Literature DB >> 36258821

UK Transcatheter Aortic Valve Implantation trial - time to differentiate "non-inferiority" from "equivalence"?

Pradeep Narayan1.   

Abstract

The UK Transcatheter Aortic Valve Implantation (UK-TAVI) trial has compared transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in patients above the age of 70 years with moderate operative risk. The primary outcome was 1-year all-cause mortality. This was a non-inferiority trial that concluded that TAVI in this cohort was non-inferior to SAVR. This appraisal reports the main findings of the study and discusses the strengths and weaknesses of the trial. © Indian Association of Cardiovascular-Thoracic Surgeons 2022, Springer Nature or its licensor holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Entities:  

Keywords:  Surgical aortic valve replacement (SAVR); Transcatheter aortic valve implantation (TAVI); UK-TAVI trial

Year:  2022        PMID: 36258821      PMCID: PMC9569247          DOI: 10.1007/s12055-022-01411-5

Source DB:  PubMed          Journal:  Indian J Thorac Cardiovasc Surg        ISSN: 0970-9134


  6 in total

1.  Non-inferiority trials are unethical because they disregard patients' interests.

Authors:  Silvio Garattini; Vittorio Bertele'
Journal:  Lancet       Date:  2007-10-23       Impact factor: 79.321

2.  Transcatheter Aortic-Valve Replacement with a Self-Expanding Valve in Low-Risk Patients.

Authors:  Jeffrey J Popma; G Michael Deeb; Steven J Yakubov; Mubashir Mumtaz; Hemal Gada; Daniel O'Hair; Tanvir Bajwa; John C Heiser; William Merhi; Neal S Kleiman; Judah Askew; Paul Sorajja; Joshua Rovin; Stanley J Chetcuti; David H Adams; Paul S Teirstein; George L Zorn; John K Forrest; Didier Tchétché; Jon Resar; Antony Walton; Nicolo Piazza; Basel Ramlawi; Newell Robinson; George Petrossian; Thomas G Gleason; Jae K Oh; Michael J Boulware; Hongyan Qiao; Andrew S Mugglin; Michael J Reardon
Journal:  N Engl J Med       Date:  2019-03-16       Impact factor: 91.245

3.  Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients.

Authors:  Michael J Mack; Martin B Leon; Vinod H Thourani; Raj Makkar; Susheel K Kodali; Mark Russo; Samir R Kapadia; S Chris Malaisrie; David J Cohen; Philippe Pibarot; Jonathon Leipsic; Rebecca T Hahn; Philipp Blanke; Mathew R Williams; James M McCabe; David L Brown; Vasilis Babaliaros; Scott Goldman; Wilson Y Szeto; Philippe Genereux; Ashish Pershad; Stuart J Pocock; Maria C Alu; John G Webb; Craig R Smith
Journal:  N Engl J Med       Date:  2019-03-16       Impact factor: 91.245

4.  Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement.

Authors:  Raj R Makkar; Vinod H Thourani; Michael J Mack; Susheel K Kodali; Samir Kapadia; John G Webb; Sung-Han Yoon; Alfredo Trento; Lars G Svensson; Howard C Herrmann; Wilson Y Szeto; D Craig Miller; Lowell Satler; David J Cohen; Todd M Dewey; Vasilis Babaliaros; Mathew R Williams; Dean J Kereiakes; Alan Zajarias; Kevin L Greason; Brian K Whisenant; Robert W Hodson; David L Brown; William F Fearon; Mark J Russo; Philippe Pibarot; Rebecca T Hahn; Wael A Jaber; Erin Rogers; Ke Xu; Jaime Wheeler; Maria C Alu; Craig R Smith; Martin B Leon
Journal:  N Engl J Med       Date:  2020-01-29       Impact factor: 91.245

5.  Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Authors:  William D Toff; David Hildick-Smith; Jan Kovac; Michael J Mullen; Olaf Wendler; Anita Mansouri; Ines Rombach; Keith R Abrams; Simon P Conroy; Marcus D Flather; Alastair M Gray; Philip MacCarthy; Mark J Monaghan; Bernard Prendergast; Simon Ray; Christopher P Young; David C Crossman; John G F Cleland; Mark A de Belder; Peter F Ludman; Stephen Jones; Cameron G Densem; Steven Tsui; Manoj Kuduvalli; Joseph D Mills; Adrian P Banning; Rana Sayeed; Ragheb Hasan; Douglas G W Fraser; Uday Trivedi; Simon W Davies; Alison Duncan; Nick Curzen; Sunil K Ohri; Christopher J Malkin; Pankaj Kaul; Douglas F Muir; W Andrew Owens; Neal G Uren; Renzo Pessotto; Simon Kennon; Wael I Awad; Saib S Khogali; Maciej Matuszewski; Richard J Edwards; Bandigowdanapalya C Ramesh; Miles Dalby; Shahzad G Raja; Giovanni Mariscalco; Clinton Lloyd; Ian D Cox; Simon R Redwood; Mark G Gunning; Paul D Ridley
Journal:  JAMA       Date:  2022-05-17       Impact factor: 157.335

6.  Fractional flow reserve-guided PCI as compared with coronary bypass surgery (FAME III)- another brick in the wall!

Authors:  Pradeep Narayan
Journal:  Indian J Thorac Cardiovasc Surg       Date:  2022-04-05
  6 in total

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