TY - JOUR
T1 - Medically Treated Nonischemic Thin-Cap Fibroatheroma Lesions Versus Fractional Flow Reserve-Guided Complete Revascularization in Diabetic Patients
AU - Hommels, Tobias M.
AU - Hermanides, Renicus S.
AU - Fabris, Enrico
AU - Malinowski, Krzysztof P.
AU - Berta, Balázs
AU - Roleder, Tomasz
AU - Alfonso, Fernando
AU - De Luca, Giuseppe
AU - Oemrawsingh, Rohit M.
AU - Wojakowski, Wojciech
AU - van 't Hof, Arnoud W.J.
AU - Kedhi, Elvin
N1 - Funding Information:
The study team is grateful to its participating centers and research facilities. The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. This investigator-initiated study was supported by Isala Hartcentrum, Zwolle, the Netherlands, by an unrestricted institutional grant from St. Jude Medical/Abbott Vascular. The COMBINE OCT-FFR trial (NTR5376/NCT02989740) was performed in accordance with the Declaration of Helsinki and was registered at the Netherlands Trial Register (NTR) and acknowledged by the World Health Organization (WHO) and International Committee of Medical Journal Editors (ICMJE) with additional registration at ClinicalTrials.gov. Approval for ethical committees was sought in all participating centers and countries. The clinical investigations did not test any nonapproved device. These clinical trials do not involve a medicinal product and are therefore not subject to The European Clinical Trials Directive (2001/20/EC).
Funding Information:
This investigator-initiated study was supported by Isala Hartcentrum, Zwolle, the Netherlands, by an unrestricted institutional grant from St. Jude Medical/Abbott Vascular.
Publisher Copyright:
© 2023 The Author(s)
PY - 2024/3
Y1 - 2024/3
N2 - Background: Fractional flow reserve (FFR) is an established method to guide decisions on revascularization; however, in patients with diabetes mellitus (DM), FFR-negative lesions carrying an optical coherence tomography-detected thin-cap fibroatheroma (TCFA) remain at high risk for adverse cardiac events. Methods: In this prespecified subanalysis of the COMBINE OCT-FFR trial, DM patients with ≥1 FFR-negative, TCFA-positive medically treated target lesions referred to as vulnerable plaque (VP group), were compared to patients with exclusively FFR-positive target lesions who underwent complete revascularization (CR group). The primary endpoint was first and recurrent event analysis for target lesion failure and the secondary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion revascularization, or hospitalization due to unstable angina. Results: Among 550 patients enrolled, 98 belonged to the VP group while 93 to the CR group and were followed up to 5 years. The VP group had a higher occurrence of the primary endpoint (20.4% vs 8.6%; HR, 2.22; 95% CI, 0.98-5.04; P = .06). Recurrent event analysis showed that the VP group had significantly higher rates of the primary and secondary endpoints (9.17 vs 3.76 events per 100 PY; RR, 2.44; 95% CI, 1.16-5.60; P = .01 and 13.45 vs 5.63 events per 100 PY; RR, 2.39; 95% CI, 1.30-4.62; P < .01). Conclusions: In a population with DM, medically treated nonischemic, TCFA-carrying target lesions were associated with higher risk of reoccurring adverse cardiac events compared to target lesions that underwent complete revascularization, opening the discussion about whether a focal preventive revascularization strategy could be contemplated for highly vulnerable lesions.
AB - Background: Fractional flow reserve (FFR) is an established method to guide decisions on revascularization; however, in patients with diabetes mellitus (DM), FFR-negative lesions carrying an optical coherence tomography-detected thin-cap fibroatheroma (TCFA) remain at high risk for adverse cardiac events. Methods: In this prespecified subanalysis of the COMBINE OCT-FFR trial, DM patients with ≥1 FFR-negative, TCFA-positive medically treated target lesions referred to as vulnerable plaque (VP group), were compared to patients with exclusively FFR-positive target lesions who underwent complete revascularization (CR group). The primary endpoint was first and recurrent event analysis for target lesion failure and the secondary endpoint was a composite of cardiac death, target vessel myocardial infarction, target lesion revascularization, or hospitalization due to unstable angina. Results: Among 550 patients enrolled, 98 belonged to the VP group while 93 to the CR group and were followed up to 5 years. The VP group had a higher occurrence of the primary endpoint (20.4% vs 8.6%; HR, 2.22; 95% CI, 0.98-5.04; P = .06). Recurrent event analysis showed that the VP group had significantly higher rates of the primary and secondary endpoints (9.17 vs 3.76 events per 100 PY; RR, 2.44; 95% CI, 1.16-5.60; P = .01 and 13.45 vs 5.63 events per 100 PY; RR, 2.39; 95% CI, 1.30-4.62; P < .01). Conclusions: In a population with DM, medically treated nonischemic, TCFA-carrying target lesions were associated with higher risk of reoccurring adverse cardiac events compared to target lesions that underwent complete revascularization, opening the discussion about whether a focal preventive revascularization strategy could be contemplated for highly vulnerable lesions.
KW - diabetes mellitus
KW - fractional flow reserve
KW - optical coherence tomography
KW - percutaneous coronary intervention
KW - thin-cap fibroatheroma
U2 - 10.1016/j.jscai.2023.101256
DO - 10.1016/j.jscai.2023.101256
M3 - Article
SN - 2772-9303
VL - 3
JO - Journal of the Society for Cardiovascular Angiography and Interventions
JF - Journal of the Society for Cardiovascular Angiography and Interventions
IS - 3
M1 - 101256
ER -