Key result
Alirocumab cuts cardiovascular events ~22% after ACS in preserved renal function, but not eGFR <60.
Why the study?
Does alirocumab reduce major adverse cardiovascular events in patients with recent acute coronary syndrome across different levels of renal function?
RCT (n=18,918)
randomized
Does alirocumab reduce major adverse cardiovascular events in patients with recent acute coronary syndrome across different levels of renal function?
Alirocumab reduces cardiovascular events in patients with recent ACS and dyslipidemia, with consistent relative risk reductions across continuous eGFR levels, though subgroup analysis showed significant benefit only in those with eGFR ≥60 mL/min/1.73 m2.
AIMS: Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the PCSK9 inhibitor alirocumab to reduce cardiovascular events and death after ACS are influenced by renal function. METHODS AND RESULTS: ODYSSEY OUTCOMES compared alirocumab with placebo in patients with recent ACS and dyslipidaemia despite intensive statin treatment. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 was exclusionary. In 18 918 patients, baseline eGFR was 82.8 ± 17.6 mL/min/1.73 m2, and low-density lipoprotein cholesterol (LDL-C) was 92 ± 31 mg/dL. At 36 months, alirocumab decreased LDL-C by 48.5% vs. placebo but did not affect eGFR (P = 0.65). Overall, alirocumab reduced risk of the primary outcome (coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization) with fewer deaths. There was no interaction between continuous eGFR and treatment on the primary outcome or death (P = 0.14 and 0.59, respectively). Alirocumab reduced primary outcomes in patients with eGFR ≥90 mL/min/1.73 m2 (n = 7470; hazard ratio 0.784, 95% confidence interval 0.670-0.919; P = 0.003) and 60 to <90 (n = 9326; 0.833, 0.731-0.949; P = 0.006), but not in those with eGFR < 60 (n = 2122; 0.974, 0.805-1.178; P = 0.784). Adverse events other than local injection-site reactions were similar in both groups across all categories of eGFR. CONCLUSIONS: In patients with recent ACS, alirocumab was associated with fewer cardiovascular events and deaths across the range of renal function studied, with larger relative risk reductions in those with eGFR > 60 mL/min/1.73 m2.
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Tuñón et al. (2020) conducted an RCT in recent acute coronary syndrome and dyslipidaemia despite intensive statin treatment (n=18,918). Alirocumab vs. Placebo was evaluated on coronary heart disease death, non-fatal myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization. Alirocumab reduced primary cardiovascular events in patients with recent ACS and eGFR ≥90 (HR 0.784; 95% CI 0.670-0.919) and 60-<90 (HR 0.833; 95% CI 0.731-0.949), but not in eGFR <60.
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