1-Year Outcomes of TAVR With ACURATE neo2 vs SAPIEN/Evolut

BACKGROUND: The ACURATE IDE trial demonstrated increased death, stroke, and rehospitalization at 1 year with ACURATE neo2 transcatheter aortic valve replacement (TAVR) devices compared with control devices, possibly caused by suboptimal pre- and postdilatation. OBJECTIVES: The aim of this study was to investigate clinical outcomes of TAVR with ACURATE neo2 vs control valves using rigorous pre- and postdilatation. METHODS: The nationwide SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) registry to emulate a target trial comparing TAVR with the ACURATE neo2 vs SAPIEN or Evolut in Sweden, using the same inclusion and exclusion criteria as the investigational device exemption trial. The primary outcome was mortality, stroke, and heart failure hospitalization combined at 1 year. Adjustment by balancing weighting was used. RESULTS: The ACURATE neo2 was used in 644 patients (33%) and control prostheses in 1,299 patients (67%). With the ACURATE neo2, predilatation was used in 100% and postdilatation in 45% (n = 288). Balloons undersized ≤1 mm were used in 47% (n = 304) of the predilatations and 74% (n = 214) of the postdilatations with the ACURATE neo2. Median follow-up duration was 352 days (Q1-Q3: 193.5-365 days). There was no difference between the ACURATE neo2 and control at 12 months in the primary endpoint (adjusted HR: 0.97; 95% CI: 0.75-1.23), as individual outcomes, or for myocardial infarction, percutaneous intervention, or major bleeding. Within the ACURATE neo2 group, postdilatation was not significantly associated with adverse outcomes. CONCLUSIONS: There was no difference in clinical outcomes at 1 year between the ACURATE neo2 and the Evolut or SAPIEN valves. The discrepancy with the investigational device exemption trial findings may be explained by more rigorous pre- and postdilatation.