Barili, F;
Freemantle, N;
Folliguet, T;
Muneretto, C;
De Bonis, M;
Czerny, M;
Obadia, JF;
... Menicanti, L; + view all
(2017)
The flaws in the detail of an observational study on transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate-risks patients.
European Journal of Cardio-Thoracic Surgery
, 51
(6)
pp. 1031-1035.
10.1093/ejcts/ezx058.
Preview |
Text
Freemantle_THOURANI LANCET CRITICISMS SHORTER NF-4.pdf - Accepted Version Download (537kB) | Preview |
Abstract
The PARTNER group recently published a comparison between the latest generation SAPIEN 3 transcatheter aortic valve implantation (TAVI) system (Edwards Lifesciences, Irvine, CA, USA) and surgical aortic valve replacement (SAVR) in intermediate-risk patients, apparently demonstrating superiority of the TAVI and suggesting that TAVI might be the preferred treatment method in this risk class of patients. Nonetheless, assessment of the non-randomized methodology used in this comparison reveals challenges that should be addressed in order to elucidate the validity of the results. The study by Thourani and colleagues showed several major methodological concerns: suboptimal methods in propensity score analysis with evident misspecification of the propensity scores (PS; no adjustment for the most significantly different covariates: left ventricular ejection fraction, moderate–severe mitral regurgitation and associated procedures); use of PS quintiles rather than matching; inference on not-adjusted Kaplan–Meier curves, although the authors correctly claimed for the need of balancing score adjusting for confounding factors in order to have unbiased estimates of the treatment effect; evidence of poor fit; lack of data on valve-related death. These methodological flaws invalidate direct comparison between treatments and cannot support authors’ conclusions that TAVI with SAPIEN 3 in intermediate-risk patients is superior to surgery and might be the preferred treatment alternative to surgery.
| Type: | Article |
|---|---|
| Title: | The flaws in the detail of an observational study on transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate-risks patients |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1093/ejcts/ezx058 |
| Publisher version: | http://doi.org/10.1093/ejcts/ezx058 |
| Language: | English |
| Additional information: | VC The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved. This version is the author accepted manuscript. For information on re-use, please refer to the publisher’s terms and conditions. |
| Keywords: | Science & Technology, Life Sciences & Biomedicine, Cardiac & Cardiovascular Systems, Respiratory System, Surgery, Cardiovascular System & Cardiology, Transcatheter valve therapy, Valve disease, Aortic valve replacement, Propensity score analysis, Statistical analysis, MITRAL REGURGITATION, MORTALITY, SOCIETY, EUROSCORE, SURGERY, SCORES, METAANALYSIS, RELIABILITY, STENOSIS, OUTCOMES |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > Comprehensive CTU at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1571995 |
Archive Staff Only
 |
View Item |
