Enrico Fabris1, MD, PhD; Balázs Berta2,3, MD, PhD; Tobias Hommels3, MD; Tomasz Roleder4, MD, PhD; Renicus S. Hermanides3, MD, PhD; Alexander J.J. IJsselmuiden5, MD, PhD; Floris Kauer6, MD; Fernando Alfonso7, MD, PhD; Fernando Rivero7, MD; Clemens von Birgelen8,9, MD, PhD; Javier Escaned10, MD, PhD; Cyril Camaro11, MD, PhD; Mark W. Kennedy12, MD, PhD; Bruno Pereira13, MD; Michael Magro14, MD, PhD; Holger Nef15, MD, PhD; Sebastian Reith16, MD, PhD; Magda Roleder-Dylewska17, MD; Pawel Gasior17, MD, PhD; Krzysztof Piotr Malinowski18, MSc; Giuseppe De Luca19, MD, PhD; Hector M. Garcia-Garcia20, MD, PhD; Juan F. Granada21,22, MD; Wojciech Wojakowski17, MD, PhD; Elvin Kedhi17,23, MD, PhD
1. Cardiovascular Department, University of Trieste, Trieste, Italy; 2. Heart and Vascular Centre, Semmelweis University, Budapest, Hungary; 3. Isala Hartcentrum, Zwolle, the Netherlands; 4. Department of Cardiology, Wroclaw Medical University, Wroclaw, Poland; 5. Department of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands; 6. Department of Cardiology, Albert Schweitzer Ziekenhuis, Dordrecht, the Netherlands; 7. Department of Cardiology, Hospital Universitario de La Princesa, Madrid, Spain; 8. Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; 9. Technical Medical Centre, Health Technology and Services Research, University of Twente, Enschede, the Netherlands; 10. Hospital Clínico San Carlos IdISSC, Complutense University, Madrid, Spain; 11. Radboud University Medical Center, Nijmegen, the Netherlands; 12. Beaumont Hospital, Dublin, Ireland; 13. INCCI Haerz-Zenter, Luxembourg, Luxembourg; 14. Elisabeth-TweeSteden Ziekenhuis, Tilburg, the Netherlands; 15. Universitätsklinikum Gießen und Marburg, Gießen/Marburg, Germany; 16. Uniklinik RWTH, Aachen, Germany; 17. Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland; 18. Department of Bioinformatics and Telemedicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland; 19. AOU Sassari, Università degli Studi di Sassari, Sassari, Italy; 20. Interventional Cardiology, MedStar Washington Hospital Center, Washington DC, USA; 21. Cardiovascular Research Foundation, New York, NY, USA; 22. Columbia University Irving Medical Center, New York, NY, USA; 23. Erasmus Hospital, Université libre de Bruxelles, Brussels, Belgium
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
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clinical trialsdiabetesfractional flow reserveoptical coherence tomography
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