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Re-Examination of the BEST Trial Using Composite Outcomes, Including Emergency Department Visits

Li Shen1, Pardeep S Jhund1, Ulrik M Mogensen2

  • 1BHF Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom.

JACC. Heart Failure
|August 5, 2017
PubMed

Insights

Choosing the right endpoint in heart failure trials significantly impacts study size and duration. Broader composite endpoints, like cardiovascular death or heart failure hospitalization, reduce trial requirements compared to mortality alone.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Biostatistics

Background:

  • Endpoint selection in heart failure trials has evolved over three decades.
  • The Beta-blocker Evaluation of Survival Trial (BEST) provides a case study for endpoint analysis.

Purpose of the Study:

  • To examine the influence of endpoint choice on trial size, duration, and interpretation of results in heart failure patients.
  • To compare different composite endpoints and recurrent event analysis within the BEST trial.

Main Methods:

  • Cox regression analysis was used to compare bucindolol's effect on mortality, cardiovascular death/heart failure hospitalization (CVD/HFH), and expanded composites including ED visits.
  • The Lin, Wei, Ying, and Yang model was employed for recurrent event analysis.

Main Results:

  • The composite endpoint of CVD/HFH showed a significant benefit for bucindolol (HR: 0.80; p < 0.001) compared to placebo.
  • Using CVD/HFH as the endpoint instead of all-cause mortality would have reduced trial size by 40% and duration by 69%.
  • Recurrent CVD/HFH events also favored bucindolol (rate ratio: 0.83; p = 0.003).

Conclusions:

  • Endpoint selection critically influences heart failure trial logistics and outcome interpretation.
  • Broader composite endpoints and the analysis of recurrent events warrant further investigation in clinical trials.
Abstract

Keywords:
BESTendpointheart failurerecurrent events

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