ESC 2024: PACMAN-AMI trial reveals Praluent efficacy insights

Participants gathered in front of the European Society of Cardiology logo at a previous meeting. The 2024 conference took place in London from 30 August to 2 September. Image credit: Shutterstock/hydebrink

On the final day of the European Society of Cardiology (ESC) 2024 Congress, two subanalyses from the PACMAN-AMI trial were unveiled.

Coronary heart disease remains the leading cause of death in industrialized nations, with hypercholesterolemia being a significant risk factor. While statins are the primary treatment, they are not always fully effective. Research has shown that PCSK9 inhibitors can reduce low-density lipoprotein cholesterol (LDL-C) and adverse cardiovascular events. The Phase III PACMAN-AMI trial (NCT03067844) examined the impact of Praluent (alirocumab), a PCSK9 inhibitor developed by Regeneron Pharmaceuticals, on patients with acute myocardial infarction (AMI).

Earlier in the conference, some findings from the study, demonstrating the efficacy of antibodies like Praluent in lowering LDL-C levels, were discussed. In the investigation, patients were given Praluent or a placebo biweekly alongside statins. After 52 weeks, the PCSK9 inhibition significantly decreased percent atheroma volume (PAV) and other measures of blood vessel blockage compared to statin therapy alone.

Dr. Yasushi Ueki from Shinshu University Hospital in Japan presented the first subanalysis. His research team employed risk stratification to identify patients most likely to benefit from plaque reduction. Patients were categorized into three groups based on their risk factors for chronic coronary disease: none, one, or two or more major risk factors. Blood vessel imaging for these patients was analyzed before and after 52 weeks of Praluent or placebo treatment.

Ueki's team discovered that PAV only significantly decreased among patients with one or no risk factors. There was no notable difference among those with two or more risk factors. This trend also applied to changes in the maximum lipid core burden index and macrophage angle. Ueki remarked, "Among AMI patients with no or one atherothrombotic risk factors, the addition of alirocumab to high-intensity statin demonstrated greater coronary plaque regression; patients with fewer risk factors thus appear to be more susceptible to atheroma regression."

Dr. Flavio Biccirè from the University Hospital of Bern in Switzerland presented the second subanalysis. His team concentrated on vessel lesions, areas with the most significant plaque buildup, as opposed to the broader vessel-level analysis of the PACMAN-AMI trial.

Using imaging data from 245 patients, Biccirè and his colleagues reassessed clinical outcomes. They observed that at the lesion level, the PAV change with Praluent at 52 weeks was -4.9 compared to a -2.1 change in the placebo group, which is significantly more substantial than the original analysis suggested. Biccirè concluded, "LDL-C lowering induced an extensive atheroma burden reduction at the lesion-level," adding that "significant changes in coronary lesions, rather than mild effects described at the vessel-level, underlie the protective vascular effects of contemporary lipid-lowering therapies."

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