American heart journal · 2026
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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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
Аннотация
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 noninferior 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 noninferiority is proven, superiority analyses may apply. Based on a power of 80%, alpha level of 0.05, 1-sided test, noninferiority margin of 4.5%, and expected event rate of 12%, the necessary sample size has been estimated to be 1,364 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.
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 noninferior 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 noninferiority is proven, superiority analyses may apply. Based on a power of 80%, alpha level of 0.05, 1-sided test, noninferiority margin of 4.5%, and expected event rate of 12%, the necessary sample size has been estimated to be 1,364 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.