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Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma.


ABSTRACT:

Background

The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled.

Aims

The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population.

Methods

COMBINE OCT-FFR is a prospective, international, double-blind, natural history study. Patients with DM and with ≥1 FFR-negative lesion were classified into 2 groups based on the presence or absence of ≥1 TCFA lesion. The primary endpoint (PE) is a composite of cardiac mortality, target vessel-related myocardial infarction (TV-MI), clinically driven target lesion revascularisation (TLR), or unstable angina (UA) requiring hospitalisation during follow-up up to 5 years.

Results

Among 390 DM patients (age 67.5±9 years; 37% female) with ≥1 FFR-negative lesion, 292 (74.9%) were TCFA-negative while 98 (25.1%) were TCFA-positive. The PE occurred more frequently in TCFA-positive than in TCFA-negative patients (21.4% vs 8.2%, hazard ratio [HR] 2.89, 95% confidence interval [CI]: 1.61-5.20; p<0.001; 6.42 vs 2.46 events per 100 patient-years, rate ratio [RR] 2.61, 95% CI: 1.38-4.90; p=0.002). Furthermore, when TV-MI, TLR, and UA were treated as recurrent components of the PE, TCFA-positive patients experienced a higher risk of recurrent events (HR 2.89, 95% CI; 1.74-4.80; p<0.001; 13.45 vs 2.87 events per 100 patient-years, RR 4.69, 95% CI: 2.86-7.83; p<0.001). A multivariable analysis identified the presence of TCFA as an independent predictor of the PE (HR 2.76, 95% CI: 1.53-4.97; p<0.001).

Conclusions

OCT-detected TCFA-positive lesions, although not ischaemia-generating, are associated with an increased risk of adverse events during long-term follow-up.

Clinicaltrials

gov: NCT02989740.

SUBMITTER: Fabris E 

PROVIDER: S-EPMC9909454 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature

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Publications

Long-term outcomes of patients with normal fractional flow reserve and thin-cap fibroatheroma.

Fabris Enrico E   Berta Balázs B   Hommels Tobias T   Roleder Tomasz T   Hermanides Renicus S RS   Rivero Fernando F   von Birgelen Clemens C   Escaned Javier J   Camaro Cyril C   Kennedy Mark W MW   Pereira Bruno B   Magro Michael M   Nef Holger H   Reith Sebastian S   Roleder-Dylewska Magda M   Gasior Pawel P   Malinowski Krzysztof Piotr KP   De Luca Giuseppe G   Garcia-Garcia Hector M HM   Granada Juan F JF   Wojakowski Wojciech W   Kedhi Elvin E  

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20230206 13


<h4>Background</h4>The long-term prognostic implications of fractional flow reserve (FFR)-negative lesions hosting vulnerable plaques remain unsettled.<h4>Aims</h4>The aim of this study was to evaluate the association of non-ischaemic lesions hosting optical coherence tomography (OCT)-detected thin-cap fibroatheromas (TCFA) with first and recurrent cardiovascular events during follow-up up to 5 years in a diabetes mellitus (DM) patient population.<h4>Methods</h4>COMBINE OCT-FFR is a prospective,  ...[more]

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