Aortic Irbesartan Marfan Study - AIMS

Jan 24, 2020
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
British Heart Foundation, UK Marfan Trust, UK Marfan Association.
Date Published:
12/10/2019
Date Updated:
01/24/2020
Original Posted Date:
12/16/2019
References

Contribution To Literature:

The AIMS trial showed that an ARB was superior to placebo at slowing the rate of aortic root dilatation in Marfan syndrome patients.

Description:

The goal of the trial was to evaluate an angiotensin receptor blocker (ARB) compared with placebo among patients with confirmed Marfan syndrome.

Study Design

  • Randomized
  • Parallel
  • Placebo
  • Double-blind

Patients with clinically confirmed Marfan syndrome were randomized to irbesartan 300 mg daily (n = 104) versus placebo (n = 88).

  • Total number of enrollees: 192
  • Duration of follow-up: median 4 years
  • Mean patient age: 18 years
  • Percentage female: 52%

Inclusion criteria:

  • Clinically confirmed Marfan syndrome
  • 6-40 years of age
  • Aortic Z score >0

Exclusion criteria:

  • Prior or planned cardiac or aortic surgery
  • Aortic diameter ≥4.5 cm
  • Hemodynamically severe valve disease
  • Indication or contraindication for ARB
  • Heart failure
  • Pregnancy

Other salient features/characteristics:

  • Aortic root diameter at baseline: 34.4 mm in the irbesartan group versus 34.4 mm in the placebo group
  • Aortic Z score at baseline: 3.3 mm in the irbesartan group versus 3.2 mm in the placebo group
  • Use of beta-blocker at baseline: 56%

Principal Findings:

The primary outcome, mean rate of aortic root dilatation, was 0.53 mm per year in the irbesartan group versus 0.74 mm per year in the placebo group (p = 0.030). There was no evidence for treatment interaction, including use of beta-blocker.

Secondary outcomes:

  • Rate of change in aortic Z score: reduced by irbesartan (difference in means –0.10 per year, p = 0.035)
  • Difference in systolic blood pressure at 1 year (irbesartan vs. placebo): -6.3 mm Hg
  • Difference in diastolic blood pressure at 1 year (irbesartan vs. placebo): -3.6 mm Hg
  • Serious adverse events: 24% with irbesartan vs. 23% with placebo

Interpretation:

Among patients with Marfan syndrome, irbesartan was associated with a reduction in the rate of aortic root dilatation compared with placebo. The optimal treatment for patients with Marfan syndrome has been controversial with no conclusive benefit for beta-blockers or other ARBs (i.e., losartan). Irbesartan was associated with a reduction in blood pressure and was well tolerated. Although further investigation is needed, this study supports the use of irbesartan to slow the rate of aortic root dilatation in patients with Marfan syndrome.

References:

Mullen M, Jin XY, Child A, et al. Irbesartan in Marfan syndrome (AIMS): a double-blind, placebo-controlled randomised trial. Lancet 2019;394:2263-70.

Editorial Comment: Muiño-Mosquera L. Angiotensin-II receptor blockade in Marfan syndrome. Lancet 2019;394:2206-7.

Keywords: Adrenergic beta-Antagonists, Angiotensin Receptor Antagonists, Aortic Diseases, Blood Pressure, Blood Pressure Determination, Dilatation, Heart Defects, Congenital, Losartan, Marfan Syndrome, Primary Prevention, Treatment Outcome


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