Less Than Optimal OMT Analyses: Is the Glass Half Full, Half Empty, or Largely Irrelevant?
ACCEL | The COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) trial demonstrated that, compared with a strategy of percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT), an initial strategy of OMT alone—with PCI reserved for those with refractory angina—had similar rates of death or nonfatal myocardial infarction (MI) in individuals with stable coronary artery disease (CAD) who had undergone coronary angiography before randomization. Moreover, during a median follow up of 4.6 years, only 33 percent of individuals randomized to OMT required revascularization, suggesting that two-thirds of individuals with stable CAD could potentially avoid PCI if treated initially with OMT.1
So, what defines OMT and how often is it achieved? The COURAGE investigators defined it by seven treatment goals:
- Aspirin use
- Blood pressure <130/85 mm Hg (<80 mm Hg if diabetic)
- LDL-C <85 mg/dl, HDL-C >40 mg/dl, and triglycerides (TG) <150 mg/dl
- Fasting glucose <126 mg/dl (a surrogate for the COURAGE trial goal of HbA1c <7 percent in diabetics)
- Nonsmoking status
- Body mass index (BMI) <25 kg/m2 (the COURAGE trial goal was 10 percent relative weight loss if baseline BMI was >27.5 kg/m2)
- Exercise >4 days per week (a surrogate for the COURAGE trial goal of 30 to 45 minutes of moderate-intensity physical activity 5 times per week).
Look at that list again and you’ll notice that, in reality, there were 10 goals targeted, with two components to the blood pressure target (systolic and diastolic) and three components to the lipid target (LDL, HDL, and TGs). How relevant is such a laundry list of variables?
In Regards To OMT
The REGARDS (REasons for Geographic And Racial Differences in Stroke) study is a national prospective cohort study of 30,239 African-American and white community-dwelling individuals older than 45 years of age who were enrolled from 2003 through 2007. Investigators calculated the proportion of 3,167 participants with self-reported CAD meeting the seven risk factor goals used in the COURAGE trial.
On average, four of the seven risk factor goals were met in the REGARDS analysis, with <1 percent of individuals achieving all seven goals.2
The results expand on data recently published from the National Cardiovascular Data Registry (NCDR®) that focused on the intensity of pharmacological management in patients undergoing elective PCI.3 Although risk factor levels were not reported, fewer than one-half of all patients undergoing elective PCI for stable angina were receiving guideline-directed pharmacological therapy with antiplatelet agents, beta-blockers, and statins before undergoing PCI both before and after publication of the COURAGE trial.
Thw "Enemy of the Good"
In an editorial comment to the REGARDS study results,4 David J. Maron, MD, FACC, and William E. Boden, MD, FACC, who led the COURAGE trial, decided to reanalyze data from the COURAGE trial to see what proportion of their participants achieved all seven treatment goals. Among nondiabetic patients, only 0.2 percent were at target for all goals at baseline and 1.9 percent achieved them at 1 year. Among diabetic patients, only 0.1 percent were at target for all goals (including HbA1c) at baseline, compared to 0.6 percent who reached all goals at one year. Hence, even among presumably more motivated patients participating in clinical research—for whom free medications were provided—the rate of achieving multiple risk factor goals was just as disappointing as unselected patients in real-world clinical practice.
Maron and Boden choose to view the REGARDS study results through a more optimistic lens. Not all risk factors are equal, although the REGARDS analysis does not account for this fact. A secondary analysis of REGARDS that focused on the attainment of three Class I recommendations (aspirin use, systolic and diastolic blood pressure control and LDL-C control) revealed that 91 percent of participants met at least one of these goals.
They wrote, “Although skepticism persists that the treatment targets achieved in the COURAGE trial can be replicated in the real world, we need to also recognize that it may be unrealistic to achieve each and every goal and that success in secondary prevention need not be measured in binary terms (all or nothing). As such, we should not fall prey to the aphorism that "the perfect is the enemy of the good." We should recognize the value of achievement of individual Class I recommendations for secondary prevention.”
They added that the more ambitious, broad-based success all physicians seek can only be achieved by designing and implementing better strategies to improve guideline adherence at the patient, provider and system levels. “With REGARDS to these noteworthy challenges,” they concluded, “let us not lose the COURAGE and conviction that we need to identify new ways of doing better.”
- Boden WE, O’Rourke RA, Teo KK, et al. N Engl J Med. 2007;356:1503-16.
- Brown TM, Voeks JH, Bittner V, et al. J Am Coll Cardiol. 2014;63:1626-33.
- Borden WB, Redberg RF, Mushlin AI, Dai D, Kaltenbach LA, Spertus JA. JAMA. 2011;305:1882-9.
- Maron DJ, Boden WE. J Am Coll Cardiol. 2014;63:1634-5.
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