Bivalirudin as compared to unfractionated heparin in patients undergoing percutaneous coronary revascularization: A meta-analysis of 22 randomized trials. Issue 5 (May 2015)

• Record Type: Journal Article
• Authors: Verdoia, Monica; Schaffer, Alon; Barbieri, Lucia; Suryapranata, Harry; De Luca, Giuseppe
• Is Part Of: Thrombosis research. Volume 135:Issue 5(2015)
• Page Start: 902
• Page End: 915
• Publication Date: 2015-05
• Subjects: Thrombosis -- Periodicals; 616.135
• DOI: 10.1016/j.thromres.2015.03.004
• Languages: English
• ISSNs: 0049-3848

Abstract

<abstract abstract-type="author" id="ab0005"> <title id="st0005">Abstract</title> <sec> <p id="sp0005">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.</p> </sec> <sec> <title id="st0060">Methods and study outcomes</title> <p id="sp0015">Literature archives (Pubmed, EMBASE, Cochrane) and main 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).</p> </sec> <sec> <title id="st0015">Results</title> <p id="sp0020">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).</p> </sec> <sec> <title id="st0020">Conclusions</title> <p id="sp0025">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.</p> </sec> </abstract>