Mortality, heart failure hospitalization and stroke are similar between-groups when comparing the ACURATE neo2 and Sapien/Evolut transcatheter aortic valve implantation (TAVI), observational data from Swedish studies show. Andreas Rück, MD, PhD, of the Karolinska Institutet, Stockholm, presented these results during a late-breaking clinical trial session at Cardiovascular Research Technologies (CRT) 2025 on Sunday. Dr. Rück emphasized that the E.U. and the U.S. can work together to bring about results for these valve studies, and panelist Nicolas Van Miegham, MD, PhD, from the Thoraxcenter, Rotterdam, agreed. “How we handle these valves in Europe is very different than how it was handled in the [ACURATE] IDE trial,” said Dr. Van Miegham during the late-breaking clinical trial session Sunday afternoon. The ACURATE neo2 TAVI device (Boston Scientific) had higher rates of death, stroke and rehospitalization at 1-year compared with control devices — Evolut (Medtronic) and SAPIEN (Edwards) — in the recent ACURATE IDE (investigational device exemption) trial. This present study evaluated the clinical outcomes of the same TAVI devices in the context of rigorous pre- and post-dilatation. “We used high-quality Swedish registry data to replicate the ACURATE IDE trial, comparing 1-year clinical outcomes between ACURATE and Sapien/Evolut TAVI,” Dr. Rück told CRT Times. The SWEDEHEART registry was used to mimic the ACURATE IDE trial by comparing patients who underwent TAVI in Sweden between 2020 and 2022. In the ACURATE IDE trial, non-inferiority against the control valves was not met at 12-months for death, heart failure hospitalization and stroke, Dr. Rück said. This present study used the same inclusion and exclusion criteria as the ACURATE IDE trial, and the combination of mortality, stroke and heart failure hospitalization at 1-year was the primary outcome. A total of 1,943 patients were included in the study (ACURATE neo2, n=33%; control prosthesis, n=67%). In the ACURATE group, pre-dilatation took place in 100% of patients and post-dilatation in 45% of patients. Of the pre-dilatations, ballons ≤ 1mm smaller than the annular diameter were used in 45%, and in 74% of the post-dilatations in the ACURATE group. No significant differences in mortality, stroke and heart failure hospitalization were observed between the ACURATE group and control at 12-months. No differences were observed between-groups when combining stroke and heart failure hospitalization (adjusted hazard ratio [HR]=0.97, 95% confidence interval [CI]=0.75-1.23) or individual outcomes. Additionally, there were no differences for myocardial infarction, percutaneous intervention or major bleeding. In the ACURATE group specifically, post-dilatation was not significantly associated with adverse outcomes. “In the Swedish dataset, pre- and postdilatation was done more often and with larger balloons than in the [ACURATE] IDE trial, which likely explains the better outcome,” Dr. Rück said. “We could also show that postdilatation was not associated with adverse effects, such as stroke or new permanent pacemaker.” Overall, no differences in death, heart failure hospitalization and stroke at were observed between the ACURATE neo2 group and control at 1-year. Image Credit: Bailey G. Salimes Image Caption: Andreas Rück, MD, PhD, presents his late-breaking clinical trial during a press conference at Cardiovascular Research Technologies (CRT) 2025 on Sunday.