Optimal medical therapy in COURAGE was no magic

Medical therapy was typical; promoting a more balanced approach to managing CAD could require third-party payers to help.

After the controversy over the results of the COURAGE trial, cardiologists may wonder whether the researchers offered typical optimal medical therapy.

The COURAGE trial showed that when patients with stable angina were given American College of Cardiology and American Heart Association Clinical Practice Guideline-defined optimal medical therapy, the addition of percutaneous coronary intervention offered no better outcomes for death, MI or hospitalizations.

“The implicit message has been that if you have angina and objective evidence of ischemia, you need a revascularization procedure,” study investigator William E. Boden, MD, a professor of medicine and public health at the University at Buffalo School of Medicine and Biomedical Sciences, said in an interview. “COURAGE suggests that we should be taking a collective time-out from this thinking. The COURAGE results give us more options and take away from the sense that if we offer optimal medical therapy, we are offering something less than the best medical care.”

Best practices offered

Looking at the strong optimal medical therapy results evoked the question of whether the optimal medical therapy offered in COURAGE was the optimal medical therapy typically offered to patients. The drug therapies offered included aspirin, clopidogrel (Plavix; Sanofi Aventis, Bristol-Myers Squibb), simvastatin (Zocor, Merck) alone or with ezetimibe (Zetia, MSP) or emergency department-administered niacin, lisinopril or losartan, long-acting metoprolol, amlodipine and isosorbide 5-mononitrate. Lifestyle intervention included exercise programs, nutrition counseling, weight control and encouragement of smoking cessation.

“I’ve heard it said that COURAGE does not represent the ‘real world,’ and that these kinds of results can’t be achieved in clinical practice because it’s too hard,” Boden said. “My response is that’s rubbish. Fundamentally, there was no difference between what patients got in COURAGE and what you are entitled to receive through Medicare, an HMO or any private practice plan. We reasoned that if we gave these proven therapies in combination to all patients and moreover treated them to the targets proven to be associated with improved clinical outcomes, it would translate into improved clinical outcomes. There was nothing magical.”

Best practice, Boden said, included the availability of nurse practitioners, physician assistants or other “physician extenders” common to most practices to answer questions, discuss goals and urge compliance.

But no patient-extender contacts were proscribed.

Furthermore, at the outset, patients were told that the treatment approach was counter to prevailing practice but that some data shedding doubt on MI or survival benefits of stenting were extant. Researchers stressed the importance of sticking to the regimen. Follow-up was every three months for the first year and every six months thereafter. Mean follow-up was about four and a half years. Participating physicians met annually.

“After the first year, we grew more confident because we saw that we were not putting patients in harm’s way,” Boden said.

ACC President James T. Dove, MD, said he was impressed with the follow-up in COURAGE.

“The fact that 70% of the COURAGE patients achieved LDL less than 85 mg/dL means the investigators were being tenacious in following patients and getting them to adhere to their medications.

“It takes a lot of time from physicians and their support staff to ensure that patients get their blood tests and fill their prescriptions,” he added. “The cognitive services that help patients adhere to guidelines and medical therapy are poorly rewarded in the current system. Some practices may not be able to support those services because of the cost structure.”

Insurers’ involvement

Boden acknowledged that promoting this more balanced and thoughtful approach to managing coronary disease might require third-party payers to “get into the mix.”

“Insurers may see an opportunity to prevent events short of having to pay for procedures or interventions that may not be of benefit to patients,” Boden said. “Unfortunately, treating patients to target levels is not appropriately incentivized. If the HMOs, Medicare and others provided financial incentives for doing the things we were vigilant about doing, that would make a difference.”

“The ACC has always been standing behind appropriate support of primary and secondary prevention,” Dove said. “We’ve talked to Congress and insurers many times about the importance of prevention in cardiovascular medicine.”

For example, in testimony before the Health Subcommittee of the House Committee on Energy and Commerce in July 2006, John E. Brush, MD, speaking on behalf of the ACC, said, “Many practitioners note that high quality does not always pay and sometimes can lead to less pay. Traditional models of payment, such as fee-for-service, pay for inputs of medical care but do not pay for outcomes and do not create a solid business case for investing in long-term system improvements that yield better outcomes.”

But, as Dove pointed out, “Neither the federal government nor insurers have yet rewarded the workload that cognitive behavior services represent. We’ve been talking about this for some time, but that has not translated into a structural change.” – by Walter Alexander

For more information:

• Boden WE, O’Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. NEJM. 2007;356:1503-1516.