A1 Refereed original research article in a scientific journal
Design and rationale of the COMPARE-TAVI 2 trial: An all-comers head-to-head comparison of Evolut FX+ and Sapien 3 Ultra Resilia transcatheter heart valves
Authors: Thim, Troels; Nissen, Henrik; Niemelä, Matti; Eftekhari, Ashkan; Jalanko, Mikko; Savontaus, Mikko; Jääskeläinen, Pertti; Hensey, Mark; Jensen, Rebekka Vibjerg; Nørgaard, Bjarne Linde; Frederiksen, Christian Alcaraz; Vase, Henrik Ølholm; Pedersen, Lars; Sørensen, Henrik Toft; Christiansen, Evald Høj; Terkelsen, Christian Juhl
Publisher: Elsevier BV
Publication year: 2026
Journal: American Heart Journal
Article number: 107387
Volume: 297
ISSN: 0002-8703
eISSN: 1097-6744
DOI: https://doi.org/10.1016/j.ahj.2026.107387
Publication's open availability at the time of reporting: Open Access
Publication channel's open availability : Partially Open Access publication channel
Web address : https://doi.org/10.1016/j.ahj.2026.107387
Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/515793111
Self-archived copy's licence: CC BY
Self-archived copy's version: Publisher`s PDF
Introduction: The COMPARE-TAVI trial framework was launched for direct comparison of transcatheter aortic valve implantation (TAVI) valves. The COMPARE-TAVI 1 trial, comparing Myval/Myval Octacor versus Sapien 3/Sapien 3 Ultra transcatheter heart valves (THVs), was recently published. Here, we present the design and rationale for the COMPARE-TAVI 2 trial comparing the Evolut FX+ self-expandable THV with the Sapien 3 Ultra Resilia balloon-expandable THV.
Methods and analysis: In the COMPARE-TAVI 2 trial (ClinicalTrials.gov NCT06470022), patients will be randomized 1:1 between the THVs. The trial will test whether the Evolut FX+ self-expandable THV is non-inferior to the Sapien 3 Ultra Resilia balloon-expandable THV in terms of the combined 1-year primary composite endpoint of all-cause mortality, stroke, moderate/severe total aortic regurgitation, or moderate/severe hemodynamic THV deterioration, according to VARC-3 criteria. If non-inferiority is proven, superiority analyses may apply. Based on a power of 80%, alpha level of 0.05, one-sided test, non-inferiority margin of 4.5%, and expected event rate of 12%, the necessary sample size has been estimated to be 1364 patients. Prespecified secondary endpoints, including long-term follow-up for 10 years, will also be investigated.
Summary: The COMPARE-TAVI 2 will provide important information on the short- and long-term outcomes among patients treated with the Evolut FX+ self-expandable and the Sapien 3 Ultra Resilia balloon-expandable THVs.
Keywords: Evolut; RCT; Sapien; TAVI; THV; all comers.
Downloadable publication This is an electronic reprint of the original article. |  |
Funding information in the publication:
The COMPARE-TAVI organization was supported by a grant from The Danish Heart Foundation. The COMPARE-TAVI 2 trial was supported by an unrestricted grant from Medtronic Bakken Research Center, Maastricht, Netherlands.
