NEW ORLEANS — Patients with acute coronary disease and dyslipidemia with a history of CVD, peripheral artery disease or both may have increased risk for major CV events, even with intensive statin therapy, according to findings presented at the American College of Cardiology Scientific Session.
Johan W. Jukema, MD, PhD, and colleagues sought to identify whether the benefits of using the PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron) were influenced by concurrent PAD, CVD, or both.
“If you suffer from acute coronary syndrome, your risk of getting another coronary syndrome is high,” Jukema, professor of interventional cardiology at Universiteit Leiden in The Netherlands, told Cardiology Today. “So, you’re always looking for which subgroups have a particularly high risk because if your risk is even higher you will benefit more from the drug.”
The researchers analyzed data from the ODYSSEY OUTCOMES trial, which studied the effectiveness of alirocumab vs. placebo in patients with recent ACS and elevated atherogenic lipoproteins despite intensive statin therapy.
The study included 18,924 randomly assigned to alirocumab or placebo 1 to 12 months following ACS. The primary major CV event endpoint was CHD death, nonfatal MI, ischemic stroke or unstable angina that required hospitalization. The secondary endpoint was all-cause death.
Patients with acute coronary disease and dyslipidemia with a history of CVD, peripheral artery disease or both may have increased risk for major CV events, even with intensive statin therapy, according to findings presented at the American College of Cardiology Scientific Session.
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For the present study, patients were stratified by whether they had CVD alone, CVD and PAD, CVD and cerebrovascular disease or all three combined. Rates of the primary endpoint were higher in the other groups than in the CVD-alone group in both those assigned alirocumab and those assigned placebo.
According to the researchers, the treatment effect of alirocumab for the primary outcome was greatest in patients with CVD, PAD and cerebrovascular disease combined (HR = 0.54; 95% CI, 0.32-0.89; absolute risk reduction, 13%; 95% CI, –2 to 28). Absolute risk reduction associated with alirocumab was 1.4% in the CVD-only group, 3.4% in the CVD and PAD group and 4.5% in the CVD and cerebrovascular disease group.
For all-cause death, the treatment effect with alirocumab was also greatest in the group with CVD, PAD and cerebrovascular disease (HR = 0.2; 95% CI, 0.07-0.57; absolute risk reduction, 16.2%; 95% CI, 5.5-26.8). Absolute risk reduction associated with alirocumab was 0.4% in the CVD-only group, 2.8% in the CVD and PAD group and 4.9% in the CVD and cerebrovascular disease group.
“Patients with polyvascular disease may be considered among preferred candidates for this treatment,” the researchers wrote in an abstract. – by Earl Holland Jr.
Jukema JW, et al. Highlighted Original Research: Vascular Medicine and the Year in Review. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.
Disclosure: Jukema reported he has received funding from Amgen, Astellas, AstraZeneca, Daiichi-Sankyo, Lilly, Merck-Schering-Plough, Pfizer, Roche, and Sanofi.