5-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Bibliographic record
Abstract
BACKGROUND: The Evolut Low Risk trial demonstrated that transcatheter aortic valve replacement (TAVR) was noninferior to surgery for the primary endpoint of all-cause mortality or disabling stroke at 2 years. Outcomes at 5 years have not been reported. OBJECTIVES: This study sought to evaluate 5-year clinical and hemodynamic outcomes with TAVR vs surgery in patients from the Evolut Low Risk trial. METHODS: We randomly assigned low-risk patients with severe aortic stenosis to TAVR or surgery. The primary endpoint was a composite of all-cause mortality or disabling stroke. Secondary endpoints included clinical, echocardiographic, and quality-of-life outcomes through 5 years. RESULTS: A total of 1,414 patients underwent an attempted implant (n = 730 TAVR, n = 684 surgery). The mean age was 74 years (range 51-88 years), and women accounted for 35% of patients. At 5 years the Kaplan-Meier estimate for the primary endpoint of all-cause mortality or disabling stroke was 15.5% for the TAVR group and 16.4% for the surgery group (P = 0.47). The Kaplan-Meier estimates in the TAVR and surgery groups for all-cause mortality were 13.5% and 14.9% (P = 0.39) and for disabling stroke were 3.6% and 4.0% (P = 0.57). Cardiovascular mortality was 7.2% in the TAVR group and 9.3% in the surgery group (P = 0.15). Noncardiovascular mortality in the TAVR group was 6.8% and 6.2% in the surgery group (P = 0.73). A site-level vital status sweep was performed for patients who were lost to follow-up or withdrew from the study. With the addition of these patients, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% (P = 0.74). Over 5 years, valve reintervention rate was 3.3% for TAVR and 2.5% for surgery (P = 0.44). A sustained improvement in quality of life was observed in both treatment arms with mean Kansas City Cardiomyopathy Questionnaire summary score of 88.3 ± 15.8 in TAVR and 88.5 ± 15.8 in surgery. CONCLUSIONS: At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke. Valve durability and performance were excellent in both arms. This midterm evaluation reinforces the position of TAVR as noninferior to surgery in patients with severe aortic stenosis at low surgical risk (Medtronic Evolut Transcatheter Aortic Valve Replacement in Low Risk Patients; NCT02701283).
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".