A Prospective Comparison of Algisyl-LVR With Standard Medical Therapy to Determine Impact on Functional Capacity and Clinic Outcomes in Patients With Advanced Heart Failure - AUGMENT-HF

Nov 11, 2015
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Presenter/Author:
Douglas L. Mann, MD, FACC
Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
LoneStar Heart
Date Presented:
11/11/2015
Original Posted Date:
11/11/2015
References

Description:

The goal of the trial was to evaluate treatment with algisyl injection in the myocardium compared with standard therapy among patients with advanced heart failure. Algisyl is a permanent implant that consists of alginate hydrogel that is intended to reduce left ventricular (LV) wall stress.

Contribution to the Literature: The AUGMENT-HF trial showed that injection of algisyl-LVR in the myocardium is feasible with improvement in functional capacity.

Study Design

  • Randomized
  • Parallel

Patients with advanced heart failure were randomized to algisyl injection in the myocardium (n = 40) versus standard medical therapy (n = 38).

Patient population:

  • Total number of enrollees: 78
  • Duration of follow-up: 6 months, 1 year
  • Mean patient age: 62 years
  • Percentage female: 15%
  • Percentage diabetics: 39%
  • Mean LV ejection fraction (LVEF): 26%

Inclusion criteria:

  • Patients with moderate to severe, highly symptomatic heart failure on optimal medical therapy
  • LVEF ≤35%
  • Peak VO2 of 9.0-14.5 ml/min/kg
  • LV end-diastolic dimension index 30-40 mm/m2

Exclusion criteria:

  • Renal or liver disease
  • LV wall thickness <8 mm

Principal Findings:

The primary outcome of change in peak VO2 from baseline to 6 months was 13.5 ml/min/kg with algisyl-LVR versus 12.2 ml/min/kg with control (p = 0.014). Patients with baseline 6-minute walk test <287 m had enhanced benefit from algisyl (p for interaction = 0.014).

Secondary outcomes:

  • Serious adverse events at 6 months: 40.0% vs. 26.3 (p = 0.063), respectively, for algisyl vs. placebo
  • Summary of 12-month outcomes (mean difference for algisyl vs. placebo):

        - Peak VO2 (ml/min/kg): 2.1 (p < 0.001)

        - Total exercise time (minutes): 1.5 (p = 0.002)

        - Six-minute walk distance (meters): 101 (p < 0.001)

  • Serious adverse events at 12 months: 53% for algisly vs. 47% for placebo (p = 0.19)
  • Deaths at 12 months: 20% for algisly vs. 11% for placebo  

Interpretation:

Among patients with advanced symptomatic heart failure, algisyl injection in the myocardium is feasible. This treatment improved functional capacity, as measured by change in VO2. This study serves as a proof-of-concept for LV augmentation with algisyl. At 1 year, there was continued improvement in functional capacity with algisyl injection. The numerical increase in cardiovascular deaths in the algisly group is concerning and needs to be monitored carefully in future studies.

References:

Presented by Dr. Douglas L. Mann at the American Heart Association Scientific Sessions, Orlando, FL, November 11, 2015.

Presented by Dr. Stefan D. Anker at ACC.15, San Diego, CA, March 16, 2015.

Keywords: ACC Annual Scientific Session, Biopolymers, Body Mass Index, Cardiomyopathies, Diabetes Mellitus, Exercise, Heart Failure, Hospitalization, Myocardium, Prospective Studies, Random Allocation, AHA Annual Scientific Sessions


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