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ANAHEIM -- Atherosclerosis is not a focal disease, thus it was expected that the PCSK-9 inhibitor evolocumab (Repatha), which already demonstrated impressive LDL-lowering as well as a reduction in cardiovascular events, could also reduce the risk of acute peripheral vascular events -- and that is exactly what was reported here.

In a subanalysis of 3,642 patients with confirmed peripheral arterial disease (PAD) participating in the study, Marc P. Bonaca, MD, MPH, from Brigham and Women's Hospital and the TIMI Study Group, reported that evolocumab treatment reduced by 42% the relative risk of major adverse limb events (HR 0.58, 95% CI 0.38-0.88 P=o.oo93).

Moreover, because the presence of PAD increases the risk for adverse cardiovascular events -- including cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina and revascularization -- the absolute reduction in risk for those primary endpoint events was greater in the PAD subset than in the overall 27,564-patient FOURIER cohort: 3.5% versus 1.6%.

Symptomatic PAD patients treated with evolocumab achieved a median LDL of 31 mg/dL (IQR 19-49), versus median 94 mg/dL (IQR 81-112) at baseline.

Findings from this were published online by Circulation and were also reported at a late-breaking clinical science session at the scientific meeting here.

Initial results from FOURIER were reported at the American College of Cardiology meeting in March.

Alfred Bove, MD, of Temple University School of Medicine, said he was very encouraged by these results because "peripheral disease is often overlooked until it becomes symptomatic, yet these findings demonstrate that aggressive lipid-lowering in these patients can produce a significant benefit."

"When looking at the composite of major adverse cardiovascular events/major adverse limb events in patients with symptomatic lower extremity peripheral artery disease and no prior myocardial infarction or stroke, evolocumab resulted in an absolute risk reduction at 2.5 years of 6.3% yielding a number needed to treat of 16," Bonaca and colleagues wrote.

In their report last March, the FOURIER investigators said that at 2.2 years follow-up, the NNT to prevent MI, stroke, or revascularization was 74.

But Bove, who was not involved in the study, didn't know if the PAD finding would be enough to convince third parties to approve payment for evolocumab treatment. Difficulty in gaining payer authorization has been a stumbling block to the PCSK9 inhibitors' uptake -- not a surprising issue since evolocumab carries a hefty $14,400/patient/year estimated price tag.

He noted that PAD is extremely common, especially in persons in the seventh and eighth decade of life, which defines the Medicare population. With an at-risk population that large, "there could be an influence on payers," but Bove said his concern was getting the message to fellow clinicians to "pay attention" to PAD.