ATLANTA — A new approach to keeping arteries flowing smoothly after angioplasty shows astonishing success in early testing, apparently solving a major shortcoming of this common procedure.
Doctors on Sunday released the longest follow-up with the new technique--the drug-coated stent. In testing on 43 patients over two years, they found it to be 100% effective, an accomplishment almost unheard of in medicine.
More than 1 million Americans undergo angioplasty annually, and the new approach is likely to be used on most of them if these promising early results hold up in further testing. They could be on the market as early as next year.
"This is a very hot topic, potentially revolutionary in the treatment of coronary artery disease," said Dr. Spencer King III of Emory University.
During angioplasty, doctors fish tiny balloons through clogged heart arteries, then inflate them briefly to open up blood flow. Frequently, though, the arteries squeeze shut again. In recent years, doctors have often left behind tiny wire coils, called stents, to prop the arteries open.
However, about 25% of the time, the reopened artery closes off, a condition called restenosis. It usually occurs when fast-growth scar-like tissue fills the artery, and it must be fixed with a repeat angioplasty or a coronary bypass.
The solution to this dilemma appears to be a new kind of stent that is coated with medicines that gradually ooze into the artery. The drugs keep cells from growing.
The first hint of their potential was made public in September at a European heart conference, and more data were released Sunday at a meeting of the American College of Cardiology in Atlanta.
At least eight varieties--coated with different growth-inhibiting medicines--are in testing, and many more are under development. The first was Cordis Corp.'s stent coated with the immune-suppressing drug rapamycin, tested on patients in Brazil and the Netherlands.
Dr. J. Eduardo Sousa of the Dante Pazzanese Institute of Cardiology in Sao Paulo, Brazil, presented two years of follow-up with those 43 initial patients. All of the areas treated with the Cordis stents are flowing freely.
Dr. Sidney Smith, chief medical officer of the American Heart Assn., cautioned that large, careful studies must be finished comparing the new stents with the ordinary kind.
Nevertheless, he said, "these are very impressive and very encouraging results. When you see zero restenosis at one year, it's a breakthrough. It's almost too good to believe when you see zero."
Manufacturers have not said how much the products will cost, but Stone said the price is likely to be about double that of ordinary stents, which sell for around $1,400.
King said the cost might limit their use, as doctors often install several stents during an angioplasty.