Surgery for Blocked Arteries Is Often Unwarranted, Researchers Find
Drug therapy alone may save lives as effectively as bypass or stenting procedures, a large federal study showed.
By Gina Kolata
Nov. 16, 2019, 2:00 p.m. ET
The findings of a large federal study on bypass surgeries and stents call into question the medical care provided to tens of thousands of heart disease patients with blocked coronary arteries, scientists reported at the annual meeting of the American Heart Association on Saturday.
The new study found that patients who received drug therapy alone did not experience more heart attacks or die more often than those who also received bypass surgery or stents, tiny wire cages used to open narrowed arteries.
That finding held true for patients with several severely blocked coronary arteries. Stenting and bypass procedures, however, did help some patients with intractable chest pain, called angina.
“You would think that if you fix the blockage the patient will feel better or do better,” said Dr. Alice Jacobs, director of Cath Lab and Interventional Cardiology at Boston University. The study, she added, “certainly will challenge our clinical thinking.”
This is far from the first study to suggest that stents and bypass are overused. But previous results have not deterred doctors, who have called earlier research on the subject inconclusive and the design of the trials flawed.
Previous studies did not adequately control for risk factors, like LDL cholesterol, that might have affected outcomes, said Dr. Elliott Antman, a senior physician at Brigham and Women’s Hospital in Boston. Nor did those trials include today’s improved stents, which secrete drugs intended to prevent opened arteries from closing again.
With its size and rigorous design, the new study, called Ischemia, was intended to settle questions about the benefits of stents and bypass.
“This is an extraordinarily important trial,” said Dr. Glenn Levine, director of cardiac care at Baylor College of Medicine in Houston.
The results will be incorporated into treatment guidelines, added Dr. Levine, who sits on the guidelines committee of the American Heart Association.
The participants in Ischemia were not experiencing a heart attack, like Senator Bernie Sanders, nor did they have blockages of the left main coronary artery, two situations in which opening arteries with stents can be lifesaving. Instead, the patients had narrowed arteries that were discovered with exercise stress tests.
With 5,179 participants followed for a median of three and a half years, Ischemia is the largest trial to address the effect of opening blocked arteries in nonemergency situations and the first to include today’s powerful drug regimens, which doctors refer to as medical therapy.
All the patients had moderate to severe blockages in coronary arteries. Most had some history of chest pain, although one in three had no chest pain in the month before enrollment in the study. One in five experienced chest pain at least once a week.
All participants were regularly counseled to adhere to medical therapy. Depending on the patient’s condition, the therapy variously included high doses of statins and other cholesterol-lowering drugs, blood pressure medications, aspirin and, for those with heart damage, a drug to slow the heart rate. Those who got stents also took powerful anti-clotting drugs for six months to a year.
Patients were randomly assigned to have medical therapy alone or an intervention and medical therapy. Of those in the intervention group, three-quarters received stents; the others received bypass surgery.
The number of deaths among those who had stents or bypass was 145, compared to 144 among the patients who received medication alone. The number of patients who had heart attacks was 276 in the stent and bypass group, compared with 314 in the medication group, an insignificant difference.
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