Despite the use of statin therapy, polyvascular disease has shown associations with increased risk for major adverse cardiovascular events and mortality among those with recent dyslipidemia/acute coronary syndrome, according to a study recently published in the Journal of the American College of Cardiology. Alirocumab has shown efficacy in reducing these risks.
This multicenter, placebo-controlled, double-blind study included 18,924 participants at least 40 years of age (ClinicalTrials.gov identifier: NCT01663402). Participants with acute coronary syndrome (unstable angina or myocardial infarction) were randomly assigned 1:1 to alirocumab 75 mg every 2 weeks or placebo within a year of acute coronary syndrome. Median follow-up lasted 2.8 years.
A composite of nonfatal myocardial infarction, ischemic stroke, unstable angina necessitating hospitalization, and death due to coronary heart disease constituted the primary endpoint. A Cox proportional hazards model was used to estimate hazard ratios.
At baseline, monovascular coronary disease was present among 17,370 participants, polyvascular disease in 2 vascular beds among 1405, and polyvascular disease in 3 beds among 149; major adverse cardiovascular events among those given placebo occurred in 10.0%, 22.2%, and 39.7%, respectively.
The absolute risk reduction with alirocumab was 1.4% (95% CI, 0.6-2.3), 1.9% (95% CI, -2.4 to 6.2), and 13.0% (95% CI, -2.0 to 28.0), respectively (P =.0006).
The placebo group had incidences of death of 3.5%, 10.0%, and 21.8%, respectively; aliocumab use resulted in absolute risk reductions of 0.4% (95% CI, -0.1 to 1.0), 1.3% (95% CI, -1.8 to 4.3), and 16.2% (95% CI, 5.5-26.8), respectively (P =.002). Adverse events did not differ significantly between groups.
One limitation to this study was the potential for undetected peripheral artery disease or cerebrovascular disease among those classified as having monovascular coronary disease.
Researchers conclude that “the large absolute benefit of PCSK9 inhibition with alirocumab, when added to high-intensity statin therapy, is a potential benefit for this population of patients.”
Disclosure: This study received funding from Sanofi and Regeneron Pharmaceuticals, Inc. Multiple authors report associations with pharmaceutical companies. For a full list of disclosures, see the reference.
Jukema JW, Szarek M, Zijlstra LE, et al; ODYSSEY OUTCOMES Committees and Investigators. Patients with recent acute coronary syndrome and polyvascular disease derive large absolute benefit from alirocumab: ODYSSEY OUTCOMES trial [published online March 12, 2019]. J Am Coll Cardiol. doi:10.1016/j.jacc.2019.03.013