Despite being associated with a long-term mortality signal, paclitaxel-coated devices are staying on the market because benefits outweigh risks for some patients, but a risk discussion between doctors and patients is crucial, an FDA official said during the International Symposium on Endovascular Therapy.
The FDA is continuing to investigate the link and is encouraging investigators of ongoing and future trials to improve data collection, Ryan Randall, MSE, acting team lead of the FDA’s Peripheral Interventional Devices Team, said during a presentation.
“The FDA’s current thinking is that the devices may remain on the market given that the benefits may outweigh the risks for some patients, based on clinical judgment,” he said. “However, for many patients, alternative options provide a more favorable benefit-risk profile. Doctors should continue to discuss benefits and risks of all treatment options with their patients and continue diligent monitoring. Updates are being made to the labeling to ensure that patients are informed of risks related to these devices and the strengths and limitations of the meta-analyses” that detected the long-term mortality signal.
The FDA has asked leaders of ongoing and future trials to update their informed consent forms to make patients aware of the results of the meta-analyses and the risks of the devices, to monitor for safety closely and to improve collection of data and minimize missing data, he said.
He noted that the agency has not yet determined how much long-term data will be required to support approval of new paclitaxel-coated devices.
The FDA is still evaluating whether the risks apply to paclitaxel-coated devices used in other patient groups, including those with arteriovenous fistula stenosis and those with critical limb ischemia, he said.
This includes investigation of a new meta-analysis that, as Healio previously reported, found that paclitaxel-coated balloons conferred worse amputation-free survival at 1 year compared with uncoated balloons in patients with below-the-knee lesions, most of whom had CLI, according to Randall.
“Multidisciplinary teams continue to work to understand the paclitaxel signal,” he said. “None of the devices in the new study are available in the U.S. Currently, there are no drug-coated stents or balloons approved for use below the knee in the U.S. The IN.PACT DEEP study appears to have a lot of weight in the new meta-analysis, but the IN.PACT Amphirion is no longer sold. Patient-level data, including causes of death and amputation, were not available to the authors.”
Points to take away so far, he said, include that there should be increased scrutiny of pharmacokinetics and particulate generation in preclinical testing and that 1-year data will be required for approval of any drug-coated device for CLI. He noted that in CLI, endpoints such as quality of life and wound healing are also weighted heavily when considering the value of a treatment.
“As always, the benefits of a device are weighed against its risks to support marketing approval,” he said. – by Erik Swain
Randall R. Session 4: Late-breaking and Hot Topics in Endovascular Therapy. Presented at: the International Symposium on Endovascular Therapy (ISET); Jan. 22-25, 2020; Hollywood, Fla.
Disclosure: Randall is an employee of the FDA and reports no relevant financial disclosures.