Clinical and research issues regarding chronic advanced coronary artery disease Part II: Trial design, outcomes, and regulatory issues

E. Marc Jolicoeur, E. Magnus Ohman, Robert Temple, Norman Stockbridge, Sidney Smith, Daniel Mark, Robert M. Califf, Timothy D. Henry, Bernard R. Chaitman, Christopher B. Granger

Research output: Contribution to journalArticlepeer-review

46 Scopus citations


The population of patients with advanced coronary artery disease (CAD) is growing as a result of the aging of the general population, the extensive use of revascularization, and the efficacy of therapies that have prolonged the survival of patients with severe atherosclerosis. Patients with symptomatic CAD survive to a point where little else can be done to relieve their angina. Despite an anticipated growth in the number of patients with this condition within the next few decades, advanced CAD receives relatively little attention by the medical and research communities. As a result, the scope of the disease is not well defined, its coverage in guidelines from professional associations is limited, and few new medical options are available. In response to this, a group of experts from different fields were brought together at a meeting held December 4 to 5, 2006. This document has been developed as a 2-part article. In the first part, the contemporary and emerging therapies for advanced CAD were reviewed. The present part reviews the current status of understanding of advanced CAD, the limits of contemporary therapies, and the difficulties in and barriers to the development of new treatments.

Original languageEnglish (US)
Pages (from-to)435-444
Number of pages10
JournalAmerican Heart Journal
Issue number3
StatePublished - Mar 2008

Bibliographical note

Funding Information:
Members of the Working Group (in addition to coauthors): Karen Alexander, MD, Duke University Medical Center, Durham, NC; Steve C. Mockrin, PhD, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD; Julie Swain, MD, FDA, CDRH, Fallbrook, CA; Celia Witten, MD, PhD, FDA, CBER, Rockville, MD. Presenters to the Working Group: Jonathan Abrams, MD, University of New Mexico Hospital, Albuquerque, NM; Brian Annex, MD, Duke VA Medical Center, Durham, NC; Gregory Barsness, MD, Mayo Clinic Rochester, Rochester, MN; Deepak Bhatt, MD, Cleveland Clinic, Cleveland, OH; Robert Califf, MD, Duke Clinical Research Institute, Durham, NC; Bernard R. Chaitman, MD, Saint Louis University School of Medicine, St Louis, MO; Bernard J. Gersh, MD, Mayo Clinic, Rochester, MN; David Holmes, MD, Mayo Clinic, Rochester, MN; Timothy D. Henry, MD, Minneapolis Heart Institute, Minneapolis, MN; Andrew Koren, MD, CV Therapeutics, Palo Alto, CA; Daniel Mark, MD, Duke Clinical Research Institute, Durham, NC; Alice M. Mascette, MD, National Institutes of Health, National Heart, Lung, and Blood Institute, Bethesda. MD; E. Magnus Ohman, MD, Duke University Medical Center, Durham, NC; Carl Pepine, MD, University of Florida, Gainesville, FL; Ileana Pina, MD, Case Western Reserve University, Cleveland Height, OH; Jyme Schafer, MPH, CMS, Baltimore, MD; Sidney Smith, MD, University of North Carolina, Chapel Hill, NC; Norman Stockbridge MD, PhD, FDA, Silver Spring, MD; Anders Svensson, MD, PhD, AstraZeneca, Molndal, Sweden; Julie Swain, FDA, Center for Devices and Radiological Health, Fallbrook, CA; Robert Temple, MD, FDA, Silver Spring, MD; Lars Wallentin, MD, PhD, Uppsala Clinical Center University Hospital, Uppsala, Sweden; Doug Weaver, MD, Henry Ford Health System, Detroit, MI; Cecelia Witten, MD, PhD, FDA/Center for Biologics Evaluation and Research, Rockville, MD; Bram Zuckerman, MD, FDA, Rockville, MD.


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