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二尖瓣修复术后抗血小板治疗与口服抗凝治疗作为抗血栓预防措施的比较

Antiplatelet versus oral anticoagulant therapy as antithrombotic prophylaxis after mitral valve repair.

作者信息

Paparella Domenico, Di Mauro Michele, Bitton Worms Keren, Bolotin Gil, Russo Claudio, Trunfio Salvatore, Scrofani Roberto, Antona Carlo, Actis Dato Guglielmo, Casabona Riccardo, Colli Andrea, Gerosa Gino, Renzulli Attilio, Serraino Filiberto, Scrascia Giuseppe, Zaccaria Salvatore, De Bonis Michele, Taramasso Maurizio, Delgado Luis, Tritto Francesco, Marmo Joseph, Parolari Alessandro, Myaseodova Veronika, Villa Emmanuel, Troise Giovanni, Nicolini Francesco, Gherli Tiziano, Whitlock Richard, Conte Manuela, Barili Fabio, Gelsomino Sandro, Lorusso Roberto, Sciatti Edoardo, Marinelli Daniele, Di Giammarco Gabriele, Calafiore Antonio Maria, Sheikh Azmat, Alfonso Juan Jaime, Glauber Mattia, Miceli Antonio

机构信息

U.O. di Cardiochirurgia Università di Bari Aldo Moro, Italy.

U.O. Cardiologia Università dell'Aquila, Italy.

出版信息

J Thorac Cardiovasc Surg. 2016 May;151(5):1302-8.e1. doi: 10.1016/j.jtcvs.2015.12.036. Epub 2016 Jan 5.

Abstract

OBJECTIVE

To verify the rate of thromboembolic and hemorrhagic complications during the first 6 months after mitral valve repair and to assess whether the type of antithrombotic therapy influenced clinical outcome.

METHODS

Retrospective data were retrieved from 19 centers. Inclusion criteria were isolated mitral valve repair with ring implantation. Exclusion criteria were ongoing or past atrial fibrillation and any combined intraoperative surgical procedures. The study cohort consisted of 1882 patients (aged 58 ± 15 years; 36% women), and included 1517 treated with an oral anticoagulant (VKA group) and 365 with antiplatelet drugs (APLT group). Primary efficacy outcome was the incidence of arterial thromboembolic events within 6 months and primary safety outcome was the incidence of major bleeding within 6 months. Propensity matching was performed to obtain 2 comparable cohorts (858 vs 286).

RESULTS

No differences were detected for arterial embolic complications in matched cohort (1.6% VKA vs 2.1% APLT; P = .50). Conversely, patients in the APLT group showed lower incidence of major bleeding complications (3.9% vs 0.7%; P = .01). Six-month mortality rate was significantly higher in the VKA group (2.7% vs 0.3%; P = .02). Multivariable analysis in the matched cohort found VKA as independent predictor of major bleeding complications and mortality at 6 months.

CONCLUSIONS

Vitamin K antagonist therapy was not superior to antiplatelet therapy to prevent thromboembolic complications after mitral valve repair. Our data suggest that oral anticoagulation may carry a higher bleeding risk compared with antiplatelet therapy, although these results should be confirmed in an adequately powered randomized controlled trial.

摘要

目的

验证二尖瓣修复术后前6个月内血栓栓塞和出血并发症的发生率,并评估抗血栓治疗类型是否影响临床结局。

方法

从19个中心检索回顾性数据。纳入标准为单纯二尖瓣修复并植入人工瓣环。排除标准为持续性或既往有房颤以及任何术中联合手术操作。研究队列包括1882例患者(年龄58±15岁;36%为女性),其中1517例接受口服抗凝药治疗(VKA组),365例接受抗血小板药物治疗(APLT组)。主要疗效结局为6个月内动脉血栓栓塞事件的发生率,主要安全性结局为6个月内大出血的发生率。进行倾向匹配以获得两个可比队列(858例对286例)。

结果

在匹配队列中,动脉栓塞并发症未发现差异(VKA组为1.6%,APLT组为2.1%;P = 0.50)。相反,APLT组患者大出血并发症的发生率较低(3.9%对0.7%;P = 0.01)。VKA组的6个月死亡率显著更高(2.7%对0.3%;P = 0.02)。匹配队列中的多变量分析发现VKA是6个月时大出血并发症和死亡率的独立预测因素。

结论

在预防二尖瓣修复术后血栓栓塞并发症方面,维生素K拮抗剂治疗并不优于抗血小板治疗。我们的数据表明,与抗血小板治疗相比,口服抗凝治疗可能具有更高的出血风险,尽管这些结果应在足够样本量的随机对照试验中得到证实。

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