March 16, 2003, St. Louis - The U.S. Food and Drug Administration (FDA) today approved the use of a drug-coated stent to treat patients with clogged cardiac arteries. Washington University physicians at Barnes-Jewish Hospital did research that led to approval.
These stents -- metal mesh tubes used as scaffolding to keep blood vessels open and unclogged -- are laced with low doses of the drug sirolimus to help prevent clogging. Washington University School of Medicine in St. Louis was one of the key participants in the research that led to FDA approval. These are the first drug-coated stents to receive federal approval.
"Drug-coated stents may be the most important advancement in interventional cardiology this decade," says John M. Lasala, M.D., Ph.D., director of cardiac catheterization at Washington University School of Medicine and Barnes-Jewish Hospital in St. Louis. Lasala was the medical center''s principal investigator for studies involving sirolimus-coated stents, and currently is leading the team in three such trials.
About 11 million Americans suffer from coronary artery disease (CAD), an inflammation of the blood vessels that deliver oxygen to the heart. CAD can lead to chest pain or heart attack and remains the single leading killer of men and women in this country.
To treat the buildup of plaque that causes CAD, interventional cardiologists first use a balloon to reopen the blood vessel (a procedure called angioplasty) and then insert an expandable stent, which supports the vessel wall and maintains blood flow. This approach is less invasive and less expensive than the alternative traditional bypass surgery. In 2002 alone, there were 1320 stent procedures at Barnes-Jewish Hospital.
Unfortunately, roughly 15 to 20 percent of all stented vessels close again, or restenose, after the procedure, and patients must undergo a second catheterization.
By coating the stent with drugs, researchers hope to block the cell growth that produces scar tissue, and thereby to prevent reclogging. Studies of drug-coated stents in Europe and in the United States indicate that these new devices can more than halve the rate of restenosis.
"It is absolutely astounding how much progress we''ve made in the last decade," Lasala says. "Now, thanks to drug-coated stents, we''re close to the holy grail of single digit restenosis rates. These results provide hope for treating millions of cardiac patients."
The stents coated in sirolimus (also known as rapamycin or Rapamune®) are manufactured by Johnson & Johnson.
For more information, please call Jason Merrill at 314-286-0302.