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.
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.


OBJECTIVE
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.
Chacko
Matthews
M
Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Lincoff
A Michael
AM
Wolski
Katherine E
KE
Cohen
David J
DJ
Bittl
John A
JA
Lansky
Alexandra J
AJ
Tsuchiya
Yoshihiro
Y
Betriu
Amadeo
A
Yen
Michael H
MH
Chew
Derek P
DP
Cho
Leslie
L
Topol
Eric J
EJ
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects* / Q000401:mortality; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced*; D006493:Heparin / Q000627:therapeutic use; D006629:Hirudins / Q000009:adverse effects*; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000209:etiology*; D009204:Myocardial Revascularization / Q000706:statistics & numerical data; D010446:Peptide Fragments / Q000009:adverse effects* / Q000627:therapeutic use; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors; D016032:Randomized Controlled Trials as Topic; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012189:Retrospective Studies; D018570:Risk Assessment; D012737:Sex Factors
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin