A new study offers a fresh strategy for treating patients suffering from both coronary artery disease and heart failure, afflictions linked to poor quality of life and high risk of death that affect as many as two million Americans.The 1,212-patient study calls into question the need for immediate bypass surgery in these patients—an approach commonly recommended by doctors. The study, called Stich, found benefits in treating people with medication only, and in treating people with a combination of bypass surgery and medication. Both approaches can be effective, with risks and benefits associated with each one."You don't have a good therapy and a bad therapy, you have a choice," said Clyde Yancy, chief of cardiology at Northwestern University's Feinberg School of Medicine, who wasn't involved with the study. "It really is about choice and not about which is superior."How best to treat these patients has been fraught with uncertainty. Many patients aren't evaluated for heart surgery to treat diseased arteries because they don't suffer classic chest pain or because doctors worry that hearts weakened by heart failure won't benefit from the procedure. Other doctors recommend immediate bypass surgery despite a lack of vigorous studies to support that strategy.In the Stich study, 41% of patients assigned to treatment with drugs alone died during the follow-up period, which averaged five years. That compared with a mortality rate of 36% among patients who received bypass surgery plus medication. Although the relative reduction in risk of death was 14%, the result didn't meet tests for statistical significance, meaning it could have resulted from chance alone.The findings were presented Monday at the annual scientific meeting of the American College of Cardiology in New Orleans and published online in the New England Journal of Medicine.In many cases, patients tested for coronary-artery disease "get put on an express train," said Eric J. Velazquez, a cardiologist at Duke University Medical Center, Durham, N.C., and lead investigator of the Stich study. "By the time people realize it, they've had bypass surgery."An arsenal of drugs has hit the market in recent decades that has transformed treatment for coronary artery disease and heart failure. Drug regimens, including aspirin, cholesterol-lowering statins, and such blood-pressure medications as beta blockers, ACE inhibitors and angiotensin-receptor blockers, can either stave off blockages that cause heart attacks or reduce the heart's workload, easing symptoms of heart failure.The Stich findings suggested that contrary to current practice, doctors and patients have time to consider bypass surgery over drug treatment alone. Open-heart surgery has an early risk of death, with nearly 5% of patients who underwent bypass surgery in the study dying within 30 days of surgery. The result was in line with surgical outcomes in both Europe and the U.S. for high-risk patients, Dr. Velazquez said. It was two years before the death rates in the two study groups evened out.Dr. Velazquez, who isn't a surgeon, said that even though the study didn't show an overall benefit for surgery he thinks the data generally favor the more aggressive treatment. He suggested that a patient with both heart failure and coronary artery disease who has a daughter or son getting married in three months might want to avoid or delay a decision to have bypass surgery. But, he said, if a wedding was, say, three years away, surgery might offer a better chance of survival.However, in an editorial in the New England Journal of Medicine accompanying the study, James Fang, a cardiologist at University Hospitals Case Medical Center in Cleveland, said doctors "should be comfortable" generally that surgery isn't better than the best medical therapy for the kind of patients participating in the study.Two participants in the Stich study, Donald Ferguson and Jimmy Spell, both of North Carolina, were each diagnosed eight years ago with heart failure and coronary artery disease. Mr. Ferguson and Mr. Spell both enrolled in the study at Duke and they are among the 750 participants alive at the end of the study.At the time he signed on, Mr. Ferguson, a retired commercial refrigeration repairman, appeared so gray when he looked in the mirror that it was as if "somebody made you over with clay," he said. He was assigned to the medical-therapy group.Mr. Spell, a retired textile technician whose health was complicated by diabetes, was regularly so short of breath, "I just couldn't do anything. I felt like my life was coming to an end," he said. He received bypass surgery and medication.Now 75, Mr. Ferguson still gets assignments repairing refrigeration on private airplanes. He says he keeps his temper under control, gets regular exercise and enjoys time with his grandchildren. "I'm still here and I don't intend to go anywhere," he said. He steadfastly takes his medicines, convinced that they are part of the reason he is still alive.Mr. Spell, who is a double amputee due to complications from diabetes, nevertheless remains active with the help of prostheses. The 66-year-old said he exercises three times a week, went on a missionary trip to Brazil two years ago and has four grandchildren. He knew he could have died during surgery, but said entering the study was the right decision. "I went from dying to living," he said."If patients are informed, they will make different decisions based on their own background," experiences and perception of risk, said Raymond Gibbons, a cardiologist at the Mayo Clinic who wasn't involved in the study. "I don't think doctors should be making the judgment for them."
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