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FDA cleared zotarolimus-eluting stent for use in coronary arteries
Rates of late stent thrombosis at one year were similar in zotarolimus- and paclitaxel-eluting stent
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The FDA recently approved the zotarolimus-eluting stent for use in the treatment of patients with narrowed coronary arteries.
The zotarolimus-eluting stent (Endeavor, Medtronic) was the first stent approval since 2004, and also the first since the Circulatory System Devices Panel convened in 2006 to evaluate the extent of restenosis and late stent thrombosis in patients who had received drug-eluting stents.
“The Endeavor drug-eluting stent provides cardiologists with another option for treating the 1 million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries,” Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “This important approval is the result of a substantial amount of clinical evidence and a careful review by both the FDA and its advisory committees.”
Comparable with other stents
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Source: Medtronic Inc. |
The Circulatory System Devices Advisory Panel recommended the zotarolimus-eluting stent for premarket approval in November, and the FDA followed the recommendation of the panel. In clinical trials, the stent had a comparable safety and efficacy profile with a paclitaxel-eluting stent (Taxus, Boston Scientific) and a sirolimus-eluting stent (Cypher, Cordis), as well as with bare metal stents already on the market.
Safety data for the zotarolimus-eluting stent were collected during the ENDEAVOR clinical program, a series of three pivotal studies and three substudies including 2,133 patients, with 1,287 receiving zotarolimus-eluting stents. The studies compared the performance and safety of the zotarolimus-eluting not only with the two most widely used drug-eluting stents but with bare metal stents as well. According to a press release, the stent thrombosis rate at one year with the zotarolimus-eluting stent (0.4% at one year and 0.5% at two years) was similar to that of a bare metal stent.
Although the rate of restenosis was slightly elevated with the zotarolimus-eluting stent compared with that of the paclitaxel-eluting stent, the rates of late stent thrombosis at one year were roughly the same between the two stents. In addition, the zotarolimus-eluting stent demonstrated no additional incidents of MI, noncardiac death or stent thrombosis during the studies.
The safety and efficacy of the newly approved stent have also not yet been studied in many patient populations. Of particular interest to the FDA and cardiologists is the stent’s performance in patients with smaller artery diameters, patients who have suffered an acute MI or patients with two or more previously implanted stents. - by Eric Raible
The concern that we all still have is the incidence of late stent thrombosis after one year. With this stent, the rate appears no different than a bare metal stent. If that is true when we have more open-label and generalized use in a nonrandomized trial setting, and as we get into the phase for more clinical use of the stent, a lower rate of late stent thrombosis would be an acceptable trade-off for a slightly higher rate of restenosis. Frankly, I would worry more about late stent thrombosis and less about restenosis. We continue to dance around the rate of incidence. Is it half of 1%? Is it 1%? Anything that comes out that would result in a lower rate of late stent thrombosis that would rival that of bare metal stents would be an important innovation.
— William E. Boden, MD
Chief of Cardiology at Buffalo General and Millard Fillmore Hospitals, Buffalo, N.Y.