Cerebrovascular events with self-expanding versus balloon-expandable valves in patients with or without peripheral arterial disease.

IF 1.6 4区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS
Tullio Palmerini, Francesco Saia, Antonio Giulio Bruno, Won-Keun Kim, Alessandro Iadanza, Gabriele Ghetti, Ole De Backer, Francesco Burzotta, Nicholas M Van Mieghem, Elena Nardi, Mateusz Orzalkiewicz, Thomas Pilgrim, Tiziana Claudia Aranzulla, Max M Meertens, Nevio Taglieri, Michael Joner, Giulia Nardi, Stefan Toggweiler, Enrico Gallitto, Mauro Gargiulo, Luca Testa, Sergio Berti, Matteo Montorfano, Alessandro Leone, Davide Pacini, Daniel Braun, Fausto Castriota, Marco De Carlo, Marco Barbanti, Pier Pasquale Leone, Georg Nickenig, Tommaso Piva, Azeem Latib, Matteo Vercellino, Pablo Codner, Antonio L Bartorelli, Chiara Fraccaro, Mohamed Abdel-Wahab, Gregg W Stone
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引用次数: 0

Abstract

Objectives: The authors compared the risk of cerebrovascular events (CVE) with self-expanding vales (SEV) vs balloon-expandable valves (BEV) in patients with or without peripheral artery disease (PAD), stratified by the access route and the complexity of PAD (Hostile score).

Methods: The PAD-related risk of CVE between SEV vs BEV was investigated using data from the HOSTILE Registry, an observational study including 1707 patients with severe PAD undergoing transcatheter aortic valve replacement (TAVR) via different access routes. The relative risk of CVE with SEV vs BEV in patients without PAD was investigated in a meta-analysis of randomized controlled transfemoral access (TFA)-TAVR trials of patients with normal femoral arteries. The primary endpoint was the risk of 30-day CVE.

Results: Among the 1021 patients undergoing TAVR through TFA or transaxillary access (TAxA), 674 (66.0%) received SEVs and 329 (32.2%) received BEVs. The 30-day propensity-adjusted risk of CVE was higher for SEV compared with BEV (adjusted hazard ratio [HR], 2.70; 95% CI, 1.16-6.23), with no significant interaction between the transcatheter heart valve and either the access route or the Hostile score. Similar results were apparent at 1 year (adjusted HR, 2.98; 95% CI, 1.30-6.83). In contrast, in a meta-analysis of 4 RCTs and 2131 patients with femoral arteries suitable for TAVR, there were no significant differences in the 30-day rates of CVE between SEV and BEV (odds ratio, 0.58; 95% CI, 0.24-1.40).

Conclusions: Compared with BEVs, SEVs were associated with higher 30-day and 1-year rates of CVE in patients with PAD, a finding not apparent in patients with suitable femoral arteries enrolled in RCTs.

伴有或不伴有外周动脉疾病患者的自扩张与球囊扩张瓣膜的脑血管事件。
目的:作者比较有或无外周动脉疾病(PAD)患者采用自扩瓣膜(SEV)与球囊可扩瓣膜(BEV)的脑血管事件(CVE)的风险,并根据通路和PAD的复杂性(敌对评分)进行分层。方法:使用HOSTILE Registry的数据调查SEV与BEV之间PAD相关的CVE风险,该观察性研究包括1707例通过不同通路接受经导管主动脉瓣置换术(TAVR)的严重PAD患者。在一项针对正常股动脉患者的随机对照经股通道(TFA)-TAVR试验的荟萃分析中,研究了无PAD患者中CVE合并SEV与BEV的相对风险。主要终点是30天CVE的风险。结果:1021例经TFA或经腋窝通道(TAxA)行TAVR的患者中,674例(66.0%)接受了sev, 329例(32.2%)接受了bev。与BEV相比,SEV的30天倾向校正CVE风险更高(校正风险比[HR], 2.70;95% CI, 1.16-6.23),经导管心脏瓣膜与通路或敌意评分之间没有显著的相互作用。相似的结果在1年后也很明显(调整后的HR, 2.98;95% ci, 1.30-6.83)。相比之下,在一项针对4项随机对照试验和2131例适合进行TAVR的股动脉患者的荟萃分析中,SEV和BEV在30天CVE发生率方面没有显著差异(优势比,0.58;95% ci, 0.24-1.40)。结论:与bev相比,sev与PAD患者较高的30天和1年CVE发生率相关,这一发现在纳入随机对照试验的合适股动脉患者中并不明显。
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来源期刊
Journal of Invasive Cardiology
Journal of Invasive Cardiology CARDIAC & CARDIOVASCULAR SYSTEMS-
CiteScore
2.90
自引率
6.70%
发文量
214
审稿时长
3-8 weeks
期刊介绍: The Journal of Invasive Cardiology will consider for publication suitable articles on topics pertaining to the invasive treatment of patients with cardiovascular disease.
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