A new US study has found that a combination of lifestyle changes and aggressive medication (optimal medical therapy or OMT) may be sufficient to treat patients with stable heart disease and questions the value of angioplasty, stent insertion and similar invasive coronary procedures.
The study is published early online in the New England Medical Journal (NEJM) and is being presented today at the American College of Cardiology’s 56th Annual Scientific Session in the Ernest N Morial Convention Center, New Orleans.
Percutaneous coronary intervention (PCI) is a range of methods for opening up blocked coronary arteries to improve the blood supply to the heart. One example is angioplasty where a catheter is inserted in the patient’s arm or leg along the inside of the artery until it reaches the heart region where a balloon is inflated inside the blocked part of the artery, thus widening it.
Sometimes a stent, a small lattice-shaped tube of metal, is inserted to keep the artery propped open.
One million PCI procedures are carried out every year in the US.
The study found that while it can alleviate symptoms of angina, using PCI to unblock arteries neither reduces mortality nor prevents heart attacks more effectively than optimal medical therapy.
Even in the case of angina patients the researchers recommended that optimal medical therapy (OMT) be given a chance to work first.
The study, conducted from 1999 and 2004, was part of the Clinical Outcomes Utilizing Revascularization and Aggressive DruG Evaluation (COURAGE) trial of 2,287 patients from 50 hospitals in the US and Canada who had chronic chest pain (angina pectoris) and had at least a 70 percent blockage of one or more coronary arteries.
The researchers assigned 1,149 participants to have optimal medical therapy and PCI (PCI group), and 1,138 to have only optimal medical therapy (OMT group). They followed them up for between 2.5 to 7.0 years (median follow up was 4.6 years). The main outcome measure was death (from any cause) and non-fatal heart attack (myocardial infarction).
The results showed 211 incidences of death or non-fatal heart attack in the PCI group and 202 in the OMT group. There were no significant differences between the two groups in the combined overall rate of death (from any cause), heart attack, and stroke. And neither were there significant differences in the rates of hospital admission for acute coronary syndrome or heart attack (myocardial infarction).
The PCI group did however experience reduced angina symptoms compared with the OMT group, suggesting that while, on average, PCI does not allow patients to live longer or reduce their chances for a heart attack, it does improve quality of life.
The study concluded that “Although the addition of PCI to optimal medical therapy reduced the prevalence of angina, it did not reduce long-term rates of death, nonfatal myocardial infarction, and hospitalization for acute coronary syndromes”.
“Conventional wisdom would indicate that PCI and OMT together would be superior to OMT alone, said Dr Boden, lead investigator of the study which was sponsored by the Department of Veteran Affairs.
“But results of the COURAGE trial demonstrate that two treatments are not always better than one. These findings, along with data from recent studies of more than 5,000 patients combined, show that PCI has no impact on reducing major cardiovascular events,” he added.
“Optimal Medical Therapy with or without PCI for Stable Coronary Disease.”
William E. Boden, Robert A. O’Rourke, Koon K. Teo, Pamela M. Hartigan, David J. Maron, William J. Kostuk, Merril Knudtson, Marcin Dada, Paul Casperson, Crystal L. Harris, Bernard R. Chaitman, Leslee Shaw, Gilbert Gosselin, Shah Nawaz, Lawrence M. Title, Gerald Gau, Alvin S. Blaustein, avid C. Booth, Eric R. Bates, John A. Spertus, Daniel S. Berman, John Mancini, William S. Weintraub.
NEJM Online March 26, 2007 (10.1056/NEJMoa070829)
Written by: Catharine Paddock
Writer: Medical News Today