瑞士伯尔尼大学Stephan Windecker研究团队经过不懈努力，进行了一项经导管主动脉瓣置换术后应用利伐沙班的对照试验。相关论文2019年11月16日发表在《新英格兰医学杂志》上。

目前尚不清楚直接Xa因子抑制剂利伐沙班，能否预防经导管主动脉瓣置换术（TAVR）后的血栓栓塞事件。

研究组招募了1644名TAVR成功后且无口服抗凝指征的患者，并随机分组接受利伐沙班+阿司匹林（利伐沙班组）和阿司匹林+氯吡格雷治疗（抗血小板组）。

平均17个月后，利伐沙班组中有105名患者发生死亡或血栓栓塞事件，发病率为每100人年9.8例，抗血小板组中有78名，发病率为每100人年7.2例，差异显著。利伐沙班组中有46例患者发生严重、致残或危及生命的大出血（每100人年4.3例），抗血小板组有31例（每100人年2.8例）。利伐沙班组中有64例患者死亡（每100人年5.8例），抗血小板组有38例（每100人年3.4例）。

总之，对于TAVR成功后没有明确抗凝指征的患者，与抗血小板治疗方案相比，利伐沙班治疗方案会导致更高的死亡与血栓栓塞风险，以及出血风险。

附：英文原文

Title: A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement

Author: George D. Dangas, M.D., Ph.D.,, Jan G.P. Tijssen, Ph.D.,, Jochen Whrle, M.D.,, Lars Sndergaard, M.D.,, Martine Gilard, M.D.,, Helge Mllmann, M.D.,, Raj R. Makkar, M.D.,, Howard C. Herrmann, M.D.,, Gennaro Giustino, M.D.,, Stephan Baldus, M.D.,, Ole De Backer, M.D., Ph.D.,, Ana H.C. Guimares, Ph.D.,, Lars Gullestad, M.D.,, Annapoorna Kini, M.D.,, Dirk von Lewinski, M.D.,, Michael Mack, M.D.,, Raúl Moreno, M.D.,, Ulrich Schfer, M.D.,, Julia Seeger, M.D.,, Didier Tchétché, M.D.,, Karen Thomitzek, M.D.,, Marco Valgimigli, M.D., Ph.D.,, Pascal Vranckx, M.D., Ph.D.,, Robert C. Welsh, M.D.,, Peter Wildgoose, Ph.D.,, Albert A. Volkl, Pharm.D.,, Ana Zazula, M.D.,, Ronald G.M. van Amsterdam, Ph.D., Dip.Phar.Med.,, Roxana Mehran, M.D.,, and Stephan Windecker, M.D.

Issue&Volume: November 16, 2019

Abstract:

Background

Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.

Methods

We randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns.

Results

After a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P=0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P=0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53).

Conclusions

In patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.)

DOI: 10.1056/NEJMoa1911425

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911425