ODYSSEY OUTCOMES

Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 18,924 patients with recent acute coronary syndrome on high-intensity statin, alirocumab reduced major adverse cardiovascular events compared with placebo (HR 0.85, 95% CI 0.78-0.93).

18.924

Disegno

Double-blind, placebo-controlled RCT

Esito

Composite of CHD death, nonfatal MI, ischaemic stroke, or unstable angina requiring hospitalisation

Rilevanza

RisultatoMACE 9.5% with alirocumab vs 11.1% with placebo (HR 0.85, 95% CI 0.78-0.93; P<0.001). All-cause death lower (3.5% vs 4.1%; HR 0.85, 95% CI 0.73-0.98), greatest benefit with baseline LDL-C ≥100 mg/dL.

Schwartz GG, et al. N Engl J Med. 2018;379(22):2097-2107. 10.1056/NEJMoa1801174

Discussione e critica

Benefit concentrated in patients with higher baseline LDL-C, and absolute risk reduction was modest. Informs guidelines to reserve PCSK9 inhibitors for very-high-risk post-ACS patients not at LDL goal on maximally tolerated statin/ezetimibe.