SCOPE I: Acurate neo does not meet noninferiority for TAVR safety, efficacy vs. Sapien 3
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SAN FRANCISCO — Transcatheter aortic valve replacement with the self-expanding Acurate neo device did not meet noninferiority compared with the balloon-expandable Sapien 3 device for the primary composite safety and efficacy endpoint at 30 days, according to results of the SCOPE I trial.
SCOPE I is the first comparison of the two prostheses in an elderly population with symptomatic severe aortic stenosis and increased surgical risk.
“Differences between the two TAVR devices were driven by moderate or severe paravalvular regurgitation and stage 2 or 3 acute kidney injury in favor of the Sapien 3 device,” Jonas Lanz, MD, MSc, from the department of cardiology at Bern University Hospital, said during a press conference at TCT 2019.
SCOPE I enrolled 793 patients who were randomly assigned to undergo transfemoral TAVR with the self-expanding Acurate neo (Symetis/Boston Scientific; n = 372) or the balloon-expandable Sapien 3 (Edwards Lifesciences; n = 367) transcatheter heart valve systems.
The primary endpoint was a combination of Valve Academic Research Consortium (VARC-2)-derived early safety and clinical efficacy at 30 days. Within 30 days, the primary endpoint occurred in 24% of patients assigned TAVR with Acurate neo vs. 16% assigned TAVR with Sapien 3 (absolute risk difference, 7.1%). Thus, Lanz said, noninferiority of the Acurate neo system was not met (P for noninferiority = .42).
Secondary analyses of the primary endpoint showed superiority of Sapien 3 over Acurate neo (95% CI for risk difference, -1.3 to -12.9; P = .0156). There was no difference in all-cause death (2.5% vs. 0.8%, respectively; P = .09) and stroke (1.9 vs. 3%, respectively; P = .33) between the groups. New pacemaker implantation was also similar, at 11.5% among patients who received the Acurate neo vs. 10.3% who received Sapien 3 (P = .68).
Other components of the primary endpoint were similar between the two groups, except the Acurate neo group had higher rates of stage 2 or 3 acute kidney injury (3% vs. 0.8%; P = .034) and valve-related dysfunction (9.7% vs. 4.7%; P = .0084).
In addition, there were higher rates of multiple valve implantation with the Acurate neo, Lanz said during the presentation.
“An early composite safety and efficacy endpoint proved useful in discriminating the performance of different TAVR systems,” he said.
Echocardiographic findings showed higher moderate or severe paravalvular aortic regurgitation at follow-up in the Acurate neo group (9% vs. 3%). Median mean transprosthetic gradient was lower and median effective orifice areas was larger in those treated with the Acurate neo device.
The SCOPE I data were simultaneously published in The Lancet.
The trial was conducted at 20 sites in Germany, Switzerland, the Netherlands and United Kingdom. The mean age of those enrolled was 83 years, 57% were women and the median STS Predicted Risk of Mortality was 3.5%.
Looking ahead, Lanz said there is already a newer generation of this device — the Acurate neo2, which maintains key features of the original Acurate neo system, including a self-expanding nitinol frame, supra-annular positioning and a two-step, top-down deployment method. New to the next-generation device is annular sealing technology to further reduce paravalvular leak and a new radiopaque marker to enhance visibility of positioning and ease of use, according to the company.
The SCOPE II trial is currently underway, Lanz said, comparing Acurate neo with the CoreValve Evolut R (Medtronic). The randomized, controlled, noninferiority trial will look at the primary composite outcome of all-cause mortality or stroke at 1 year in patients with symptomatic severe AS. – by Katie Kalvaitis
References:
Lanz J, et al. Late-Breaking Trials 2. Presented at: TCT Scientific Symposium; Sept. 25-29, 2019; San Francisco.
Lanz J, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)32220-2.
Disclosures: The SCOPE I trial was funded by Boston Scientific. Lanz reports no relevant financial disclosures.
Perspective
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Ajay J. Kirtane, MD, SM
What is relevant going forward is the newer trial (SCOPE II) that is being done with a modification of the valve. Because, to my opinion, the degree of paravalvular leak that was seen in the difference between the two valves in this study will likely have some outcome related to it, late. We do not want to see that for patients. For me, iterations of the Acurate neo valve need to be made.
Perspective
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David J. Moliterno, MD, FACC
This study compared a first-generation device with a third-generation one. The Acurate neo was not found to be noninferior to the Sapien 3 in what appears to be an intermediate-risk group. While that is disappointing, it is terrific that there was a head-to-head comparison, which gives the opportunity for the next generations of the Acurate neo device to further address some of the issues observed in the first-generation device, particularly paravalvular leak. The second generation is trying to address paravalvular leak with a new annular system.
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