Author + information
- Kausik Kumar Raya,b,
- Antonio Vallejo-Vaza,b,
- Henry Ginsberga,b,
- Michael Davidsona,b,
- Robert H. Eckela,b,
- Veronica Leea,b,
- Laurence Bessaca,b,
- Robert Pordya,b,
- Alexia Letiercea,b and
- Christopher Cannona,b
Background: Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibition was approved for treating patients with atherosclerotic cardiovascular disease (ASCVD) and elevated low-density lipoprotein cholesterol (LDL-C) despite maximally tolerated statin. We assessed the relationship between lower on-treatment LDL-C levels and major adverse cardiovascular events (MACE) in the alirocumab ODYSSEY phase 3 program in all patients with ASCVD and in ASCVD subgroups of these patients with very high risk due to underlying comorbidities (polyvascular disease [PoVD], ASCVD + diabetes mellitus [DM] or ASCVD + estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2).
Methods: Data from 10 Phase 3 ODYSSEY trials comparing alirocumab (ALI) vs placebo (PBO) or ezetimibe (EZE) were pooled. Patients had ASCVD with LDL-C >70 mg/dL at baseline mostly + maximally tolerated statin therapy. We assessed rates of MACE per 39 mg/dL lower mean on treatment LDL-C.
Results: Baseline LDL-C values were 119, 116, 114, and 113 mg/dL for ASCVD (n=3503), PoVD (n=943), ASCVD+DM (n=980) and ASCVD+eGFR <60 mL/min/1.73 m2 (n=660), respectively. Overall, 39 mg/dL lower LDL-C was associated with 25% lower MACE risk, with a similar trend seen in very high risk ASCVD subgroups (Figure). Safety of alirocumab in all ASCVD groups was comparable to the overall cohort.
Conclusions: Among very high risk patient subgroups with ASCVD and mean baseline LDL-C >70 mg/dL, lower LDL-C levels were associated with lower rates of MACE.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Traditional and Novel Factors Used to Assess the Risk of, and Used for the Treatment of, Coronary Artery Disease
Abstract Category: 2. Acute and Stable Ischemic Heart Disease: Clinical
Presentation Number: 1126-316
- 2017 American College of Cardiology Foundation