Lorusso Roberto, Folliguet Thierry, Shrestha Malakh, Meuris Bart, Kappetein Arie Pieter, Roselli Eric, Klersy Catherine, Nozza Michele, Verhees Luc, Larracas Cristina, Goisis Giovanni, Fischlein Theodor
Department of Cardio-Thoracic Surgery, Heart and Vascular Centre, Maastricht University Medical Centre (MUMC + ), Maastricht, The Netherlands.
Chirurgie Cardiaque & Transplantation, Assistance Publique, Hôpital, Henri Mondor, Université Paris 12 UPEC, France.
Thorac Cardiovasc Surg. 2020 Mar;68(2):114-123. doi: 10.1055/s-0038-1675847. Epub 2018 Nov 29.
Sutureless biological valves for surgical aortic valve replacement (SAVR), characterized by the absence of anchoring sutures at the aortic annulus, are gaining popularity because of ease and reproducibility of implant, shorter operating times, and enhancement of minimally invasive approaches. The stentless configuration of the sutureless valve was designed to achieve optimal hemodynamic performance.
PERSIST-AVR (PERceval Sutureless Implant versus STandard Aortic Valve Replacement) is a prospective, randomized, adaptive, open-label, international, postmarket trial (NCT02673697). The primary objective of the trial is to assess the safety and efficacy of the Perceval (LivaNova, London, UK) sutureless bioprosthesis among patients undergoing SAVR in the presence of severe aortic stenosis to demonstrate the noninferiority of Perceval as compared with standard sutured stented bioprosthetic aortic valve as an isolated procedure or combined with coronary artery bypass grafting. Sample size will be determined adaptively through interim analyses performed by an Independent Statistical Unit till a maximum of 1,234 patients, enrolled at ∼60 sites in countries where the device is commercially available. Patients will be followed up for 5 years after implant. The primary end point is the number of patients free from major adverse cardiac and cerebrovascular-related events at 1 year. Additional secondary outcomes will be assessed up to 5 years.
PERSIST-AVR is the first prospective, randomized study comparing in-hospital and postdischarge outcomes in a robust population of patients undergoing SAVR with either the Perceval sutureless bioprosthesis or a conventional sutured stented bioprosthesis up to 5 years.
用于外科主动脉瓣置换术（SAVR）的无缝合生物瓣膜，其特点是在主动脉瓣环处没有固定缝线，由于植入操作简便且可重复性强、手术时间短以及微创方法的改进而越来越受欢迎。无缝合瓣膜的无支架结构旨在实现最佳的血流动力学性能。
PERSIST-AVR（PERceval无缝合植入术与标准主动脉瓣置换术对比研究）是一项前瞻性、随机、适应性、开放标签、国际性的上市后试验（NCT02673697）。该试验的主要目的是评估在患有严重主动脉瓣狭窄的接受SAVR的患者中，Perceval（LivaNova，英国伦敦）无缝合生物假体的安全性和有效性，以证明Perceval与标准缝合带支架生物假体主动脉瓣相比，作为单独手术或与冠状动脉旁路移植术联合使用时的非劣效性。样本量将通过独立统计单位进行的中期分析进行适应性确定，最多纳入1234例患者，这些患者在该设备商业可用的国家的约60个地点入组。患者将在植入后随访5年。主要终点是1年内无重大心脏和脑血管相关不良事件的患者数量。还将评估长达5年的其他次要结局。
PERSIST-AVR是第一项前瞻性、随机研究，比较了使用Perceval无缝合生物假体或传统缝合带支架生物假体进行SAVR的大量患者在住院期间和出院后的长达5年的结局。
