Transcatheter aortic valve replacement in low-risk patients: superiority or shifting goalposts and statistical crystal-gazing?
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Transcatheter aortic valve replacement (TAVR) has been compared to surgical aortic valve replacement (SAVR) in two different industry-sponsored trials (Edwards Lifesciences—the SAPIEN 3 system; Medtronic—the CoreValve, EvolutR, and EvolutPRO) in patients with low risk for surgical aortic valve replacement. In the balloon-expandable SAPIEN 3 system, requirements for both non-inferiority (P < 0.001) and superiority (P < 0.001) were met for the primary outcome which was a composite of death from any cause, stroke, or re-hospitalization. In the self-expanding EVOLUT valve study, the requirement for the non-inferiority of TAVR was met for a composite of death and stroke. In both studies, the mean age of patients was 74, and extrapolation of these results to a younger low-risk population cannot be recommended. Moreover, unblinded adjudication of end points, the large numbers of concomitant procedures in the SAVR group, using a composite end point as the primary outcome and the use of estimated rather than actual figures remain some of the important concerns of these studies.
KeywordsPARTNER 3 trial SAPIEN 3 EVOLUT
Compliance with ethical standards
There was no funding for this manuscript. No funds were received by the author, and there are no conflicts of interest. This Critical Appraisal of Trials does not mention any patient or patient details and hence formal ethical approval is not required.
Conflict of interest
The author declares no conflict of interest.