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

Philip Urban, Alexandre Abizaid, Adrian Banning, Antonio L. Bartorelli, Ana Cebrian Baux, Vladimr Davk, Stephen Ellis, Runlin Gao, David Holmes, Myung Ho Jeong, Victor Legrand, Franz Josef Neumann, Maria Nyakern, Christian Spaulding, Stephen Worthley

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1445-1454
Number of pages10
JournalJournal of the American College of Cardiology
Volume57
Issue number13
DOIs
StatePublished - Mar 29 2011

Fingerprint

Sirolimus
Stents
Registries
Thrombosis
Hemorrhage
Population
Incidence
Myocardial Infarction
Enoxaparin
Drug-Eluting Stents
Mortality
Acute Coronary Syndrome
Causality
Comorbidity
Therapeutics
Multivariate Analysis
Guidelines

Keywords

  • antithrombotic therapy
  • bleeding complication
  • coronary stent
  • drug-eluting stent
  • sirolimus-eluting stent
  • stent thrombosis

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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. / Urban, Philip; Abizaid, Alexandre; Banning, Adrian; Bartorelli, Antonio L.; Baux, Ana Cebrian; Davk, Vladimr; Ellis, Stephen; Gao, Runlin; Holmes, David; Jeong, Myung Ho; Legrand, Victor; Neumann, Franz Josef; Nyakern, Maria; Spaulding, Christian; Worthley, Stephen.

In: Journal of the American College of Cardiology, Vol. 57, No. 13, 29.03.2011, p. 1445-1454.

Research output: Contribution to journalArticle

Urban, Philip ; Abizaid, Alexandre ; Banning, Adrian ; Bartorelli, Antonio L. ; Baux, Ana Cebrian ; Davk, Vladimr ; Ellis, Stephen ; Gao, Runlin ; Holmes, David ; Jeong, Myung Ho ; Legrand, Victor ; Neumann, Franz Josef ; Nyakern, Maria ; Spaulding, Christian ; Worthley, Stephen. / 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. In: Journal of the American College of Cardiology. 2011 ; Vol. 57, No. 13. pp. 1445-1454.
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abstract = "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.",
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author = "Philip Urban and Alexandre Abizaid and Adrian Banning and Bartorelli, {Antonio L.} and Baux, {Ana Cebrian} and Vladimr Davk and Stephen Ellis and Runlin Gao and David Holmes and Jeong, {Myung Ho} and Victor Legrand and Neumann, {Franz Josef} and Maria Nyakern and Christian Spaulding and Stephen Worthley",
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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

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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.

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KW - bleeding complication

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KW - drug-eluting stent

KW - sirolimus-eluting stent

KW - stent thrombosis

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