Giuseppe Gargiulo1,2, Andreas Goette3,4,5, Jan Tijssen6,7, Lars Eckardt5,8, Thorsten Lewalter5,9, Pascal Vranckx10, Marco Valgimigli1. 1. Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Freiburgstrasse 10, Bern, Switzerland. 2. Department of Advanced Biomedical Sciences, Federico II University of Naples, Via S. Pansini 5, Naples, Italy. 3. St. Vincenz-Hospital, Am Busdorf 2, Paderborn, Germany. 4. Working Group of Molecular Electrophysiology, University Hospital Magdeburg, Leipziger Str. 44, Magdeburg, Germany. 5. Atrial Fibrillation Network (AFNET), Mendel Str.11, Münster, Germany. 6. Department of Cardiology, Amsterdam UMC - University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands. 7. Cardialysis B.V., Westblaak 98, KM Rotterdam, The Netherlands. 8. Department of Cardiology II -Electrophysiology; University of Münster, Albert-Schweitzer-Campus 1, Gebäude A1, D-48149 Münster, Germany. 9. Department of Cardiology and Intensive Care, Peter Osypka Heart Center Munich, Hospital Munich-South, Am Isarkanal 36, Munich/Germany. 10. Department of Cardiology and Intensive Care Medicine, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Stadsomvaart 11, Hasselt, Belgium.
Abstract
AIMS: To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). METHODS AND RESULTS: A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AF patients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56-0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01-2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17-0.65; P = 0.001; I2 = 0%). CONCLUSION: Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac-mainly stent-related-but not cerebrovascular ischaemic occurrences.
AIMS: To investigate the safety and efficacy of double vs. triple antithrombotic therapy (DAT vs. TAT) in patients with atrial fibrillation (AF) and acute coronary syndrome or who underwent percutaneous coronary intervention (PCI). METHODS AND RESULTS: A systematic review and meta-analysis was performed using PubMed to search for non-vitamin K antagonist oral anticoagulant (NOAC)-based randomized clinical trials comparing DAT vs. TAT in AFpatients undergoing PCI. Four trials encompassing 10 234 patients (DAT = 5496 vs. TAT = 4738) were included. The primary safety endpoint (ISTH major or clinically relevant non-major bleeding) was significantly lower with DAT compared with TAT [risk ratio (RR) 0.66, 95% confidence interval (CI) 0.56-0.78; P < 0.0001; I2 = 69%], which was consistent across all available bleeding definitions. This benefit was counterbalanced by a significant increase of stent thrombosis (RR 1.59, 95% CI 1.01-2.50; P = 0.04; I2 = 0%) and a trend towards higher risk of myocardial infarction with DAT. There were no significant differences in all-cause and cardiovascular death, stroke and major adverse cardiovascular events. The comparison of NOAC-based DAT vs. vitamin K antagonist (VKA)-TAT yielded consistent results and a significant reduction of intracranial haemorrhage (RR 0.33, 95% CI 0.17-0.65; P = 0.001; I2 = 0%). CONCLUSION: Double antithrombotic therapy, particularly if consisting of a NOAC instead of VKA and a P2Y12 inhibitor, is associated with a reduction of bleeding, including major and intracranial haemorrhages. This benefit is however counterbalanced by a higher risk of cardiac-mainly stent-related-but not cerebrovascular ischaemic occurrences.
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