Serial Coronary Plaque Composition After Inclisiran Initiation Assessed by Automated CCTA: A Retrospective Pilot Study.
Authors
Affiliations (3)
Affiliations (3)
- Department of Cardiology, Minamino Cardiovascular Hospital, 1-25-1 Hyoue, Hachioji, Tokyo 192-0918, Japan.
- Department of Radiology, Minamino Cardiovascular Hospital, 1-25-1 Hyoue, Hachioji, Tokyo 192-0918, Japan.
- Division of Basic and Clinical Medicine, Nagano College of Nursing, 1694 Akaho, Komagane, Nagano 399-4117, Japan.
Abstract
<b>Background/Objectives</b>: Inclisiran provides durable low-density lipoprotein cholesterol (LDL-C) lowering, but serial coronary plaque composition after treatment initiation remains incompletely characterized. This study evaluated temporal plaque changes using automated coronary computed tomography angiography (CCTA). <b>Methods</b>: In this uncontrolled, retrospective, observational pilot study, consecutive patients who initiated inclisiran between 1 January 2024 and 29 April 2026 were screened. A random-intercept mixed-effects model included every eligible quantitative plaque observation obtained by the prespecified data cutoff. <b>Results</b>: Of the 230 screened patients, 215 contributed 468 plaque observations (baseline, <i>n</i> = 186; 3 months, <i>n</i> = 196; 15 months, <i>n</i> = 86); 74 had all three examinations. The LDL-C levels decreased from 117.4 mg/dL (95% confidence interval [CI], 113.3-121.6) to 45.9 mg/dL (39.5-52.3) at 15 months. No significant time effect was detected for the total plaque volume (<i>p</i> = 0.713). Low-density non-calcified plaque (LDNC) decreased from 27.3 mm<sup>3</sup> (23.1-31.6) to 22.7 mm<sup>3</sup> (18.0-27.4; overall <i>p</i> = 0.0035), whereas calcified plaque increased from 56.5 mm<sup>3</sup> (45.6-67.3) to 67.1 mm<sup>3</sup> (55.9-78.2; <i>p</i> < 0.0001). The adjusted baseline-to-15-month differences were -4.64 mm<sup>3</sup> for LDNC (95% CI, -7.54 to -1.74; Bonferroni-adjusted <i>p</i> = 0.0052) and +10.60 mm<sup>3</sup> for calcified plaque (6.60-14.60; adjusted <i>p</i> < 0.0001). In the tube voltage-adjusted sensitivity analysis of 107 patients and 278 observations, these findings were maintained. <b>Conclusions</b>: Patients initiating inclisiran showed temporal changes in attenuation-defined plaque composition. The uncontrolled design, incomplete acquisition data in the expanded cohort, and technical variability preclude causal or histologic interpretation.