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经导管主动脉瓣置换术后双重抗血小板治疗与口服抗凝治疗的比较:一项回顾性单中心注册研究分析。

Comparison of dual antiplatelet therapy versus oral anticoagulation following transcatheter aortic valve replacement: A retrospective single-center registry analysis.

作者信息

Holy Erik W, Kebernik Julia, Allali Abdelhakim, El-Mawardy Mohamed, Richardt Gert, Abdel-Wahab Mohamed

机构信息

Heart Center Bad Segeberg.

出版信息

Cardiol J. 2017;24(6):649-659. doi: 10.5603/CJ.a2017.0050. Epub 2017 May 12.

DOI:10.5603/CJ.a2017.0050
PMID:28497845
Abstract

BACKGROUND

The choice of optimal antithrombotic regimen after transcatheter aortic valve replace-ment (TAVR) remains a matter of debate. The objective of this study was to compare both efficacy and safety outcomes based on the type of antithrombotic therapy prescribed after TAVR Methods: This is a retrospective analysis of 514 consecutive patients treated with either dual antiplate¬let therapy (DAPT) (n = 315; 61.3%) or oral anticoagulation (OAC) plus clopidogrel (n = 199; 38.7%) for a minimum of 3 months after TAVR followed by antiplatelet monotherapy or OAC only, respectively. Patients had pre-defined clinical and echocardiographic follow-ups at 30 days, 6 and 12 months. The key efficacy endpoint was a composite of all-cause death, myocardial infarction, stroke and valve throm¬bosis at 1 year. The key safety endpoint was the occurrence of life-threatening/major bleeding at 1 year.

RESULTS

Baseline characteristics did not differ between both groups, except for a higher incidence of atrial fibrillation in the OAC group. No significant differences in both efficacy and safety endpoints were observed at 30 days and 6 months. At 1 year, the key efficacy endpoint occurred in 21.5% of the DAPT group compared to 19.7% of the OAC group (p = 0.61). The key safety endpoint occurred in 25.1% and 27.8%, respectively (p = 0.53). However, after 1 year valve thrombosis was reported in 8 (2.5%) patients in the DAPT group but not in the OAC group (p = 0.02).

CONCLUSIONS

OAC after TAVR seems to reduce the risk of clinical valve thrombosis without a statisti-cally significant increase in bleeding complications.

摘要

背景

经导管主动脉瓣置换术(TAVR)后最佳抗栓方案的选择仍存在争议。本研究的目的是比较TAVR术后根据所开抗栓治疗类型的疗效和安全性结果。方法:这是一项对514例连续患者的回顾性分析,这些患者在TAVR术后接受双联抗血小板治疗(DAPT)(n = 315;61.3%)或口服抗凝(OAC)加氯吡格雷(n = 199;38.7%)至少3个月,随后分别接受抗血小板单药治疗或仅接受OAC。患者在30天、6个月和12个月进行了预先定义的临床和超声心动图随访。关键疗效终点是1年时全因死亡、心肌梗死、卒中和瓣膜血栓形成的复合终点。关键安全终点是1年时发生危及生命/大出血。

结果

两组的基线特征无差异,但OAC组房颤发生率较高。在30天和6个月时,疗效和安全终点均未观察到显著差异。1年时,DAPT组关键疗效终点的发生率为21.5%,而OAC组为19.7%(p = 0.61)。关键安全终点的发生率分别为25.1%和27.8%(p = 0.53)。然而,1年后,DAPT组有8例(2.5%)患者报告发生瓣膜血栓形成,而OAC组未发生(p = 0.02)。

结论

TAVR术后OAC似乎可降低临床瓣膜血栓形成的风险,且出血并发症无统计学意义的显著增加。

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