Relative efficacy of bivalirudin vs. heparin monotherapy in STEMI patients treated with primary percutaneous coronary intervention - a network meta-analysis

Abstract

Objective: In the absence of head-to-head clinical data, the objective of this study was to indirectly compare the efficacy and safety of a bivalirudin-based anticoagulation strategy to heparin monotherapy in patients with ST-elevation myocardial infarction (STEMI) intended for primary percutaneous coronary intervention (PPCI). Methods: A systematic literature review was performed to identify randomised controlled trials (RCTs) to build a network of bivalirudin and heparin monotherapy strategies in STEMI patients using heparin with glycoprotein IIb/IIIa inhibitor (GPI) as a common reference strategy. Identified data were analysed using fixed and random effects network meta-analysis (NMA). A base-case analysis was constructed from intention-to-treat populations in the RCTs. Sensitivity analysis was also performed. Outcomes (mortality, stroke, myocardial infarction, ischaemic target vessel revascularisation (TVR), major adverse cardiovascular events (MACE), TIMI major and minor bleeding) were evaluated at 30 days and 1 year. Results: Eight RCTs (including 8,807 patients) were identified for inclusion in the NMA. At 30 days, the bivalirudin-based strategy was expected to result in lower mortality rates than heparin monotherapy (odds ratio (OR) 0.55; credible interval (CrL: 0.32, 0.95). This relationship was sustained at 1 year. At 30 days, the risk of stroke (OR: 0.88; CrL: 0.37, 2.13), myocardial infarction (OR: 0.79; CrL: 0.40, 1.55), ischaemic TVR (OR: 0.75; CrL: 0.38, 1.46), TIMI major bleeding (OR: 0.85; CrL: 0.47, 1.52), TIMI minor bleeding (OR: 0.70; CrL: 0.41, 1.18) and TIMI major and minor bleedings (OR: 0.66; CrL: 0.45, 0.98) tended to be numerically reduced with bivalirudin in comparison to heparin monotherapy. The findings of sensitivity analyses were in line with the base case analysis. Conclusion: For patients with STEMI intended for PPCI, bivalirudin is associated with lower mortality rates in comparison to heparin monotherapy. Also, the risk of ischaemic and bleeding outcomes may also be reduced by bivalirudin. This study suggests that bivalirudin is more effective and safer than heparin monotherapy and should therefore be preferred over heparin monotherapy.