Drug-coated stents eliminate major shortcoming of angioplasty

By

Posted 8:32AM on Monday, March 18, 2002

ATLANTA - Doctors believe they have solved one of the most frustrating problems in heart care the stubborn tendency of heart arteries to clog up after angioplasty. New data released Sunday suggest the approach virtually eliminates this complication, which occurs in about one-quarter of angioplasties now done on 1 million Americans annually. The approach is the drug-coated stent, a wire coil engineered to prop open the artery and keep it from refilling with scar tissue. ``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. The tendency of the freshly opened artery to close up again with scar tissue within a few months has always been its major drawback. Doctors have tried a variety of gadgets, such as lasers and whirring knives, to prevent this complication, called restenosis. The introduction of ordinary stents a few years ago was a big improvement, reducing the failure rate from around 40 percent to about 25 percent. However, the latest advance has the potential of eliminating it almost completely. The first hint of this was made public last 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 different varieties coated with different growth-inhibiting medicines are now 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 presented two years of follow up with those 43 initial patients. While three of them have needed heart procedures for worsening disease in other parts of their hearts, all of the areas treated with the Cordis stents are flowing freely. Sousa projected an X-ray of one of the patient's hearts, showing a wide, obstruction-free artery. ``No lesion. No problem,'' he said. ``The artery is completely open after two years follow up.'' Dr. Jean Fajadet of Thoraxcenter in Rotterdam gave results with the same stent after seven months in 238 patients. Again, not a single stent clogged up, compared with restenosis in 26 percent of those getting ordinary stents. Dr. Sidney Smith, chief medical officer of the American Heart Association, 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.'' Especially encouraging, Smith said, is the fact they seem to work in unusually small arteries and in those of diabetic patients. Both are very prone to reclogging. Dr. Greg Stone of Lenox Hill Hospital in New York City said the first of these stents could be available in 2003. Results of at least three large studies, necessary to win Food and Drug Administration approval, are expected on rival products within the next year. Manufacturers have not said how much they will cost, but Stone said the price is likely to be about double that of ordinary stents, which sell for around $1,400 apiece. Meeting site: http://www.acc.org/