USA

[11] Chonnam Natl Univ Hosp, Ctr Heart, Kwangju, South Korea

[12] Ctr Hosp Univ, Liege, Belgium

[13] Herz Zentrum Bad Krozingen, Bad Krozingen, Germany

[14] Paris Descartes Univ, Cochin Hosp, AP HP, Dept Cardiol, Paris, France

[15] Paris Descartes Univ, INSERM, U970, Paris, France

[16] Royal Adelaide Hosp, Cardiovasc Invest Unit, Adelaide, SA 5000, Australia

关键词: antithrombotic therapy;    bleeding complication;    coronary stent;    drug-eluting stent;    sirolimus-eluting stent;    stent thrombosis;   

DOI  :  10.1016/j.jacc.2010.11.028

来源: Elsevier

【 摘 要 】

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) (J Am Coll Cardiol 2011;57:1445-54) (c) 2011 by the American College of Cardiology Foundation

【 授权许可】

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