SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial.

BACKGROUND

Transcatheter aortic valve implantation (TAVI) is a guideline-directed treatment for severe aortic stenosis and degenerated aortic bioprostheses. When new transcatheter heart valve (THV) platforms for TAVI are launched, they should be compared with best-in-practice contemporary THVs for their short-term and long-term performance. The COMPARE-TAVI 1 trial was designed to provide a head-to-head comparison of the SAPIEN 3 or SAPIEN 3 Ultra THVs and the Myval or Myval Octacor THVs.

METHODS

This multicentre, all-comers, randomised, non-inferiority trial was done at three university hospitals in Denmark. Eligible patients were aged 18 years or older, scheduled for transfemoral TAVI, and eligible for treatment with SAPIEN 3 THVs or Myval THVs. Patients were randomly assigned (1:1) to treatment with SAPIEN 3 (29 mm diameter) or SAPIEN 3 Ultra (20 mm, 23 mm, or 26 mm diameter) THVs or Myval or Myval Octacor THVs (20-32 mm diameter). The TAVI procedure was performed according to local practice and under local anaesthesia unless leaflet laceration was performed. The primary endpoint was a composite of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration at 1 year according to Third Valve Academic Research Consortium criteria. All patients assigned to THV treatment were included in the intention-to-treat analysis, and all patients who were treated as randomly assigned were included in the per-protocol analysis. With an expected event rate of 13%, the prespecified non-inferiority margin was 5·3%. This trial is registered with ClinicalTrials.gov, NCT04443023, and is closed to accrual.

FINDINGS

Between June 15, 2020, and Nov 3, 2023, 1031 patients were enrolled. Enrolment was paused twice because of patent-related legal proceedings. Of 1031 patients, 517 patients were randomly assigned to SAPIEN 3 THVs and 514 to Myval THVs. The median patient age was 81·6 years (IQR 77·6-85·0), and 415 (40%) of 1031 patients were female and 616 (60%) were male. The primary endpoint occurred in 67 (13%) of 517 patients randomly assigned to SAPIEN 3 THVs versus 71 (14%) of 514 patients randomly assigned to Myval THVs (risk difference -0·9% [one-sided upper 95% CI 4·4%]; p=0·019).

INTERPRETATION

Myval THVs were non-inferior to SAPIEN 3 THVs in terms of a 1-year composite endpoint of death, stroke, moderate or severe aortic regurgitation, or moderate or severe haemodynamic THV deterioration.

FUNDING

Meril Life Sciences, Vingmed Denmark, the Danish Heart Foundation, and the Central Denmark Region.