维生素K拮抗剂或直接口服抗凝剂持续使用情况下经导管主动脉瓣置换术的安全性和有效性
Safety and Efficacy of Transcatheter Aortic Valve Replacement With Continuation of Vitamin K Antagonists or Direct Oral Anticoagulants.
作者信息
Brinkert Miriam, Mangner Norman, Moriyama Noriaki, Keller Lukas S, Hagemeyer Daniel, Crusius Lisa, Lehnick Dirk, Kobza Richard, Abdel-Wahab Mohamed, Laine Mika, Stortecky Stefan, Pilgrim Thomas, Nietlispach Fabian, Ruschitzka Frank, Thiele Holger, Linke Axel, Toggweiler Stefan
机构信息
Heart Center Lucerne, Luzerner Kantonsspital, Lucerne, Switzerland.
Heart Center Dresden, Technische Universität Dresden, Department of Internal Medicine and Cardiology, Dresden, Germany.
出版信息
JACC Cardiovasc Interv. 2021 Jan 25;14(2):135-144. doi: 10.1016/j.jcin.2020.09.062. Epub 2020 Dec 23.
OBJECTIVES
This study investigated whether transcatheter aortic valve replacement (TAVR) with peri-procedural continuation of oral anticoagulation is equally safe and efficacious as TAVR with peri-procedural interruption of anticoagulation.
BACKGROUND
A significant proportion of patients undergoing TAVR have an indication for long-term oral anticoagulation. The optimal peri-procedural management of such patients is unknown.
METHODS
Consecutive patients on oral anticoagulation who underwent transfemoral TAVR at 5 European centers were enrolled. Oral anticoagulation was either stopped 2 to 4 days before TAVR or continued throughout the procedure. Primary safety outcome was major bleeding. Secondary efficacy endpoints included vascular complications, stroke, and mortality.
RESULTS
Of 4,459 patients, 584 patients were treated with continuation of anticoagulation and 733 with interruption of anticoagulation. At 30 days, major or life-threatening bleedings occurred in 66 (11.3%) versus 105 (14.3%; odds ratio [OR]: 0.86; 95% confidence interval [CI]: 0.61 to 1.21; p = 0.39) and major vascular complications in 64 (11.0%) versus 90 (12.3%; OR: 0.89; CI: 0.62 to 1.27; p = 0.52) of patients with continuation and with interruption of anticoagulation, respectively. Transfusion of packed red blood cells was less often required in patients with continuation of anticoagulation (80 [13.7%] vs. 130 [17.7%]; OR: 0.59; 95% CI: 0.42 to 0.81; p = 0.001). Kaplan-Meier estimates of survival at 12 months were 85.3% in patients with continuation of anticoagulation and 84.0% in patients with interruption of anticoagulation (hazard ratio: 0.90; 95% CI: 0.73 to 1.12; p = 0.36).
CONCLUSIONS
Continuation of oral anticoagulation throughout TAVR did not increase bleeding or vascular complication rates. Moreover, packed red blood cell transfusions were less often required in patients with continuation of oral anticoagulation.
目的
本研究调查了经导管主动脉瓣置换术（TAVR）围手术期持续口服抗凝治疗与围手术期中断抗凝治疗相比是否同样安全有效。
背景
接受TAVR的患者中有很大一部分有长期口服抗凝治疗的指征。此类患者围手术期的最佳管理方案尚不清楚。
方法
纳入在5个欧洲中心接受经股动脉TAVR的持续口服抗凝治疗的连续患者。口服抗凝治疗在TAVR前2至4天停止或在整个手术过程中持续。主要安全结局是大出血。次要疗效终点包括血管并发症、中风和死亡率。
结果
在4459例患者中，584例患者接受了抗凝治疗的持续，733例患者接受了抗凝治疗的中断。在30天时，抗凝治疗持续组和中断组分别有66例（11.3%）和105例（14.3%）发生大出血或危及生命的出血（优势比[OR]：0.86；95%置信区间[CI]：0.61至1.21；p = 0.39），分别有64例（11.0%）和90例（12.3%）发生主要血管并发症（OR：0.89；CI：0.62至1.27；p = 0.52）。抗凝治疗持续组患者较少需要输注浓缩红细胞（80例[13.7%]对130例[17.7%]；OR：0.59；95% CI：0.42至0.81；p = 0.001）。抗凝治疗持续组患者12个月时的Kaplan-Meier生存估计值为85.3%，抗凝治疗中断组为84.0%（风险比：0.90；95% CI：0.该研究的目的是比较经导管主动脉瓣置换术（TAVR）围手术期持续口服抗凝与中断抗凝的安全性和有效性。研究发现，持续抗凝在大出血、血管并发症和输血需求方面不劣于中断抗凝，且不影响生存率。
结论
TAVR全过程持续口服抗凝不会增加出血或血管并发症发生率。此外，持续口服抗凝的患者较少需要输注浓缩红细胞。 73至1.12；p = 0.36）。
结论
TAVR全过程持续口服抗凝不会增加出血或血管并发症发生率。此外，持续口服抗凝的患者较少需要输注浓缩红细胞。
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