Five-Year Multiple Comparison of Transcatheter Aortic Valves: Insights From the OBSERVANT II study.

Abstract

Background: Head-to-head comparisons of second and third generations of transcatheter heart valves (THVs) are mostly limited to 2-arm studies and to mid-term follow-up. The aim of this study was to simultaneously compare clinical outcomes of transcatheter aortic valve replacement (TAVR) with 4 different THVs at 5 years.

Methods: Patients undergoing transfemoral TAVR with 4 second-generation THV platforms and enrolled in the multicentre prospective OBSERVANT II study from December 2016 to September 2018 were compared according to the THV received. Outcomes were adjudicated through a linkage with administrative databases and adjusted by means of inverse propensity of treatment weighting (IPTW) based on propensity score. The primary end points were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 5 years. Cumulative rates were reported consecutively for Evolut R/Pro, Sapien 3, Acurate Neo, and Portico groups.

Results: A total of 2493 patients were considered. The median age was 83 years and median EuroSCORE 2 was 4.9%. After IPTW adjustment, the rates of all-cause death (53.6%, 46.7%, 50.5%, and 46.3%; P = 0.06) and MACCE (57.2%, 51.2%, 54.4%, and 50.6%; P = 0.08) did not differ among the groups at 5 years. The rate of rehospitalisation for heart failure (HF) (33.9%, 27.0%, 31.6%, 33.7%; P = 0.02) was significantly lower for Sapien 3 at 5 years.

Conclusions: Data from real-world practice showed sustained and similar effectiveness of TAVR considering all the available THVs up to 5 years, but Sapien 3 showed a lower rate of rehospitalisation for HF.