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Observational Study
. 2023 Nov 1;8(11):1013-1021.
doi: 10.1001/jamacardio.2023.2910.

Fractional Flow Reserve-Negative High-Risk Plaques and Clinical Outcomes After Myocardial Infarction

Affiliations
Observational Study

Fractional Flow Reserve-Negative High-Risk Plaques and Clinical Outcomes After Myocardial Infarction

Jan-Quinten Mol et al. JAMA Cardiol. .

Abstract

Importance: Even after fractional flow reserve (FFR)-guided complete revascularization, patients with myocardial infarction (MI) have high rates of recurrent major adverse cardiovascular events (MACE). These recurrences may be caused by FFR-negative high-risk nonculprit lesions.

Objective: To assess the association between optical coherence tomography (OCT)-identified high-risk plaques of FFR-negative nonculprit lesions and occurrence of MACE in patients with MI.

Design, setting, and participants: PECTUS-obs (Identification of Risk Factors for Acute Coronary Events by OCT After STEMI [ST-segment elevation MI] and NSTEMI [non-STEMI] in Patients With Residual Non-flow Limiting Lesions) is an international, multicenter, prospective, observational cohort study. In patients presenting with MI, OCT was performed on all FFR-negative (FFR > 0.80) nonculprit lesions. A high-risk plaque was defined containing at least 2 of the following prespecified criteria: (1) a lipid arc at least 90°, (2) a fibrous cap thickness less than 65 μm, and (3) either plaque rupture or thrombus presence. Patients were enrolled from December 14, 2018, to September 15, 2020. Data were analyzed from December 2, 2022, to June 28, 2023.

Main outcome and measure: The primary end point of MACE, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, at 2-year follow-up was compared in patients with and without a high-risk plaque.

Results: A total of 438 patients were enrolled, and OCT findings were analyzable in 420. Among included patients, mean (SD) age was 63 (10) years, 340 (81.0) were men, and STEMI and non-STEMI were equally represented (217 [51.7%] and 203 [48.3%]). A mean (SD) of 1.17 (0.42) nonculprit lesions per patient was imaged. Analysis of OCT images revealed at least 1 high-risk plaque in 143 patients (34.0%). The primary end point occurred in 22 patients (15.4%) with a high-risk plaque and 23 of 277 patients (8.3%) without a high-risk plaque (hazard ratio, 1.93 [95% CI, 1.08-3.47]; P = .02), primarily driven by more unplanned revascularizations in patients with a high-risk plaque (14 of 143 [9.8%] vs 12 of 277 [4.3%]; P = .02).

Conclusions and relevance: Among patients with MI and FFR-negative nonculprit lesions, the presence of a high-risk plaque is associated with a worse clinical outcome, which is mainly driven by a higher number of unplanned revascularizations. In a population with a high recurrent event rate despite physiology-guided complete revascularization, these results call for research on additional pharmacological or focal treatment strategies in patients harboring high-risk plaques.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Mol reported receiving grant funding from Abbott Laboratories and Health~Holland during the conduct of the study. Dr Volleberg reported receiving grant funding from Abbott Laboratories and Health~Holland during the conduct of the study. Dr Belkacemi reported receiving speaker’s fees from Daiichi Sankyo Inc outside the submitted work. Dr Hermanides reported receiving grant funding from Bayer AG and speaker fees from Amgen Inc, Novartis AG, and Abbott Laboratories outside the submitted work. Dr Oemrawsingh reported receiving grant funding from Abbott Laboratories outside the submitted work and is shareholder of Caredo BV. Dr Lipsic reported receiving grant funding from Abbott Laboratories outside the submitted work. Dr Rodwell reported receiving grant funding from Abbott BV and Health~Holland during the conduct of the study. Dr Camaro reported receiving honorarium for organizing regional meetings from AstraZeneca during the conduct of the study. Dr Damman reported receiving grant funding from Abbott Laboratories during the conduct of the study. Dr van Leeuwen reported receiving grant funding from AstraZenica, Top Sector Life Sciences & Health, Terumo Corporation, TOP Medical BV, and Abbott Laboratories and speakers’ fees and consulting from Terumo Corporation, Daiichi Sankyo Inc, and Abbott Laboratories outside the submitted work. Dr van Geuns reported receiving grant funding from Abbott Vascular during the conduct of the study and personal fees from Infraredx and grant funding from Infraredx and Amgen Inc outside the submitted work. Dr van Royen reported receiving grant funding and personal fees from Abbott Laboratories during the conduct of the study and grants from Koninklijkie Philips NV, Biotronik, and Medtronic Inc and personal fees from MicroPort, Bayer AG, and RainMed Medical outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Study Flowchart
OCT indicates optical coherence tomography.
Figure 2.
Figure 2.. Primary and Composite Outcomes
A, Kaplan-Meier curves for the primary outcome of major adverse cardiovascular events (including all-cause mortality, nonfatal myocardial infarction, or unplanned revascularization) at 2-year follow-up. B, Kaplan-Meier curves for the composite outcome of all-cause mortality or nonfatal myocardial infarction at 2-year follow-up. A hazard ratio (HR) greater than 1.00 indicates greater hazard in the high-risk plaque (HRP) group.

References

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