SUB-ANALYSIS: MORTALITY IN THE OVERALL POPULATION
Effect of alirocumab on mortality after acute coronary syndromes
Steg PG, Szarek M, Bhatt DL, et al. Circulation 2019:140(2):103-112.
Treatment effect on all-cause mortality before and after 1 year of treatment
Mortality in participants eligible for ≥3 years of follow-up
All-cause, CV, and non-CV mortality
Association between the risks of nonfatal CV events and CV or non-CV death
Footnotes
CV=cardiovascular; CVD=cardiovascular disease; LDL-C=low-density lipoprotein cholesterol.
KEY FINDINGS
Alirocumab was associated with a reduction in all-cause mortality1,2
Alirocumab significantly reduced the relative risk of MACE (primary endpoint) by 15%; HR 0.85 (95% CI 0.78, 0.93) p=0.0003.
All-cause mortality in patients treated with alirocumab (plus statins) vs placebo (plus statins)1,2*
*This finding is considered nominally significant based on the prespecified hierarchical analysis of secondary endpoints.
† Prespecified analysis. First year: HR 1.01 (95% CI 0.77-1.32); for patients eligible for <3 years of follow-up: HR 0.96 (95% CI 0.76-1.21).
‡ Post hoc analysis.
¥ Interaction p value for the effect of alirocumab on relative risk of death across the predefined subgroup of baseline LDL-C levels across the categories of baseline LDL-C (<80mg/dL, 80-100mg/dL and ≥100mg/dL).2
Greater reduction in all-cause mortality was seen in patients with longer follow-up (≥3 years), and in patients with baseline LDL-C ≥100mg/dL.1
Footnotes
CI=confidence interval; HR=hazard ratio; LDL-C=low-density lipoprotein cholesterol; RRR=relative risk reduction.
KEY FINDINGS
CVD death occurred in 240 (2.5%) patients in the alirocumab group and 271 (2.9%) patients in the placebo group1
All-cause, CV and non-CV mortality1
CVD death occurred in 240 (2.5%) patients in the alirocumab group and 271 (2.9%) patients in the placebo group (HR 0.88; 95% CI 0.74-1.05), and represented 511 (70.4%) of all-cause deaths.1
Non-CV death was also numerically lower with alirocumab (94 [1.0%] vs 121 [1.3%]).1
Adjudicated causes of CV death
Adjudicated causes of CV death (>5 cases per treatment group)3
There was a low proportion of undetermined causes of death. Among 31 fewer CV deaths in the alirocumab group than in the placebo group, the largest differences between groups were for fatal MI (n=10) and sudden cardiac death (n=8).1
Adjudicated causes of non-CV death
Adjudicated causes of non-CV death (>5 cases per treatment group)3
mong the 27 fewer non-CV causes of death in the alirocumab group versus the placebo group, the largest difference was for death due to pulmonary (n=14) causes.1
CI=confidence interval; CV=cardiovascular; HR=hazard ratio; MI=myocardial infarction.
1.Steg PG, et al. Circulation 2019;140(2):103-112.
2.Schwartz G, et al. N Engl J Med 2018;379(22):2097-2107.
3.Steg PG, et al. Circulation 2019;140(2):103-112. Supplementary Appendix.