Bivalirudin infusion to reduce ventricular infarction: the open-label, randomised Bivalirudin Infusion for Ventricular InfArction Limitation (BIVAL) study

EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Robert Jan van GeunsLudovic Drouet

Abstract

The aim of the study was to investigate whether bivalirudin versus unfractionated heparin (UFH) reduces infarct size (IS) for primary percutaneous coronary intervention (PPCI) in large acute myocardial infarction (AMI). This multicentre open-label trial randomised 78 patients undergoing PPCI for large AMI to bivalirudin or UFH. The primary endpoint was IS, assessed by cardiac magnetic resonance (CMR) five days after PPCI. Secondary endpoints included index of microcirculatory resistance (IMR), CMR-assessed microvascular obstruction (MVO) and ejection fraction, and biomarkers for thrombin activity and cell injury. No difference was observed in mean IS at five days (25.0±19.7 g for bivalirudin vs. 27.1±20.7 g for UFH; p=0.75). Early MVO was numerically lower with bivalirudin (5.3±5.8 g vs. 7.7±6.3 g; p=0.17), with no significant difference in ejection fraction at 90 days (54.6±12.0% vs. 49.1±12.1%; p=0.11). In the biomarkers, thrombin-antithrombin complexes were reduced by 4.8 ug/L over the first day for bivalirudin versus an increase of 1.9 ug/L in the heparin arm (p=0.0003). Acute IMR was lower (43.5±21.6 vs. 68.7±35.8 mmHg×s, respectively; p=0.014). In a planned interim analysis, an approximate 11% reduction in IS was observed...Continue Reading

References

Aug 2, 2001·American Heart Journal·M M GrahamUNKNOWN APPROACH Investigators (Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease
Feb 2, 2008·Journal of the American College of Cardiology·William F FearonAlan C Yeung
May 24, 2008·The New England Journal of Medicine·Gregg W StoneUNKNOWN HORIZONS-AMI Trial Investigators
Sep 13, 2014·JACC. Cardiovascular Imaging·Matthijs van KranenburgRobert-Jan van Geuns
Sep 2, 2015·The New England Journal of Medicine·Marco ValgimigliUNKNOWN MATRIX Investigators

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Citations

Aug 7, 2017·EuroIntervention : Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology·Darren Mylotte, Robert A Byrne
Jul 28, 2020·Journal of Cardiovascular Translational Research·James XuDominic Y Leung

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