https://m2.mtmt.hu/ hun 2026-09-21 15:58 JournalArticle 32660118 VALIDATED true Funding Agency and Grant Number: Isala Hartcentrum, Zwolle, the Netherlands; St Jude Medical/Abbott Vascular Funding text: This investigator-initiated study was sponsored by Isala Hartcentrum, Zwolle, the Netherlands, and supported from an unrestricted institutional grant from St Jude Medical/Abbott Vascular. Trial Registration: ClinicalTrials.gov Identifier: NCT02989740. 0 false 2026-07-24T11:42:30.927+0000 2022-08-10T13:09:03.841+0000 2022-02-09T11:43:35.770+0000 true 10080205 Szalóky-Siki Ágnes /api/admin/10080205 Admin true 2024-06-11T13:26:15.611+0000 2022-08-10T13:09:04.086+0000 true 10015544 Csajbók Edit /api/admin/10015544 Admin true 10015544 true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Kedhi, Elvin Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial true true /api/journal/1482 REVIEWED true false 1482 false 1482 true 0195-668X 1522-9645 Journal FOREIGN 42 45 4671 4679 4671 9 2021 Aims The aim of this study was to understand the impact of optical coherence tomography (OCT)-detected thin-cap ibroatheroma (TCFA) on clinical outcomes of diabetes mellitus (DM) patients with fractional flow reserve (FFR)-negative lesions. Methods and results COMBINE OCT-FFR study was a prospective, double-blind, international, natural history study. After FFR assessment, and revascularization of FFR-positive lesions, patients with >= 1 FFR-negative lesions (target lesions) were classified in two groups based on the presence or absence of >= 1 TCFA lesion. The primary endpoint compared FFR-negative TCFA-positive patients with FFR-negative TCFA-negative patients for a composite of cardiac mortality, target vessel myocardial infarction, clinically driven target lesion revascularization or unstable angina requiring hospitalization at 18 months. Among 550 patients enrolled, 390 (81%) patients had >= 1 FFR-negative lesions. Among FFR-negative patients, 98 (25%) were TCFA positive and 292 (75%) were TCFA negative. The incidence of the primary endpoint was 13.3% and 3.1% in TCFA-positive vs. TCFA-negative groups, respectively (hazard ratio 4.65; 95% confidence interval, 1.99-10.89; P < 0.001). The Cox regression multivariable analysis identified TCFA as the strongest predictor of major adverse clinical events (MACE) (hazard ratio 5.12; 95% confidence interval 2.12-12.34; P < 0.001). Conclusions Among DM patients with >= 1 FFR-negative lesions, TCFA-positive patients represented 25% of this population and were associated with a five-fold higher rate of MACE despite the absence of ischaemia. This discrepancy between the impact of vulnerable plaque and ischaemia on future adverse events may represent a paradigm shift for coronary artery disease risk stratification in DM patients. 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<span class="author-name" >Kedhi Elvin ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10022848"><a href="/gui2/?type=authors&mode=browse&sel=10022848" target="_blank">Berta Balazs (<span class="authorship-author-name">Berta Balázs</span> <span class="authorAux-mtmt"> Orvostudományok</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Városmajori Szív- és Érgyógyászati Klinika</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Roleder Tomasz </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hermanides Renicus S. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Fabris Enrico </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >IJsselmuiden Alexander J. J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kauer Floris </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Alfonso Fernando </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >von Birgelen Clemens </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Escaned Javier </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Camaro Cyril </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Kennedy Mark W. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Pereira Bruno </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Magro Michael </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Nef Holger </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Reith Sebastian </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Al Nooryani Arif </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Rivero Fernando </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Malinowski Krzysztof </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >De Luca Giuseppe </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Garcia Hector Garcia </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Granada Juan F. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Wojakowski Wojciech </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;32660118" target="_blank">Thin-cap fibroatheroma predicts clinical events in diabetic patients with normal fractional flow reserve: the COMBINE OCT-FFR trial</a></div> <div> <span class="journal-title">EUROPEAN HEART JOURNAL</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0195-668X">0195-668X</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1522-9645">1522-9645</a>)</span>: <span class="journal-volume">42</span> <span class="journal-issue">45</span> <span class="page"> pp 4671-4679 </span> <span class="year">(2021)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1093/eurheartj/ehab433" target="_blank" href="https://doi.org/10.1093/eurheartj/ehab433"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000743553700012" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000743553700012"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85119183744" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85119183744"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="34345911" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=34345911&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Cardiology and Cardiovascular Medicine&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 281</span> | Független: 228 | Függő: 53 | Nem jelölt: 0 | WoS jelölt: 255 | Scopus jelölt:&nbsp;267 | WoS/Scopus jelölt:&nbsp;281 | DOI jelölt:&nbsp;278 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;32660118&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 2 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 32660118</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">WOS TAGGED</span> </div> <div class="lastModified">Utolsó módosítás: 2022.08.10. 15:09 Csajbók Edit (SE_KK_Admin5_CSE, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Funding Agency and Grant Number: Isala Hartcentrum, Zwolle, the Netherlands; St Jude Medical/Abbott Vascular Funding text: This investigator-initiated study was sponsored by Isala Hartcentrum, Zwolle, the Netherlands, and supported from an unrestricted institutional grant from St Jude Medical/Abbott Vascular. Trial Registration: ClinicalTrials.gov Identifier: NCT02989740.</pre> </div></div>