Methodologic Considerations on Four Cardiovascular Interventions Trials With Contradictory Results

Mario Gaudino, Marc Ruel, Jean Francois Obadia, Michele De Bonis, John Puskas, Giuseppe Biondi-Zoccai, Dominick J. Angiolillo, Mary Charlson, Filippo Crea, David P. Taggart

Research output: Contribution to journalReview articlepeer-review

8 Scopus citations


Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)690-699
Number of pages10
JournalAnnals of Thoracic Surgery
Issue number2
StatePublished - Feb 2021
Externally publishedYes


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