Evolocumab reduces the relative risk of major adverse limb events (MALEs), which can lead to limb loss, in patients with stable atherosclerotic cardiovascular (CV) disease with or without peripheral artery disease (PAD), a subgroup analysis of the FOURIER trial has shown. [Bonaca MP, et al, AHA 2017, session LBS02; Circulation 2017, doi: 10.1161/CIRCULATIONAHA.117.032235]    

In the overall population of FOURIER, evolocumab reduced the relative risk of MALEs by 42 percent vs placebo (0.27 vs 0.45 percent; hazard ratio [HR], 0.58; p=0.0093). The relative risk reduction was 37 percent (1.5 vs 2.4 percent; HR, 0.63) in those with known PAD and 63 percent in those with no known PAD (0.076 vs 0.16 percent; HR, 0.37).

PAD is challenging to manage and increases patients’ risk of CV events, including CV death, MI, stroke, hospitalization for unstable angina and revascularization.

In patients with PAD, evolocumab reduced the relative risk of these CV events (the primary endpoint of FOURIER) by 21 percent vs placebo (13.3 vs 16.8 percent; HR, 0.79; p=0.0098). The relative risk reduction for the composite of CV death, MI or stroke was 27 percent (9.5 vs 13 percent; HR, 0.73; p=0.004) – of greater magnitude than the 19 percent relative risk reduction (7.6 vs 6.2 percent; HR, 0.81; p<0.001) in patients with no PAD.

LDL-cholesterol (LDL-C) also decreased among symptomatic PAD patients given evolocumab, to a median of 31 mg/dL compared with a median of 94 mg/dL at baseline.

“Few therapies have been proven to reduce major adverse CV events in patients with lower extremity PAD,” said Dr Marc Bonaca from Brigham and Women’s Hospital in Boston, Massachusetts, US. “These data support reducing LDL-C to very low levels in patients with symptomatic lower extremity PAD, including those without concomitant coronary or cerebrovascular disease.”