Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients

The GLAGOV Randomized Clinical Trial

OBJECTIVE
To determine the effects of PCSK9 inhibition with evolocumab on progression of coronary atherosclerosis in statin-treated patients.

DESIGN, SETTING,ANDPARTICIPANTS
The GLAGOV multicenter, double-blind, placebo-controlled, randomized clinical trial (enrollment May 3, 2013, to January 12, 2015) conducted at 197 academic and community hospitals in North America, Europe, South America, Asia, Australia, and South Africa and enrolling 968 patients presenting for coronary angiography.

RESULTS
Among the 968 treated patients (mean age, 59.8 years [SD, 9.2]; 269 [27.8%] women; mean LDL-C level, 92.5mg/dL [SD, 27.2]), 846 had evaluable imaging at follow-up.
Compared with placebo, the evolocumab group achieved lower mean, time-weighted LDL-C levels (93.0 vs 36.6mg/dL; difference, −56.5mg/dL [95%CI, −59.7 to −53.4]; P < .001).

The primary efficacy parameter, PAV, increased 0.05%with placebo and decreased 0.95%with evolocumab (difference, −1.0% [95%CI, −1.8%to −0.64%]; P < .001).

The secondary efficacy parameter, normalized TAV, decreased 0.9mm3 with placebo and 5.8mm3 with evolocumab (difference, −4.9mm3 [95%CI, −7.3 to −2.5]; P < .001). Evolocumab induced plaque regression in a greater percentage of patients than placebo (64.3%vs 47.3%; difference, 17.0%[95%CI, 10.4%to 23.6%]; P < .001 for PAV and 61.5%vs 48.9%; difference, 12.5% [95%CI, 5.9% to 19.2%]; P < .001 for TAV).

CONCLUSIONS AND RELEVANCE
Among patients with angiographic coronary disease treated with statins, addition of evolocumab, compared with placebo, resulted in a greater decrease in PAV after 76 weeks of treatment. Further studies are needed to assess the effects of PCSK9 inhibition on clinical outcomes

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