Abstract
Introduction 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.
Materials and Methods 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.
Discussion 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.
Keywords
sutureless - randomized trial - aortic stenosis - aortic valve replacement - study
design - stented bioprostheses
