NEW ORLEANS (Reuters Health) - Performing percutaneous coronary intervention (PCI), in addition to aggressive medical therapy to control symptoms of angina in patients with relatively stable but extensive atherosclerosis, does not prevent or even reduce risk of adverse cardiovascular events, investigators announced here Monday at the 56th annual scientific session of the American College of Cardiology.

"I believe this will be a landmark trial to advance the care of angina patients," principal investigator Dr. William E. Boden of Buffalo (New York) General Hospital said in presenting the results of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial.

COURAGE involved 2,287 patients with objective evidence of myocardial ischemia and significant coronary artery disease but who were reasonably stable. Between 1999 and 2004, 1,149 patients were randomized to PCI with optimal medical therapy and 1,138 patients were assigned to maximal medical therapy alone. Mean follow-up was 4.6 years. The primary outcome measure was death from any cause and non-fatal MI.

Dr. Boden reported that there were 211 primary events in the PCI arm and 202 events in the medical therapy arm during follow-up. The cumulative primary-event rates during follow-up were 19.0% with preventive PCI and 18.5% with medical therapy alone.

The composite end-point of death, MI, and stroke was statistically the same in both groups, at 20.0% with PCI and 19.5% with medical therapy. Hospitalization for acute coronary syndrome was 12.4% with invasive management and 11.8% without. The incidence of MI was 13.2% with PCI plus medical therapy and 12.3% with medical therapy only.

Results of the COURAGE trial were published online in The New England Journal of Medicine on March 26th, and are scheduled to appear in the April 12th print issue. The study is accompanied by an editorial by Drs. Judith S. Hochman of New York University and P. Gabriel Steig of Universite Paris VII-Denis Diderot in Paris, France.

D. Hochman told Reuters Health that the findings will have a definite impact on medical practice. "The striking finding was how effective maximal medical treatment was at making patients angina-free," she said.

At five years of follow-up, 74% of patients in the PCI arm and 72% of patients in the medical therapy arm were symptom-free. At baseline, only 12-13% of patients were free of angina.

"Stable patients with extensive coronary disease should have a trial of intensive medical therapy first," Dr. Hochman said. "If their symptoms are reasonably well-managed, then they may not need angioplasty. Approximately one-third will fail, and will need PCI. But two-thirds will be well-managed with medical therapy alone."

Co-investigator Dr. William S. Weintraub of Christiana Care Health System in Newark, Delaware, presented unpublished quality of life and economic data from COURAGE.

"Improvements in quality of life in both arms were rather substantial," Dr. Weintraub told meeting attendees. Dr. Hochman concurred, saying that "as long as the patient is happy, then PCI can be avoided...The patient needs to be engaged, and he needs to know his numbers."

Dr. Weintraub added that "we could not find PCI plus maximal medical therapy to be cost-effective compared with medical management alone."

The cost of PCI plus medical therapy was $217,000 per quality of life year gained. The benchmark for assessing cost-effectiveness is considered to be around $50,000.

"The good news is that optimal medical therapy was thought of as a less effective approach to management of disease," Dr. Boden said. "The other news is that this is a modifiable disease."

Dr. Hochman cautioned that these findings can not be extrapolated to patients with unstable disease.

American Heart Association president Dr. Raymond J. Gibbons, of the Mayo Clinic in Rochester, Minnesota, said in a press release that "at least some of the procedures that are performed are based on an assumption by both patients and physicians that 'fixing' the coronary narrowings (or blockages) will lead to a longer life and fewer heart attacks."

"This trial shows convincingly that that assumption is incorrect," Dr. Gibbons continued.