There were no significant differences in clinical and functional outcomes in patients with severe aortic stenosis undergoing transfemoral TAVR with the self-expanding ACURATE neo compared with the balloon-expanding SAPIEN 3, said researchers presenting the SCOPE I trial Oct. 17 during TCT 2020. The trial did not meet criteria for non-inferiority.

Thomas Walther, MD, et al., looked at 739 patients (mean age 82.3 years) who were randomized to either the ACURATE neo (N=372) or SAPIEN 3 (N=367). One-year follow-up was completed for 96% of patients in the ACURATE neo group and 97% in the SAPIEN 3 group.

The primary outcome was all-cause death or disabling stroke at one year, which occurred in 12% of the ACURATE neo group and 9.4% in the SAPIEN 3 group. Researchers also observed "the rate of paravalvular regurgitation remained higher, but the hemodynamic profile [was] better with lower transprosthetic mean gradients and higher effective orifice area at one year in patients treated with ACURATE neo."

Based on the findings, SCOPE 1 investigators said that extended follow-up data "will be crucial to determine the impact of the differential valve performance on long-term outcomes."

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement, Heart Valve Prosthesis

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