Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design

Area of Science:

• Cardiovascular Surgery
• Biomedical Engineering
• Clinical Trials

Background:

• Sutureless biological valves offer advantages in surgical aortic valve replacement (SAVR), including easier implantation, shorter procedures, and suitability for minimally invasive techniques.
• These valves are designed for optimal hemodynamic performance, addressing limitations of traditional sutured valves.

Purpose of the Study:

• To evaluate the safety and efficacy of the Perceval sutureless bioprosthesis compared to conventional sutured stented bioprosthetic valves in patients with severe aortic stenosis undergoing SAVR.
• To demonstrate the noninferiority of the Perceval valve in a prospective, randomized trial.

Main Methods:

• The PERSIST-AVR trial is a prospective, randomized, adaptive, open-label, international, postmarket study (NCT02673697).
• It involves up to 1,234 patients across approximately 60 sites, comparing the Perceval sutureless valve with standard sutured stented valves.
• The primary endpoint is freedom from major adverse cardiac and cerebrovascular events at 1 year, with follow-up extending to 5 years.

Main Results:

• This is the first prospective, randomized study to compare in-hospital and postdischarge outcomes for sutureless versus conventional sutured stented bioprosthetic aortic valves.
• The study aims to provide robust data on the performance and safety of sutureless valves in a large patient cohort.

Conclusions:

• The PERSIST-AVR trial will provide critical evidence on the comparative effectiveness and safety of sutureless aortic valve technology.
• Findings will inform clinical practice regarding the adoption of sutureless valves in SAVR procedures.