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

- Safety and effectiveness of Bivalirudin during PCI is still debated.
- Present is the most comprehensive meta-analysis on Bivalirudin, with 22 RCTs.
- Bivalirudin did not reduce mortality as compared with UFH, independently from presentation.
- The reduction in major bleedings with Bivalirudin did not impact on mortality
- Bivalirudin increased early stent thrombosis and reinfarction among STEMI patients

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 outcomesLiterature 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).ResultsA 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).ConclusionsIn 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.