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FDA advisory panel backs drug-eluting stent for PAD
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The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted 11-0 today for approval of a new paclitaxel-eluting stent designed for the improvement of luminal diameter for the treatment of de novo or restenotic symptomatic vascular disease of above-the-knee femoral arteries.
The self-expanding nitinol stent (Zilver PTX, Cook Medical) is coated on its outer surface with paclitaxel without any polymer, binder or excipient at a dose density of 3 mcg/mm2. If approved, this device would be the first-ever paclitaxel-eluting stent available in the US for the treatment of symptomatic peripheral arterial disease.
Unanimous vote
The committee unanimously agreed that the stent is safe for use in patients who meet the proposed indication criteria of maximum lesion length of 140 mm per limb and 280 mm per patient. The 11 panel members further voted that there is reasonable assurance that the stent is effective for patients who meet the aforementioned criteria. Overall, the committee said the benefits of this stent outweigh the risks for use in patients who meet the criteria specified in the proposed indication.
Post-approval trial
Along with the recommended approval, the advisory committee also discussed whether a post-approval study would be necessary for further safety and efficacy data.
The sponsor proposed a long-term follow-up of the randomized control trial that enrolled 479 patients with symptomatic de novo or restenotic superficial femoral artery lesions to be used as a post-approval study. The post-approval study would require 900 patients and would analyze a non-inferiority comparison of the rate of event-free survival between percutaneous transluminal angioplasty and paclitaxel-eluting stent groups at 5 years. The proposed primary endpoint is event-free survival and the rate of stent fracture and late stent thrombosis for patients is the proposed secondary endpoint.
Some panel members questioned whether the post-approval study would require a patient population of 900, or if a cohort that large is necessary. Committee member Richard Lange, MD, from the University of Texas Health Science Center, said finishing the 5-year randomized control trial would provide enough results for the paclitaxel-eluting stent. "I am less convinced that the long-term data will give us any information we don't have already," Lange said during the meeting. "I think the current study going on for 5 years probably tells us enough about stent thrombosis."
John C. Somberg, MD, a panel member from Rush University Medical Center, said a larger study would provide the sponsor with more sufficient data. He suggested continuation of the cohort study, but added that the committee "should advance the idea that there is need for a larger study follow-up that can look for smaller effects, such as stent thrombosis and … whether diabetics are equally benefited from the stent [as are] other populations, such as females.
Other recommended additions for post-approval study included inclusion of bleeding risks and the addition of more women and patients with diabetes.
Although the FDA is not required to follow the recommendations of the advisory committees, it usually does.
Disclosures: The committee members report no relevant financial disclosures.
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