Martial Hamon1, Christopher A Nienaber2, Stefano Galli3, Kurt Huber4, Janusz Lipiecki5, Jonathan M Hill6, Nicolas Amabile7, Debra Bernstein8, Efthymios Deliargyris8, Antoine Lafont9, Philippe Gabriel Steg10. 1. University of Caen, France; INSERM U 744, Lille, France. Electronic address: hamon-m@chu-caen.fr. 2. Heart Center Rostock, Rostock, Germany. 3. Centro Cardiologico Monzino, IRCCS, University of Milan, Italy. 4. Medizinische Abteilung (Kardiologie) Wilhelminenspital Montleartstrasse, Wien, Austria. 5. Centre de Cardiologie Interventionnelle, Pôle Santé République, Clermont-Ferrand, France. 6. King's College Hospital, Denmark Hill, London SE5 9RS, UK. 7. Cardiology Department, Centre Marie Lannelongue, Le Plessis-Robinson, France. 8. The Medicines Company, Parsippany, NJ, USA. 9. INSERM U-970, AP-HP, Paris, France; Université Paris-Descartes, Paris, France. 10. Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France; INSERM U-698, Paris, France; Hôpital Bichat, AP-HP, Paris, France.
Abstract
PURPOSE: The prospective EUROVISION Registry was designed to capture patterns of use and short term outcomes in consecutive patients undergoing PCI with bivalirudin (BIV) in European centres. METHODS: A total of 2018 consecutive BIV-treated patients were included from 58 sites in 5 countries (Germany, Italy, France, Austria, United Kingdom). In-hospital and 30-day outcomes were prospectively collected and included: death, myocardial infarction (MI), stroke, urgent revascularization (URV), major and minor bleeding, stent thrombosis (ST) and thrombocytopenia (TCP). RESULTS: In this all-comer population, indication for PCI included STEMI (34%), NSTEMI (25%), unstable angina (16%) and stable angina (26%). Diabetes was present in 24% of patients and 30% of cases were performed via radial access. Preloading with a P2Y12 inhibitor was frequent (74%) while procedural glycoprotein inhibitor (GPI) use was low at 4.2%. Almost half (45%) of patients had received at least one additional anticoagulant prior to receiving BIV for PCI. The overall 30-day mortality was 1.0%, with low rates of MI (1.1%), URV (0.8%), ST (0.3%) and stroke (0.2%). The rate of ACUITY major bleeding was 1.6% and no TCP was reported. Dosing variations representing possible under- or over-dosing of BIV were frequent at 35%. CONCLUSION: In this prospective registry of consecutive patients intended for PCI, use of BIV was associated with low rates of ischemic complications and excellent safety.
PURPOSE: The prospective EUROVISION Registry was designed to capture patterns of use and short term outcomes in consecutive patients undergoing PCI with bivalirudin (BIV) in European centres. METHODS: A total of 2018 consecutive BIV-treated patients were included from 58 sites in 5 countries (Germany, Italy, France, Austria, United Kingdom). In-hospital and 30-day outcomes were prospectively collected and included: death, myocardial infarction (MI), stroke, urgent revascularization (URV), major and minor bleeding, stent thrombosis (ST) and thrombocytopenia (TCP). RESULTS: In this all-comer population, indication for PCI included STEMI (34%), NSTEMI (25%), unstable angina (16%) and stable angina (26%). Diabetes was present in 24% of patients and 30% of cases were performed via radial access. Preloading with a P2Y12 inhibitor was frequent (74%) while procedural glycoprotein inhibitor (GPI) use was low at 4.2%. Almost half (45%) of patients had received at least one additional anticoagulant prior to receiving BIV for PCI. The overall 30-day mortality was 1.0%, with low rates of MI (1.1%), URV (0.8%), ST (0.3%) and stroke (0.2%). The rate of ACUITY major bleeding was 1.6% and no TCP was reported. Dosing variations representing possible under- or over-dosing of BIV were frequent at 35%. CONCLUSION: In this prospective registry of consecutive patients intended for PCI, use of BIV was associated with low rates of ischemic complications and excellent safety.