The safety and effectiveness of bivalirudin in female patients with acute myocardial infarction undergoing primary angioplasty: A subgroup analysis of the BRIGHT trial

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Abstract

Background:

Being female is an independent predictor of adverse events during percutaneous coronary interventions (PCI).

Objective:

To evaluate the safety and efficiency of bivalirudin during emergency PCI in female patients with acute myocardial infarction (AMI).

Methods:

The present study was a subgroup analysis of the randomized Bivalirudin in Acute Myocardial Infarction vs. Heparin and GPI plus Heparin (BRIGHT) trial. A total of 392 female patients enrolled in the BRIGHT trial were assigned to receive bivalirudin with post-procedure dose infusion (n= 127) or heparin with or without tirofiban (n= 265). The primary efficiency endpoint was 30-day net adverse clinical events (NACEs). The secondary efficiency endpoints were 30-day major cardiac and cerebral events (MACCEs) and bleeding events defined according to Bleeding Academic Research Consortium (BARC) definitions.

Results:

For female patients, bivalirudin treatment was associated with significantly lower incidences of 30-day NACEs (6.3% vs. 21.5%,P< 0.001), any bleeding (2.4% vs. 12.8%,P= 0.001) and BARC 2–5 type bleeding (1.6% vs. 7.2%,P= 0.021) compared with the control regimen. The incidence of MACCEs (3.4% vs. 9.4%,P= 0.055) and stent thrombosis (0% vs. 1.1%,P= 0.229) were comparable between the two groups. Multivariate analysis showed that bivalirudin (OR: 0.245, 95% CI: 0.113–0.532,P< 0.001), transradial access (OR: 0.119, 95% CI: 0.067–0.211,P< 0.001), and statin (OR: 0.254, 95% CI: 0.08–0.807,P= 0.02) were independent protective factors for 30-day NACEs in female patients.

Conclusions:

The use of bivalirudin during emergency PCI for AMI in female patients significantly reduced the bleeding risk with anticoagulation effects compared with heparin with or without tirofiban. © 2016 Wiley Periodicals, Inc.

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