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Sample size requirement in trials that use the composite endpoint major adverse cardiovascular events (MACE): new

Josep Ramon Marsal1,2, Iratxe Urreta-Barallobre2,3,4, Marimar Ubeda-Carrillo5

  • 1Cardiovascular Epidemiology and Research Unit, Vall d'Hebron Institut de Recerca (VHIR), Vall d'Hebron Barcelona Hospital Campus, Pg. Vall d'Hebron, 119-129, 08035, Barcelona, Spain.

Trials
|December 20, 2022
PubMed

Insights

The degree of association between death and acute myocardial infarction (AMI) significantly impacts sample size requirements for major adverse cardiac events (MACE) trials. Understanding this correlation is crucial for accurate clinical trial design.

Area of Science:

  • Cardiovascular Research
  • Clinical Trial Design
  • Biostatistics

Background:

  • The impact of component correlation on composite endpoint sample size is understudied.
  • This study quantifies the effect of the degree of association (DoA) between death and acute myocardial infarction (AMI) on sample size requirements (SSR) for major adverse cardiac events (MACE) trials.

Approach:

  • Systematic review and quantitative synthesis of MACE trials published in high-impact journals (2015-2020).
  • Contacted authors to estimate DoA between death and AMI using joint probability and correlation.
  • Analyzed SSR variations based on estimated DoA from randomized controlled trials (RCTs).

Key Points:

  • Sixty-three publications were included, with death, AMI, and revascularization being the most common MACE components.
  • The correlation between death and AMI ranged from -0.02 to 0.31 across 5 trials.
  • Sample size requirements varied by 16%, from 14,602 to 12,259, based on the strength of correlation.

Conclusions:

  • The degree of association between death and AMI is highly variable.
  • This variability can lead to substantial fluctuations in sample size requirements for MACE trials.
Abstract

Keywords:
Composite endpointsCorrelationMACESample size

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