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主动脉瓣置换术后早期应用猪生物瓣的抗凝随机对照试验(ANTIPRO)。3 年随访。

Early anticoagulation after aortic valve replacement with porcine bioprosthesis randomized control trial(ANTIPRO). 3 years follow-up.

机构信息

Instituto Nacional de Cirugia Cardiaca, Montevideo, Uruguay; Centro Cardiovascular Universitario, Universidad de la Republica del Uruguay, Montevideo, Uruguay.

Instituto Nacional de Cirugia Cardiaca, Montevideo, Uruguay.

出版信息

Int J Cardiol. 2024 Oct 15;413:132361. doi: 10.1016/j.ijcard.2024.132361. Epub 2024 Jul 14.

Abstract

BACKGROUND

Most evidence for anticoagulation in aortic bioprosthesis is centered on embolic events, bleeding and re-intervention risk. The effect of anticoagulation on hemodynamics has not been previously assessed. Our hypothesis was that patients with anticoagulation (AC) early after aortic valve replacement (AVR) with porcine bioprosthesis have better hemodynamics at 3 years of follow-up.

METHODS

This is a follow-up evaluation of the ANTIPRO trial. All patients undergoing AVR with porcine bioprosthesis were consecutively recruited. The AC group received warfarin+aspirin and the non-AC(control) only aspirin. The primary outcome was mean gradient after 3 years of AVR and change in New York Heart Association (NYHA) class. Secondary outcomes were major and minor bleeding and embolic events.

RESULTS

Of 140 participants in the study, 71 were assigned to the AC group and 69 to the control group. Mean age of the overall population was 72.4(SD: 7.1) years. Global euroSCORE was 7.65(SD: 5.73). At 3 years the mean gradient was similar between both groups (19.4(SD: 9.6 mmHg) and 18.6(SD: 8.2 mmHg) in the control and AC group respectively, p = 0.7). No differences in functional class at 3 years were found among groups. No differences were found among groups in the secondary outcomes.

CONCLUSIONS

The addition of 3 months of oral anticoagulation to anti-aggregation treatment did not affect bioprosthetic hemodynamics nor functional class at years after AVR.

摘要

背景

大多数关于主动脉生物瓣抗凝的证据都集中在栓塞事件、出血和再介入风险上。抗凝对血液动力学的影响尚未得到评估。我们的假设是,在接受猪生物瓣主动脉瓣置换(AVR)后早期接受抗凝治疗(AC)的患者在 3 年随访时具有更好的血液动力学。

方法

这是 ANTIPRO 试验的随访评估。所有接受猪生物瓣 AVR 的患者均连续入选。AC 组接受华法林+阿司匹林治疗,非 AC(对照组)仅接受阿司匹林治疗。主要结局是 3 年后 AVR 的平均梯度和纽约心脏协会(NYHA)分级的变化。次要结局是主要和次要出血以及栓塞事件。

结果

在这项研究的 140 名参与者中,71 名被分配到 AC 组,69 名被分配到对照组。总体人群的平均年龄为 72.4(SD:7.1)岁。全球 euroSCORE 为 7.65(SD:5.73)。3 年后,两组间平均梯度相似(对照组和 AC 组分别为 19.4(SD:9.6mmHg)和 18.6(SD:8.2mmHg),p=0.7)。3 年后各组的功能分级无差异。各组间次要结局无差异。

结论

在抗聚集治疗的基础上增加 3 个月的口服抗凝治疗并没有影响 AVR 后数年的生物瓣血液动力学和功能分级。

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