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Updated: Apr 11, 2026
Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Critical Appraisal of Bivalirudin versus Heparin for Percutaneous Coronary Intervention: A Meta-Analysis of
Anthony A Bavry1, Islam Y Elgendy2, Ahmed Mahmoud2
1North Florida/South Georgia Veterans Health System, Gainesville, Florida, United States of America; Department of Medicine, University of Florida, Gainesville, Florida, United States of America.
Insights
Bivalirudin use in percutaneous coronary intervention (PCI) increases stent thrombosis risk but may reduce major bleeding. This bleeding benefit is lost when compared to lower doses of unfractionated heparin.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Bivalirudin (BV) plus glycoprotein IIb/IIIa inhibitors (GPI) is as effective as unfractionated heparin (UFH) plus GPI for preventing cardiac ischemic events.
- BV offers a lower bleeding risk compared to UFH when GPI use is similar.
- The comparative efficacy and safety of BV versus UFH in PCI, specifically when GPI use is standardized, requires further investigation.
Purpose of the Study:
- To compare the efficacy and safety of bivalirudin versus heparin in patients undergoing percutaneous coronary intervention (PCI) when glycoprotein IIb/IIIa inhibitor use is similar between groups.
- To assess the impact of bivalirudin on stent thrombosis, myocardial infarction, mortality, major adverse cardiac events, and major bleeding.
- To investigate whether the dose of unfractionated heparin influences the bleeding risk associated with bivalirudin.
Main Methods:
- Systematic review and meta-analysis of randomized controlled trials (RCTs).
- Searched MEDLINE, Web of Science, and Cochrane databases until March 2015.
- Included 15 RCTs with 25,824 patients comparing bivalirudin to heparin in PCI with similar intended GPI use.
- Summary estimates constructed using the Peto method.
Main Results:
- Bivalirudin was associated with an increased hazard of stent thrombosis (OR 1.49, P = .002).
- No significant differences were observed for myocardial infarction, all-cause mortality, or major adverse cardiac events.
- Bivalirudin showed a reduced hazard of major bleeding (OR 0.80, P = .001), but this was not apparent when UFH dose was ≤ 75 units/kg (OR 1.09, P = .36).
Conclusions:
- In patients undergoing PCI, bivalirudin is associated with an increased risk of stent thrombosis.
- Bivalirudin may reduce major bleeding, but this effect is dependent on the unfractionated heparin dose used in the comparator arm.
- Clinical decisions regarding bivalirudin use should consider the potential increase in stent thrombosis and the context of heparin dosing.
Abstract:
Percutaneous coronary intervention with bivalirudin plus bail-out glycoprotein IIb/IIIa inhibitors has been shown to be as effective as unfractionated heparin plus routine glycoprotein IIb/IIIa inhibitors in preventing cardiac ischemic events, but with a lower bleeding risk. It is unknown whether bivalirudin would have the same beneficial effects if compared with heparin when the use of glycoprotein IIb/IIIa inhibitors was similar between treatment arms. We searched the MEDLINE, Web of Science, and Cochrane databases from inception until March 2015 for randomized trials that compared bivalirudin to heparin in patients undergoing percutaneous coronary intervention. We required that the intended use of glycoprotein IIb/IIIa inhibitors was similar between the study groups. Summary estimates were principally constructed by the Peto method. Fifteen trials met our inclusion criteria, which yielded 25,824 patients. Bivalirudin versus heparin was associated with an increased hazard of stent thrombosis (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.15-1.92, P = .002, I2 = 16.9%), with a similar hazard of myocardial infarction (OR 1.09, 95% CI 0.98-1.22, P = .11, I2 = 35.8%), all-cause mortality (OR 0.88, 95% CI 0.72-1.08, P = .21, I2 = 31.5%) and major adverse cardiac events (OR 1.04, 95% CI 0.94-1.14, P = .46, I2 = 53.9%). Bivalirudin was associated with a reduced hazard of major bleeding (OR 0.80, 95% CI 0.70-0.92, P = .001, I2 = 63.5%). The dose of heparin in the control arm modified this association; when the dose of unfractionated heparin in the control arm was ≥ 100 units/kg, bivalirudin was associated with a reduction in major bleeding (OR 0.55, 95% CI 0.45-0.68, P < .0001), but when the dose of unfractionated heparin was ≤ 75 units/kg, bivalirudin was not associated with reduction in bleeding (OR 1.09, 95% CI 0.91-1.31, P = .36). Among patients undergoing PCI, bivalirudin was associated with an increased hazard of stent thrombosis. Bivalirudin may be associated with a reduced hazard of major bleeding; however, this benefit was no longer apparent when compared with a dose of unfractionated heparin ≤ 75 units/kg.
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