
Medtronic’s (NYSE:MDT) Resolute drug-eluting stent proved non-inferior to Abbott’s (NYSE:ABT) Xience everolimus-eluting stent in an off-label study, including "real world" uses, in patients with complex lesions.
The data, from the Twente trial, found that rates of cardiac death, heart attack and target vessel revascularization were similar between the 2 DES models, as were individual aspects of the primary trial endpoints and rates of stent thrombosis.
More than ¾ of the 1391 stent recipients were for off-label indications, with a high proportion requiring multi-vessel intervention, TheHeart.org reported.
Medtronic previously pointed to this study as a response to study results released last week, which concluded that cobalt-chromium everolimus-eluting stents, such as Abbott’s Xience V and Boston Scientific’s (NYSE:BSX) Promus, performed best in rates of thrombosis after 2 years.
Minneapolis, Minn.-based Medtronic, 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."