1. Effects of alirocumab on endothelial function and coronary atherosclerosis in myocardial infarction: A PACMAN-AMI randomized clinical trial substudy.
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Rexhaj, Emrush, Bär, Sarah, Soria, Rodrigo, Ueki, Yasushi, Häner, Jonas D., Otsuka, Tatsuhiko, Kavaliauskaite, Raminta, Siontis, George CM., Stortecky, Stefan, Shibutani, Hiroki, Spirk, David, Engstrøm, Thomas, Lang, Irene, Morf, Laura, Ambühl, Maria, Windecker, Stephan, Losdat, Sylvain, Koskinas, Konstantinos C., and Räber, Lorenz
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INTRAVASCULAR ultrasonography , *CORONARY artery disease , *MYOCARDIAL infarction , *OPTICAL coherence tomography , *BRACHIAL artery , *CLINICAL trials - Abstract
The effects of protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors on endothelial function as assessed by flow-mediated dilation (FMD) in patients with acute myocardial infarction (AMI) are unknown. Therefore, we aimed to investigate the effects of the PCSK9 inhibitor alirocumab added to high-intensity statin on FMD, and its association with coronary atherosclerosis in non-infarct related arteries using intracoronary intravascular ultrasound (IVUS), near-infrared spectroscopy (NIRS), and optical coherence tomography (OCT). This was a pre-specified substudy among patients recruited at Bern University Hospital, Switzerland, for the randomized-controlled, double-blind, PACMAN-AMI trial, which compared the effects of biweekly alirocumab 150 mg vs. placebo added to rosuvastatin. Brachial artery FMD was measured at 4 and 52 weeks, and intracoronary imaging at baseline and 52 weeks. 139/173 patients completed the substudy. There was no difference in FMD at 52 weeks in the alirocumab (n = 68, 5.44 ± 2.24%) versus placebo (n = 71, 5.45 ± 2.19%) group (difference = −0.21%, 95% CI −0.77 to 0.35, p = 0.47). FMD improved throughout 52 weeks in both groups similarly (p < 0.001). There was a significant association between 4 weeks FMD and baseline plaque burden (IVUS) (n = 139, slope = −1.00, p = 0.006), but not with lipid pool (NIRS) (n = 139, slope = −7.36, p = 0.32), or fibrous cap thickness (OCT) (n = 81, slope = −1.57, p = 0.62). Among patients with AMI, the addition of alirocumab did not result in further improvement of FMD as compared to 52 weeks secondary preventative medical therapy including high-intensity statin therapy. FMD was significantly associated with coronary plaque burden at baseline, but not with lipid pool or fibrous cap thickness. [Display omitted] • This randomized trial assessed the effect of alirocumab/statin vs. placebo/statin on flow mediated dilation (FMD) in acute myocardial infarction (AMI). • FMD improved throughout 1 year after AMI with medical therapy similarly in alirocumab/statin vs. placebo/statin treated patients. • FMD at baseline was significantly inversely associated with coronary plaque burden on intravascular ultrasound. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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