Addition of evolocumab to statin therapy was found to lower the risk for complex coronary disease requiring revascularization, including complex percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), according to a study published in the Journal of the American College of Cardiology.
Evolocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. In this randomized study (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk; ClinicalTrials.gov Identifier: NCT01764633), 27,564 patients with stable atherosclerotic cardiovascular disease treated with statin therapy were enrolled and followed for a median of 2.2 years.
Complex revascularization was a composite of complex PCI (ie, occurrence of ≥1 multivessel PCI, ≥3 stents, ≥3 lesions treated, bifurcation PCI, or total stent length >60 mm), or CABG.
In this cohort, 1724 patients underwent coronary revascularization: 63%, simple PCI only (mean age, 61.0±8.8 years; 80% men; 89% white); 37%, complex revascularization (mean age, 62.1±8.8; 82% men; 90% white). Among participants who underwent complex revascularization, 17% had CABG and 19% had complex PCI without CABG.
Evolocumab was found to reduce the risk for any coronary revascularization by 22% (hazard ratio [HR], 0.78; 95% CI, 0.71-0.86; P <.001), of simple PCI by 22% (HR, 0.78; 95% CI, 0.70-0.88; P <.001), of complex PCI by 33% (HR, 0.67; 95% CI, 0.54-0.84; P <.001), of CABG by 24% (HR, 0.76; 95% CI, 0.60-0.96; P =.019), and of complex revascularization by 29% (HR, 0.71; 95% CI, 0.61-0.84; P <.001).
There was a nonsignificant increase with time of the effect of evolocumab on complex revascularization risk reduction, from 20% (HR, 0.80; 95% CI, 0.64-0.99) in the first year, to 36% (HR, 0.64; 95% CI, 0.49-0.84) in the second year, to 41% (HR, 0.59; 95% CI, 0.37-0.96) after the second year.
“The greatest reductions observed here with evolocumab were for the most complex revascularization procedures, indicating what appears to be a shift with evolocumab from more complex revascularization procedures toward simple PCI or no revascularization at all,” noted the researchers.
Study limitations include a lack of information on baseline granular coronary artery anatomy, precluding comparison with pre-randomization status.
“Among patients with atherosclerotic cardiovascular disease, adding evolocumab to statin therapy reduced the risk of developing complex coronary artery disease requiring revascularization, including complex PCI and CABG individually,” the study authors concluded. “Together with prior coronary imaging findings, these data suggest that very aggressive low-density lipoprotein cholesterol lowering may have beneficial effects on coronary atherosclerosis burden, anatomic complexity, and need for coronary revascularization.”
Disclosures: The FOURIER trial was supported by Amgen. Some of the authors reported affiliations with pharmaceutical companies. Please see the original reference for a full list of disclosures.
Oyama K, Furtado RHM, Fagundes A Jr, et al. Effect of evolocumab on complex coronary disease requiring revascularization. J Am Coll Cardiol. 2021;77(3):259-267.