Pooling the Evidence at the Patient Level: End of the Bivalirudin Saga?

Abstract

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

“…This shift has occurred in parallel with an increase in the use of radial access and a decrease in the use of upstream glycoprotein IIb/IIIa inhibitors [ 21 , 37 ]. The interplay between these effect modifiers has probably contributed to heterogeneity in the results [ 9 ]. Initial trials mandated glycoprotein IIb/IIIa inhibitors in the heparin arm, which may have increased the bleeding risk favouring bivalirudin [ 13 – 15 ].…”

“…In studies over two decades ago, when bivalirudin was compared to heparin as an adjunctive antithrombin agent to fibrinolytic therapy, improved ischaemic endpoints and reduced bleeding has been reported [ 5 – 8 ]. Since then, conflicting safety and efficacy outcomes for bivalirudin relative to heparin have been reported in contemporary trials of patients undergoing primary PCI [ 9 ]. Several study-level meta-analyses report reduced major bleeding and variable mortality benefits with bivalirudin compared to heparin ± glycoprotein IIb/IIIa inhibitors, at the expense of an increased risk of acute stent thrombosis [ 10 – 12 ].…”

Bivalirudin in Primary PCI: Can Its Glory Being Restored?

“…The mortality benefit of bivalirudin in STEMI was pronounced in patients treated with a post-PCI bivalirudin infusion (low-dose or high-dose), and a high-dose infusion mitigated the MI and stent thrombosis risk. As commented by Capodanno and Angiolillo, [88] the pooling of IPD enables more sophisticated efforts, including identification of independent predictors and examining the temporal relationship between treatments and outcomes, and conceptually is at the pinnacle in the hierarchy of evidence. Important details to further examine will be the relationship between access site and outcomes, and in particular subgroups of interest at particularly high-risk for either ischemia or bleeding.…”

Ticagrelor vs clopidogrel when coadministered with bivalirudin in patients with acute coronary syndrome undergoing percutaneous coronary intervention

“…Indeed, bivalirudin, a reversible and direct thrombin inhibitor, possesses several potential advantages, such as a short half-life with low risk of bleeding, linear kinetics with a predictable anticoagulant response, and low immunogenic profile without induction of heparin-induced thrombocytopenia [ 4 ]. Moreover, previous randomized trials suggest that bivalirudin determines superiority, especially in terms of decreased bleeding compared with unfractionated heparin, despite its concern about stent thrombosis [ 5 ].…”