Aggressive drug therapy appears to be just as good as angioplasty for patients with stable heart disease, a new study finds. "This is really good news for patients," said study lead author Dr. William E. Boden, a professor of medicine and public health at the University at Buffalo School of Medicine and Biomedical Sciences. "We have more treatment options for patients than we thought we did."

Exciting New Research

There has been a belief that patients with chronic stable heart disease need to have either an angioplasty or heart bypass surgery, Boden said. "There has been an unproven assumption that patients must proceed to some type of revascularization procedure," he said.

Patients with stable heart disease make up about three-quarters of all the patients who undergo angioplasty and receive stents in the United States, Boden noted. Angioplasty is a medical procedure that uses a balloon to open narrowed or clogged blood vessels of the heart. Usually, during the procedure a stent—a wire mesh tube is placed in the vessel to keep it open.

"What the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial tells us is that optimal medical (drug) therapy, when combined with lifestyle changes, appears to be the equal of angioplasty and optimal medical therapy combined," Boden said.

The Study

For the study, the COURAGE group randomly assigned almost 2,300 patients with stable but significant heart disease to one of two treatment regimens at 50 United States and Canadian treatment centers. The first group received drug therapy alone, while the second group received the drug therapy plus angioplasty. In the latter group. 94% received at least one stent.

During a follow-up from two to seven years, the researchers looked for incidence of heart attack or death. They found that 211 people (19%) in the angioplasty group had died or had a heart attack, compared with 202 people (18.5%) in the group that only received drug treatment.

There were also no significant differences between patients who had angioplasty and those who had drug therapy alone in rates of death, heart attack, stroke or hospitalization for acute coronary syndrome (20% vs. 19.5%) or heart attack alone (13.2% vs. 12.3%).

The only benefit of angioplasty, according to Boden's team, was that it reduced chest pain over the long-term compared with drug therapy alone.

Sometimes Additional Help Required

About 30% of the patients who received drug therapy alone did eventually undergo angioplasty because their symptoms couldn't be managed with drugs alone. In addition, about 21% of the patients who received stents needed to have another procedure, Boden said.

Based on these findings, Boden believes that drug therapy for patients with stable heart disease should be tried as first-line treatment. "I am hopeful that physicians will have the courage to consider medical therapy as a viable option," he said.

However, Boden doesn't think initial use of drug therapy alone will reduce the number of angioplasties being performed. "What it may do is delay the timing of when angioplasty gets done," he said.

"As an initial strategy, medical therapy is a defendable approach," Boden added. "We should no longer consider it to be putting patients in harm's way, or thinking of it as an inferior treatment strategy."

The COURAGE trial was sponsored by the US Department of Veterans Affairs Office of Research and Development and the Canadian Institutes of Health Research, and research grants from a number of top pharmaceutical companies.

Stent Type Questioned

The makers of stents and physicians who support their use were critical of the study, saying its design left it doomed to fail," according to published reports.

Addressing some of the critics' concerns, including the fact that the trial didn't include drug coated stents, Boden said that these stents were not available at the start of the trial.

"We would have loved to use them," he said. "But there is not a shred of scientific evidence to support the fact that drug-eluting stents are superior to bare-metal stents, in terms of reducing death and heart attack. Using drug-eluting stents would have no difference in the primary endpoint. It might have resulted in fewer revascularizations."

Viable Initial Option?

One expert agrees that drug therapy is a viable initial option for most patients with stable heart disease.

"Intensive medical therapy to dramatically reduce risk factors, such as reducing bad cholesterol and raising the good cholesterol, was associated with outcomes that were similar when that same therapy was used and angioplasty was added," said Dr. Judith S. Hochman, a professor of cardiology at New York University School of Medicine.

There was no additional benefit from angioplasty, beyond what has evolved to be excellent medical therapy," she added.

Hochman said it was striking that many patients had reductions in chest pain on drug therapy alone. "Many patients became angina-free," she said. "Although angioplasty was better at relieving symptoms, it wasn't better in preventing death or heart attack."

Hochman noted, however, that if a person is having a heart attack, angioplasty remains the appropriate treatment. "If you are having a highrisk unstable syndrome, angioplasty is very effective at reducing the chance of dying," she said.

But, for patients with stable heart disease, Hochman believes the first approach to care should be medications. "A trial of intensive medical therapy without angioplasty, to see how the symptoms respond, is what's indicated," she said.

Angioplasty should be reserved for patients who have continuing symptoms, Hochman said. "If you have too much angina to do the activities you want to do, despite a trial of intensive medical therapy, then angioplasty is a good option," she said.

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