Efficacy and safety of bivalirudin versus heparin in patients with diabetes mellitus undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials

BACKGROUND: The efficacy and safety of bivalirudin (Biva) versus heparin in patients with diabetes mellitus (DM) who undergo percutaneous coronary intervention (PCI) remain controversial. Our meta-analysis was undertaken to evaluate the efficacy and safety of Biva compared with those of heparin in patients with diabetes undergoing PCI. METHODS: We searched PubMed, EMBASE, Cochrane Library, and Clinical Trials.gov databases for randomized controlled trials (RCTs). The primary efficacy endpoint was the incidence of major adverse cardiovascular events (MACE), and the primary safety endpoint was the incidence of major bleeding. Secondary efficacy endpoints were incidence of net adverse clinical events (NACE), myocardial infarction (MI), and death. The pooled risk ratio (RR) with the corresponding 95% confidence intervals (CIs) were used to assess the efficacy and safety of Biva versus heparin. RESULTS: Eleven RCTs met the inclusion criteria, and 8428 patients were included. No significant difference was observed in the subgroup and overall risk of MACE (RR 0.87; 95% CI 0.74–1.02; P = .08; I(2) = 39%) and NACE (RR 0.81; 95% CI 0.61–1.07; P = .14; I(2) = 71%). Biva had an effect similar to that of heparin on the endpoint of death (RR 0.75; 95% CI 0.56–1.02; P = .07; I(2) = 0) and MI (RR 0.92; 95% CI 0.67–1.26; P = .59; I(2) = 0) but decreased the risk of major bleeding (RR 0.63; 95% CI 0.52–0.75; P < .00001; I(2) = 0%). CONCLUSION: The use of Biva and heparin is associated with a similar risk of MACE, NACE, death, and MI. Biva decreases the risk of major bleeding more significantly than heparin.