Pre-Dilatation Versus No Pre-Dilatation for Implantation of a Self-Expanding Valve in All Comers Undergoing TAVR: The DIRECT Trial
Konstantinos Toutouzas, Georgios Benetos, Vasilis Voudris, Maria Drakopoulou, Konstantinos Stathogiannis, George Latsios, Andreas Synetos, Alexios Antonopoulos, Elias Kosmas, Ioannis Iakovou, Georgios Katsimagklis, Antonios Mastrokostopoulos, Sotiris Moraitis, Vicki Zeniou, Haim Danenberg, Manolis Vavuranakis, Dimitris Tousoulis, Konstantinos Toutouzas, Georgios Benetos, Vasilis Voudris, Maria Drakopoulou, Konstantinos Stathogiannis, George Latsios, Andreas Synetos, Alexios Antonopoulos, Elias Kosmas, Ioannis Iakovou, Georgios Katsimagklis, Antonios Mastrokostopoulos, Sotiris Moraitis, Vicki Zeniou, Haim Danenberg, Manolis Vavuranakis, Dimitris Tousoulis
Abstract
Objectives: The aim of this study was to compare the implantation of a self-expanding valve with or without balloon aortic valvuloplasty (BAV) in an open-label, noninferiority, randomized trial.
Background: There are no randomized studies comparing the implantation of a self-expanding valve with (pre-BAV) or without BAV.
Methods: Consecutive patients with severe aortic stenosis were randomly assigned to undergo transcatheter aortic valve replacement with the use of self-expanding prostheses with (pre-BAV) or without (no-BAV) pre-dilatation. The primary endpoint was device success according to the Valve Academic Research Consortium 2 criteria. Secondary endpoints included periprocedural mortality and stroke, new permanent pacemaker implantation, vascular complications, and 1-year mortality. The trial was scheduled to show noninferiority (Δ = 15%) of the direct versus the pre-BAV approach.
Results: A total of 171 patients were randomized at 4 centers. Of these, 86 underwent transcatheter aortic valve replacement with pre-dilatation and 85 without. Device success was noninferior in the no-BAV group compared with the pre-BAV group (65 of 85 [76.5%] for no-BAV vs. 64 of 86 [74.4%] for pre-BAV; mean difference 2.1%; 90% confidence interval: -8.9% to 13%). In the no-BAV group, 25 patients (29.4%) underwent post-balloon dilatation, and in the pre-BAV group, 13 patients (15.1%) underwent post-balloon dilatation (p = 0.03). Regarding major vascular complications and permanent pacemaker implantation, there was no difference between the 2 groups (log-rank p = 0.49, log-rank p = 0.54). In 1-month completed follow-up for all patients, there was 1 periprocedural stroke (0.5%), without any deaths.
Conclusions: Direct, without balloon pre-dilatation, transcatheter aortic valve replacement with a self-expanding prosthesis system is noninferior to the pre-dilatation procedure. Lower post-dilatation rates were encountered in the group with pre-dilatation. (The Predilatation in Transcatheter Aortic Valve Implantation Trial [DIRECT]; NCT02448927).
Keywords: TAVR; device success; pre-dilatation; self-expanding valve.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed