In REGARDS to Optimal Medical Therapy: It’s Still a Struggle | CardioSource WorldNews

JACC in a Flash | For patients with stable coronary artery disease (CAD), optimal medical therapy alone (with PCI reserved for nonresponsive cases) has been shown to have similar rates of death or non-fatal MI to a strategy of PCI plus optimal medical therapy in the COURAGE trial. Identification and intensive management of risk factors, the results suggested, could potentially help large number of stable CAD patients avoid revascularization.

Is it reasonable to expect stable CAD patients in a non-clinical trials population to achieve these targets? Given the significant number of PCIs performed annually in the United States, Todd M. Brown, MD, MSPH, and colleagues wanted to examine the proportion of CAD patients who were failing to reach these modifiable risk factor goals, presuming that "real-world" patient would be less adherent to medical therapy and less health-conscious than patients enrolled in COURAGE.

Brown et al. investigated data from 3,167 patients with self-reported history of CAD (mean age = 69±9 years) enrolled in the national REasons for Geographic and Racial Differences in Stroke (REGARDS) study. Approximately one-third was female and one-third was African American. Risk factor goals in the current study included:

  • Aspirin use: recommended
  • Blood pressure: SBP <130 mmHg; DBP <85 mm Hg (<80 mm Hg if diabetic)
  • Lipids: LDL-C <85 mg/dL; HDL-C >39 mg/dL; triglycerides <150 mg/dL
  • Glucose: fasting glucose <126 mg/dL
  • Smoking status: nonsmoker
  • Weight: body mass index (BMI) <25 kg/m2
  • Physical activity: exercise >4 days per week

Half of patients met the systolic and diastolic blood pressure goals, and less than one-quarter met the physical activity, body mass index (BMI), or lipid goals. The most frequently met goals:

  • Nonsmoking status
  • Fasting glucose <126 mg/dL
  • Regular use of aspirin

Overall, an average of 3.6±1.2 of the seven possible total risk factor goals was met, while the median number of goals met was four. The results were rather discouraging: only 22% met five or more goals, and only 0.5% (17 participants) met all seven goals. One bright spot: REGARDS participants enrolled in 2007 met slightly more risk factor goals than those in previous years, suggesting that awareness of the need to meet these goals has increased in recent years.

Dr. Brown and colleagues conducted a multivariable adjustment to determine the socioeconomic and demographic characteristics that could predict adherence to risk factor goals, finding that older age, white race, higher income, more education, and higher physical functioning were all independently associated with meeting more treatment goals. A secondary analysis evaluating LDL-C level as a separate goal, 57% of individuals had an LDL-C <100 mg/dL, 38% had and LDL-C <85 mg/d>, and 18% had an LDL-C <70 mg/dL.

"The achievement of risk factor goals that we observed in this population-based sample was considerably lower than what participants in the COURAGE trial achieved," the authors noted. "This suggests that there is substantial opportunity to improve the risk factor profiles of individuals with CAD if optimal medical therapy, similar to that utilized in the COURAGE trial, were adopted on a wider scale."

In an accompanying editorial, David J. Maron, MD, and William E. Boden, MD, described the bar set by Brown et al.'s primary analysis as "exceedingly high," understandably leading to a very low overall success rate. "By using COURAGE trial goals rather than professional society secondary prevention goals," they added, "the authors likely over-estimated the composite target failure rate because COURAGE goals were somewhat more aggressive."

Viewing the current study results through a more optimistic lens, Drs. Maron and Boden focused on the secondary analysis that focused on attainment of three Class I recommendations (aspirin use, systolic and diastolic blood pressure control, and LDL-C control); 91% of participants met at least one of these four goals.

"We need to recognize that it may be unrealistic to achieve each and every goal, and that success in secondary prevention need not be measured in binary, all-or-nothing terms," the authors concluded. "New models of team-based health care delivery are needed to achieve enhanced adherence to multiple treatment goals, ultimately in the context of a more enlightened health care system that rewards quality and outcomes for both patients and physicians."


Brown TM, Voeks JH, Bittner V, et al. J Am Coll Cardiol. 2014;63(16):1626-1633. http://content.onlinejacc.org/article.aspx?articleID=1838326
Maron DJ, Boden WE. J Am Coll Cardiol. 2014;63(16):1634-1635. http://content.onlinejacc.org/article.aspx?articleID=1838318

Keywords: Coronary Artery Disease, Secondary Prevention, Risk Factors, Reward, Percutaneous Coronary Intervention, Goals, CardioSource WorldNews, ACC Publications


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