UPDATE 1-Heart bypasses beat drug stents in study
(Adds more details, reaction, results of J&J stent study)
MUNICH, Sept 1 (Reuters) - Patients with difficult to treat clogged arteries are better off getting bypass surgery rather than drug stents, according to the results of a major clinical study released on Monday.
Both procedures proved equally safe but those patients receiving Boston Scientific's (BSX.N) drug-coated Taxus stent were more likely to need a repeat procedure, tipping the results in favour of surgery, researchers said.
The keenly awaited findings from the so-called SYNTAX study by Dutch researchers, which was funded by Boston, were presented at the annual meeting of the European Society of Cardiology.
"Despite the advent of drug-eluting stents surgery comes out a winner," Douglas Weaver, president of the American College of Cardiology, said after the results were presented.
The one-year study of 1,800 patients found that 17.8 percent of patients receiving stents -- tiny wire-mesh tubes used to prop open clogged heart arteries -- either died, suffered a heart attack, had a stroke or needed a repeat procedure.
The figure was 12.1 percent for those undergoing surgery and receiving coronary artery bypass grafting, known as CABG, Patrick Serruys of the Erasmus Medical Center, Rotterdam, told the meeting.
The rate of death, stroke and heart attack was virtually identical at 7.7 percent for surgery patients and 7.6 percent for those getting stents -- but stented patients were more than twice as likely to need another procedure within a year.
Stenting was introduced in the 1990s and allows doctors to treat patients by inserting a catheter into the groin, resulting in very quick recovery times. CABG requires open-heart surgery.
In recent years stenting has become increasingly popular.
PRACTICE MAY NOT CHANGE
Doctors in Munich said the results would be studied carefully but might not lead to a dramatic change in practice since many of the patients in the Dutch study would probably have received surgery anyway in normal clinical practice.
"In somebody with three-vessel or left-main disease, in most cases surgery is the preferred therapy and this trial does not change my view of that," said Ray Gibbons, a cardiologist at the Mayo Clinic in the United States.
Patients with blockages in at least three coronary arteries or in the left main coronary artery are particularly sick and hard to treat.
A more favourable result for stenting could have encouraged further switching from surgery. As it is, doctors and patients will have to weigh the convenience of stenting over the risk of needing a repeat procedure months or years down the road.
"The results of this study are perhaps going to cause cardiologists to pause for a moment and think before they necessarily assume that these are balanced technologies, where one is the equivalent of the other," said Jonathan Halperin of New York's Mount Sinai Medical Center.
Keith Dawkins, Associate Chief Medical Officer at Boston Scientific, said he believed the study was reassuring for stent use, despite not achieving its main goal.
"The primary endpoint was missed. But it wasn't missed because of safety concerns; it was missed due to revascularisation," he told Reuters.
Revascularisation is the need for repeat interventions to clear blocked arteries.
Dawkins also noted there was a lower rate of stroke for patients treated with stents as compared with CABG.
Another smaller trial showed Johnson & Johnson's (JNJ.N) Cypher drug stent was as good as bypass surgery in 510 diabetics with complex heart disease. But this study did not include the need for revascularisation as part of its primary endpoint. (Editing by Greg Mahlich)
