The COMPARE-TAVI 2 trial is designed to test non-inferiority of Evolut FX+ versus Sapien 3 Ultra Resilia for 1-year death, stroke, aortic regurgitation, or valve deterioration.
Is the Evolut FX+ self-expandable THV non-inferior to the Sapien 3 Ultra Resilia balloon-expandable THV regarding death, stroke, aortic regurgitation or hemodynamic THV-deterioration in all-comers for transfemoral aortic valve implantation?
The COMPARE-TAVI 2 trial is designed to evaluate the non-inferiority of the Evolut FX+ self-expandable THV compared to the Sapien 3 Ultra Resilia balloon-expandable THV for a composite of clinical and valve performance outcomes at 1 year.
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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. 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. 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. • Majority of previous studies have indicated more aortic regurgitation with self-expandable compared to balloon-expandable transcatheter heart valves (THVs). • COMPARE-TAVI 2 study question: Is the Evolut FX+ non-inferior to the Sapien 3 Ultra Resilia regarding death, stroke, aortic regurgitation or hemodynamic THV-deterioration? • Patients: All comers for transfemoral aortic valve implantation. • Follow-up: Combined primary endpoint at 1 year and long-term follow-up included in secondary endpoints.
Egholm et al. (Sun,) reported a other. The COMPARE-TAVI 2 trial is designed to test non-inferiority of Evolut FX+ versus Sapien 3 Ultra Resilia for 1-year death, stroke, aortic regurgitation, or valve deterioration.