Boston Scientific Corp. is touting a clinical trial comparing one of its drug-eluting stents with a bare-metal stent, published today in the New England Journal of Medicine.
The Natick devices goliath, which helped fund the study along with the Cardiovascular Research Foundation and The Medicines Co., said the study, called the Horizons AMI trial, showed patients fared better one year after implantation with its Taxus Express2 paclitaxel-eluting stent than patients with its Express bare-metal stent.
The trial, of 3,006 patients with acute myocardial infarctions, involved implanting about two-thirds with the drug-eluting stent and the remaining 749 patients with the bare metal stent.
A year later, 4.5 percent of patients who received the DE stents required ischemia-driven target-lesion revascularization, compared with 7.5 percent of patients implanted with the bare stents. Target-vessel revascularization rates were also lower for the DES patients (5.8 percent vs. 8.7 percent).
In plain English, that means fewer patients with the drug-coated devices required further procedures to re-open their narrowed blood vessels.
The two devices had the same death rates after a year (3.5 percent) and similar rates of blood clots (known as stent thrombosis), at 3.2 percent and 3.4 percent, respectively.
After 13 months, the rate of binary restenosis (re-narrowing of the artery) was significantly lower for patients with the paclitaxel-eluting stents (10 percent vs. 22.9 percent for patients with the bare-metal devices).
Lead investigator Gregg Stone, a medicine professor and director of research and education at Columbia University Medical Center/New York-Presbyterian Hospital’s Center for Interventional Vascular Therapy, said the the patients in the trial will be tracked for five years to whether the results hold up.
News of the study’s results sent BSC’s stock up about 3.5 percent as of 2 p.m. today, to $8.80 after opening at $8.50.
The trial, the latest to investigate the effectiveness of drug-eluting stents, follows a comparison of the Taxus device with its Xience V competitor from Abbott Laboratories. The Taxus didn’t fare so well in that three-year study, which indicated that rates of major cardiovascular events for the Xience stent topped out at 6.4 percent during the second and third years; the Taxus device hit 10.5 percent for the second year and 14.9 percent for the third year.
The Abbott stent also showed a lower mortality rate than the Taxus, although neither caused a large number of deaths or serious complications.
One wrinkle is that Boston Scientific also markets Xience under the private-label Promus brand, though it pays royalties from those sales back to Abbott.
