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Bivalirudin lowered bleeding, increased stent thrombosis vs. heparin
Bivalirudin was associated with similar mortality, lower bleeding but higher stent thrombosis than heparin in a cohort of patients treated with those drugs after PCI, according to results of a recent meta-analysis published in EuroIntervention.
Trials comparing bivalirudin (Angiomax, The Medicines Company) to heparin with planned glycoprotein IIb/IIIa inhibitors (GPIs) were the primary basis for current recommendations for bivalirudin use in PCI. However, it is unknown whether bivalirudin is, in fact, superior to monotherapy with heparin. In the current meta-analysis of 10 randomized controlled trials, the researchers compared bivalirudin with heparin in a cohort of patients undergoing PCI without planned GPI use. The study included 9,033 patients in the bivalirudin group and 9,032 in the heparin group.
Thirty-day mortality served as the primary efficacy outcome, while bleeding at 30 days served as the primary safety endpoint. Thirty days was the cutoff point for the secondary outcomes as well, which included MI, definite stent thrombosis, urgent target vessel revascularization and overall mortality at the longest available follow-up.
A comparable mortality risk was reported at 30 days for bivalirudin and heparin (OR=1.09; 95% CI, 0.83-1.41; P=.54). Rates of MI were also similar (OR=1.10; 95% CI, 0.83-1.46; P=.50), whereas bivalirudin use was associated with a trend toward a higher risk for urgent TVR (OR=1.37; 95% CI, 0.96-1.96; P=.08), according to the results.
Bivalirudin yielded a lower risk of major bleeding (OR=0.57; 95% CI, 0.40-0.80; P=.001). When high doses of heparin were used as a comparator, the reduction in bleeding associated with bivalirudin was more pronounced (P<.001).
Bivalirudin was associated with an increase in definite stent thrombosis risk (OR=2.09; 95% CI, 1.26-3.47; P=.005) and acute stent thrombosis risk (OR=3.48; 95% CI, 1.66-7.28; P<.001).
“Bivalirudin as compared to heparin appears to reduce the risk of major bleeding at the expense of a higher risk of acute [stent thrombosis],” the researchers concluded.
For the results of a separate study published recently in The Lancet that also compared heparin with bivalirudin, click here.
Disclosure: The researchers report financial disclosures with Abbott, B. Braun, Biosensors and Biotronik.