TY - JOUR
T1 - Continuation versus Interruption of Oral Anticoagulation during TAVI
AU - van Ginkel, D. J.
AU - Bor, W. L.
AU - Aarts, H. M.
AU - Dubois, C.
AU - De Backer, O.
AU - Rooijakkers, M. J. P.
AU - Rosseel, L.
AU - Veenstra, L.
AU - van der Kley, F.
AU - van Bergeijk, K. H.
AU - Van Mieghem, N. M.
AU - Agostoni, P.
AU - Voskuil, M.
AU - Schotborgh, C. E.
AU - Ijsselmuiden, A. J. J.
AU - van der Heyden, J. A. S.
AU - Hermanides, R. S.
AU - Barbato, E.
AU - Mylotte, D.
AU - Fabris, E.
AU - Frambach, P.
AU - Dujardin, K.
AU - Ferdinande, B.
AU - Peper, J.
AU - Rensing, B. J. W. M.
AU - Timmers, L.
AU - Swaans, M. J.
AU - Brouwer, J.
AU - Nijenhuis, V. J.
AU - Overduin, D. C.
AU - Adriaenssens, T.
AU - Kobari, Y.
AU - Vriesendorp, P. A.
AU - Montero-Cabezas, J. M.
AU - El Jattari, H.
AU - Halim, J.
AU - van den Branden, B. J. L.
AU - Leonora, R.
AU - Vanderheyden, M.
AU - Lauterbach, M.
AU - Wykrzykowska, J. J.
AU - van 't Hof, A. W. J.
AU - van Royen, N.
AU - Tijssen, J. G. P.
AU - Delewi, R.
AU - ten Berg, J. M.
AU - POPular PAUSE TAVI Investigators
PY - 2024/8/31
Y1 - 2024/8/31
N2 - Background One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. Methods We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. Results A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P=0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). Conclusions In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.)
AB - Background One third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism. Methods We conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI. Results A total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P=0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6). Conclusions In patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.)
KW - AORTIC-VALVE-REPLACEMENT
KW - ATRIAL-FIBRILLATION
KW - CLINICAL-OUTCOMES
KW - IMPLANTATION
KW - DEFINITIONS
KW - MANAGEMENT
KW - ABLATION
KW - EFFICACY
KW - STROKE
KW - IMPACT
U2 - 10.1056/NEJMoa2407794
DO - 10.1056/NEJMoa2407794
M3 - Article
SN - 0028-4793
JO - New England Journal of Medicine
JF - New England Journal of Medicine
M1 - 2407794
ER -