MASSDEVICE ON CALL — Six-month data from the Levant-2 trial of C.R. Bard‘s (NYSE:BCR) Lutonix drug-coated balloon for treating femoropopliteal artery disease came as a surprise for those hoping the device will be a breakthrough treatment for peripheral artery disease.
Presented last week at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco, the data showed a significant difference in restenosis but no difference in target lesion revascularization.
Endpoints for the trial, designed to compare treatment with the paclitaxel-coated Lutonix balloon and treatment with standard balloon angioplasty, are patency of the target lesion and lack of restenosis after a year. The 6-month results revealed that 92.3% of the Lutonix cohort showed primary patency, compared with 82.7% of the control group. But TLR rates for both arms were about 3%, casting doubt on the chances for FDA approval if the 12-month results are similar.
"If TLR at 12 months isn’t lower, that would be a problem. Then, [Bard] would have an issue. I would want TLR to be different because that’s what matters to patients," Dr. Renu Virmani, president & CEO of CV/Path, told MedPage Today. "Binary restenosis tells you the drug is effective."
But trial investigator Dr. Chris Metzger of the Wemonth CVA Heart Institute in Kingsport, Tenn., said that the trial’s design might account for the similar TLR rates in the trial’s 2 arms.
TLR represents the patient "who says his leg is still killing him," Metzger told the website.
"There will be a difference in TLR at 12 months – it just hasn’t surfaced yet," he said, noting that patients had 6-month duplex ultrasonography follow-up and clinical follow-up the same day. "So they had the DUS, and I was blinded to those results, and if they told me their leg was still killing them, I’m going to schedule a revascularization – but that isn’t going to be done for another month or so."
That means the TLR difference wouldn’t show up in the 6-month analysis, but would be counted in the 12-month data.
"It’s a catch-up issue," Metzger said.
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