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Advanced coronary artery disease: Appropriate end points for trials of novel therapies

D E Kandzari1, L C Lam, E L Eisenstein

  • 1Division of Cardiology and Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA. kandz002@onyx.dcri.duke.edu

American Heart Journal
|October 31, 2001
PubMed

Insights

Patients with advanced coronary artery disease (CAD) showed improved general health status, similar to those receiving conventional treatments. Trial endpoints for novel CAD therapies should include angina and mortality.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Health Outcomes Research

Background:

  • Growing population of patients with advanced coronary artery disease (CAD) unsuitable for conventional revascularization.
  • Uncertainty regarding appropriate clinical trial endpoints for novel CAD therapies due to undefined natural history.

Purpose of the Study:

  • To compare outcomes of patients with advanced CAD to a reference group undergoing standard revascularization.
  • To inform the design of clinical trials for novel CAD therapies.

Main Methods:

  • Prospective follow-up of 1189 patients in the Mediators of Social Support Study (MOSS).
  • Comparison of long-term survival, quality of life, resource use, and costs between advanced CAD patients and a control group.

Main Results:

  • Patients with advanced CAD experienced higher disease burden, costs, and mortality.
  • Self-reported general health status improved similarly in advanced CAD patients compared to the control group.

Conclusions:

  • General health status improvements in advanced CAD patients suggest novel trial endpoints.
  • Angina status and mortality should be primary endpoints for novel CAD therapy trials.
  • Larger sample sizes may be needed for definitive efficacy characterization of new CAD therapies.
Abstract

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