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New Type of Stent Appears Safe, Effective

Artery-opening device emits drug from a biodegradable polymer

MONDAY, Sept. 1 (HealthDay News) -- One of a "new generation" of artery-opening, drug-eluting stents appears equally effective as older models in boosting outcomes for heart patients, a new head-to-head study shows.

Stents are tiny mesh tubes inserted into arteries to keep blood flowing. Drug-eluting stents emit medicines that help prevent reclosure. The latest form of drug-eluting stents releases the drugs from a biodegradable polymer coating.

In the new study, published early online Sept. 1 in The Lancet, researchers in Switzerland compared one such stent, which releases the drug biolimus, against a standard drug-eluting stent releasing sirolimus. Adult heart patients with chronic stable coronary artery disease or acute coronary syndromes were randomized to receive either of the two stents. A subset (427 patients) later underwent angiography to see how well the stent was performing.

After nine months of follow-up, researchers led by Professor Stephan Windecker of Bern University Hospital reported that biolimus-eluting stents were as effective as the sirolimus stent in terms of the number of patients who experienced a combination of cardiac death, heart attack or need for a repeat revascularization procedure of the treated vessel -- 9 percent for the biolimus group and 11 percent for those receiving the sirolimus stent.

There were also no significant difference between the biolimus and sirolmus stent groups when each event was looked at separately: cardiac death (1.6 percent vs. 2.5 percent, respectively), heart attack (5.7 percent vs. 4.6 percent) and repeat procedures (4.4 percent vs. 5.5 percent). Each stent also performed similarly in terms of the percentage of vessel diameter that reclosed over the nine-month period, the team noted.

According to the authors, the study, "establishes the non-inferiority" of the newer biolimus-eluting stent.

But in an editorial, Dr. Ron Waksman, of Washington Hospital Center, Washington, D.C., was more cautious. "Before we become overly enthused with new-generation drug-eluting stents, we should call for new-generation trial designs that will enable us to assess whether or not these new stents are necessarily better," he wrote.

The study, which was expected to be presented Monday at the European Society of Cardiology meeting in Munich, was funded by the maker of the biolimus stent, Biosensors Europe SA, Switzerland.

More information

There's more on stents and stenting at the American Heart Association.

-- E.J. Mundell

SOURCE: The Lancet, news release, Sept. 1, 2008

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