Aspirin with or without clopidogrel after transcatheter aortic-valve implantation
| Autor: | Gert van Houwelingen, Arnoud W J van 't Hof, Bernard De Bruyne, Pieter R. Stella, Peter Frambach, Johannes C. Kelder, Jan Baan, Leo Timmers, Jan Van der Heyden, Leo Veenstra, Joyce Peper, Wouter Holvoet, Jurriën M Ten Berg, Dean R P P Chan Pin Yin, Jorn Brouwer, Renicus S Hermanides, Carl E. Schotborgh, Vincent J. Nijenhuis, Bert Ferdinande, Ian Buysschaert, Petr Toušek, Frank van der Kley, John Roosen, Christophe L F Dubois, Ronak Delewi, Pim van der Harst, Benno J W M Rensing, Martin J. Swaans, Frederick W. Thielen |
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| Přispěvatelé: | General Practice, Cardiology, Department of Business-Society Management, Pediatrics, Cardiothoracic Surgery, Public Health, Erasmus MC other, Health Technology Assessment (HTA), Medical Informatics, Internal Medicine, Cardiovascular Centre (CVC), Graduate School, Neurology, ACS - Atherosclerosis & ischemic syndromes, APH - Aging & Later Life, ACS - Pulmonary hypertension & thrombosis, ACS - Microcirculation, Cardiologie, MUMC+: MA Arts Assistenten IC (9), MUMC+: MA Med Staf Spec Cardiologie (9), RS: Carim - H01 Clinical atrial fibrillation |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Transcatheter aortic Administration Oral ESC Hemorrhage 030204 cardiovascular system & hematology DISEASE Transcatheter Aortic Valve Replacement DEFINITIONS TAVI 03 medical and health sciences 0302 clinical medicine Medicine General & Internal Internal medicine General & Internal Medicine medicine Humans In patient 030212 general & internal medicine Postoperative Period METAANALYSIS Aged Aged 80 and over RISK Aspirin OUTCOMES Science & Technology business.industry Incidence DUAL ANTIPLATELET THERAPY Thrombosis General Medicine Clopidogrel REPLACEMENT Multicenter study Cardiovascular Diseases Cardiology Drug Therapy Combination Female business Life Sciences & Biomedicine Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | New England Journal of Medicine, 383(15), 1447-1457. Massachussetts Medical Society New England Journal of Medicine, 383(15), 1447-1457. MASSACHUSETTS MEDICAL SOC New England journal of medicine, 383(15), 1447-1457. Massachussetts Medical Society New England Journal of Medicine, 383(15), 1447-1457. MASSACHUSETTS MEDICAL SOCIETY |
| ISSN: | 0028-4793 2013-0031 |
| DOI: | 10.1056/nejmoa2017815 |
| Popis: | BACKGROUND: The effect of single as compared with dual antiplatelet treatment on bleeding and thromboembolic events after transcatheter aortic-valve implantation (TAVI) in patients who do not have an indication for long-term anticoagulation has not been well studied. METHODS: In a randomized, controlled trial, we assigned a subgroup of patients who were undergoing TAVI and did not have an indication for long-term anticoagulation, in a 1:1 ratio, to receive aspirin alone or aspirin plus clopidogrel for 3 months. The two primary outcomes were all bleeding (including minor, major, and life-threatening or disabling bleeding) and non-procedure-related bleeding over a period of 12 months. Most bleeding at the TAVI puncture site was counted as non-procedure-related. The two secondary outcomes were a composite of death from cardiovascular causes, non-procedure-related bleeding, stroke, or myocardial infarction (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2) at 1 year, with both outcomes tested sequentially for noninferiority (noninferiority margin, 7.5 percentage points) and superiority. RESULTS: A total of 331 patients were assigned to receive aspirin alone and 334 were assigned to receive aspirin plus clopidogrel. A bleeding event occurred in 50 patients (15.1%) receiving aspirin alone and in 89 (26.6%) receiving aspirin plus clopidogrel (risk ratio, 0.57; 95% confidence interval [CI], 0.42 to 0.77; P = 0.001). Non-procedure-related bleeding occurred in 50 patients (15.1%) and 83 patients (24.9%), respectively (risk ratio, 0.61; 95% CI, 0.44 to 0.83; P = 0.005). A secondary composite 1 event occurred in 76 patients (23.0%) receiving aspirin alone and in 104 (31.1%) receiving aspirin plus clopidogrel (difference, -8.2 percentage points; 95% CI for noninferiority, -14.9 to -1.5; P |
| Databáze: | OpenAIRE |
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