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FDA approves everolimus-eluting stent for commercial distribution
New stent demonstrated strong safety profile and positive two-year follow-up results.
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The Xience V everolimus-eluting stent, also marketed as the Promus everolimus-eluting stent, has been cleared by the FDA for the treatment of de novo coronary artery lesions.
Despite different brand names, the two stents are identical. Both everolimus-eluting stents are manufactured by Abbott, but the Promus stent is a privately labeled everolimus-eluting stent distributed by Boston Scientific.
The everolimus-eluting stent was evaluated for safety and efficacy in the SPIRIT clinical program, in which 1,362 patients were enrolled. The everolimus-eluting stent was evaluated against the paclitaxel-eluting stent (Taxus, Boston Scientific), which had been previously approved by the FDA.
“Xience V was designed to improve safety and efficacy compared with earlier-generation stents,” Gregg W. Stone, MD, director of cardiovascular research and education at Columbia University Medical Center, said in a press release. “The long-term clinical data from two studies performed in both the United States and Europe have now confirmed that Xience V is a true next-generation drug-eluting stent with clinically important benefits for patients.”
Improved late loss, flexibility
The everolimus-eluting stent demonstrated statistical superiority to the paclitaxel-eluting stent in the SPIRIT III trial by reducing in-segment late-loss at eight months by 50% (0.14 mm mean for the everolimus-eluting stent vs. 0.28 mm mean for the paclitaxel-eluting stent). The everolimus-eluting stent also demonstrated noninferiority for the coendpoint of target vessel failure. At two-year follow-up, the everolimus-eluting stent demonstrated a 45% reduction in major adverse cardiac events compared with the paclitaxel-eluting stent (7.3% vs. 12.8%; P=.004) and a 32% reduction in TVF (10.7% vs. 15.4%; P=.04).
“This is another significant advance for the whole technology of stenting,” Ted Feldman, MD, director of the cardiac catheterization laboratory at Evanston Hospital in Evanston, Ill., told Cardiology Today. “The biggest difference between what we had before and what we have now in terms of the day-to-day procedures of the practicing interventionalist is that this stent is more deliverable.”
The everolimus-eluting stent, made of cobalt chromium, has a different strut design than that of the available bare metal stents and other drug-eluting stents. This, according to Feldman, increases their utility without sacrificing strength.
“The stent has much thinner strut construction than prior drug-eluting stents, which makes it more flexible,” Feldman said. “My own use of the device with benchtop models compared with other existing products makes it clear that it is more deliverable. This is a technical advance in the family of drug-eluting stents.”
The everolimus-eluting stent had previously been available in Europe and other international markets. Distribution of the everolimus-eluting stent in the United States began immediately following FDA approval in July. – by Eric Raible