Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention: A subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial

Matthews Chacko, A. Michael Lincoff, Katherine E. Wolski, David J. Cohen, John A. Bittl, Alexandra J. Lansky, Yoshihiro Tsuchiya, Amadeo Betriu, Michael H. Yen, Derek P. Chew, Leslie Cho, Eric J. Topol

Research output: Contribution to journalArticle

33 Citations (Scopus)

Abstract

Background: Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points. Objectives: The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial. Methods: A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted. Results: Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality. Conclusions: Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.

LanguageEnglish
Pages1032.e1-1032.e7
JournalAmerican Heart Journal
Volume151
Issue number5
DOIs
Publication statusPublished - 2006

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Chacko, Matthews ; Lincoff, A. Michael ; Wolski, Katherine E. ; Cohen, David J. ; Bittl, John A. ; Lansky, Alexandra J. ; Tsuchiya, Yoshihiro ; Betriu, Amadeo ; Yen, Michael H. ; Chew, Derek P. ; Cho, Leslie ; Topol, Eric J. / Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention : A subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial. In: American Heart Journal. 2006 ; Vol. 151, No. 5. pp. 1032.e1-1032.e7.
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title = "Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention: A subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial",
abstract = "Background: Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points. Objectives: The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial. Methods: A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted. Results: Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality. Conclusions: Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.",
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Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention : A subgroup analysis of the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial. / Chacko, Matthews; Lincoff, A. Michael; Wolski, Katherine E.; Cohen, David J.; Bittl, John A.; Lansky, Alexandra J.; Tsuchiya, Yoshihiro; Betriu, Amadeo; Yen, Michael H.; Chew, Derek P.; Cho, Leslie; Topol, Eric J.

In: American Heart Journal, Vol. 151, No. 5, 2006, p. 1032.e1-1032.e7.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Ischemic and bleeding outcomes in women treated with bivalirudin during percutaneous coronary intervention

T2 - American Heart Journal

AU - Chacko, Matthews

AU - Lincoff, A. Michael

AU - Wolski, Katherine E.

AU - Cohen, David J.

AU - Bittl, John A.

AU - Lansky, Alexandra J.

AU - Tsuchiya, Yoshihiro

AU - Betriu, Amadeo

AU - Yen, Michael H.

AU - Chew, Derek P.

AU - Cho, Leslie

AU - Topol, Eric J.

PY - 2006

Y1 - 2006

N2 - Background: Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points. Objectives: The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial. Methods: A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted. Results: Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality. Conclusions: Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.

AB - Background: Outcomes in women undergoing percutaneous coronary intervention (PCI) in the contemporary era are poorly defined. The REPLACE-2 trial demonstrated that bivalirudin with provisional glycoprotein IIb/IIIa (GpIIb-IIIa) blockade is noninferior to heparin with planned GpIIb-IIIa blockade during PCI, with regard to ischemic and bleeding end points. Objectives: The aim of this study was to define sex-based clinical ischemic and bleeding outcomes from the REPLACE-2 trial. Methods: A retrospective sex-based subgroup analysis of the REPLACE-2 trial comparing clinical ischemic and inhospital bleeding end points was conducted. Results: Compared with men in REPLACE-2, women were older, had more diabetes, congestive heart failure and hypertension, and less prior revascularization and myocardial infarction. Female sex was a univariate predictor of death and bleeding complications. Among women treated with either bivalirudin or heparin, there was no significant difference in the individual or composite ischemic end points of death, myocardial infarction, or urgent revascularization at 30 days or 6 months. Protocol-defined major bleeding, minor bleeding, and access site bleeding were less frequent with bivalirudin compared with heparin. Multivariable modeling found no significant interactions between sexes, with the composite ischemic end point, major bleeding, or 1-year mortality. Conclusions: Women remain at higher risk for poorer outcomes with contemporary PCI, likely because of comorbidities. Bivalirudin with provisional GpIIb-IIIa confers similar protection against ischemic end points compared with heparin and planned GpIIb-IIIa blockade and significantly reduces the inherent bleeding risk of women undergoing contemporary PCI.

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DO - 10.1016/j.ahj.2006.02.012

M3 - Article

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SP - 1032.e1-1032.e7

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SN - 0002-8703

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