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Bivalirudin vs. Heparin During PCI in NSTEMI
Quick Takes
- The current analysis compared the effect of heparin vs. bivalirudin on clinical outcomes (ischemic and bleeding) among patients with NSTEMI undergoing PCI using individual patient-level data from five prior RCTs.
- Results show comparable mortality and ischemic outcomes among patients receiving heparin (with or without GPI) vs. bivalirudin.
- Bivalirudin was associated with significantly lower bleeding (access site and nonaccess site) compared to heparin.
Study Questions:
What are outcomes of bivalirudin and heparin in patients with non–ST-segment elevation myocardial infarction (NSTEMI) undergoing percutaneous coronary intervention (PCI)?
Methods:
The current analysis was an individual patient data meta-analysis of patients with NSTEMI in all five trials that randomized ≥1,000 patients with any MI undergoing PCI to bivalirudin versus heparin (MATRIX, VALIDATE-SWEDEHEART, ISAR-REACT 4, ACUITY [Acute Catheterization and Urgent Intervention Triage Strategy], and BRIGHT). The primary effectiveness and safety endpoints were 30-day all-cause mortality and serious bleeding.
Results:
A total of 12,155 patients were randomized: 6,040 to bivalirudin (52.3% with a post-PCI bivalirudin infusion), and 6,115 to heparin (53.2% with planned glycoprotein IIb/IIIa inhibitor [GPI] use). Thirty-day mortality was not significantly different between bivalirudin and heparin (1.2% vs. 1.1%; adjusted odds ratio [aOR], 1.24; 95% confidence interval [CI], 0.86–1.79; p = 0.25). Cardiac mortality, reinfarction, and stent thrombosis rates were also not significantly different. Bivalirudin reduced serious bleeding (both access site–related and nonaccess site–related) compared with heparin (3.3% vs. 5.5%; aOR, 0.59; 95% CI, 0.48–0.72; p < 0.0001). Outcomes were consistent regardless of use of a post-PCI bivalirudin infusion or routine GPI use with heparin and during 1-year follow-up.
Conclusions:
In patients with NSTEMI undergoing PCI, procedural anticoagulation with bivalirudin and heparin did not result in significantly different rates of mortality or ischemic events, including stent thrombosis and reinfarction. Bivalirudin reduced serious bleeding compared with heparin arising both from the access site and nonaccess sites.
Perspective:
The most recent American Heart Association/American College of Cardiology revascularization guideline supports use of unfractionated heparin (Class 1C) over bivalirudin (Class 2A) based on prior randomized controlled trial (RCT) results. Although bivalirudin has been shown to reduce bleeding events, there was concern about worst ischemic outcomes like stent thrombosis. The current analysis compared the effect of heparin versus bivalirudin on clinical outcomes (ischemic and bleeding) among patients with NSTEMI undergoing PCI using individual patient-level data from five prior RCTs. Results show comparable mortality and ischemic outcomes among patients receiving heparin (with or without GPI) versus bivalirudin. Bivalirudin was associated with significantly lower bleeding (access site and nonaccess site) compared to heparin. Findings need to be assessed in the context of current practice where default radial approach and associated lower bleeding rates may mitigate some of the bleeding advantage of the more expensive bivalirudin therapy. On the other hand, for patients with high bleeding risk, bivalirudin may be preferred.
Clinical Topics: Anticoagulation Management, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Vascular Medicine, Interventions and Vascular Medicine, Chronic Angina
Keywords: Heparin, Myocardial Ischemia, Non-ST Elevated Myocardial Infarction, Percutaneous Coronary Intervention, Platelet Glycoprotein GPIIb-IIIa Complex
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