Percutaneous coronary intervention plus optimal medical therapy does not improve outcomes in patients with coronary artery disease, compared with optimal medical therapy alone, according to study results presented at the 56th Annual Scientific Session of the American College of Cardiology in New Orleans, and published online in the New England Journal of Medicine.
The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) Trial, conducted by the Cooperative Studies Program of the U.S. Department of Veterans Affairs (VA) and the Canadian Institutes of Health Research (CIHR), was a randomized, controlled study involving 2,287 patients with stable coronary artery disease treated at 15 VA medical centers, as well as 35 other U.S. and Canadian medical centers. The study, conducted between 1999 and 2004, was also supported by several pharmaceutical and biotechnology companies that contributed funding, drugs and medical devices or supplies.
COURAGE participants, most of them Caucasian males, with an average age of 62, had at least one coronary artery that was more than 70-percent blocked. They experienced regular chest pain (angina) at least several times per week. About 38 percent had a history of heart attack, 33 percent had diabetes, 71 percent had high cholesterol and 67 percent had high blood pressure.
All participants received optimal medical therapy (OMT), which consisted of multiple medications - including drugs to lower blood pressure and cholesterol and prevent clots - and lifestyle programs for smoking cessation, physical activity, and nutrition. Half the participants also underwent percutaneous coronary intervention (PCI), a procedure in which an interventional cardiologist clears plaque from a blocked artery.
Nearly all of the PCI recipients (93 percent) also had a stent, a wire-mesh tube, placed to help keep open the affected artery. Because drug-eluting stents, which are coated with medications that help prevent scarring, were not approved until the trial was nearly completed, only 31 COURAGE patients received this type of stent. But studies have shown little difference between coated and non-coated stents in their ability to prevent heart attacks and deaths.
At a median follow-up of almost five years, the rates of death, nonfatal heart attack, stroke, and hospitalization for heart disease were the same in the two study groups: those who received only OMT, and those who received PCI plus OMT.