经导管主动脉瓣植入术期间口服抗凝治疗的持续与中断
Continuation versus Interruption of Oral Anticoagulation during TAVI.
作者信息
van Ginkel Dirk Jan, Bor Willem L, Aarts Hugo M, Dubois Christophe, De Backer Ole, Rooijakkers Maxim J P, Rosseel Liesbeth, Veenstra Leo, van der Kley Frank, van Bergeijk Kees H, Van Mieghem Nicolas M, Agostoni Pierfrancesco, Voskuil Michiel, Schotborgh Carl E, IJsselmuiden Alexander J J, Van Der Heyden Jan A S, Hermanides Renicus S, Barbato Emanuele, Mylotte Darren, Fabris Enrico, Frambach Peter, Dujardin Karl, Ferdinande Bert, Peper Joyce, Rensing Benno J W M, Timmers Leo, Swaans Martin J, Brouwer Jorn, Nijenhuis Vincent J, Overduin Daniel C, Adriaenssens Tom, Kobari Yusuke, Vriesendorp Pieter A, Montero-Cabezas Jose M, El Jattari Hicham, Halim Jonathan, Van den Branden Ben J L, Leonora Remigio, Vanderheyden Marc, Lauterbach Michael, Wykrzykowska Joanna J, van 't Hof Arnoud W J, van Royen Niels, Tijssen Jan G P, Delewi Ronak, Ten Berg Jurriën M
机构信息
From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (D.J.G., W.L.B., J.P., B.J.W.M.R., L.T., M.J.S., J.B., V.J.N., D.C.O., J.M.B.), the Department of Cardiology, Amsterdam UMC, Amsterdam (H.M.A., J.G.P.T., R.D.), the Department of Cardiology, University Medical Center Utrecht, Utrecht (H.M.A., M. Voskuil), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.J.P.R., V.J.N., N.R.), the Department of Cardiology, Maastricht University Medical Center (L.V., A.J.J.I., P.A.V., A.W.J.H.), and Cardiovascular Research Institute Maastricht (L.V., P.A.V., A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Leiden University Medical Center, Leiden (F.K., J.M.M.-C.), the Department of Cardiology, University Medical Center Groningen, Groningen (K.H.B., J.J.W.), the Department of Cardiology, Erasmus University Medical Center, Rotterdam (N.M.V.M.), the Department of Cardiology, Haga Hospital, the Hague (C.E.S.), the Department of Cardiology, Amphia Hospital, Breda (A.J.J.I., J.H., B.J.L.V.B.), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H., R.L.), and the Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg (J.H.) - all in the Netherlands; the Department of Cardiovascular Medicine, University Hospital Leuven, Leuven (C.D., T.A.), the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (L.R.), and Cardiovascular Center Aalst, Onze Lieve Vrouw Hospital (E.B., M. Vanderheyden), Aalst, the Department of Cardiology, Hospital Network Antwerp (ZNA) Middelheim, Antwerp (P.A., H.E.J.), the Department of Cardiology, Sint-Jan Hospital, Bruges (J.A.S.V.D.H.), the Department of Cardiology, AZ Delta, Roeselare (K.D.), and the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.) - all in Belgium; the Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen (O.D.B., Y.K.); the Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome (E.B.), and the Cardiothoracovascular Department, University of Trieste, Trieste (E.F.) - both in Italy; the Department of Cardiology, University Hospital Galway, Galway, Ireland (D.M.); and the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg (P.F., M.L.).
出版信息
N Engl J Med. 2025 Jan 30;392(5):438-449. doi: 10.1056/NEJMoa2407794. Epub 2024 Aug 31.
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.).
背景
三分之一接受经导管主动脉瓣植入术（TAVI）的患者因合并疾病而有口服抗凝治疗的指征。TAVI 期间中断口服抗凝治疗可能会降低出血风险，而继续使用则可能降低血栓栓塞风险。
方法
我们进行了一项国际、开放标签、随机、非劣效性试验，纳入正在接受口服抗凝剂且计划接受 TAVI 的患者。患者按 1:1 的比例随机分配，在围手术期继续或中断口服抗凝治疗。主要结局是 TAVI 后 30 天内心血管原因死亡、任何原因导致的中风、心肌梗死、主要血管并发症或大出血的复合结局。
结果
改良意向性分析人群共纳入 858 例患者：431 例被分配至继续口服抗凝治疗组，427 例被分配至中断口服抗凝治疗组。继续治疗组 71 例患者（16.5%）发生主要结局事件，中断治疗组 63 例患者（14.8%）发生主要结局事件（风险差异为 1.7 个百分点；95%置信区间[CI]，-3.1 至 6.6；非劣效性检验 P = 0.18）。继续治疗组 38 例患者（8.8%）发生血栓栓塞事件，中断治疗组 35 例患者（8.2%）发生血栓栓塞事件（风险差异为 0.6 个百分点；95%CI，-3.1 至 4.4）。继续治疗组 134 例患者（31.1%）发生出血，中断治疗组 91 例患者（21.3%）发生出血（风险差异为 9.8 个百分点；95%CI，3.9 至 15.6）。
结论
在有口服抗凝治疗指征且接受 TAVI 的患者中，就 30 天时心血管原因死亡、中风、心肌梗死、主要血管并发症或大出血的复合发生率而言，围手术期继续口服抗凝治疗并不非劣于 TAVI 期间中断口服抗凝治疗。（由荷兰卫生研究与发展组织和圣安东尼研究基金资助；POPular PAUSE TAVI 临床试验注册号，NCT04437303。）
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