A Continuing Clinical Challenge

The COURAGE trial found that, despite medical therapy with or without percutaneous coronary intervention (PCI), angina often persists.1

  • Patients with coronary artery disease (CAD) were managed with either optimal medical therapy (OMT) alone or OMT with PCI*1
  • 88% of patients with CAD had angina at baseline in the COURAGE trial1
  • At one year, a substantial number of patients in both treatment groups continued to experience angina; however, the rate of angina was significantly lower in the group treated with OMT + PCI1
  • At year 5, there was no difference in the rate of angina between the 2 groups1

Angina rates graph 1 Click to enlarge

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*OMT included anti-platelet therapy, aspirin or clopidogrel, long-acting metoprolol, amlodipine, and isosorbide mononitrate, alone or in combination, along with either lisinopril or losartan. All patients received aggressive therapy to reduce low-density lipoprotein levels, raise high-density lipoprotein levels, and reduce triglyceride levels.1

COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) was a randomized trial of 2287 patients who had objective evidence of myocardial ischemia and significant CAD. Between 1999 and 2004, patients were assigned to receive OMT alone or with PCI. They were followed for a median of 4.6 years.1

In a separate study by Serruys et al, 1205 patients who had not previously undergone coronary artery bypass graft (CABG) or angioplasty were randomized to undergo stent implantation or CABG.2

  • Patients were eligible for coronary revascularization if they had either stable angina pectoris or unstable angina pectoris or if they had silent ischemia and at least two new lesions that were located in different vessels and territories (not including the left main coronary artery) and that were potentially amenable to stent implantation.2
  • Patients had to have a left ventricular ejection fraction (LVEF) of > 30% and patients with overt heart failure were excluded from the study. Other exclusion criteria included history of cerebrovascular accident, incidence of transmural myocardial infarction (MI) within the previous week, severe hepatic or renal disease, diseased saphenous veins, neutropenia or thrombocytopenia or an intolerance or contraindication to aspirin or ticlodipine, or a need for major concomitant surgery. For the stenting cohort, each patient had to require > 1 stent.2
  • Each patient entering the study required prior agreement between a surgeon and an interventional cardiologist that an equivalent degree of revascularization could be obtained by either CABG or stenting.2
  • The primary endpoint was freedom from major adverse cardiac or cerebrovascular events (death, stroke, transient ischemic attacks, reversible ischemic neurologic deficits), documented nonfatal MI; and repeated revascularization by percutaneous coronary intervention or surgery at 12 months postrandomization.2
  • Baseline clinical characteristics were similar in the groups assigned to CABG or stenting.2
  • Events were counted from randomization, and clinical assessments were performed at 1, 6, and 12 months post-intervention.2
  • Additionally, Serruys et al reported that in patients treated for multivessel disease with stent implantation or bypass surgery (N = 1205), a substantial subset (21.1% and 10.5%, respectively) continued to experience angina 1 year after revascularization.2

Courage Trial graph 2 Click to enlarge

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References

  • Boden WE, O'Rourke RA, Teo KK, et al; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007;356:1503-1516.

  • Serruys PW, Unger F, Sousa JE, et al; for the Arterial Revascularization Therapies Study Group. Comparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease. N Engl J Med. 2001;344(15):1117-1124.

  • Data on file, Gilead Sciences, Inc.

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