接受经导管主动脉瓣置入术的严重外周动脉疾病患者的单药与双药抗血小板治疗：来自敌对登记研究的见解

Single versus Dual Antiplatelet Therapy in Patients with Severe Peripheral Arterial Disease Undergoing TAVI: Insights from The Hostile Registry.

作者信息

Galli Mattia, Nerla Roberto, Castriota Fausto, Saia Francesco, Kim Won-Keun, Iadanza Alessandro, De Backer Ole, Burzotta Francesco, Van Mieghem Nicolas M, Pilgrim Thomas, Musumeci Giuseppe, Meertens Max M, Joner Michael, Meucci Francesco, Toggweiler Stefan, Testa Luca, Berti Sergio, Montorfano Matteo, Braun Daniel, De Carlo Marco, Barbanti Marco, Stefanini Giulio, Nickenig Georg, Piva Tommaso, Latib Azeem, Porto Italo, Kornowski Ran, Bartorelli Antonio L, Abdel-Wahab Mohamed, Palmerini Tullio

机构信息

Department of Medical-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina 04100, Italy.

Maria Cecilia Hospital, GVM Care & Research, Cotignola 48033, Italy.

出版信息

Eur Heart J Cardiovasc Pharmacother. 2025 Jul 15. doi: 10.1093/ehjcvp/pvaf049.

DOI:10.1093/ehjcvp/pvaf049

PMID:40659499

Abstract

AIMS

Single antiplatelet therapy (SAPT) has been shown to be a safer alternative to dual antiplatelet therapy (DAPT) in patients without atrial fibrillation undergoing transcatheter aortic valve implantation (TAVI). However, antithrombotic therapy for TAVI patients with severe peripheral artery disease (PAD) remains an underexplored area. This study aimed to evaluate and compare the outcomes of SAPT and DAPT in this high-risk patient population.

METHODS AND RESULTS

The HOSTILE registry was a multicenter, international, observational study including 1,707 consecutive patients with hostile femoral access undergoing TAVI in 28 international centers. Among 573 patients without atrial fibrillation treated through transfemoral or non-thoracic alternative approach, 144 received SAPT and 429 DAPT after TAVI. The primary efficacy endpoint was the propensity-adjusted rate of major adverse cardiovascular events (MACE), a composite of cardiovascular death, myocardial infarction, stroke or transient ischemic attack. The primary safety endpoint was the propensity-adjusted rate of major bleeding. Outcomes were reported at 30 days and 12 months. DAPT was associated with a non-significant reduction in MACE at 30 days (HR 0.74, 95% CI 0.25-2.18; p=0.59) and at 12 months (HR 0.89, 95% CI 0.35-2.24; p=0.80) compared to SAPT, but with a significant interaction between antiplatelet strategy and PAD severity (p=0.01), suggesting a greater benefit of DAPT in patients with a high PAD severity. DAPT was associated with reduced all-cause death at 12 months (HR 0.22, 95% CI 0.10-0.47; p<0.001) but not at 30 days (HR 0.26, 95% CI 0.05-1.22; p=0.09) compared with SAPT. There was no difference in major bleeding at 30 days (p=0.13) or 12 months (p=0.10) between groups. There were no differences between groups in any bleeding at 30 days (p=0.16) or 12 months (p=0.17).

CONCLUSIONS

In TAVI patients with severe PAD, DAPT was associated with a trend toward improved outcomes compared with SAPT, particularly in those with higher PAD severity. These findings, including the observed reduction in 1-year mortality with DAPT, warrant further investigation in prospective studies.

摘要

目的

对于接受经导管主动脉瓣植入术（TAVI）且无房颤的患者，单药抗血小板治疗（SAPT）已被证明是比双联抗血小板治疗（DAPT）更安全的选择。然而，对于患有严重外周动脉疾病（PAD）的TAVI患者，抗栓治疗仍是一个未得到充分探索的领域。本研究旨在评估和比较在这一高危患者群体中SAPT和DAPT的疗效。

方法与结果

HOSTILE注册研究是一项多中心、国际性、观察性研究，纳入了28个国际中心连续1707例接受TAVI且股动脉入路困难的患者。在573例通过经股动脉或非开胸替代入路治疗且无房颤的患者中，144例在TAVI后接受了SAPT，429例接受了DAPT。主要疗效终点是倾向调整后的主要不良心血管事件（MACE）发生率，MACE是心血管死亡、心肌梗死、卒中或短暂性脑缺血发作的复合终点。主要安全终点是倾向调整后的大出血发生率。在30天和12个月时报告结果。与SAPT相比，DAPT在30天时MACE有非显著性降低（HR 0.74，95%CI 0.25 - 2.18；p = 0.59），在12个月时也有非显著性降低（HR 0.89，95%CI 0.35 - 2.24；p = 0.80），但抗血小板策略与PAD严重程度之间存在显著交互作用（p = 0.01），提示DAPT对PAD严重程度高的患者益处更大。与SAPT相比，DAPT在12个月时全因死亡降低（HR 0.22，95%CI 0.10 - 0.47；p < 0.001），但在30天时无降低（HR 0.26，95%CI 0.05 - 1.22；p = 0.09）。两组在30天（p = 0.13）或12个月（p = 0.10）时大出血无差异。两组在30天（p = 0.16）或12个月（p = 0.17）时任何出血情况均无差异。