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覆膜/分支腔内主动脉修复术后抗血小板和抗凝治疗的实践模式。

Practice patterns of antiplatelet and anticoagulant therapy after fenestrated/branched endovascular aortic repair.

机构信息

University of Massachusetts, Worcester, MA.

University of Alabama, Birmingham, AL.

出版信息

J Vasc Surg. 2024 Oct;80(4):968-978.e3. doi: 10.1016/j.jvs.2024.05.041. Epub 2024 May 23.

Abstract

OBJECTIVE

Antiplatelet and/or anticoagulant therapy are commonly prescribed after fenestrated/branched endovascular aortic repair (F/BEVAR). However, the optimal regimen remains unknown. We sought to characterize practice patterns and outcomes of antiplatelet and anticoagulant use in patients who underwent F/BEVAR.

METHODS

Consecutive patients enrolled (2012-2023) as part of the United States Aortic Research Consortium (US-ARC) from 10 independent physician-sponsored investigational device exemption studies were evaluated. The cohort was characterized by medication regimen on discharge from index F/BEVAR: (1) Aspirin alone OR P2Y12 alone (single-antiplatelet therapy [SAPT]); (2) Anticoagulant alone; (3) Aspirin + P2Y12 (dual-antiplatelet therapy [DAPT]); (4) Aspirin + anticoagulant OR P2Y12 + anticoagulant (SAPT + anticoagulant); (5) Aspirin + P2Y12 + anticoagulant (triple therapy [TT]); and (6) No therapy. Kaplan-Meier analysis and Cox proportional hazards modeling were used to compare 1-year outcomes including survival, target artery patency, freedom from bleeding complication, freedom from all reinterventions, and freedom from stent-specific reintervention.

RESULTS

Of the 1525 patients with complete exposure and outcome data, 49.6% were discharged on DAPT, 28.8% on SAPT, 13.6% on SAPT + anticoagulant, 3.2% on TT, 2.6% on anticoagulant alone, and 2.2% on no therapy. Discharge medication regimen was not associated with differences in 1-year survival, bleeding complications, composite reintervention rate, or stent-specific reintervention rate. However, there was a significant difference in 1-year target artery patency. On multivariable analysis comparing with SAPT, DAPT conferred a lower hazard of loss of target artery patency (hazard ratio [HR], 0.48; 95% confidence interval [CI], 0.27-0.84; P = .01). On sub-analyses of renal stents alone or visceral stents alone, DAPT no longer had a significantly lower hazard of loss of target artery patency (renal: HR, 0.66; 95% CI, 0.35-1.27; P = .22; visceral: HR, 0.31; 95% CI, 0.05-1.9; P = .21). Lastly, duration of DAPT therapy (1 month, 6 months, or 1 year) did not significantly affect target artery patency.

CONCLUSIONS

Practice patterns for antiplatelet and anticoagulant regimens after F/BEVAR vary widely across the US-ARC. There were no differences in bleeding complications, survival or reintervention rates among different regimens, but higher branch vessel patency was noted in the DAPT cohort. These data suggest there is a benefit in DAPT therapy. However, the generalizability of this finding is limited by the retrospective nature of this data, and the clinical significance of this finding is unclear, as there is no difference in survival, bleeding, or reintervention rates amongst the different regimens. Hence, an "optimal" regimen, including the duration of such regimen, could not be clearly discerned. This suggests equipoise for a randomized trial, nested within this cohort, to identify the most effective antiplatelet/anticoagulant regimen for the growing number of patients being treated globally with F/BEVAR.

摘要

目的

在接受开窗/分支血管腔内主动脉修复术(F/BEVAR)后,通常会开具抗血小板和/或抗凝治疗。然而,最佳方案仍不清楚。我们旨在描述接受 F/BEVAR 治疗的患者使用抗血小板和抗凝药物的治疗方案和结局。

方法

连续评估了来自 10 个独立医生赞助的研究设备豁免研究的美国主动脉研究联盟(US-ARC)作为一部分的连续患者。根据出院时的药物治疗方案对队列进行了特征描述:(1)单独使用阿司匹林或单独使用 P2Y12(单一抗血小板治疗[SAPT]);(2)单独使用抗凝剂;(3)阿司匹林+ P2Y12(双重抗血小板治疗[DAPT]);(4)阿司匹林+ P2Y12+抗凝剂(SAPT+抗凝剂);(5)阿司匹林+ P2Y12+抗凝剂(三联治疗[TT]);(6)无治疗。使用 Kaplan-Meier 分析和 Cox 比例风险模型比较了 1 年的结局,包括存活率、靶动脉通畅率、无出血并发症、无所有再介入、无支架特异性再介入。

结果

在具有完整暴露和结局数据的 1525 名患者中,49.6%出院时接受 DAPT,28.8%出院时接受 SAPT,13.6%出院时接受 SAPT+抗凝剂,3.2%出院时接受 TT,2.6%出院时接受单独抗凝剂,2.2%出院时无治疗。出院时的药物治疗方案与 1 年存活率、出血并发症、复合再介入率或支架特异性再介入率无差异。然而,在靶动脉通畅率方面存在显著差异。与 SAPT 相比,DAPT 使靶动脉通畅率丧失的风险显著降低(风险比[HR],0.48;95%置信区间[CI],0.27-0.84;P=0.01)。在肾支架或内脏支架的亚分析中,DAPT 不再显著降低靶动脉通畅率丧失的风险(肾:HR,0.66;95%CI,0.35-1.27;P=0.22;内脏:HR,0.31;95%CI,0.05-1.9;P=0.21)。最后,DAPT 治疗的持续时间(1 个月、6 个月或 1 年)并不显著影响靶动脉通畅率。

结论

在美国主动脉研究联盟中,F/BEVAR 后抗血小板和抗凝药物方案的治疗方案差异很大。不同方案之间的出血并发症、存活率或再介入率无差异,但 DAPT 组的分支血管通畅率更高。这些数据表明 DAPT 治疗有获益。然而,由于该数据的回顾性性质,这种发现的普遍性受到限制,并且不同方案之间的存活率、出血或再介入率没有差异,因此这种发现的临床意义尚不清楚。因此,无法明确“最佳”方案,包括这种方案的持续时间。这表明在这个队列中嵌套进行随机试验存在均衡,以确定对于越来越多的全球接受 F/BEVAR 治疗的患者,最有效的抗血小板/抗凝药物方案。

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