Long-Term Efficacy of Evolocumab in Patients With or Without Multivessel Coronary Disease.

BACKGROUND

In FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk), during a median follow-up of 2.2 years, risk reduction for major adverse cardiovascular event with evolocumab was greater in patients with multivessel disease (MVD). The FOURIER Open-Label Extension (FOURIER-OLE) provides an additional median follow-up of 5 years.

OBJECTIVES

The purpose of this study was to assess the long-term benefit of evolocumab in patients with and without MVD.

METHODS

FOURIER randomized 27,564 patients to evolocumab vs placebo; 6,635 entered FOURIER-OLE. Patients with coronary artery disease were categorized based on the presence of MVD (≥40% stenosis in ≥2 large vessels). The primary endpoint was cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization; the key secondary endpoint was cardiovascular death, myocardial infarction, or stroke.

RESULTS

Of 23,656 patients in FOURIER with coronary artery disease, 25.4% had MVD; 5,887 patients continued into FOURIER-OLE. The risk reduction with initial allocation to evolocumab tended to be greater in patients with MVD than in those without: 23% (HR: 0.77 [95% CI: 0.68-0.87]) vs 11% (HR: 0.89 [95% CI: 0.82-0.96]) for the primary and 31% (HR: 0.69 [95% CI: 0.59-0.81]) vs 15% (HR: 0.85 [95% CI: 0.77-0.94]) for the key secondary endpoints (P

CONCLUSIONS

Evolocumab reduced the rate of major adverse cardiovascular event in patients with and without MVD. The benefit tended to occur earlier and was larger in patients with MVD. However, the magnitude grew over time in both groups. These data support early initiation of intensive low-density lipoprotein cholesterol lowering both in patients with and without MVD.

Informations de copyright

Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures FOURIER and FOURIER-OLE were funded by Amgen. Dr O’Donoghue has received grant funding through Brigham and Women’s Hospital from Amgen, Novartis, AstraZeneca, Janssen, Intarcia, and GlaxoSmithKline; and has received consulting fees from Amgen, Novartis, AstraZeneca, and Janssen. Dr De Ferrari has received research support through his institution from Livanova, Merck, and Novartis; has received a steering committee fee from Amgen; and has received consulting and speaker fees from Amgen, AstraZeneca, Boehringer Ingelheim, Merck Sharp & Dohme, and Novartis. Ms Ran and Dr Im are employees of the TIMI Study Group, which has received research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, Inc, ARCA Biopharma, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Ionis, Merck, Novartis, Pfizer, Regeneron Pharmaceuticals, Roche, Saghmos Therapeutics, Siemens Healthcare Diagnostics, Softcell Medical Limited, Verve Therapeutics, and Zora Biosciences. Dr López, Ms Elliott-Davey, Dr Wang, and Dr Monsalvo are employed by and own stock in Amgen. Dr Atar has received speaker and consultancy honoraria from Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Novo Nordisk, Pfizer, Pharmacosmos, Philips, Roche-Diagnostics, Sanofi, Takeda, and Vifor Pharma; and has received research grant support (to the institution) from Bristol Myers Squibb/Pfizer, Medtronic, Bayer, and Roche Diagnostics. Dr Keech has received grants and personal fees from Abbott and Mylan; and has received personal fees from Amgen, AstraZeneca, Pfizer, Sanofi, and Novartis. Dr Giugliano has received research grant support through Brigham and Women’s Hospital from Amgen, Daiichi-Sankyo, and Ionis; has received speaker honoraria from Amgen, Daiichi-Sankyo, Dr Reddy’s Laboratories, Medical Education Resources, and SUMMEET; and has received consulting fees from Daiichi-Sankyo, Inventiva, and Sanofi. Dr Sabatine has received research grant support through Brigham and Women’s Hospital from Abbott, Amgen, Anthos Therapeutics, Inc, AstraZeneca, Boehringer Ingelheim, Daiichi-Sankyo, Ionis, Merck, Novartis, Pfizer, Saghmos Therapeutics, and Verve Therapeutics; and has received consulting fees from Amgen, Beren Therapeutics, Boehringer Ingelheim, Dr Reddy’s Laboratories, Merck, Novo Nordisk, and Precision BioSciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.