Meta‐analysis of bivalirudin versus heparin in transradial coronary interventions

Abstract

Objectives: We sought to evaluate the efficacy and safety of bivalirudin versus heparin in patients with coronary artery disease undergoing transradial artery coronary intervention (TRI). Background: Bivalirudin and radial artery access are independently associated with improved cardiovascular outcomes. However, data supporting a strategy of combining both to achieve additive improvements in cardiovascular outcomes provide conflicting results. Methods: A systematic search was performed to identify randomized controlled trials (RCTs) of bivalirudin, in which vascular access sites were reported. The primary outcome was net adverse clinical events (NACE) at 30 days. Secondary outcomes were long-term NACE, short-, and long-term major adverse cardiovascular events, all-cause mortality, myocardial infarction, unplanned revascularization, stent thrombosis, and major bleeding. Results: We identified 10 RCTs, including 16,328 patients who underwent TRI (mean age 64.6 ± 15.7 years, 72.5% male). Bivalirudin use was associated with decreased 30-day NACE compared with heparin (6.3 vs. 7.4%; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.76-0.99; p = .04; number needed to treat = 91). No significant interactions were observed based on clinical presentation, administration of P2Y 12 inhibitors, or glycoprotein IIb/IIIa-receptor inhibitors (GPI) use. There were no significant differences between groups in any prespecified secondary outcomes. There was, however, a significant reduction of major bleeding in the bivalirudin group compared with heparin when used in combination with routine GPI (RR = 0.41; 95% CI = 0.19-0.90; p = .03). Conclusions: Among patients undergoing TRI, use of bivalirudin was associated with significantly reduced 30-day NACE compared with heparin. There was no significant difference in long term NACE, ischemic, or bleeding events compared with heparin.

Reperfusion After Fibrinolytic Therapy (RAFT): An open-label, multi-centre, randomised controlled trial of bivalirudin versus heparin in rescue percutaneous coronary intervention

“…A meta-analysis in 2016 by Mina et al suggested that bivalirudin reduces bleeding risk only with femoral access [ 44 ]. Furthermore, in a recent updated meta-analysis by Kheiri et al examining bivalirudin in patients undergoing transradial PCI, bivalirudin compared with heparin ± glycoprotein IIb/IIIa inhibitors was associated with a reduced risk of net adverse clinical events; however, there was no significant difference in the risk of major bleeding at 30 days [ 45 ]. A significant reduction in major bleeding was only observed compared with heparin + planned glycoprotein IIb/IIIa inhibitors [ 45 ].…”

“…Furthermore, in a recent updated meta-analysis by Kheiri et al examining bivalirudin in patients undergoing transradial PCI, bivalirudin compared with heparin ± glycoprotein IIb/IIIa inhibitors was associated with a reduced risk of net adverse clinical events; however, there was no significant difference in the risk of major bleeding at 30 days [ 45 ]. A significant reduction in major bleeding was only observed compared with heparin + planned glycoprotein IIb/IIIa inhibitors [ 45 ]. However, most trials examined in these meta-analyses did not randomise patients according to procedural access, and there may have been confounding factors that were unaccounted for [ 44 , 45 ].…”

“…A significant reduction in major bleeding was only observed compared with heparin + planned glycoprotein IIb/IIIa inhibitors [ 45 ]. However, most trials examined in these meta-analyses did not randomise patients according to procedural access, and there may have been confounding factors that were unaccounted for [ 44 , 45 ]. MATRIX was the only trial that allocated access by randomisation (50% radial access) and showed that the bleeding benefit with bivalirudin was irrespective of access site, with reductions in access site-related and non-access site-related bleeding [ 21 ].…”

Bivalirudin Attenuates Thrombin-Induced Endothelial Hyperpermeability via S1P/S1PR2 Category: Original Articles

“…Previous studies have shown that hirudin can inhibit increased EC permeability ( Chen et al, 2020 ); however, hirudin has not been clinically recommended because it has not been available in adequate amounts. Increasing new evidence has suggested that patients treated with bivalirudin show reduced rates of hemorrhage compared to those treated with unfractionated heparin in many procedures in which anticoagulation is needed, such as transradial coronary interventions ( Kheiri et al, 2020 ), emergency percutaneous coronary intervention (PCI) for acute myocardium infarction ( Han et al, 2015 ), especially emergency interventional therapy for elderly individuals ( Meng et al, 2020 ), implantation of a left ventricular assist device ( Bates et al, 2020 ) and cardiac surgery in children ( Goswami et al, 2020 ) . There are currently no reports on whether bivalirudin can inhibit the changes in EC permeability induced by thrombin.…”

Radial access and risk guided use of bivalirudin?

“…Kheiri et al provide an aggregate (study‐level) data network meta‐analysis of bivalirudin versus heparin in the transradial access subgroups of PCI randomized trials 1 . While there is a significant decrease in net adverse cardiovascular events (NACE) with bivalirudin versus heparin (6.3 vs. 7.4%) at 30 days, there is no significant difference in long‐term ischemic, bleeding, or NACE between bivalirudin and heparin.…”