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Clinical Trial
. 2023 Oct 27;24(11):1536-1543.
doi: 10.1093/ehjci/jead110.

Impact of statins based on high-risk plaque features on coronary plaque progression in mild stenosis lesions: results from the PARADIGM study

Hyung-Bok Park  1   2 , Reza Arsanjani  3 , Ji Min Sung  2 , Ran Heo  2   4 , Byoung Kwon Lee  5 , Fay Y Lin  6 , Martin Hadamitzky  7 , Yong-Jin Kim  8 , Edoardo Conte  9 , Daniele Andreini  9 , Gianluca Pontone  9 , Matthew J Budoff  10 , Ilan Gottlieb  11 , Eun Ju Chun  12 , Filippo Cademartiri  13 , Erica Maffei  13 , Hugo Marques  14 , Pedro de Araújo Gonçalves  14   15 , Jonathon A Leipsic  16 , Sang-Eun Lee  2   17 , Sanghoon Shin  2   17 , Jung Hyun Choi  18 , Renu Virmani  19 , Habib Samady  20 , Kavitha Chinnaiyan  21 , Peter H Stone  22 , Daniel S Berman  23 , Jagat Narula  24 , Leslee J Shaw  6 , Jeroen J Bax  25 , James K Min  6 , Hyuk-Jae Chang  2   26
Affiliations
Clinical Trial

Impact of statins based on high-risk plaque features on coronary plaque progression in mild stenosis lesions: results from the PARADIGM study

Hyung-Bok Park et al. Eur Heart J Cardiovasc Imaging. .

Abstract

Aims: To investigate the impact of statins on plaque progression according to high-risk coronary atherosclerotic plaque (HRP) features and to identify predictive factors for rapid plaque progression in mild coronary artery disease (CAD) using serial coronary computed tomography angiography (CCTA).

Methods and results: We analyzed mild stenosis (25-49%) CAD, totaling 1432 lesions from 613 patients (mean age, 62.2 years, 63.9% male) and who underwent serial CCTA at a ≥2 year inter-scan interval using the Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging (NCT02803411) registry. The median inter-scan period was 3.5 ± 1.4 years; plaques were quantitatively assessed for annualized percent atheroma volume (PAV) and compositional plaque volume changes according to HRP features, and the rapid plaque progression was defined by the ≥90th percentile annual PAV. In mild stenotic lesions with ≥2 HRPs, statin therapy showed a 37% reduction in annual PAV (0.97 ± 2.02 vs. 1.55 ± 2.22, P = 0.038) with decreased necrotic core volume and increased dense calcium volume compared to non-statin recipient mild lesions. The key factors for rapid plaque progression were ≥2 HRPs [hazard ratio (HR), 1.89; 95% confidence interval (CI), 1.02-3.49; P = 0.042], current smoking (HR, 1.69; 95% CI 1.09-2.57; P = 0.017), and diabetes (HR, 1.55; 95% CI, 1.07-2.22; P = 0.020).

Conclusion: In mild CAD, statin treatment reduced plaque progression, particularly in lesions with a higher number of HRP features, which was also a strong predictor of rapid plaque progression. Therefore, aggressive statin therapy might be needed even in mild CAD with higher HRPs.

Clinical trial registration: ClinicalTrials.gov NCT02803411.

Keywords: coronary atherosclerosis; coronary computed tomography angiography; high-risk plaque; mild coronary stenosis; statin.

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Conflict of interest statement

Conflict of interest: Dr. Chang receives funding from by the Korea Medical Device Development Fund grant funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, the Ministry of Food and Drug Safety) (Project Number: 1711139017); Dr. Min receives funding from the National Institutes of Health (Grant Nos. R01 HL111141, R01 HL115150, R01 118019, and U01 HL 105907), the Qatar National Priorities Research Program (Grant No. 09-370-3-089), and GE Healthcare. Dr. Min served as a consultant to HeartFlow, serves on the scientific advisory board of Arineta, and has an equity interest in MDDX. Dr. Bax receives unrestricted research grants from Biotronik, Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Chun receives funding from National Research Foundation (NRF) grant funded by the Korea government (Ministry of Education, Science and Technology; NRF-2015R1D1A1A01059717). Dr. Leipsic is a consultant and holds stock options in HeartFlow and Circle CVI. He receives modest speaking fees from Philips and GE Healthcare. Dr. Budoff receives grant support from the National Institutes of Health and GE Healthcare. Dr. Marques is a Consultant and holds stock options for Cleerly Inc. Dr. Samady is a co-founder and equity holder of Covanos, a consultant for Philips and Valo, and receives grant support from Phillips and St Jude Abbott/Medtronic. Dr. Andreini is on the Speakers Bureau for GE Healthcare and receives grant support from GE Healthcare and Bracco. Dr. Pontone receives institutional research grants from GE Healthcare, HeartFlow, Medtronic, Bracco, and Bayer. Dr. Berman receives software royalties from Cedars-Sinai. Dr. Virmani has received institutional research support from 480 Biomedical, Abbott Vascular, Arterial Remodeling Technologies, BioSensors International, Biotronik, Boston Scientific, Celonova, Claret Medical, Cook Medical, Cordis, Edwards Lifesciences, Medtronic, MicroVention, OrbusNeich, ReCord, SINO Medical Technology, Spectranetics, Surmodics, Terumo Corporation, W.L. Gore and Xeltis. Dr. Virmani also receives honoraria from 480 Biomedical, Abbott Vascular, Boston Scientific, Cook Medical, Lutonix, Medtronic, Terumo Corporation, and W.L. Gore, and is a consultant for 480 Biomedical, Abbott Vascular, Medtronic, and W.L. Gore. Dr. Min is an employee and holds equity interest in Cleerly, Inc. He is also on the Medical Advisory Board at Arineta. The other authors report no conflicts.

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