Long-term multiple comparison of transcatheter aortic valves – Insights from the OBSERVANT II study

Published in congress: EuroPCR 2024

Link: https://www.pcronline.com/Cases-resources-images/Resources/Course-videos-slides/2024/EuroPCR/Late-breaking-trials-TAVI-head-to-head

Dr. Ayşe Nur Özkaya İbiş

Introduction:
Transcatheter aortic valve replacement (TAVR) is becoming increasingly widespread due to advancements in operator experience and technological improvements in current transcatheter aortic valves (TAVs). Each of the TAVs in use today has unique features in terms of design and valve placement. The selection of the TAV to be implanted can be tailored based on specific patient characteristics, the anticipated benefits of the device, and the operator's confidence and expertise with different valve delivery systems. Until now, comparisons of TAVs have primarily been limited to two-arm design studies highlighting the potential benefits of certain TAVs over others. There is a growing need to compare the long-term effectiveness of the main TAV platforms used in real-world settings to identify the potential benefits of specific TAV designs.

Objective:
This study aims to compare the five-year outcomes of the five most commonly used second- and third-generation TAV platforms in clinical practice, based on patients enrolled in the multicenter OBSERVANT II study.

Methods:
This national prospective cohort study included patients who underwent TAVR for severe aortic stenosis at 28 centers in Italy between December 2016 and September 2018. Patients with an indication for TAVR received the most commonly used TAVs in daily practice in Italy: Medtronic Evolut R or PRO (Medtronic Inc, Minneapolis, MN), Edwards SAPIEN 3 (Edwards Lifesciences, Irvine, CA), Boston ACURATE neo (Boston Scientific, Marlborough, MA), and Abbott Portico (Abbott Vascular, Santa Clara, CA, USA). Patients were divided into four groups according to the implanted TAV. The primary composite endpoint was all-cause mortality and major adverse cardiac and cerebrovascular events (MACCE), including death, stroke, myocardial infarction, percutaneous coronary intervention, and coronary artery bypass grafting over five years. The secondary composite endpoint included stroke, myocardial infarction, repeat valve intervention, and heart failure (HF)-related hospitalization, with superiority tested among the valve groups.

Results:
A total of 2493 patients from 28 TAVR centers were included in the study: 1352 in the Evolut R/PRO group, 675 in the SAPIEN 3 group, 270 in the ACURATE neo group, and 196 in the Portico group. The average age of the patients was 83, and baseline characteristics were similar across groups. There was no significant difference among the TAV groups in the primary composite endpoints at five-year follow-up (MACCE p=0.08; all-cause mortality p=0.06). The rate of HF-related hospitalization, a secondary endpoint, was lower in the SAPIEN 3 group at 27% compared to the other groups (p=0.023). No significant differences were observed among the groups in other secondary endpoints.

Conclusions:
This study demonstrates that the outcomes of TAVR with the most commonly used Evolut R/PRO, SAPIEN 3, ACURATE neo, and Portico valves in daily practice are acceptable and similar up to the fifth year post-procedure. The rate of HF-related hospitalization within five years was lower in the group that received the SAPIEN 3 valve compared to the other groups.

Commentary:
Consistent with the one-year results of the OBSERVANT II study, the five-year results show sustainable and comparable outcomes for TAVR with Evolut R/PRO, SAPIEN 3, ACURATE neo, and Portico valves used in daily practice. The lower rate of paravalvular regurgitation with the SAPIEN 3 valve at one year likely contributed to the lower rate of HF-related hospitalization within five years. This study is significant as it is the first to compare these four valve groups and demonstrate their mid-term efficacy in clinical practice. Identifying the long-term effects of the hemodynamic and design features of TAVs will enhance clinical outcomes post-TAVR. Long-term studies in specific patient populations are needed for this purpose.