Allopurinol and Cardiovascular Outcomes in Patients With Ischemic Heart Disease - ALL-HEART

Oct 19, 2022
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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:
UK National Institute for Health and Care Research
Date Presented:
08/27/2022
Date Published:
10/08/2022
Date Updated:
10/19/2022
Original Posted Date:
08/29/2022
References

Contribution To Literature:

Highlighted text has been updated as of October 19, 2022.

The ALL-HEART trial failed to show that allopurinol improves cardiovascular outcomes among patients with ischemic heart disease.

Description:

The goal of the trial was to evaluate allopurinol compared with usual care among patients with ischemic heart disease.

Study Design

  • Randomization
  • Parallel
  • Open-label

Patients with ischemic heart disease were randomized to allopurinol (n = 2,853) versus usual care (n = 2,868). Allopurinol was given at a dose of 100 mg daily for 2 weeks, then 300 mg daily for 2 weeks, then 600 mg daily. Among patients with estimated glomerular filtration rate (GFR) 30-59 cc/min/1.73 m2, allopurinol was given at a dose of 100 mg daily for 2 weeks, then 300 mg daily.

  • Total number randomized: 5,721
  • Duration of follow-up: 4.8 years
  • Mean patient age: 72 years
  • Percentage female: 24%
  • Percentage with diabetes: 22%

Inclusion criteria:

  • Patients ≥60 years of age with ischemic heart disease

Exclusion criteria:

  • Gout
  • Severe renal impairment (eGFR <30 cc/min/1.73 m2)
  • Significant hepatic impairment
  • Participation in another clinical trial
  • Allergy to allopurinol
  • Serious adverse cutaneous reaction to any drug
  • Patients already on urate lowering therapy
  • Taking azathioprine, mercaptopurine, cyclosporine, or theophylline
  • Malignancy within the last 5 years

Principal Findings:

The primary outcome, cardiovascular death, myocardial infarction, or stroke, occurred in 11.0% of the allopurinol group vs. 11.3% of the usual care group (p = 0.65). Outcomes were the same among tested subgroups.

Secondary outcomes:

  • All-cause death: 10.1% of the allopurinol group vs. 10.6% of the usual care group (p = 0.77)
  • Hospitalization for heart failure: 2.6% of the allopurinol group vs. 3.4% of the usual care group (p = 0.18)

Interpretation:

Among patients with ischemic heart disease and without gout, allopurinol did not improve outcomes compared with usual care. Safety issues were similar between treatment groups. Allopurinol cannot be recommended for cardiovascular event reduction among patients with ischemic heart disease.

References:

Mackenzie IS, Hawkey CJ, Ford I, et al. Allopurinol versus usual care in UK patients with ischemic heart disease (ALL-HEART): a multicenter, prospective, randomized, open-label, blinded-endpoint trial. Lancet 2022;400:1195-205.

Presented by Dr. Isla Shelagh Mackenzie at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 27, 2022.

Clinical Topics: Geriatric Cardiology, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: ESC22, ESC Congress, Allopurinol, Angina Pectoris, Geriatrics, Heart Failure, Glomerular Filtration Rate, Myocardial Infarction, Myocardial Ischemia, Stroke


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