Gregory Y H Lip1, Laura Mauri2, Gilles Montalescot3, Mick Ozkor4, Panagiotis Vardas5, Philippe Gabriel Steg6, Deepak L Bhatt7, Stefan H Hohnloser8, Corinna Miede9, Matias Nordaby10, Martina Brueckmann11, Joerg Kreuzer12, Takeshi Kimura13, Jonas Oldgren14, Jurrien M Ten Berg15, Christopher P Cannon7. 1. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. Electronic address: gregory.lip@liverpool.ac.uk. 2. Brigham and Women's Hospital, Boston, MA. 3. Sorbonne University-Paris VI, ACTION Study Group, Pitié-Salpêtrière Hospital, Paris, France. 4. St Bartholomew's Hospital, London, United Kingdom. 5. Heart Sector, Hygeia Group Hospitals, Athens, Greece. 6. FACT, an F-CRIN Network, DHU FIRE, Université Paris Diderot, INSERM U_1148 and Hôpital Bichat Assistance Publique-Hôpitaux de Paris, Paris, France. 7. Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA. 8. Johann Wolfgang Goethe University, Department of Cardiology, Division of Clinical Electrophysiology, Frankfurt/Main, Germany. 9. HMS Analytical Software GmbH, Weimar, (Lahn), Germany. 10. Boehringer Ingelheim International GmbH, Ingelheim, Germany. 11. Boehringer Ingelheim International GmbH, Ingelheim, Germany; Faculty of Medicine, University of Heidelberg, Mannheim, Germany. 12. Boehringer Ingelheim Singapore Pte. Ltd, Singapore. 13. Kyoto University, Department of Cardiovascular Medicine, Kyoto, Japan. 14. Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden. 15. St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
Abstract
BACKGROUND: In the RE-DUAL PCI trial of patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI), dabigatran dual therapy (110 or 150 mg bid, plus clopidogrel or ticagrelor) reduced International Society on Thrombosis and Haemostasis bleeding events compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. This analysis assessed outcomes in relation to patient bleeding and stroke risk profiles, based on the modified HAS-BLED and CHA2DS2-VASc scores. METHODS: The primary endpoint, major bleeding event (MBE) or clinically relevant nonmajor bleeding event (CRNMBE), was compared across study arms in patients categorized by modified HAS-BLED score 0-2 or ≥3. The composite endpoint of death, thromboembolic event, and unplanned revascularization rates was compared in patients categorized by CHA2DS2-VASc score 0-1, 2, or ≥3. RESULTS: Risk of MBE or CRNMBE was lower with dabigatran dual therapy (both doses) versus warfarin triple therapy, irrespective of modified HAS-BLED category (treatment-by-subgroup interaction P-value 0.584 and 0.273 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Risk of the composite thromboembolic endpoint was similar across CHA2DS2-VASc categories and consistent with overall study results (interaction P-value 0.739 and 0.075 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Higher HAS-BLED scores were associated with higher risks of bleeding in AF patients after PCI in a treatment-independent analysis. CONCLUSION: Dabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.
BACKGROUND: In the RE-DUAL PCI trial of patients with atrial fibrillation (AF) who underwent percutaneous coronary intervention (PCI), dabigatran dual therapy (110 or 150 mg bid, plus clopidogrel or ticagrelor) reduced International Society on Thrombosis and Haemostasis bleeding events compared with warfarin triple therapy, with noninferiority in overall thromboembolic events. This analysis assessed outcomes in relation to patientbleeding and stroke risk profiles, based on the modified HAS-BLED and CHA2DS2-VASc scores. METHODS: The primary endpoint, major bleeding event (MBE) or clinically relevant nonmajor bleeding event (CRNMBE), was compared across study arms in patients categorized by modified HAS-BLED score 0-2 or ≥3. The composite endpoint of death, thromboembolic event, and unplanned revascularization rates was compared in patients categorized by CHA2DS2-VASc score 0-1, 2, or ≥3. RESULTS: Risk of MBE or CRNMBE was lower with dabigatran dual therapy (both doses) versus warfarin triple therapy, irrespective of modified HAS-BLED category (treatment-by-subgroup interaction P-value 0.584 and 0.273 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Risk of the composite thromboembolic endpoint was similar across CHA2DS2-VASc categories and consistent with overall study results (interaction P-value 0.739 and 0.075 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin). Higher HAS-BLED scores were associated with higher risks of bleeding in AFpatients after PCI in a treatment-independent analysis. CONCLUSION:Dabigatran dual therapy reduced bleeding events irrespective of bleeding risk category and demonstrated similar efficacy regardless of stroke risk category when compared with warfarin triple therapy.
Authors: Samer Al Said; Samer Alabed; Klaus Kaier; Audrey R Tan; Christoph Bode; Joerg J Meerpohl; Daniel Duerschmied Journal: Cochrane Database Syst Rev Date: 2019-12-19