One-Year Outcomes of a Randomized Trial Comparing a Self-Expanding With a Balloon-Expandable Transcatheter Aortic Valve
Bibliographic record
Abstract
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
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.009 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.005 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.002 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.004 | 0.005 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".