Doctors are now reporting that Boston Scientific Corporation’s Taxus stent did not fare as well as bypass surgery in improving medical outcomes for the sickest patients with a build-up of fatty deposits in their arteries. After one year, 12.1 percent of bypass patients had died, experienced a heart attack or stroke, or required repeat surgery versus the 17.8 percent of those patients who received a tube—known as a stent—to prop open a clogged artery. The announcement was made at the European Society of Cardiology meeting in Munich today; Patrick Serruys at Rotterdam’s Erasmus University led the cardiologist team.
Improved stent development prompted doctors to test whether stents are as good as surgery in replacing blocked arteries. Surgery is currently used in about four-fifths of the patients in the United States and in slightly less cases in Europe, the doctors said. Long-term, patients may need to consider surgery followed by a month of recuperation, they added. “Surgeons won’t be out of work,” Douglas Weaver, the president of the American College of Cardiology said. Meanwhile, with the exception of repeat procedures, stents and surgery did equally well. “For the bad outcomes—death, heart attack or stroke—the procedures were equal,” Eckart Fleck, a cardiologist at the German Heart Center in Berlin, said.
Boston Scientific—this country’s largest stent manufacturer—funded the study, which tracked patients with built-up plaque in blood vessels that feed the heart, including the one vessel that doctors commonly call the “widow-maker.” Apparently, a blockage to the widow-maker is especially problematic as this cuts off the supply to the heart, causing patients to suddenly die.
Of 3,075 patients studied, approximately 1,200 had no options between a stent implant or bypass surgery due to the severity of their condition. The 1,800 remaining patients either had a device implanted or underwent chest surgery. Patients were followed for a year. The doctors report that bypass surgery remains the best option because its effects can last for over 10 years, whereas Stent patients had to return for repeat procedures more than twice as often; 13.7 percent compared with 5.9 percent for the surgery group. The study won’t change current practice, Timothy Gardner, a surgeon who is president of the American Heart Association, said. “Some patients just want to avoid surgery at any cost, and these results provide some comfort,” Gardner said.
Boston Scientific has had multiple voluntary recalls of its drug-coated Taxus devices because of defects in the delivery system. About 200 Taxus stents were recalled in July 2004. After identifying further problems, the company recalled 85,000 additional Taxus stents—both drug coated and bare metal types—later that month. In August 2004, an additional 3,000 Taxus stents were recalled that had been manufacture red prior to these recalls. The catheter problems appear to have been caused when too much heat was applied during the laser welding stage in the manufacturing process, the company said.
Other, earlier studies have found no benefit over stent implantation and indicated that surgery and implantation offer similar outcomes.
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