Initially presented in 2019, the SCOPE I trial compared the Acurate Neo Self expanding valve versus the Edwards S3 balloon expandable valve in patients at intermediate to high risk for surgery with severe and symptomatic aortic stenosis via a trans-femoral approach. The study enrolled patients in a 1:1 fashion with a total of 739 patients (Acurate neo = 372; Edwards Sapien 3 = 367). The initial 30-day outcomes presented in 2019 showed that the Acurate neo did not meet its predefined definition for non-inferiority due to increased rates of moderate paravalvular leak and acute kidney injury.

In order to evaluate the long-term clinical impact of these outcomes, three-year data was presented at TCT in 2022. All-cause mortality was not significantly different (Acurate neo 24.3%, Sapien S3 25%, p>0.05). Additionally, cardiovascular death, hospitalization for valve related dysfunction, NYHA class III or IV all were not significantly different. Hemodynamics were shown to be superior for the Acurate neo versus Sapien S3 (mean gradient 8mmHg versus 12.1mmHg p<0.001; AVA 1.95cm2 versus 1.69cm2 p=0.011) as well as a trend for less valve thrombosis (0.3% versus 1.8%).

The SCOPE I trial addresses head-to-head outcomes of different trans-catheter valve replacement platforms, an area where there is a paucity of prospective data available. Interestingly, despite an increase in paravalvular leak following initial implantation of the Acurate neo, it did not translate to a worse clinical outcome or valve deterioration at three years.

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Presented by Dr. Jonas Lanz at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2022), Boston, MA, September 2022.