Updated March 26, 2012 at 9:23 a.m. with new details on Promus/Xience private label deal and March 23, 2012 at 1:15 p.m. with comments from Medtronic.
Drug-eluting stents proved safer and more effective than their bare-metal forebears in the largest meta-analysis to date, with certain DES, such as Abbott’s (NYSE:ABT) Xience V and Boston Scientific’s (NYSE:BSX) Promus, besting others in thrombosis rates after 2 years.
Researchers considered data from more than 50,000 patients among 49 randomized trials, finding that rates of stent thrombosis were "significantly lower" with cobalt-chromium everolimus-eluting stents (CoCr-EES) like the Xience V and Promus devices, when compared with other alloy-drug combinations.
"Although drug-eluting stents are more effective than bare-metal stents in reducing restenosis, their safety has continued to be questioned in view of the ongoing propensity of 1st-generation drug-eluting stents for very late stent thrombosis," the study authors wrote. "The finding that CoCr-EES also reduced stent thrombosis compared with bare-metal stents, if confirmed in future randomized trials, represents a paradigm shift."
The 2 technologies have been dueling it out in studies for years, with data slowly beginning to favor DES. In the latest study, published in the Lancet, DES resulted in fewer re-narrowings than bare-metal stents, but the CoCr-EES stents in particular were the 1st to show lower rates of thrombosis during follow-up.
"On this basis, CoCr-EES should be regarded as the standard against which future design improvements are compared," Drs. John Ormiston and Mark Webster wrote in an accompanying editorial. "These findings might also give pause to those who are developing stents with resorbable coatings with the thought that a so-called bare-metal-equivalent stent would be less thrombogenic."
While Abbott notched the study as a win, it could be bad news for Boston Scientific, which plans this year to phase out the Promus stents in favor of the Promus Element platinum-chromium everolimus-eluting stents, according to the Natick, Mass.-based med-tech titan’s annual report.
The Promus stent is a private-label version of Abbot’s Xience V device. The private-label deal ended in Europe in 2009, but a similar arrangement in the U.S. is slated to go until mid-2012, an Abbott spokesman told MassDevice.com via email.
Boston Scientific won FDA clearance for its Promus Element DES in November 2011 and launched the system in the 4th quarter. The company launched the Promus Element in Japan earlier this month.
"Our Promus Element stent system has significantly higher gross profit and operating profit margins as compared to our Promus stent system, which is supplied to us by Abbott," the company wrote in regulatory filings. "We expect to fully convert our U.S. drug-eluting stent system sales to self-manufactured Promus Element and Taxus stent systems during 2012."
Minneapolis, Minn.-based Medtronic (NYSE:MDT), the world’s largest pure-play medical device maker but a relative newcomer to the stents game, questioned the study’s conclusions.
"There are a number of limitations inherent in this analysis," a Medtronic spokeswoman told MassDevice in an email. "Importantly, stent thrombosis is not a clinical event but rather it manifests as either death, heart attack or a repeat procedure. There are no data suggesting that there are differences in hard endpoints so the clinical importance of the apparent difference in this particular analysis is questionable."
Medtronic pointed to data from a pair of head-to-head randomized trials comparing Medtronic’s Resolute drug-eluting stent with the Xience V, which found that "there is absolutely no difference between these devices with regard to rates of death from cardiac causes, heart attacks and repeat procedures."
The news didn’t rouse much activity on Wall Street, where ABT shares were up 22¢ to $60.33 and BSX shares were down 5¢ to $5.95 as of about 11:45 a.m. today. Medtronic’s shares were up 5¢ to $38.91 as of about 1:00 p.m.
"This analysis reinforces why Xience leads the market," Abbott wrote in a press release. "The data show that Xience is the safest stent on the market, compared to both other drug eluting stents, as well as bare metal stents – a key new finding."
Boston Scientific did not respond to requests for comment.
