Major Study May Upend Heart Disease Care
Our family practice doctors in Delray Beach have received numerous questions from many of our patients regarding a new study released last month. It appears to reverse decades of traditional practice for treating some patients with cardiovascular disease (CVD).
So we would like to explain the study’s findings and clear up the confusion that seems to be surrounding it.
A federally funded, $100 million study, presented at the American Heart Association’s (AHA) annual meeting, found that such common interventions as coronary artery bypass surgery, angioplasty, and the implantation of stents in patients with stable heart disease is no better at preventing heart attacks and deaths than medication and lifestyle changes.
In fact, among study participants, those who underwent one of these popular procedures were more likely to experience a heart problem or die over the next year than those who were treated with drug therapy alone.
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) sponsored the trial, which included 5,179 subjects from 37 countries, all of whom had prior indications of severe heart disease. At the beginning of the study, all participants were given stress tests—walking on a treadmill while researchers tested their arterial blood flow—with the results suggesting some degree of blockage.
Half of the subjects were directed to continue with the medication they were receiving from their own doctors, while the other half received angiograms (dye tests to pinpoint the area of blockage). Of those, three-quarters received angioplasty (inserting a stent to the blockage through blood vessels), while the fourth quarter received a bypass operation.
After one year, seven percent of those who received the invasive procedures had a heart attack, heart-related death, went into cardiac arrest, or were hospitalized for increasing chest pain or heart failure. The medication group experienced similar events five percent of the time.
After four years, the numbers flipped: 13 percent of those who had angioplasty to insert a stent or a bypass suffered a cardiac event as opposed to 15 percent of those on medication alone.
Dr. David Maron of Stanford University was one of the study’s lead researchers. He said that if stents and bypasses didn’t have their own risks attached.
“I think the results would have shown an overall benefit” from these procedures. “But that’s not what we found. We found early harm and late benefit, and they canceled each other out.”
These findings hold true only for those with so-called stable angina; that is, those with chest pain on exertion, but who are not having a heart attack. In those who are experiencing a heart attack, angioplasty or bypass surgery are required to immediately restore blood flow to the heart.
And participants with chest pain did markedly better with angioplasty or bypass surgery in relief of their symptoms than those who used medication alone. Half those who received an invasive procedure were free of their daily or weekly chest pain a year later versus only 20 percent of those taking drugs.
Researchers suspected that some of those who experienced relief from their chest pain may have been subject to the placebo effect—that is, undergoing procedure conditions the patient to expect relief, which the body then produces.
This is not unlike the results seen in a 2013 study which found that “sham” arthroscopic knee surgery produced relief of pain just as effectively as the real thing. When the body believes a procedure will help, the mind can cooperate in finding ways to comply with that belief.
They also surmised that, because the invasive procedures zero in on only a single blockage, medications might produce a better result overall because they affect all the arteries, thus preventing other blockages from forming.
As far back as 2007, studies were finding that angioplasty and stents were no better than medication for the treatment of non-emergency heart disease. But because these results contradicted decades of their training, many doctors were reluctant to accept the results, which is why the federal government undertook the current study.
According to Judith Hockman, senior associate dean for clinical sciences at New York University’s Grossman School of Medicine, and one of the trial’s leaders, this study confirms the findings from earlier ones, and show there’s:
“absolutely no risk in trying medicines [first] and seeing if the patient gets better.”
For non-emergency patients, she said, the study shows “there’s no need to rush” into the traditional interventions.
We concur, with the caveat that each patient is different, with differing needs and expectations. But this study provides additional information for both patient and doctor to consider when seeking the best way to treat stable, i.e., non-emergency heart disease.