Tens or even hundreds of thousands of Americans are having coronary artery angioplasty and stenting every year when they should be having bypass grafts, and the result is an extra 5,000 or more deaths annually, researchers said Sunday.
Patients and cardiologists frequently prefer angioplasty and the insertion of a stent to keep arteries open because it is quicker and easier; patients go home sooner and return to work more quickly.
"This is one of the strongest studies yet demonstrating that, in advanced coronary disease, bypass has a real patient advantage," said Dr. Robert Guyton, chief of cardiothoracic surgery at the Emory University School of Medicine, who was not involved in the study.
"This will change practice," he said. "It may not reverse some of the use of stenting, but it is certainly going to slow it down and make people think. Stenting is a little bit easier on you and the return to work is quicker. But the benefits of surgery are more enduring and tend to emerge as time goes by."
Dr. Richard Shemin, chief of cardiac and thoracic surgery at UCLA's Ronald Reagan Medical Center, echoed that view. "Surgeons have had a strong feeling that, over time, surgery would be better for the most complex forms of heart disease," said Shemin, who also was not involved in the study.
The findings are "very strong, independent data that the public, payers and practitioners need to factor into how we make decisions in taking care of patients," he said.
"Any time that you compare angioplasty and surgery, the longer you go, the better surgery looks," said Dr. Michael J. Mack, first vice president of the Society of Thoracic Surgeons and a co-author of the study.
Coronary artery bypass grafts, commonly called CABG (pronounced cabbage), were the first treatment for blocked arteries. In the procedure, a blood vessel removed from elsewhere in the body, most often the chest or the leg, is used to bypass the blocked area, providing a new channel for blood to flow to the heart.
Hospital stays generally last five or six days, and the patient can return to work after a few weeks.
In recent years, however, cardiologists have turned more and more to balloon angioplasty, in which a catheter is threaded through a blood vessel in the groin to reach the blockage and a balloon is inflated at the site to compress the plaque. Originally, that was all that was done. Then physicians began inserting bare-metal stents, spring-like devices that hold the artery open.
More recently, doctors have begun using drug-eluting stents, which release a drug that helps prevent clot formation. Hospital stays are typically overnight, and the patient can return to work after a couple of days.
More than 1.3 million Americans now undergo angioplasty every year, compared with 448,000 who undergo bypass, according to the National Center for Health Statistics.
The new study, reported Sunday at a Geneva meeting of the European Assn. for Cardio-Thoracic Surgery, is the first large trial to compare stenting and CABG directly. Called SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery), the trial enrolled 1,800 patients at 85 centers in Europe and the United States.
Patients were randomized to receive either angioplasty with stenting or bypass.
Patients were considered to have mild disease if they had a single blocked artery. Their disease was considered moderate or severe if they had a blockage in the left main artery — the primary artery supplying blood to the heart — plus blockage in one of the other three arteries, or if they had blockages in all three other arteries. They were also considered severe if they had very long blockages, arteries that were totally blocked, or "very tortuous, curvy arteries" that make angioplasty difficult, Mack said.
For patients with mild disease, the two procedures produced equivalent results, so angioplasty might be preferred because it is easier on the patient. Previous studies have also shown that such patients can be successfully treated with medical therapy alone. But the differences were much more dramatic for those with more severe disease, which is present in about half of all patients undergoing angioplasty in the U.S.
Dr. John Conte, associate director of cardiac surgery at Johns Hopkins Hospital in Baltimore, noted that it is now incumbent on physicians to make sure patients have all the facts before they undergo any procedure. "It's absolutely amazing that the federal government and private insurers don't insist on it," he said. "Wouldn't it make sense to do the right procedure the first time, rather than do it over and over and drive up the cost of healthcare? To me, it's a no-brainer."