先前的球囊瓣膜成形术与直接经导管主动脉瓣植入术（DIRECTAVI）：一项随机对照试验的研究方案。
Prior balloon valvuloplasty versus DIRECT transcatheter Aortic Valve Implantation (DIRECTAVI): study protocol for a randomized controlled trial.
作者信息
Leclercq Florence, Robert Pierre, Labour Jessica, Lattuca Benoit, Akodad Mariama, Macia Jean-Christophe, Gervasoni Richard, Roubille Francois, Gandet Thomas, Schmutz Laurent, Nogue Erika, Nagot Nicolas, Albat Bernard, Cayla Guillaume
机构信息
Department of Cardiology, University Hospital of Montpellier, Montpellier, France.
Department of Cardiology, Arnaud de Villeneuve Hospital, University of Montpellier, Avenue du doyen Giraud, 34295, Montpellier cedex 5, France.
出版信息
Trials. 2017 Jul 4;18(1):303. doi: 10.1186/s13063-017-2036-y.
BACKGROUND
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence has suggested that aortic valvuloplasty may cause complications and that high success rates may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation of the aortic valve and using new-generation balloon-expandable transcatheter heart valves is associated with a better net clinical benefit than TAVI performed with predilatation.
METHODS/DESIGN: The transcatheter aortic valve implantation without prior balloon dilatation (DIRECTAVI) trial is a randomized controlled open label trial that includes 240 patients randomized to TAVI performed with prior balloon valvuloplasty (control arm) or direct implantation of the valve (test arm). All patients with an indication for TAVI will be included excepting those requiring transapical access. The trial tests the hypothesis that the strategy of direct implantation of the new-generation balloon-expandable SAPIEN 3 valve is noninferior to current medical practice using predilatation of the valve. The primary endpoint assessing efficacy and safety of the procedure consists of immediate procedural success and secondary endpoints include complications at 30-day follow-up (VARC-2 criteria). A subgroup analysis evaluates neurological ischemic events with cerebral MRI imaging (25 patients in each strategy group) performed before and between 1 and 3 days after the procedure.
DISCUSSION
This prospective randomized study is designed to assess the efficacy and safety of TAVI performed without prior dilatation of the aortic valve using new-generation balloon-expandable transcatheter heart valves. We aim to provide robust evidence of the advantages of this strategy to allow the interventional cardiologist to use it in everyday practice.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02729519 . Registered on 15 July 2016.
背景
在经导管主动脉瓣植入术（TAVI）过程中，主动脉瓣球囊预扩张一直被视为关键步骤。然而，近期证据表明，主动脉瓣成形术可能引发并发症，且在不预先扩张瓣膜的情况下也可获得高成功率。我们推测，使用新一代球囊扩张式经导管心脏瓣膜、不进行主动脉瓣预扩张的TAVI与进行预扩张的TAVI相比，具有更好的净临床效益。
方法/设计：不经球囊预扩张的经导管主动脉瓣植入术（DIRECTAVI）试验是一项随机对照开放标签试验，纳入240例患者，随机分为先行球囊瓣膜成形术的TAVI组（对照组）或直接瓣膜植入组（试验组）。除需要经心尖入路的患者外，所有有TAVI指征的患者均纳入。该试验旨在验证新一代球囊扩张式SAPIEN 3瓣膜直接植入策略不劣于当前使用瓣膜预扩张的医疗实践这一假设。评估该手术疗效和安全性的主要终点包括手术即刻成功，次要终点包括30天随访时的并发症（VARC-2标准）。亚组分析采用术后1至3天及术前的脑部MRI成像评估神经缺血事件（每个策略组25例患者）。
讨论
这项前瞻性随机研究旨在评估使用新一代球囊扩张式经导管心脏瓣膜、不预先扩张主动脉瓣的TAVI的疗效和安全性。我们旨在提供有力证据证明该策略的优势，以便介入心脏病专家在日常实践中应用。
试验注册
ClinicalTrials.gov标识符：NCT02729519。于2016年7月15日注册。
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