KEY FINDINGS
Alirocumab is associated with larger ARRs in MACE and all-cause mortality in patients with polyvascular disease compared to monovascular disease1
In patients with recent ACS and dyslipidemia despite statin therapy, alirocumab is associated with larger ARRs in MACE and all-cause mortality in patients with polyvascular disease compared to monovascular disease.1
In ODYSSEY OUTCOMES, patients with polyvascular disease comprise an easily identifiable subgroup of patients with recent ACS with a high absolute risk of MACE and death.1
MACE¹
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MACE=major adverse cardiovascular events
Adapted from Jukema J, et al. J Am Coll Cardiol 2019.
For polyvascular disease (including 2 and 3 vascular beds), ARR 3.1% (95% CI -1.1, 7.2).
All-cause death by history of PAD or CeVD
category
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*HRs reflect stratification by geographic region in models with interaction between treatment and the three disease bed subgroups (monovascular disease, disease in two beds, and disease in three beds).
For polyvascular disease (including 2 and 3 vascular beds), ARR 2.8% (95% CI -0.2, 5.7).
There were no significant differences in the incidence of adverse events or laboratory abnormalities between alirocumab and placebo groups, with the exception of local injection site reactions, which occurred more frequently in the alirocumab group (3.8% vs 2.1%; p<0.001).1,2
No major differences in safety were observed between vascular disease subgroups.1
KEY FINDINGS
Patients with polyvascular disease in three beds had more comorbidities than those with monovascular disease1
PAD included arterial disease of the extremities or abdominal aortic aneurysm.1
CeVD included a history of carotid endarterectomy, carotid stenting, prior stroke, or transient ischemic attack.1
Compared to patients with monovascular disease, those with polyvascular disease in three beds had more comorbidities, including history of hypertension (62.9% vs 91.3%), MI (18.1% vs 41.6%), and CABG (4.8% vs 32.2%), higher prevalence of diabetes (27.7% vs 43.6%): GFR <60 mL/min/1.73m2, and current and former cigarette smoking.1
Baseline characteristics by history of PAD or
CeVD category
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†P values reflect the statistical comparison between the four vascular disease subgroups (coronary without PAD or CeVD; coronary and PAD; coronary and CeVD; coronary, PAD, and CeVD).
Values are median (quartile 1, quartile 3), n (%), or n. The p values reflect the statistical comparison among the 4 vascular disease subgroups (coronary without PAD or CeVD; coronary and PAD; coronary and CeVD; coronary, PAD, and CeVD).
ACS=acute coronary syndrome; ARR=absolute risk reduction; CABG=coronary artery bypass graft; CeVD=cerebrovascular disease; CI=confidence interval; GFR=glomerular filtration rate; HR=hazard ratio; IQR=interquartile range; LDL-C=low-density lipoprotein cholesterol; LLT=lipid-lowering therapy; MACE=major adverse cardiovascular events; MI=myocardial infarction; PAD=peripheral artery disease; NSTEMI=non-ST-elevation myocardial infarction; STEMI=ST-elevation myocardial infarction.
1. Jukema J, et al. J Am Coll Cardiol 2019;74(9):1167–1176.
2. Schwarz G, et al. N Engl J Med 2018;379(22):2097–2107.
