Methodologic Considerations on Four Cardiovascular Interventions Trials With Contradictory Results.

The Annals of Thoracic Surgery
Mario GaudinoDavid P Taggart

Abstract

Contradictory findings from randomized trials addressing similar research questions are not uncommon in medicine. Although differing results may reflect true differences in the treatment effects or in the deliverability of the intervention, more commonly it is as a consequence of small but important discrepancies in study design. The writing group selected 4 recent trials with apparently contradictory results (2 on revascularization for left main coronary stenosis and 2 on treatment of secondary mitral regurgitation). Detailed methodologic analysis was performed to elucidate the difference in findings. Differences in the definition of the primary outcome are the most likely explanation for the contradictory findings of NOBLE versus EXCEL. Differences in study design (leading to substantially different patient populations) and in outcome definition might explain the discrepant findings of MITRA-FR versus COAPT. As shown by the comparative analysis of NOBLE and EXCEL and MITRA-FR and COAPT, changes in study design, outcome definitions, and patient population can markedly affect the outcome of randomized clinical trials.

References

Mar 10, 2015·Journal of Clinical Epidemiology·Maria Elena FlaccoJohn P A Ioannidis
Nov 1, 2016·The New England Journal of Medicine·Gregg W StoneUNKNOWN EXCEL Trial Investigators
Apr 22, 2017·Journal of the American College of Cardiology·Mouin S AbdallahUNKNOWN SYNTAX Trial Investigators
Sep 10, 2017·European Heart Journal·Helmut BaumgartnerUNKNOWN ESC Scientific Document Group
Sep 14, 2017·JAMA Cardiology·Marc RuelDeepak L Bhatt
Aug 28, 2018·The New England Journal of Medicine·Jean-François ObadiaUNKNOWN MITRA-FR Investigators
Aug 30, 2018·Journal of the American College of Cardiology·Kristian ThygesenUNKNOWN Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American He
Aug 31, 2018·European Heart Journal·Kristian ThygesenUNKNOWN ESC Scientific Document Group
Sep 28, 2018·Journal of the American College of Cardiology·Duk-Woo ParkSeung-Jung Park
Oct 4, 2018·The New England Journal of Medicine·Gregg W StoneUNKNOWN COAPT Investigators
Nov 15, 2018·Journal of the American College of Cardiology·Michael E FarkouhUNKNOWN FREEDOM Follow-On Study Investigators
Dec 20, 2018·Circulation·Marc RuelDavid P Taggart

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Citations

Jun 17, 2020·The Annals of Thoracic Surgery·Thoralf M Sundt
Mar 1, 2021·The Journal of Thoracic and Cardiovascular Surgery·Mario Gaudino, James M Brophy
Aug 11, 2021·International Journal of Cardiology·Arturo GiordanoCorrado Tamburino

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