Abstract

Introduction: Chronic total occlusion (CTO) percutaneous intervention (PCI) is an evolving challenge within interventional cardiology. Anticoagulation during percutaneous intervention remains part of the standard of care for patients undergoing PCI to prevent thrombotic complications peri-procedurally. Unfractionated heparin (UFH) is a commonly used for CTO PCI-related anticoagulation. However, bivalirudin (BV), a synthetic, reversible, direct thrombin inhibitor, has been utilized as an alternative to UFH in CTO patients undergoing PCI. This meta-analysis aims to investigate the efficacy and safety of bivalirudin versus UFH for CTO PCI. Methods: We performed a comprehensive literature search using PubMed, Embase, and Cochrane Library databases through May 2022 for all studies evaluating efficacy and safety of bivalirudin versus UFH in CTO patients undergoing PCI. The primary outcome was mortality. Secondary outcomes were major adverse cardiac events (MACE), major bleeding events, peri-procedure myocardial infarction (MI), in-stent thrombosis, and unplanned revascularization. Pooled risk ratio (RR) and 95% confidence intervals (CIs) were obtained by the Mantel-Haenszel method within a random-effects model. Heterogeneity was assessed by I2 statistic. Results: A total of 5 studies containing 1347 patients with CTO undergoing PCI on anticoagulation (631 BV versus 716 UFH) were included. No significant difference existed between BV and UFH regarding mortality [RR: 0.54 (95% CI: 0.19-1.56); P 0.26 , I2 0%]. Major bleeding events were significantly lower in BV compared with UFH [RR: 0.33 (95% CI: 0.19-0.66); P 0.001, I2 0%]. MACE [RR: 0.75 (95% CI: 0.55-1.00); P 0.05, I2 2%], peri-procedure MI [RR: 0.80 (95% CI: 0.56-1.15); P 0.24, I2 0%], in-stent thrombosis [RR: 0.68 (95% CI: 0.19-2.39); P 0.55, I2 17%] and unplanned revascularization [OR: 0.77 (95% CI: 0.29-2.07); P 0.61, I2 0%] were similar between the two groups. Conclusions: BV seems to be safer than UFH in preventing major bleeding in anticoagulated patients with CTO undergoing PCI; there is no significant difference between groups in terms of mortality, MACE, peri-procedure MI, in-stent thrombosis, or unplanned revascularization. Future randomized controlled trials are needed.

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