Key result
Bivalirudin monotherapy shows no benefit over heparin for MACE or major bleeding in PCI.
Why the study?
Recent clinical trials revealed that bivalirudin has comparable efficacy to heparin, prompting a comparison of the efficacy and safety of bivalirudin and heparin administered as monotherapy or with glycoprotein IIb/IIIa inhibitors in ACS patients undergoing PCI.
Does bivalirudin (as monotherapy or with glycoprotein IIb/IIIa inhibitors) reduce major bleeding and major adverse cardiovascular events compared to heparin (as monotherapy or with glycoprotein IIb/IIIa inhibitors) in patients with acute coronary syndromes undergoing percutaneous coronary intervention?
Meta-Analysis (n=72,628)
Mixed (Double-blind, Single-blind, Open-label)
Randomized controlled trials included
Yes
Does bivalirudin (as monotherapy or with glycoprotein IIb/IIIa inhibitors) reduce major bleeding and major adverse cardiovascular events compared to heparin (as monotherapy or with glycoprotein IIb/IIIa inhibitors) in patients with acute coronary syndromes undergoing percutaneous coronary intervention?
In over 72,000 ACS patients undergoing PCI, bivalirudin monotherapy and heparin monotherapy showed comparable efficacy and bleeding safety, while adding GP IIb/IIIa inhibitors increased major bleeding with heparin and stent thrombosis with bivalirudin.
Supports either bivalirudin or heparin monotherapy in ACS PCI; confirms equivalence from recent RCTs while cautioning against routine GP IIb/IIIa addition.
Introduction Recent clinical trials have revealed that bivalirudin has comparable efficacy to heparin. In this network meta-analysis, we aimed to compare the efficacy and safety of bivalirudin and heparin administered as monotherapy or with glycoprotein IIb/IIIa inhibitors, in patients of acute coronary syndromes undergoing percutaneous coronary intervention (PCI). Material and methods We performed a systematic search of PubMed and Embase to identify studies with acute coronary syndrome patients > 18 years, who underwent PCI, and were treated with bivalirudin or heparin either as monotherapy or with glycoprotein IIb/IIIa inhibitors. Outcomes were major bleeding, major adverse cardiovascular events (MACE), all-cause mortality, reinfarction, stent thrombosis and cardiovascular death. Pooled relative risks (RR) were calculated using the net-meta module with/and random effects model with a 95% confidence interval (CI) for statistical significance. Higgins I2 statistic was used to assess heterogeneity. Results A total of 23 randomized controlled trials comprising 72,628 patients were included. Bivalirudin monotherapy compared to heparin monotherapy demonstrated no significant difference in risk of bleeding (RR = 0.83, 95% CI: 0.64–1.08, p = 0.17), MACE (RR = 0.99, 95% CI: 0.93–1.05, p = 0.72) and other outcomes. Bivalirudin combined with GP IIb/IIIa inhibitors had an increased risk of stent thrombosis compared with heparin monotherapy (RR = 3.62, 95% CI: 1.002–13.14). In major bleeding, heparin with GP IIb/IIIa inhibitors had a statistically significant RR of 1.454 (95% CI: 1.006–2.1009, p = 0.045). Conclusions Bivalirudin and heparin have similar efficacy and safety profiles in patients undergoing PCI for ACS. The choice of the anticoagulant should be individualized based on patient and procedural characteristics.
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Adnan et al. (2026) conducted a meta-analysis in Acute coronary syndrome undergoing percutaneous coronary intervention (n=72,628). Bivalirudin monotherapy vs. Heparin monotherapy was evaluated on Major adverse cardiovascular events (composite of all-cause mortality, myocardial infarction, and revascularization) (RR 0.989, 95% CI 0.928-1.052, p=0.719). Bivalirudin monotherapy showed no significant difference in MACE (RR 0.989, 95% CI 0.928-1.052) or major bleeding (RR 0.834, 95% CI 0.643-1.082) vs heparin monotherapy in ACS patients undergoing PCI.
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