Drug-coated stents are safe to implant in cardiac blood vessels immediately after a heart attack, according to two studies in today's New England Journal of Medicine.
The studies validate a procedure in wide use to prop open arteries. The results raise the possibility of a safety edge for Johnson & Johnson's Cypher stent over Boston Scientific Corp.'s Taxus without settling the question because differences may have been due to a statistical fluke or study design. The companies are vying for $6 billion of sales a year for the devices worldwide.
``There is no indication, at least in these two studies with a limited number of patients, that there is any harmful effect of the drug-eluting stent," said Frans Van de Werf, a Brussels cardiologist, in a telephone interview. Van de Werf wrote a commentary published with the studies.
In a study of 712 randomly assigned patients, Christian Spaulding of Cochin Hospital in Paris said patients using Cypher had almost the same rates of death and heart attack after one year as those treated with bare-metal stents.
Twice as many patients without the drug-coated devices needed repeat procedures to treat blockages, Spaulding said. There was one case of blood clotting with Cypher stents, and they hosted less regrowth of scar tissue than bare-metal stents, the report said.
The other study, led by Gerrit J. Laarman of Onze Lieve Vrouwe Gasthuis in Amsterdam, followed 619 patients and found, after one year, a lower risk of death, heart attack or repeat procedures with Taxus drug-coated stents, compared with bare-metal devices. The authors said the study couldn't establish whether the difference is meaningful.![]()