FFR-Negative Nonculprit High-Risk Plaques and Clinical Outcomes in High-Risk Populations: An Individual Patient-Data
Rick H J A Volleberg1, Andi Rroku2,3, Jan-Quinten Mol1
1Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands (R.H.J.A.V., J.-Q.M., N.v.R.).
Insights
High-risk plaques in nonculprit lesions, even with normal fractional flow reserve (FFR), increase adverse cardiovascular events. Intracoronary imaging is valuable for assessing these lesions.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Imaging
Background:
- Recurrent events are common in patients with diabetes or post-myocardial infarction despite FFR-guided deferral of revascularization.
- This study investigates the clinical outcomes associated with FFR-negative but high-risk nonculprit coronary lesions.
Purpose of the Study:
- To assess the association between FFR-negative nonculprit lesions with high-risk plaque features and clinical outcomes.
- To determine the prognostic value of intracoronary imaging in identifying high-risk plaques in FFR-negative lesions.
Main Methods:
- Pooled analysis of COMBINE (OCT-FFR) and PECTUS-obs studies.
- Optical coherence tomography (OCT) used to assess FFR-negative (FFR >0.80) nonculprit lesions.
- High-risk plaque defined by ≥2 criteria: lipid arc ≥90°, fibrous cap thickness <65 µm, plaque rupture, or thrombus.
Main Results:
- High-risk plaques were identified in 33.5% of patients and 30.6% of lesions.
- Presence of high-risk plaque significantly associated with major adverse cardiovascular events (HR 2.127) and target lesion failure (HR 2.623).
- Increased risk of adverse outcomes correlated with the number of high-risk plaque features present.
Conclusions:
- FFR-negative nonculprit lesions with high-risk plaque features are linked to adverse patient and lesion-level outcomes.
- Intracoronary imaging provides additional prognostic value for FFR-negative nonculprit lesions.
- These findings support the use of OCT for comprehensive risk assessment in nonculprit lesions.
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 ≥90o, (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.
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