Lifestyle and pharmacologic interventions with or without PCI proved to be a successful measure of secondary intervention that decreased associated risk in patients with coronary artery disease (CAD), based on results of a substudy of the COURAGE trial published March 23 in the Journal of the American College of Cardiology.
“Few clinical trials have included multiple risk factor intervention with behavioral and pharmacologic therapy as recommended by practice guidelines,” the authors noted. “Previous trials…failed to apply medical therapy that was multifaceted, aggressive and provided equally to both treatment arms."
David J. Maron, MD, of the Vanderbilt University School of Medicine in Nashville, Tenn., used data from the COURAGE trial, which enrolled 2,287 patients with stable CAD, to test the impact of lifestyle and pharmacologic optimal medical therapy (OMT) with (1,149 patients) or without PCI (1,138 patients).
Researchers looked at lifestyle medications including: smoking cessation, dietary intervention and exercise, while pharmacologic interventions included aspiring, clopidogrel, beta-blockers, angiotensin converting enzyme inhibitors and statins.
Results showed that lifestyle variables were similar between the two groups. For both groups, smoking rates had decreased from 23 percent to 19 percent and patients who reported reaching the dietary goal of consuming less than 7 percent of calories from saturated fat increased from 46 percent to 80 percent.
Additionally, patients who reported achieving the physical activity goal of walking 150 minutes per week or more increased from 58 percent to 66 percent.
Between baseline and five years, antiplatelet use increased 87 percent to 96 percent; beta-blockers 69 percent to 85 percent; and rennin-angiotensin-aldosterone system inhibitors 46 percent to 72 percent.
Before patients were randomized into the two cohorts, 31 percent took calcium channel blockers and 58 percent took long-acting nitrates. After six months these numbers rose to 40 percent and 50 percent and 55 percent and 71 percent for the PCI group and OMT group, respectively.
After five years, these same numbers were 42 percent versus 52 percent and 40 percent versus 57 percent, respectively.
The study results also showed that at baseline rates of those who took a combination of aspirin, beta-blocker and lipid drug therapy were 51 percent for both the PCI and OMT groups. After five years, these rates rose to 79 percent and 80 percent, respectively.
The number of patients taking aspirin, beta-blockers, lipid-lowering drugs and rennin-angiotensin-aldosterone system inhibitor therapy after five years was 55 percent for the PCI group and 51 percent for the OMT group, compared to 27 and 29 percent at baseline.
At six months, researchers reported that 97 percent of patients in both groups adhered to using the recommended dose of prescribed medications.
In addition, the study showed that 37 percent of patients at the beginning of the study had a fasting glucose level of less than 100 mg/dl, 28 percent had impaired fasting glucose of 100 to 125 mg/dl and 34 percent had diabetes. During the study, 191 patients developed diabetes—97 patients in the PCI group and 94 in the OMT group.
Because during the study medications were paid for, the researchers said they therefore “cannot assess to what extent free medication influenced behavior.”
“The delivery of OMT in the COURAGE trial is a model for secondary prevention in practice, with potential policy implications regarding the use of nurse case mangers and free medications to optimally manage patients with chronic CAD,” the authors concluded.
In an accompanied editorial, Patrick T. O’Gara, MD, of Brigham and Women’s Hospital in Boston, said that, “with very rare exception, individual practice groups and healthcare systems are not currently structured or financed to deliver the intensity of longitudinal care provided to COURAGE trial enrollees.”
While he said that “it would be easy to dismiss the COURAGE trial results as being too impractical, expensive, or difficult to replicate in practice,” he added that “several barriers will need to be addressed and overcome” so programs that will improve public health in “ways that are both predictable and affordable from patient-centered and societal perspectives” can be implemented.