Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

Обзор

This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.

Подробное описание

Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.

Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Вмешательства

• Устройство self-expandable valves
  patients undergoing TAVR use self-expandable valves
• Устройство balloon-expandable valves
  patients undergoing TAVR use balloon-expandable valves

Первичные конечные точки

• 30-day all-cause mortality [Срок оценки: 30 days after TAVR procedure]
• 30-day adverse aortic events [Срок оценки: 30 days after TAVR procedure]
• The rate of device success [Срок оценки: 30 days]

Вторичные конечные точки (5)

• 1-year all-cause mortality [Срок оценки: 1 year after TAVR procedure]
• 1-year cardiovascular mortality [Срок оценки: 1 year after TAVR procedure]
• 1-year adverse aortic events [Срок оценки: 1 year after TAVR procedure]
• Ascending aortic diameter expansion rate ≥3mm/year [Срок оценки: 1 year after TAVR procedure]
• Hospitalization (or re-hospitalization) [Срок оценки: 1 year after TAVR procedure]

Критерии участия

Критерии включения

• Severe aortic stenosis;
• Transfemoral access;
• Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and <55mm;
• Anticipated life expectancy >1 year;
• Age ≥ 65 years.

Критерии исключения

• Dominant aortic regurgitation,;
• A history of SAVR or TAVR;
• A history of aortic surgery;
• Emergent TAVR.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• National Center for Cardiovascular Disease, China & Fuwai Hospital, Chinese Academy of Med — Пекин

Публикации

• VARC-3 WRITING COMMITTEE:; Genereux P, Piazza N, Alu MC, Nazif T, Hahn RT, Pibarot P, Bax JJ, Leipsic JA, Blanke P, Blackstone EH, Finn MT, Kapadia S, Linke A, Mack MJ, Makkar R, Mehran R, Popma JJ, Reardon M, Rodes-Cabau J, Van Mieghem NM, Webb JG, Cohen DJ, Leon MB. Valve Academic Research Consortium 3: Updated Endpoint Definitions for Aortic Valve Clinical Research. J Am Coll Cardiol. 2021 Jun PMID 33888385
• An K, Zhang F, Ouyang W, Li S, Pan X. Protocol for a randomized controlled trial for comparison of self- and balloon-expandable valves in patients with Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement (AAD-CHOICE). Trials. 2025 Nov 28;27(1):1. doi: 10.1186/s13063-025-09233-7. PMID 41316413

Идентификаторы

NCT: NCT06009588 · 2023-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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