ACC: Stenting Found No Better than Optimal Medical Therapy

March 26, 2007

NEW ORLEANS -- An analysis of coronary stenting plus optimal medical therapy found no advantage in any major cardiovascular endpoint over medical therapy alone, researchers reported here today.

NEW ORLEANS, March 26 -- An analysis of coronary stenting plus optimal medical therapy found no advantage in any major cardiovascular endpoint over medical therapy alone, researchers reported here today.

Nor was stenting any better than medical therapy at longterm symptom relief, William E. Boden, M.D., of the University of Buffalo (N.Y.), principal investigator of the COURAGE trial , reported at a press conference at the American College of Cardiology meeting. The COURAGE results were also published online by the New England Journal of Medicine.

After 4.6 years the primary event rate was 19.0 in the percutaneous coronary intervention group versus 18.5% in the medical therapy arm, a statistical dead heat.

And by every major individual endpoint measure -- stroke, hospitalizations for acute coronary syndrome, myocardial infarction, and death-- there were no significant differences.

Raymond Gibbons, M.D. of the Mayo Clinic and president of the American Heart Association, said the findings suggest that "hundreds of thousands of Americans with stable angina who received coronary stents did not need them." Steven Nissen, M.D., of the Cleveland Clinic and president of the ACC, said the results could have a significant clinical impact.

Even before the ink was dry on the results, industry execs and interventional cardiologists were trying to minimize the impact. Donald Baim, M.D., chief medical officer of Boston Scientific, the stent-maker, tried to persuade reporters to put a positive spin on the COURAGE data. He suggested that instead of a headline such as "Yet Another Failure of Percutaneous Coronary Intervention," the headline could be "Another Study Saying for Stable Angina You Have PCI to Improve Symptoms."

The study from 1999 through 2004, the trial recruited 2,287 patients who had stable angina at 50 U.S. and Canadian centers and assigned 1,149 patients to percutaneous coronary intervention plus maximum medical therapy and 1,138 to maximum medical therapy alone.

The primary outcome was death from any cause and non-fatal myocardial infarction during a follow-up of 2.5 to 7 years.

Optimum medical included daily aspirin (81mg to 325 mg), or 75 mg of clopidogrel (Plavix) for patients who were aspirin intolerant; long-acting metoprolol, amlopidine, and isosorbide mononitrate alone or in combination along with either lisinopril or losartan.

Patients also received aggressive statin therapy to lower LDLs to a goal of 60 to 85 mg/dL. When the LDL goal was reached, "an attempt was made" to raise HDL to above a threshold of 40 mg/dL and lower triglyceride to a goal of less than 150 mg/dL. That intervention included diet, exercise, extended-release niacin and fibrates alone or in combination.

Among the findings:

  • There were 211 primary events in the percutaneous coronary intervention arm and 202 in the medical therapy arm (NS).
  • There were 85 deaths in the percutaneous coronary intervention arm included 23 cardiac deaths and 95, of which 25 were cardiac deaths in the medical therapy group (NS).
  • There were 143 myocardial infarctions in the percutaneous coronary intervention group and 128 in the medical therapy arm (NS).
  • There were 22 strokes in the percutaneous coronary intervention arm and 14 in the (NS)

There was a statistically significant difference in revascularization that favored percutaneous coronary intervention, 228 versus 348 (P