This is good news, said Dr. Gregg W. Stone, an interventional cardiologist who is a professor of medicine at Columbia University and who took part in the controlled trials that led to FDA approval of Xience.
"This more real-world experience is reassuring," Stone said. But additional studies are needed because "the patient size in this trial was small, and it is more difficult to draw conclusions from non-randomized trials," Stone explained.
Nevertheless, the American cardiology community appears to have drawn its own conclusions already, Stone said. Drug-coated stents now are used in about 75 percent of cases, and the Xience stent is used in "50 to 60 percent of that 75 percent," he said.
Everolimus is a more potent drug than those used in the first-generation coated stents and also is contained in a thin, inert polymer that is less likely to cause inflammation, Stone said. The Xience stent itself is also thinner than the previous devices, he added.
"This is a good step forward on evaluating the next generation of drug-eluting stents," said Dr. Manesh Patel, director of the catheterization research laboratory at Duke University.
"The data I see from the [new study] is reassuring," Patel said. "If you are a patient who is being evaluated and a stent is being considered for your coronary, this stent looks safe for at least six months."
Longer follow-up data on more recipients is needed, he noted. Abbott Vascular, which markets the Xience V stent, is sponsoring a data bank that already has information on 5,000 recipients, Patel said.
Stent research and development continues, Stone stated. A stent with a bioabsorbable polymer that disappears is being tested, and further down the road is
All rights reserved