荷兰圣安东尼乌斯医院Jurriën M. ten Berg团队探讨了阿司匹林伴或不伴氯吡格雷治疗经导管主动脉瓣植入术后患者的疗效。2020年8月30日，该研究发表在《新英格兰医学杂志》上。

对于没有长期抗凝指征的患者，单药与双药抗血小板治疗对经导管主动脉瓣植入术（TAVI）后出血和血栓栓塞事件的影响尚未明确。

在一项随机对照试验中，研究组招募接受TAVI治疗且无长期抗凝指征的患者，将其按1：1分配，其中331例接受单独阿司匹林治疗，334例接受阿司匹林+氯吡格雷治疗，为期3个月。两个主要结局为12个月内所有出血（包括轻度、重度和危及生命或致残性出血）和与手术无关的出血。次要综合结局1指因心血管原因死亡、非手术相关出血、中风或心肌梗死的综合结局，次要综合结局2指因心血管原因死亡、缺血性中风或心肌梗死的综合结局。

单独阿司匹林组中有50例患者（15.1％）发生出血事件，显著低于阿司匹林+氯吡格雷组（89例，26.6％）；50例患者（15.1％）发生与手术无关的出血事件，亦显著低于阿司匹林+氯吡格雷组（83例，24.9％）。单独阿司匹林组中有76例患者（23.0％）发生次要综合结局1，显著低于阿司匹林+氯吡格雷组（104例，31.1％）。单独阿司匹林组中有32例患者（9.7%）发生次要综合结局2，而阿司匹林+氯吡格雷组中有33例（9.9％）。在试验期间，两组分别有44例（13.3％）和32例（9.6％）患者接受了口服抗凝治疗。

总之，对于没有口服抗凝适应症的接受TAVI治疗的患者，单独服用阿司匹林3个月，与服用阿司匹林+氯吡格雷3个月相比，1年时的出血发生率和出血或血栓栓塞事件的发生率明显降低。

附：英文原文

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

Author: Jorn Brouwer, M.D.,, Vincent J. Nijenhuis, 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: 2020-08-30

Abstract: Abstract

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<0.001; risk ratio, 0.74; 95% CI for superiority, 0.57 to 0.95; P=0.04). A secondary composite 2 event occurred in 32 patients (9.7%) and 33 patients (9.9%), respectively (difference, 0.2 percentage points; 95% CI for noninferiority, 4.7 to 4.3; P=0.004; risk ratio, 0.98; 95% CI for superiority, 0.62 to 1.55; P=0.93). A total of 44 patients (13.3%) and 32 (9.6%), respectively, received oral anticoagulation during the trial.

Conclusions

Among patients undergoing TAVI who did not have an indication for oral anticoagulation, the incidence of bleeding and the composite of bleeding or thromboembolic events at 1 year were significantly less frequent with aspirin than with aspirin plus clopidogrel administered for 3 months.

DOI: 10.1056/NEJMoa2017815

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2017815