Boston Scientific stent safe for heart attack victims

MINNEAPOLIS - Boston Scientific Corp.'s drug-coated Taxus stent kept heart attack patients' arteries clear longer than an older, bare metal stent did without increasing complications and deaths, researchers said.

Sales of the newer drug-coated devices slumped during the past two years after they were linked to rare and potentially fatal blood clots in the months following implantation. While blood thinners can prevent clots from forming, doctors were wary about using the devices in heart attack patients who might not consistently take the medicines.

The findings of the study dubbed Horizon AMI provide reassurance about the safety of the devices from Boston Scientific, Abbott Laboratories, Medtronic Inc., and Johnson & Johnson in heart attack patients, said Gregg Stone, the lead researcher and director of research and education at New York Presbyterian-Hospital's center for interventional vascular therapy. The patients will be followed for five years to ensure the risks don't rise with time, he said.

"Drug-eluting stents were superior in efficacy to bare-metal stents and had a comparable safety profile at one year," Stone said in a statement. The findings "will have a major impact on how decisions are made regarding drug-eluting and bare-metal stents in the highest-risk patients in this trial, those in the early hours of a heart attack."

The study, funded in part by Natick, Mass.-based Boston Scientific, was presented yesterday at the Transcatheter Cardiovascular Therapeutics conference in Washington. Heart attack patients currently account for about 10 percent of the $1.9 billion US market for drug-coated stents, analysts say.

A second arm of the trial found Medicines Co.'s Angiomax, given during the stenting procedure, significantly reduced bleeding and death rates. After one year, patients given the drug had a 43 percent lower risk of dying from heart complications, saving 17 lives for every 1,000 people treated, said Roxana Mehran, director of outcomes research at New York-Presbyterian Hospital and Columbia University in New York.

"It's been a long time since any intervention in a classic heart attack has been shown to reduce mortality," said Deepak Bhatt, a cardiologist at the Cleveland Clinic in Ohio, who reviewed the study on behalf of the meeting's organizers. The benefit was "an order of magnitude" better than seen with cholesterol-lowering statin drugs and should create a new standard of care, he said in a press briefing yesterday.