TY - JOUR
T1 - Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population
T2 - A report from the e-SELECT (Multi-center Post-Market Surveillance) registry
AU - Urban, Philip
AU - Abizaid, Alexandre
AU - Banning, Adrian
AU - Bartorelli, Antonio L.
AU - Baux, Ana Cebrian
AU - Davk, Vladimr
AU - Ellis, Stephen
AU - Gao, Runlin
AU - Holmes, David
AU - Jeong, Myung Ho
AU - Legrand, Victor
AU - Neumann, Franz Josef
AU - Nyakern, Maria
AU - Spaulding, Christian
AU - Worthley, Stephen
N1 - Funding Information:
Dr. Urban has served as consultant for Cordis and Biosensors. Dr. Banning has received research funding from Boston Scientific and Cordis ; and his salary is partially funded by the NIHR Oxford Biomedical Research Centre. Dr. Bartorelli has served as a consultant to Abbott Vascular and is on the Speakers' Bureaus of Bracco and Cordis, Johnson & Johnson. Dr. Cebrian Baux has been a full-time employee of and has stock options in Cordis, Johnson & Johnson. Dr. Džavík has served as consultant for and received a research grant from Abbott Vascular and has received educational funds from Cordis . Dr. Legrand has served as a consultant for Cordis, Johnson & Johnson, and is a member of the scientific advisory board of Abbott. Dr. Nyakern has been a salaried consultant for Cordis, Johnson & Johnson. Dr. Spaulding has received research funding from Cordis , Abbott , Stentys , and Lilly ; has received speaker fees from Cordis, Lilly, and Pfizer; was on the scientific advisory board of Cordis; and has been a full-time employee of Cordis, Johnson & Johnson since July 1, 2010. All other authors have reported that they have no relationships to disclose.
PY - 2011/3/29
Y1 - 2011/3/29
N2 - 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.
AB - 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.
KW - antithrombotic therapy
KW - bleeding complication
KW - coronary stent
KW - drug-eluting stent
KW - sirolimus-eluting stent
KW - stent thrombosis
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U2 - 10.1016/j.jacc.2010.11.028
DO - 10.1016/j.jacc.2010.11.028
M3 - Article
C2 - 21435513
AN - SCOPUS:79952919635
SN - 0735-1097
VL - 57
SP - 1445
EP - 1454
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 13
ER -