One-Year Outcomes of a Randomized Trial Comparing a Self-Expanding With a Balloon-Expandable Transcatheter Aortic Valve
Authors: Won-Keun Kim, Thomas Walther, Christof Burgdorf, Helge Möllmann, Axel Linke, Simon Redwood, Christian Thilo, Michael Hilker, Michael Joner, Holger Thiele, Lars Conzelmann, Lenard Conradi, Sebastian Kerber, Gerhard Schymik, Bernard Prendergast, Oliver Husser, Johannes Blumenstein, Stefan Stortecky, Dik Heg, Arnaud Künzi, Peter Jüni, Stephan Windecker, Thomas Pilgrim, Jonas Lanz
Journal: Circulation (2021)

COPE I (Safety and Efficacy of the Symetis ACURATE neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis) is an investigator-initiated randomized clinical trial comparing the self-expanding Acurate neo (NEO) with the balloonexpandable Sapien 3 (S3) bioprosthesis in patients with symptomatic severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement (TAVR).At 30 days, TAVR with NEO did not meet noninferiority compared with S3 regarding the primary composite end point because of higher rates of prosthetic valve regurgitation (PVR) and acute kidney injury. 1 Here we report outcomes at 1 year.Patients with symptomatic severe aortic stenosis deemed at increased surgical risk were recruited at 20 tertiary centers across Europe.Clinical endpoints were adjudicated by an independent clinical events committee blinded to treatment allocation.Outcome rates at 1 year are reported as Kaplan-Meier estimates and compared by means of Cox proportional hazard models in the intention-to-treat cohort.Valve performance at follow-up was assessed by an independent echocardiography core laboratory and is reported for the valve implant cohort.Details concerning administrative structure, study design, and end point definitions have been reported. 1Study approval was obtained from institutional ethics committees at each site.The study is registered (URL: https://www.clinicaltrials.gov;Unique identifier: NCT03011346).The data that support the findings of this study are available from the corresponding author on reasonable request.A total of 739 patients were randomly assigned (1:1) to TAVR with NEO (n=372) or S3 (n=367) between February 2017 and 2019.One-year follow-up was available in 715 (96.8%) patients.Baseline characteristics have been previously reported. 1Major clinical outcome rates and hazard ratios comparing the 2 groups are depicted in the Figure .At 1 year, rates of all-cause death were 10.9% in the NEO and 8.3% in the S3 group (hazard ratio, 1.31 [95% CI, 0.81-2.10]).Disabling stroke occurred in 2.9% (NEO) and 1.7% (S3) at 1 year (hazard ratio, 1.66 [95% CI, 0.60-4.57]),and the composite of all-cause death and disabling stroke in 12.0% and 9.4%, respectively (hazard ratio, 1.27 [95% CI, 0.81-1.98]).At 1 year, the prevalence of moderate or severe PVR remained numerically higher in the NEO group (15/168 [8.9%] versus 6/165 [3.6%]; P=0.07), whereas mean transprosthetic gradients were lower (7.2±3.3 versus 11.5±5.4mm Hg; P<0.001).At 1 year, no differences in clinical outcomes were observed in the randomized comparison of the NEO and S3 in patients undergoing TAVR for symptomatic severe aortic stenosis.The rate of PVR remained higher and transprosthetic mean gradients lower in NEO recipients from 30 days to 1-year follow-up.One-year death rates observed in SCOPE I are in the range of those previously reported for intermediate risk patients using newer generation devices. 2,3The numerically higher rate of all-cause death at 1 year in the NEO group partly results from periprocedural adverse events that occurred more frequently in the NEO group. 1 It may be difficult to ascribe longer-term mortality to specific transcatheter One-Year Outcomes of a Randomized Trial Comparing a Self-Expanding With a Balloon-Expandable Transcatheter Aortic Valve