Bivalirudin as compared to unfractionated heparin in patients undergoing percutaneous coronary revascularization: A meta-analysis of 22 randomized trials

Bivalirudin has gained ground against unfractionated heparin (UFH) in percutaneous coronary interventions (PCI), due to a reported better safety profile. However, whether bivalirudin may provide also advantages in clinical outcome beyond the known benefits in major bleedings, is still a debated matter and was, therefore, the aim of present meta-analysis of randomized trials, evaluating efficacy and safety of bivalirudin as compared with UFH in PCI. Methods and study outcomes: Literature archives (Pubmed, EMBASE, Cochrane) andmain scientific sessions were scanned. Primary endpoint was overall mortality. Secondary endpoints were: 1) mortality within 30-days; 2) overall and within 30-days non fatal myocardial infarction; 3) overall and within 30-days stent thrombosis. Safety endpoints were major bleedings (per protocol definition or TIMI classification). A prespecified analysis was conducted according to clinical presentation (Elective, ACS, STEMI). Results: A total of 22 randomized clinical were finally included, involving 40156 patients randomized to bivalirudin (52.9%) or to UFH (47.1%). Death occurred in 1100 (2.8%) of patients, with no difference between bivalirudin and UFH (2.7% vs 2.8% OR[95%C] = 0.94[0.83,-.06], p = 0.32, phet = 0.48). The results did not change according to clinical presentation. By meta-regression analysis, the effects on mortality were not related to patients risk profile (r = -0.38(-0.89-0.14), p = 0.15) or the reduction in bleeding complications (r = -0.008(-0.86-0.85), p = 0.98). A significant increase in short-term stent thrombosis was observed with bivalirudin (OR[95%CI] = 1.42[1.10-1.83], p = 0.006). However, Bivalirudin significantly reduced bleedings according to both study protocol definition (OR[95%CI] = 0.62[0.56-0.69], p < 0.00001; phet = 0.0003) or TIMI major criteria (OR[95%CI] = 0.65[0.53-0.79], p < 0.0001, phet = 0.95). Conclusions: In present meta-analysis, among patients undergoing PCI, bivalirudin, as compared with UFH, is associated with a significant reduction in major bleeding complications that, however, does not translate into mortality benefits. Furthermore, bivalirudin is associated with higher rate of 30-days stent thrombosis and recurrent MI among STEMI patients. (C) 2015 Elsevier Ltd. All rights reserved.