Open AccessTranscatheter aortic valve replacement in low-risk patients: superiority or shifting goalposts and statistical crystal-gazing?
Author(s) -
Pradeep Narayan
Publication year - 2019
Publication title -
indian journal of thoracic and cardiovascular surgery/indian journal of thoracic and cardiovascular surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.114
H-Index - 9
eISSN - 0973-7723
pISSN - 0970-9134
DOI - 10.1007/s12055-019-00835-w
Subject(s) - medicine , aortic valve replacement , valve replacement , cardiac surgery , stroke (engine) , cardiology , surgery , concomitant , cardiothoracic surgery , aortic valve , stenosis , mechanical engineering , engineering
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.