SCOPE I Study Does Not Meet Noninferiority Endpoint for TAVR Device

September 27, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the SCOPE I study were presented by Jonas Lanz, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California.

The randomized SCOPE I trial to compare the safety and efficacy of the Symetis Acurate Neo self-expanding transcatheter heart valve (Boston Scientific Corporation) with the Sapien 3 transcatheter aortic valve replacement (TAVR) device (Edwards Lifesciences) did not meet noninferiority in patients with severe aortic stenosis.

Conducted between February 2017 and February 2019, the study was composed of 739 patients with severe, symptomatic aortic stenosis at increased surgical risk. These patients were randomized 1:1 to transfemoral TAVR with the Acurate Neo (n = 372) or the Sapien 3 (n = 367) system at 20 European sites. Clinical follow-up information at 30 days was available for 98.9% and echocardiographic follow-up for 98.0% of the total study population.

The study was designed to investigate the noninferiority of the primary endpoint, which was a composite of safety and efficacy derived from the Valve Academic Research Consortium-2 criteria.

These criteria include all-cause death, any stroke, life-threatening or disabling bleeding, major vascular complications, coronary artery obstruction requiring intervention, acute kidney injury stage 2 or higher, valve-related dysfunction requiring repeat procedure, rehospitalization for valve-related symptoms or congestive heart failure, moderate or severe prosthetic valve regurgitation, or prosthetic valve stenosis at 30 days.

The primary endpoint rate in the intention-to-treat cohort for Acurate Neo was 23.7% compared to 16.5% with Sapien 3 (P_{noninferiority} = .42), which did not meet noninferiority.

The differences between the two TAVR devices were mainly driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the Sapien 3 device, reported CRF.

Dr. Lanz commented in the CRF announcement, “Accurate Neo did not meet noninferiority compared to the Sapien 3 device regarding the primary composite safety and efficacy endpoint at 30 days. An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems.”