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"snippet" : true }, "validState" : "IDENTICAL", "idValue" : "34345911", "realUrl" : "http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=34345911&dopt=Abstract", "published" : false, "snippet" : true } ], "journal" : { "otype" : "Journal", "mtid" : 1482, "link" : "/api/journal/1482", "label" : "EUROPEAN HEART JOURNAL 0195-668X 1522-9645", "pIssn" : "0195-668X", "eIssn" : "1522-9645", "reviewType" : "REVIEWED", "noIF" : false, "sciIndexed" : true, "scopusIndexed" : true, "lang" : "FOREIGN", "hungarian" : false, "published" : true, "oldId" : 1482, "snippet" : true }, "volume" : "42", "issue" : "45", "firstPage" : "4671", "lastPage" : "4679", "firstPageOrInternalIdForSort" : "4671", "pageLength" : 9, "publishedYear" : 2021, "abstractText" : "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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