荷兰圣安东尼医院Jurrin M. ten Berg团队比较了经导管主动脉瓣植入术后用或不用氯吡格雷抗凝的效果。2020年3月29日，《新英格兰医学杂志》在线发表了这一成果。

经导管主动脉瓣植入术（TAVI）后单独使用抗凝剂或联用抗血小板剂的抗凝作用尚未确定。

研究组进行了一项随机试验，招募接受TAVI且有抗凝治疗适应症的患者。将其按1：1随机分组，其中157例患者仅接受口服抗凝治疗，156例接受口服抗凝+氯吡格雷治疗，持续3个月。

治疗12个月，单独口服抗凝治疗组中有34例（21.7%）患者发生出血，口服抗凝+氯吡格雷组中有54例（34.6%），风险比为0.63，大多数出血事件发生在TAVI进入点；与手术无关的出血发生率分别为21.7%和34.0%，风险比为0.64。大多数出血发生在第一个月，但较轻微。

单独口服抗凝治疗组中有49例患者（31.2%）发生心血管原因死亡、非手术相关的出血、中风或心肌梗死，口服抗凝+氯吡格雷组中有71例（45.5%）；两组中分别有13.4%和17.3%的患者发生心血管原因死亡、中风或心肌梗死。

综上，在接受口服抗凝治疗的TAVI患者中，单独口服抗凝治疗在1个月或1年内严重出血的发生率低于口服抗凝加氯吡格雷治疗。

附：英文原文

Title: Anticoagulation with or without Clopidogrel after Transcatheter Aortic-Valve Implantation | NEJM

Author: Vincent J. Nijenhuis, M.D.,, Jorn Brouwer, M.D.,, Ronak Delewi, M.D., Ph.D.,, Renicus S. Hermanides, M.D., Ph.D.,, Wouter Holvoet, M.D.,, Christophe L.F. Dubois, M.D., Ph.D.,, Peter Frambach, M.D.,, Bernard De Bruyne, M.D., Ph.D.,, Gert K. van Houwelingen, M.D.,, Jan A.S. Van Der Heyden, M.D., Ph.D.,, Petr Touek, M.D., Ph.D.,, Frank van der Kley, M.D.,, Ian Buysschaert, M.D., Ph.D.,, Carl E. Schotborgh, M.D.,, Bert Ferdinande, M.D.,, Pim van der Harst, M.D., Ph.D.,, John Roosen, M.D.,, Joyce Peper, M.Sc.,, Frederick W.F. Thielen, M.Sc.,, Leo Veenstra, M.D.,, Dean R.P.P. Chan Pin Yin, M.D.,, Martin J. Swaans, M.D., Ph.D.,, Benno J.W.M. Rensing, M.D., Ph.D.,, Arnoud W.J. van ’t Hof, M.D., Ph.D.,, Leo Timmers, M.D., Ph.D.,, Johannes C. Kelder, M.D., Ph.D.,, Pieter R. Stella, M.D., Ph.D.,, Jan Baan, M.D., Ph.D.,, and Jurrin M. ten Berg, M.D., Ph.D.

Issue&Volume: 2020-03-29

Abstract: Abstract

Background

The roles of anticoagulation alone or with an antiplatelet agent after transcatheter aortic-valve implantation (TAVI) have not been well studied.

Methods

We performed a randomized trial of clopidogrel in patients undergoing TAVI who were receiving oral anticoagulation for appropriate indications. Patients were assigned before TAVI in a 1:1 ratio not to receive clopidogrel or to receive clopidogrel for 3 months. The two primary outcomes were all bleeding and non–procedure-related bleeding over a period of 12 months. Procedure-related bleeding was defined as Bleeding Academic Research Consortium type 4 severe bleeding, and therefore most bleeding at the 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 at 12 months (secondary composite 1) and a composite of death from cardiovascular causes, ischemic stroke, or myocardial infarction (secondary composite 2), both tested for noninferiority (noninferiority margin, 7.5 percentage points) and superiority.

Results

Bleeding occurred in 34 of the 157 patients (21.7%) receiving oral anticoagulation alone and in 54 of the 156 (34.6%) receiving oral anticoagulation plus clopidogrel (risk ratio, 0.63; 95% confidence interval [CI], 0.43 to 0.90; P=0.01); most bleeding events were at the TAVI access site. Non–procedure-related bleeding occurred in 34 patients (21.7%) and in 53 (34.0%), respectively (risk ratio, 0.64; 95% CI, 0.44 to 0.92; P=0.02). Most bleeding occurred in the first month and was minor. A secondary composite 1 event occurred in 49 patients (31.2%) receiving oral anticoagulation alone and in 71 (45.5%) receiving oral anticoagulation plus clopidogrel (difference, 14.3 percentage points; 95% CI for noninferiority, 25.0 to 3.6; risk ratio, 0.69; 95% CI for superiority, 0.51 to 0.92). A secondary composite 2 event occurred in 21 patients (13.4%) and in 27 (17.3%), respectively (difference, 3.9 percentage points; 95% CI for noninferiority, 11.9 to 4.0; risk ratio, 0.77; 95% CI for superiority, 0.46 to 1.31).

Conclusions

In patients undergoing TAVI who were receiving oral anticoagulation, the incidence of serious bleeding over a period of 1 month or 1 year was lower with oral anticoagulation alone than with oral anticoagulation plus clopidogrel.

DOI: 10.1056/NEJMoa1915152

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915152