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Purpose and Methods

In hospital and 30 day outcomes in all-comer PCI with bivalirudin : Initial report of the prospective EUROVISION Registry. Hamon M 1 , Nienaber C 2 , Galli S 3 , Huber K 4 , Gulba D 5 , Hill J 6 , Lafont A 7 , Cequier A 8 , Bernstein D 9 , Deliargyris E 9

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Purpose and Methods

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  1. In hospital and 30 day outcomes in all-comer PCI with bivalirudin:Initial report of the prospective EUROVISION Registry Hamon M1, Nienaber C2, Galli S3, Huber K4, Gulba D5, Hill J6, Lafont A7, Cequier A8, Bernstein D9, Deliargyris E9 Institutions: 1. Centre HospitalierUniversitaire de Caen, France.2. Department of Cardiology and Angiology, University Hospital Rostock, Rostock School of Medicine, Rostock, Germany.3. Department of Cardiovascular Sciences, University of Milan, Centro CardiologicoMonzino, IRCCS, Milan, Italy.4. Third Department of Medicine, Cardiology and Emergency Medicine, Wilhelminen hospital, Vienna, Austria. 5. Department of Cardiology, KrankenhausDüren, Düren, Germany. 6. King's College Hospital, King's College, London, UK. 7. Cardiology Department, University Paris-Descartes; AP-HP; European Georges Pompidou Hospital, Paris, France. 8. Hospital de Bellvitge, Barcelona, Spain. 9. The Medicines Company, Parsippany NJ, USA.

  2. Purpose and Methods • Eurovision was a prospective observational study conducted in58 European sites to track utilization patterns of bivalirudinin PCI. • Outcomes were collected for ischemic events (death, MI, stroke and urgent revascularization), and bleeding in hospital and at 30 days • Major bleeding, ACUITY definition (any one of the following): Intracranial, retroperitoneal, or intraocular bleeding, access site hemorrhage requiring radiological or surgical intervention, ≥5 centimeter(cm) diameter hematoma at puncture site, decrease in hemoglobin (Hgb) concentration of ≥4 g/dl without an overt source of bleeding, decrease Hgb concentration of ≥3 g/dl with an overt source of bleeding, re-operation for bleeding, any blood product transfusion • Minor bleeding was any bleeding not included in the definition of major bleeding

  3. Methods • A total of 2018 consecutive bivalirudin-treated patients were included from 58 sites in 5 countries • Germany (31.1%) • France (28.9%) • Italy (19.0%) • Austria (17.0%) • United Kingdom (4.0%) • In-hospital and 30-day outcomes were collected and included: Death, MI, stroke, revascularization, major and minor bleeding, stent thrombosis and thrombocytopenia

  4. Baseline characteristics

  5. Procedural characteristics

  6. Distribution of study population Overall, 58% of patients were cardiac marker -positive N=523 N=315 N=499 N=678

  7. Results • Overall, P2Y12 inhibitor preloading occurred in 95% of patients • 91% clopidogrel (65% with 600 mg, 33% with 300 mg) • 9% prasugrel • 45% of patients received other antithrombin therapy prior to PCI and were then switched to bivalirudin • Activated clotting time was checked in only 2.8% suggesting operator familiarity with bivalirudin predictable mode of action and treatment effect

  8. Outcomes Stroke Death MI Urgent revasc D/ MI/ UrR/ Stroke/ Major bleed Major bleed

  9. Independent predictors of ischemic events and major bleeding

  10. Stent thrombosis by diagnosis • Overall rate of stent thrombosis 0.3% (6/2018)

  11. Outcomes by post-PCI infusion Among STEMI patients, 62% received a post-procedural bivalirudin infusion for a median duration of 122 minutes

  12. Conclusion • Adaptation of bivalirudin as the foundation for all-comer PCI (including high percentage of STEMI and NSTEMI patients) is associated with excellent ischemic protection and safety, • The rates observed in EUROVISION compare favorably to other large existing registry datasets.

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