ODYSSEY OUTCOMES: Addition of PCSK9i to Background Statin Therapy Further Reduces MACE

Polyvascular Disease Sub-analysis Overview

Alirocumab in Patients with Polyvascular Disease and Recent Acute Coronary Syndrome


In this prespecified analysis of the ODYSSEY OUTCOMES trial, we investigate the influence of polyvascular disease (PVD) on:

  • Risks of MACE and death in patients with recent ACS and dyslipidemia despite intensive statin therapy
  • The modification of risk by alirocumab

For the heterogeneity of alirocumab treatment effed by polyvascular disease category, Cox models were used for interaction terms for relative risk reduction and Gail-Simon tests for AR

CeVD, cerebrovascular disease; PAD, peripheral artery disease

Primary MACE: One, Two or Three Vascular Beds

RRR interaction p=0.40. *In overall population, there were no differences in the incidence of adverse events or laboratory abnormalities between alirocumab and placebo groups, except for local injection-site reactions

Death: One, Two or Three Vascular Beds

HRs and p-values reflect stratification by geographic region

Polyvascular Disease Sub-Analysis Conclusions

  • Increasing risk of death in patients with affected vascular beds remain a challenge for clinicians
  • This study demonstrates that PVD is associated with high risk of death, and yet with alirocumab, the corresponding ARR for incidence of death was 0.4% (P-interaction = 0.002)
  • Alirocumab, when added to high-intensity statin therapy, was associated with a reduction in mortality in this group of patients

    Jukema JW, et al. JACC. 2019; 74(9):1167-76.