New Heart Stent Looks Good in Study
Xience V Experimental Drug-Coated Stent May Offer Advantages Over Current Devices
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Stent May Promote Faster Healing continued...
And the metal tube itself is a highly malleable, cobalt-chromium blend. That makes it easier for the doctor to get it exactly where he wants it, Stone says.
The question, he tells WebMD, was whether the polymer and stent would work together.
To find out, the researchers studied 1,002 people with blockages in up to two arteries. About two-thirds got the Xience stent; the rest were implanted with the standard Taxus stent.
After implantation, participants were treated with the drug Plavix to prevent blood clots for at least six months.
After nine months, 8.1% of people who got the Taxus stent died, had a heart attack, or had artery reclogging, compared with only 4.6% of those who got the Xience stent.
The Xience stent also reduced reclogging of the treated arteries compared with the standard drug-coated stent (4.7% vs. 8.9%), Stone says.
The findings should satisfy regulatory hurdles set by the FDA for approving the device, Stone says.
In addition to Taxus, the Cypher drug-eluting stent, from Cordis Corp., a subsidiary of Johnson & Johnson, is also approved in the U.S.
Abbott, which makes Xience, funded the research. The company is expected to submit the data to the FDA by the end of the year.
Spencer B. King III, MD, head of interventional cardiology at Piedmont Hospital in Atlanta, says that if approved, Xience will offer another option for treating the more than 1 million Americans who undergo angioplasty each year.
That said, it won’t make the Taxus or Cypher stents obsolete, he says.
“All three stents are highly effective,” he tells WebMD. “It’s always good to have options.”