Global Assessment of Plaque Regression With a PCSK9 Antibody as Measured by Intravascular Ultrasound - GLAGOV

Aug 29, 2017
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Presenter/Author:
Stephen J. Nicholls, MBBS, PhD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Amgen Inc.
Date Presented:
08/29/2017
Date Published:
11/15/2016
Date Updated:
08/29/2017
Original Posted Date:
11/15/2016
References

Contribution To Literature:

The GLAGOV trial showed that evolocumab was superior to placebo at reducing coronary plaque.

Description:

The goal of the trial was to evaluate treatment with the PCSK9 inhibitor evolocumab compared with placebo among patients with angiographic evidence of coronary artery disease on chronic statin therapy.

Study Design

  • Randomized
  • Parallel
  • Blinded
  • Stratified

Patients with angiographic coronary artery disease with elevated low-density lipoprotein (LDL) cholesterol on chronic statin therapy were randomized to monthly subcutaneous evolocumab (n = 484) versus monthly subcutaneous placebo (n = 486).

Inclusion criteria:

  • Angiographic coronary artery disease
  • On stable statin therapy with LDL cholesterol ≥80 mg/dl or between 60 and 80 mg/dl with one major or three minor cardiovascular risk factors
  • Total number of enrollees: 970
  • Duration of follow-up: 76 weeks
  • Mean patient age: 60 years
  • Percentage female: 28%
  • Percentage with diabetes: 21%

 Other salient features/characteristics:

  • About 60% were on high-intensity statin therapy at baseline
  • LDL cholesterol at 76 weeks: 36.6 mg/dl in the evolocumab group versus 93.0 mg/dl in the placebo group (p < 0.001)

Principal Findings:

The primary outcome, nominal change in percent atheroma volume at 78 weeks, was -0.95% in the evolocumab group versus 0.05% in the placebo group (p < 0.001 for between-group comparison). Results were the same in multiple tested subgroups.

Secondary outcomes:

  • Patients with plaque regression: 64.3% with evolocumab versus 47.3% with placebo (p < 0.001)
  • Major adverse cardiac events: 12.2% with evolocumab versus 15.3% with placebo

Among patients who underwent virtual histology, the change in normalized dense calcium volume was 1.0 in the evolocumab group versus 0.6 in the placebo group (p = 0.49).

Interpretation:

Among patients with angiographic evidence of coronary artery disease and on chronic statin therapy, the PCSK9 inhibitor evolocumab resulted in a greater change in percent atheroma volume and a greater proportion of patients with plaque regression. Virtual histology was unable to provide incremental information on plaque composition. Although not powered for clinical outcomes, major adverse cardiac events were numerically reduced with evolocumab. Larger studies powered for clinical outcomes are warranted.

References:

Presented by Dr. Stephen J. Nicholls at the European Society of Cardiology Congress, Barcelona, Spain, August 29, 2017.

Nicholls SJ, Puri R, Anderson T, et al. Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated Patients: The GLAGOV Randomized Clinical Trial. JAMA 2016;316:2373-84.

Presented by Dr. Steven E. Nissen at the American Heart Association Annual Scientific Sessions (AHA 2016), New Orleans, LA, November 15, 2016.

Keywords: ESC Congress, ESC2017, AHA Annual Scientific Sessions, Antibodies, Monoclonal, Cholesterol, Cholesterol, LDL, Coronary Angiography, Coronary Artery Disease, Disease Progression, Dyslipidemias, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Plaque, Atherosclerotic, Primary Prevention, Risk Factors, Ultrasonography


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