Impact of bivalirudin on mortality and bleeding complications in acute coronary syndrome patients undergoing invasive revascularization : A real world experience.

Miklos Rohla,Kurt Huber,Matthias K Freynhofer,Rudolf Jarai,Thomas W Weiss,Serdar Farhan,Florian Egger,Johann Wojta,Adnan Kastrati,Ioannis Tentzeris,Gregg W Stone,Alexander Geppert

doi:10.1007/s00508-016-1078-6

Abstract

SummaryBackgroundIn a retrospective analysis of a prospective single center registry we compared the use of bivalirudin, unfractionated heparin (UFH) monotherapy, UFH + abciximab in 1240 consecutive patients with acute coronary syndrome (ACS) undergoing stent implantation.ResultsBivalirudin was associated with tendentially reduced in-hospital minor or major bleeding rates compared to UFH monotherapy (5.9 % vs. 9.4 % adjusted odds ratio (OR) 0.82, 95 % confidence interval CI 0.45–1.51, p = 0.53) and compared to the pooled UFH group (5.9 % vs. 11.9 %, adjusted OR 0.62, 95 % CI 0.36–1.08, p = 0.09) but with significantly lower bleeding hazards compared to UFH + abciximab (5.9 % vs. 16 %, adjusted OR 0.41, 95 % CI 0.22–0.78, p < 0.01). After 3 years of follow-up, adjusted cardiovascular mortality rates were similar between all groups, particularly between bivalirudin vs. UFH monotherapy (hazard ratio HR 1.12, 95 % CI 0.58–2.16, p = 0.73) and vs. UFH + abciximab (HR 0.91, 95 % CI 0.40–2.10, p = 0.83). Acute or subacute stent thrombosis occurred at a rate of 0.8 % with no significant differences between the groups.ConclusionsThis retrospective analysis in a real world situation of medium to high-risk ACS patients undergoing invasive revascularization confirmed the results of most large-scale randomized trials by demonstrating reduced bleeding rates in favor of bivalirudin vs. UFH + GPI but with no significant differences between treatment strategies for long-term all-cause and cardiovascular mortality.

Highlights

Acute or subacute stent thrombosis occurred at a rate of 0.8 % with no significant differences between the groups. This retrospective analysis in a real world situation of medium to high-risk acute coronary syndrome (ACS) patients undergoing invasive revascularization confirmed the results of most large-scale randomized trials by demonstrating reduced bleeding rates in favor of bivalirudin vs. unfractionated heparin (UFH) + glycoprotein IIb/IIIa inhibitor (GPI) but with no significant differences between treatment strategies for long-term all-cause and cardiovascular mortality
Invasive revascularization with stent implantation is the standard of care for the majority of patients presenting with acute coronary syndrome (ACS) and improves clinical outcomes compared to a more conservative approach [1]
Original article bivalirudin translated into lower 30-day major bleeding rates compared to unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) and vs. UFH monotherapy but exhibited similar or even worse rates in ischemic events depending on study design, patient selection and concomitant therapy [4, 7,8,9]

Summary

Introduction

Invasive revascularization with stent implantation is the standard of care for the majority of patients presenting with acute coronary syndrome (ACS) and improves clinical outcomes compared to a more conservative approach [1]. 906 Impact of bivalirudin on mortality and bleeding complications in acute coronary syndrome patients. K original article bivalirudin translated into lower 30-day major bleeding rates compared to unfractionated heparin (UFH) plus a glycoprotein IIb/IIIa inhibitor (GPI) and vs UFH monotherapy but exhibited similar or even worse rates in ischemic events depending on study design, patient selection and concomitant therapy [4, 7,8,9]. We investigated the efficacy and safety of bivalirudin compared to heparin-based strategies in patients with ST-elevation or non-ST-elevation myocardial infarction (STEMI and NSTEMI, respectively) referred for acute angiography who subsequently received PCI and stent implantation

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