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Trans-radial approach for percutaneous coronary intervention (PCI) has been shown to be superior to trans-femoral approach in reducing the risks of adverse events; However, it is unknown whether bivalirudin would offer any added benefit.
Electronic databases were searched for randomized trials comparing bivalirudin with unfractionated heparin in patients undergoing PCI through a trans-radial approach. Random effects overall risk ratios (RR) were calculated using DerSimonian and Laird model.
A total of 8,044 patients from 5 trials were included. The incidence of major bleeding was 1.8% in the bivalirudin group versus 2.2% in the unfractionated heparin group (RR 0.72, 95% CI 0.44-1.17, p=0.18). Subgroup analysis showed benefit with bivalirudin when compared with unfractionated heparin plus planned or provisional glycoprotein IIb/IIIa inhibitors, but not when compared with unfractionated heparin plus provisional glycoprotein IIb/IIIa inhibitors (Pinteraction=0.03). Meta-regression analysis demonstrated that the risk of major bleeding was lower with bivalirudin when higher doses of unfractionated heparin were used in the control arm (p=0.02). There were no significant differences in the incidence of major adverse cardiac events, all-cause mortality, and net adverse clinical events between both groups (RR 1.15, 95% CI 0.81-1.64, p=0.44; RR 0.98, 95% CI 0.70-1.36, p=0.89; and RR 0.79, 95% CI 0.62-1.03, p=0.08; respectively).
Bivalirudin does not appear to be associated with improved outcomes, when compared with unfractionated heparin for PCI through a trans-radial approach.