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Drug-Coated Stents Safe for Patients With Complex Artery Disease

BETHESDA, MD - April 7, 2004 — Patients with multiple or complex coronary artery blockages can be treated safely using stents coated with a drug that helps prevent the arteries from renarrowing, according to a new study in the April 7, 2004 issue of the Journal of the American College of Cardiology.

"These stents are safe, even in a population traditionally treated with surgery. They are effective when compared to historical controls. The only caveat is that cardiologists can't tell patients that they will be 100 percent free of the potential need for a second procedure, because 16 percent of the time they may need a touch-up later," said Antonio Colombo, MD, FACC with the EMO Centro Cuore Columbus Hospital in Milan, Italy.

The researchers followed 155 consecutive patients treated with multiple sirolimus-eluting stents between April 2002 and March 2003. Each patient had at least two lesions blocking blood flow in different coronary arteries. Earlier studies have demonstrated that patients with a single, simple artery narrowing held open with a sirolimus-eluting stent are less likely to need retreatment than similar patients who received a bare metal stent. However, those studies excluded patients with complex or multiple artery lesions.

This study provides a look at patients who are more typical of real-world clinical practice, Dr. Colombo said.

"The lesions were a variety of complex bifurcations, total occlusions, very long lesions, which were not included in any other study. Also, each patient was treated on all critical lesions; so we have patients who underwent four, five, six, even seven stent implantations in different blood vessels. So this population is comparable to any group of patients who usually undergo coronary bypass graft surgery. It's a good benchmark against which you can compare with surgical results," Dr. Colombo said.

Dr. Colombo said about 7 percent to 8 percent of the treated lesions required later treatment for a renarrowing (restenosis) of an artery, which is in line with earlier studies. However, since each patient had multiple blockages, about 16 percent required retreatment. He said more work needs to be done to reduce the rate of retreatment.

Ronald E. Vlietstra, MD, FACC, an interventional cardiologist in Lakeland, Fla., who was not part of this study, noted that the initial trials of sirolimus-eluting stents involved only carefully selected samples of patients. He commended the authors of this article for studying patients with complex disease, thus providing clinicians with a more realistic understanding of likely outcomes.

"So profound has been the relief that, finally, some solution has been found for restenosis that it is not surprising that the very good results of early trials may have been overhyped. This paper offers some balance and cautions that further improvements in technology and application are still needed," Dr. Vlietstra said.

To view the article, click here.

Source: Journal of the American College of Cardiology

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