Efficacy of bivalirudin versus heparin for patients with acute coronary syndrome undergoing primary percutaneous coronary intervention: a Meta-analysis

Objective To evaluate the impact of bivalirudin versus heparin on efficacy and safety outcomes for patients with acute coronary syndrome (ACS) undergoing primary percutaneous coronary intervention (PCI). Methods The databases of PubMed, Medline, Embase, Elsevier, Cochrane Library, CNKI and WanFang Database were retrieved with computer for searching the randomized controlled trials (RCTs) about the bivalirudin versus heparin for patients with ACS undergoing primary PCI. All materials were retrieved and evaluated independently by 2 reviewers, and then performed a Meta-analysis using RevMan 5.3 software. The short-term (during hospitalization to 30 days) outcomes mainly are major adverse cardiovascular events (MACE including all-cause death, myocardial infarction, revascularization), postoperative bleeding complications/major bleeding, acute and subacute stent thrombosis. Results There were finally 12 RCT included involving 26 822 cases. The results of Meta-analysis showed that all-cause death (RR=1.02, 95%CI: 0.85-1.22, P=0.85), myocardial infarction (RR=1.15, 95%CI: 0.95-1.40, P=0.16), stent thrombosis in 30 d (RR=1.36, 95%CI: 0.89-2.07, P=0.15), subacute stent thrombosis (24 h-30 d) (RR=0.88, 95%CI: 0.54-1.42, P=0.60), revascularization (RR=1.15, 95%CI: 0.98-1.34, P=0.08) were not significantly different between bivalirudin and heparin with or without Glycoprotein Ⅱb/Ⅲa Inhibitors. In short-term post operation, major bleeding was significantly reduced by bivalirudin compared to heparin (RR=0.61, 95%CI: 0.46-0.81, P=0.0008). However, bivalirudin increased the risk of acute stent thrombosis (RR=3.76, 95%CI: 2.12-6.66, P<0.00001) compared to that of heparin. Conclusions In patients with ACS undergoing primary PCI, using bivalirudin and heparin preparation have similar outcomes on all-cause death, myocardial infarction, and subacute stent thrombosis in >24 hours to 30 days, but bivalirudin is superior to heparin preparation in reducing bleeding risk after PCI. However, bivalirudin increases the rate of acute stent thrombosis in ≤24 hours. Key words: Bivalirudin; Heparin; Acute coronary syndrome; Angioplasty, transluminal, percutaneous coronary; Meta-analysis