Jacksonville, Fla. – Researchers last week presented a European study that found antibiotic-coated stents completely eliminated re-blocking in coronary arteries. The study mirrors a study currently being conducted by physician researchers at several U.S. hospitals, including University of Florida physicians practicing at The Cardiovascular Center at Shands Jacksonville.
Each year, more than 900,000 patients in the U.S. undergo angioplasty, in which a balloon is used to clear an obstruction in a coronary artery and a stent is deployed to keep it open. However, about 15 to 20 percent of the procedures fail within six months because scar tissue clogs the stents.
The European study, presented last Tuesday at the European Society of Cardiology’s annual meeting in Stockholm, showed drug-coated stents, being developed by Johnson & Johnson’s Cordis unit, dramatically reduce the incidence of restenosis – or the re-clogging of arteries – to “zero” in patients with heart disease.
In January, The Cardiovascular Center at Shands Jacksonville began the FDA-approved clinical research trials for the U.S. trial known as SIRUS, which is designed to compare the safety and effectiveness of a drug-coated stent device that may treat and prevent excessive tissue growth and prevent arteries from re-narrowing after balloon angioplasty or stent placement.
Known as in-stent restonosis, the re-narrowing of a previously treated artery occurs in approximately one-half of all heart patients and often indicates the need for coronary bypass surgery or a second balloon angioplasty.
According to Theodore Bass, M.D., a University of Florida professor of medicine and director of The Cardiovascular Center, the trials will compare the safety and effectiveness of the sirolimus-coated stent to the uncoated stent. Dr. Bass, along with a team of University of Florida interventional cardiologists and cardiothoracic surgeons, are studying the effectiveness of the new stent device, which is inserted into the heart patient’s arteries.
Results in Europe appear promising.
“The data from this European study demonstrate unprecedented results,” said Marie-Claude Morice, M.D., head of interventional cardiology at Institut Hospitalier Jaques Cartier, Massy, France and the principal investigator for the study.
Johnson & Johnson licensed sirolimus, the active drug released from the stent, from American Home Products Corp. Sirolimus, a natural antibiotic called rapamycin that is marketed as Rapamune by American Home, is an immune-system suppressant used to prevent the body from rejecting organ transplants.
Sirolimus halts the replication of certain cells that, as part of the body’s response to injury, are involved in proliferation of scar tissue. Other companies hope to bring their research results of drug-coated stents in the coming weeks.
The Johnson & Johnson clinical trial, known as the Ravel study, involved 238 patients at 19 centers across Europe and Latin America. “These results strongly suggest that stent-based drug delivery of sirolimus directly to the site of vascular injury via polymeric-coated stents is a feasible way to achieve adequate tissue drug concentration,” Morice said.
The results of the study corroborate results of a smaller study several months ago. The results of a third, more wide-scale study are expected later September. The larger trial of the sirolimus-coated stent will include a U.S. multicenter study in which cardiologists will compare uncoated stents with sirolimus stents in about 1,100 patients.
Dennis Donohoe, vice president of global clinical research for Cordis, said the company expects European approval early in the second quarter of next year, and U.S. approval by early 2003. Cordis, which merged with Johnson & Johnson in 1996, develops and manufactures products for interventional medicine and minimally invasive imaging.
The results are a boon for Johnson & Johnson, and the New Brunswick, N.J., health-care giant is widely viewed as being well ahead of competitors.
Johnson & Johnson sparked a new era of heart treatment with its first stent in 1994 and dominated the market for three years. But it was routed by other manufacturers that finally arrived with better technology in late 1997, and just recently regained a foothold in the nearly $2 billion market for stents.
The SIRUS trial is just one research endeavor at The Cardiovascular Center aimed at coronary disease.
Prior to being granted the SIRUS trial, Shands Jacksonville was the only area hospital to be selected by Novoste Corporation in the FDA-approved clinical study on the Beta-Cath System. The procedure is designed to use a localized dose of beta radiation to inhibit cell growth inside the stented artery, called vascular brachytherapy.