Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/45362
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dc.contributor.authorVERBEECK, Johan-
dc.contributor.authorDe Backer, Mickael-
dc.contributor.authorBUYSE, Marc-
dc.date.accessioned2025-02-20T08:44:02Z-
dc.date.available2025-02-20T08:44:02Z-
dc.date.issued2025-
dc.date.submitted2025-02-17T12:37:42Z-
dc.identifier.citationEuropean Heart Journal. Acute Cardiovascular Care,-
dc.identifier.issn2048-8726-
dc.identifier.urihttp://hdl.handle.net/1942/45362-
dc.description.abstractThe recently published REC-CAGEFREEI trial 1 provides an interesting example of non-inferiority vs. superiority design of clinical trials. The trial failed to show non-inferiority (P = 0.65) of drug-coated balloon angioplasty (with the option of rescue stenting) to the intended deployment of drug-eluting stents on the primary composite endpoint of car-diovascular death, target vessel myocardial infarction, and target lesion revascularization. However, not the result, but the motivation and reporting on the trial draw our attention (Figure 1). Non-inferiority designs aim to show that a novel therapy is not worse than a standard of care by more than a pre-specified non-inferiority margin on an efficacy outcome. This margin represents an acceptable loss on efficacy, which is justified by a putative advantage of the novel therapy on patient outcomes other than efficacy, such as improved safety, better quality of life, more convenient administration, or lower cost. A non-inferiority design should thus be motivated by a clear advantage. In stent trials, for example, a short-term reduction in-
dc.language.isoen-
dc.publisherOXFORD UNIV PRESS-
dc.rightsThe Author(s) 2025. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.-
dc.titleFrom non-inferiority to superiority: the shift towards patient-centric outcomes-
dc.typeJournal Contribution-
local.format.pages2-
local.bibliographicCitation.jcatA2-
dc.description.notesVerbeeck, J (corresponding author), Univ Hasselt, DSI Data Sci Inst & I Biostat, Agoralaan Bldg, B-3590 Diepenbeek, Belgium.-
dc.description.notesjohan.verbeeck@uhasselt.be-
local.publisher.placeGREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND-
local.type.refereedRefereed-
local.type.specifiedEditorial Material-
local.bibliographicCitation.statusEarly view-
local.classdsPublValOverrule/author_version_not_expected-
dc.identifier.doi10.1093/ehjacc/zuaf004-
dc.identifier.pmid39797912-
dc.identifier.isi001408465700001-
dc.contributor.orcidVerbeeck, Johan/0000-0002-4923-1032; Buyse, Marc/0000-0002-4559-0994-
dc.identifier.eissn2048-8734-
local.provider.typewosris-
local.description.affiliation[Verbeeck, Johan] Univ Hasselt, DSI Data Sci Inst & I Biostat, Agoralaan Bldg, B-3590 Diepenbeek, Belgium.-
local.description.affiliation[De Backer, Mickael] UCB, Stat Innovat Team, Brussels, Belgium.-
local.description.affiliation[Buyse, Marc] IDDI, Louvain La Neuve, Belgium.-
local.uhasselt.internationalno-
item.fullcitationVERBEECK, Johan; De Backer, Mickael & BUYSE, Marc (2025) From non-inferiority to superiority: the shift towards patient-centric outcomes. In: European Heart Journal. Acute Cardiovascular Care,.-
item.accessRightsRestricted Access-
item.fulltextWith Fulltext-
item.contributorVERBEECK, Johan-
item.contributorDe Backer, Mickael-
item.contributorBUYSE, Marc-
crisitem.journal.issn2048-8726-
crisitem.journal.eissn2048-8734-
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