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

DOI: 10.4244/EIJ-D-22-00306

Enrico Fabris
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

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

clinical trialsdiabetesfractional flow reserveoptical coherence tomography
Read next article
Diagnostic performance of exercise stress tests for detection of epicardial and microvascular coronary artery disease: the UZ Clear study

Latest news