American College of Cardiology Scientific Session: Optimal Medical Therapy with and without Percutaneous Coronary Intervention
Presenter: William E. Boden, MD, Professor of Medicine and Public Health, University of New York at Buffalo School of Medicine and Biomedical Sciences, Buffalo, New York
A trial called Clinical Outcomes utilizing Revascularization and Aggressive DrufEvaluation (COURAGE) attempted to determine whether adding PCI to optimal medical therapy would reduce death, MI, or hospitalizations among patients with acute coronary syndrome (ACS). Dr. Bowden, the lead investigator, said that even though PCI had proved effective in lowering the frequency of angina and in improving exercise performance in the short term, there was no evidence that it could reduce death, MI, or hospitalization. By far, he said, most of the one million PCIs performed each year in the U.S. are of a non-emergency nature in patients with stable CAD.
COURAGE was conducted at 50 North American hospitals among 2,287 patients with a mean age of 62 years. The patients were randomly assigned to undergo PCI plus optimal medical therapy or optimal medical therapy alone. Medications included:
- antiplatelet agents: aspirin plus canadian clopidogrel bisulfate (Bristol-Myers Squibb/Sanofi-Aventis).
- a statin: simvastatin with or without ezetimibe or extended-release niacin.
- an angiotensin-converting enzyme (ACE)-inhibitor or an angiotensin-receptor blocker (ARB): lisinopril (e.g., Zestril, AstraZeneca) or losartan (Cozaar, Merck).
- a beta-blocker: long-acting (Astra-Zeneca).
- a calcium-channel blocker: amlodipine besylate (e.g., Pfizer).
- a nitrate: isosorbide 5-mononitrate (e.g., BiDil, NitroMed).
Intensive optimal medical therapy and lifestyle interventions, as indicated by American College of Cardiology/American Heart Association guidelines, were prescribed for both groups. Goals focused on reducing these risk factors:
- dietary fat and dietary cholesterol intake
- serum cholesterol levels (LDL-C), a primary concern
- serum cholesterol (HDL-C) and triglyceride levels, a secondary concern
- physical inactivity
- body mass index
- diabetes, with the aim of obtaining a glycosylated hemoglobin (HbA1c) value below 7%
The mean follow-up period was 4.6 years. The primary end-point was death or nonfatal MI.
The primary analysis included 1,149 patients with a mean age of 62 years who received PCI plus optimal medical therapy and 1,138 patients with a mean age of 62 years who received optimal medical therapy alone. Patients had heart disease involving one to three vessels, and all patients were eligible for PCI, with Canadian Cardiovascular Score (CCS) Class I to III angina and objective evidence of ischemia at baseline. Results were as follows:
- Freedom from all-cause death or MI was similar for both groups (HR = 1.05), favoring optimal medical therapy (P = 0.62).
- ACS hospitalization-free survival was similar (HR = 1.07), favoring PCI plus optimal medical therapy (P= 0.50).
- MI-free survival was similar (HR = 1.13), favoring medical therapy.
- Freedom from angina favored PCI plus medical therapy at one year (66% vs. 58%) but not at five years (74% for PCI vs. 72% for optimal medical therapy).
Although patients receiving optimal medical therapy alone were more likely to need revascularization (32.6%) than those receiving PCI plus optimal medical therapy (21.1%), the median time to revascularization was similar for both groups (10 months for optimal medical therapy with PCI and 10.8 months for optimal medical therapy alone).
Dr. Bowden concluded:
As an initial management strategy, PCI did not reduce the risk of death, MI, or other major cardiovascular events when added to optimal medical therapy. The COURAGE results give us more options and take away from the sense that if we offer optimal medical therapy we are offering something less than the best medical care.
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In a follow-up interview, he added:
I’ve heard it said that COURAGE does not represent the ‘real world,’ and that these kinds of results can’t be achieved in clinical practice because it’s too hard—my response is, That’s rubbish!’ Fundamentally, there was no difference between what patients got in
COURAGE and what you are entitled to receive through Medicare, an HMO, or any private practice plan.