One-year outcomes were not significantly different between patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR) with a self-expanding ACURATE neo valve or the balloon-expandable SAPIEN 3 device, according to study results presented Saturday at the TCT Connect virtual conference.
Jonas Lanz, MD, of Bern University Hospital, Switzerland, presented the results of the SCOPE I trial.
At 30 days, the ACURATE neo valve (Boston Scientific) did not meet noninferiority for the composite safety and clinical efficacy endpoint when compared to the SAPIEN 3 valve (Edwards Lifesciences) in patients undergoing TAVR for the treatment of severe aortic stenosis. Higher rates of moderate to severe prosthetic aortic regurgitation and acute kidney injury were found in patients undergoing TAVR with the ACURATE neo valve.
In the SCOPE I trial, patients with severe aortic stenosis who were scheduled for transfemoral TAVR were randomized in a 1-to-1 fashion to receive either an ACUTRTE neo or a SAPIEN 3 valve. All patients were followed for 1 year.
The primary endpoint was all-cause death or disabling stroke at 1 year. A total of 739 patients were randomized, 372 to ACURATE neo and 367 to SAPIEN 3. Their mean age was 82.3 years and their median Society of Thoracic Surgeons Predicted Risk of Mortality score was 3.5%.
In the ACURATE neo group, 11 patients had multiple valve implantations, compared to two in the SAPIEN 3 group. Six patients in the ACURATE neo group received a SAPIEN 3, and one patient in the SAPIEN 3 arm received an ACURATE neo. There were two conversions to SAVR in the ACURATE arm and none in the SAPIEN 3 group. One-year clinical follow-up rates were high in both groups.
There was no significant difference between the groups as far as the primary endpoint of all-cause death or disabling stroke at 1 year (ACURATE neo, 12%, vs. SAPIEN 3, 9.5%; hazard ratio [HR], 1.28, 95% confidence interval [CI], 0.81 to 2.0). Furthermore, there were no differences between the groups with respect to clinical events, including all-cause death, stroke, endocarditis, permanent pacemaker implantation and valve thrombosis.
There was little change in echocardiographic parameters between 30 days and 1 year, even though follow-up rates at 1 year were lower than at 30 days. In the ACURATE neo group, there was a lower mean transprosthetic gradient across the valve (7.9 mmHg vs. 12.5 mmHg; p < 0.001) and a larger mean effective orifice area (1.74 cm2 vs. 1.57 cm2; p<0.001) at 1 year. These findings were similar to the 30-day results. This is attributed to the ACURATE neo valve having supra-anular leaflets as part of its design. Finally, there was a higher rate of moderate to severe aortic regurgitation in the ACURATE neo valve group than in the SAPIEN 3 group, which was seen at both 30 days (9.7% vs. 2.8%; p<0.001) and 1 year (8.9% vs. 3.6%; p=0.006).
Lanz concluded by saying there were no significant differences the primary or secondary outcomes between the patients who received the ACURATE neo or the SAPIEN 3 valve. The rate of paravalvular regurgitation was higher with the ACURTE neo valve; however, it had lower transprosthetic mean gradients and higher effective orifice area, giving it a better hemodynamic profile at 1 year.
“Extended follow-up data will be crucial to determine the impact of the differential valve performance on long-term outcomes,” he said.
The SCOPE I study was supported by a dedicated research grant from Boston Scientific.