FFR-Negative Nonculprit High-Risk Plaques and Clinical Outcomes in High-Risk Populations: An Individual Patient-Data Pooled Analysis From COMBINE (OCT-FFR) and PECTUS-obs
Rick Volleberg, Andi Rroku, Jan‐Quinten Mol, Renicus S. Hermanides, Maarten A.H. van Leeuwen, Balázs Berta, Martijn Meuwissen, Fernándo Alfonso, Wojciech Wojakowski, Anouar Belkacemi, Tomasz Roleder, Elvin Kedhi, Niels van Royen, Elvin Kedhi, Balázs Berta, Tomasz Roleder, Renicus S. Hermanides, Enrico Fabris, Alexander Ijsselmuiden, Floris Kauer, Fernándo Alfonso, Clemens von Birgelen, Javier Escaned, Cyril Camaro, Mark Kennedy, Bruno Pereira, Michael Magro, Holger Nef, Sebastian Reith, Arif Al Nooryani, Fernando Rivero, Krzysztof Piotr Malinowski, Giuseppe De Luca, Héctor García García, Juan F. Granada, Wojciech Wojakowski, Jan‐Quinten Mol, Rick H.J.A. Volleberg, Anouar Belkacemi, Renicus S. Hermanides, Martijn Meuwissen, А. В. Протопопов, Peep Laanmets, Oleg Krestyaninov, Robert Dennert, Rohit M. Oemrawsingh, Jan‐Peter van Kuijk, Karin Arkenbout, Dirk J. van der Heijden, Saman Rasoul, Erik Lipšic, Laura Rodwell, Cyril Camaro, Peter Damman, Tomasz Roleder, Elvin Kedhi, Maarten van Leeuwen, Robert‐Jan van Geuns, Niels van Royen
Abstract
BACKGROUND: Despite fractional flow reserve (FFR)–guided deferral of revascularization, recurrent events in patients with diabetes or after myocardial infarction remain common. This study aimed to assess the association between FFR-negative but high-risk nonculprit lesions and clinical outcomes. METHODS: This is a patient-level pooled analysis of the prospective natural-history COMBINE (OCT-FFR) study (Optical Coherence Tomography Morphologic and Fractional Flow Reserve Assessment in Diabetes Mellitus Patients) and PECTUS-obs study (Identification of Risk Factors for Acute Coronary Events by OCT After STEMI and NSTEMI Patients With Residual Non- Flow Limiting Lesions). Optical coherence tomography was performed on all FFR-negative (FFR >0.80) native nonculprit lesions. Patients or lesions with a high-risk plaque were compared with those without a high-risk plaque. A high-risk plaque was defined in the presence of at least 2 prespecified criteria: (1) lipid arc ≥90 o , (2) minimum fibrous cap thickness <65 µm, and (3) presence of either plaque rupture or thrombus. The primary end points were native major adverse cardiovascular events (composite of all-cause mortality, nonfatal myocardial infarction, or unplanned revascularization excluding stent-failure–related events and nonattributable events) and target lesion failure (composite of cardiac death, target vessel myocardial infarction, or target lesion revascularization). RESULTS: Among 810 patients, 450 (55.6%) had a history of diabetes and 482 (59.5%) presented with myocardial infarction. At least 1 high-risk plaque was identified in 271 (33.5%) patients and 287 (30.6%) lesions. Over a median follow-up of 761 (interquartile range, 731–1175) days, the presence of a high-risk plaque was associated with patient-level native major adverse cardiovascular events (hazard ratio, 2.127 [95% CI, 1.451–3.120]; P <0.001) and lesion-level target lesion failure (hazard ratio, 2.623 [95% CI, 1.559–4.414]; P <0.001). The risk of adverse outcomes increased with the copresence of multiple high-risk features. CONCLUSIONS: FFR-negative but high-risk nonculprit lesions are associated with adverse patient- and lesion-level clinical outcomes. These findings emphasize the additional value of intracoronary imaging in patients with FFR-negative nonculprit lesions. REGISTRATION: URL: https://clinicaltrials.gov ; Unique identifier: NCT02989740; Unique identifier: NCT03857971.