Doctors, investors get latest data on heart devices

By Debra Sherman

CHICAGO (Reuters) - After years of controversy and concern over the safety and overuse of drug-coated heart stents, physicians and investors attending a cardiology meeting next week will get a clearer look at how these devices are used.

Drug-coated, or drug-eluting, stents were once hailed as the biggest innovation in interventional cardiology in decades because of the medicine's ability to prevent restenosis, or reclogging of the vessel. But their use has declined steadily in recent years amid concerns about a small but serious risk of thrombosis, or blood clots.

Amid the waning popularity of drug-eluting stents, Medtronic and Abbott Laboratoriesintroduced their own versions of the devices earlier this year, ending the duopoly held for years by Johnson & Johnson and Boston Scientific.

This year's annual Transcatheter Cardiovascular Therapeutics meeting in Washington will provide data that may further quell safety concerns and possibly result in minor market share shifts among the manufacturers, although no groundbreaking results are expected.

Studies on different drug-eluting stents used in different patient populations will help physicians objectively understand risks, said Dr. Steven Bailey, president-elect of the Society for Cardiovascular Angiography and Interventions.

"There has been appropriate caution about using (drug-eluting stents) in acute (heart attack) patients because of the risk of thrombosis," he added.

STENTS AFTER HEART ATTACK

One study funded by Boston Scientific compares its Taxus drug-eluting stent against its own traditional bare metal stents in patients who have had the most severe type of heart attack. Results from the 3,000-person trial, dubbed Horizons-AMI, will be presented on Wednesday.

The study's patient population accounts for about 10 percent of all stent procedures in the United States, with current drug-eluting stent utilization in this segment probably lower than the 68 percent to 70 percent penetration seen in the market overall, said JPMorgan analyst Michael Weinstein.

Boston Scientific will also present results from a study called Syntax, which compares the use of its drug-eluting stent with coronary artery bypass surgery in patients with complex heart disease.

Dr. Lloyd Klein, an interventional cardiologist at Gottlieb Memorial Hospital in the Chicago area, said he was most interested in learning more about how patients with three-vessel heart disease and other complex conditions fare with drug-eluting stents.

TWO-YEAR DATA ON ENDEAVOR

Another highlight will come from Medtronic on Tuesday, when the company presents two-year follow-up data on its Endeavor drug-eluting stent, which was approved in the United States in the first quarter. The trial, called Endeavor IV, compared Endeavor with Taxus.

Scott Ward, head of Medtronic's vascular business, said the increasing body of long-term safety data would strengthen confidence in the company's drug-eluting stent.

Abbott will release results from an analysis comparing its Xience drug-eluting stent with Taxus. Abbott will also report on two-year data on its bioabsorbable stent.