Sapien 3 balloon-expandable TAVR was associated with a lower yearly incidence of all-cause death compared to Evolut R self-expanding TAVR (RR 0.88; P=0.005).
Cohort (n=31,113)
Yes
Does Sapien 3 balloon-expandable TAVR reduce mortality and heart failure rehospitalization compared to Evolut R self-expanding TAVR in patients with aortic stenosis?
In a large nationwide French cohort, Sapien 3 balloon-expandable TAVR was associated with lower rates of mortality, heart failure rehospitalization, and pacemaker implantation compared to Evolut R self-expanding TAVR.
Relative Risk: 0.88
p-value: p=0.005
Background: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. Methods: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. Results: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean SD, 358 384; median interquartile range, 232 10–599 days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P =0.005), cardiovascular death (relative risk, 0.82; corrected P =0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P <0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P <0.0001). Conclusions: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.
Deharo et al. (Sat,) conducted a cohort in Aortic Stenosis (n=31,113). Sapien 3 balloon-expandable TAVR vs. Evolut R self-expanding TAVR was evaluated on All-cause death (RR 0.88, p=0.005). Sapien 3 balloon-expandable TAVR was associated with a lower yearly incidence of all-cause death compared to Evolut R self-expanding TAVR (RR 0.88; P=0.005).