Birmingham's Cardiovascular Associates has become the highest enrolling site in North America for the Surmodics TRANSCEND drug-coated balloon (DCB) trial. The randomized trial seeks to find an improved treatment for peripheral artery disease (PAD), a build-up of deposits that cause narrowing or blockages of blood vessels in the legs.
"Historically, when we repair femoral arteries, the biggest challenge has been that, over time, they shut down and the patient is back with the same problem a few months after the procedure," said Jan Skowronski, MD, MBA, FSCAI, director of Endovascular Therapies at Brookwood Baptist Medical Center. "This has been frustrating to the patients as well as to the medical community.
"Over the last five years, balloons containing medication to prevent restenosis entered the market. These drug-coated balloons have helped tremendously. St Jude and Medtronic were the first to the market with them. CVA was invited to be one of the sites for a randomized clinical study with an iteration of the device, potentially allowing a better penetration of the medication into the arterial wall."
"Drug-eluding balloons have helped tremendously to prevent the re-blockage of femoral arteries," Gary Roubin, MD, FACC said. "This study has looked at a variety of balloons that we believe will be superior to what we've been using over the past few years. This new technology allows more of the medication that prevents restenosis. The medication is attached to the balloon, and Surmodics has perfected a way to deliver more of the drug in a more uniform way up and down the entire length of the treated segment. We're excited to be able to offer this to our patients within the confines of the study."
CVA is one of 78 study locations enrolling a total of 450 patients. With 55 to 60 percent already enrolled, Skowronski anticipates the trial will end enrollment this spring and the study will be un-blinded a year later. "We think we will cut the restenosis rate by two-thirds compared to regular balloons," he said.
The minimally invasive procedure requires only mild sedation. The blocked artery is first opened with a regular balloon. Then a balloon with the drug paclitaxel is inflated to treat the lesion. The procedure is typically outpatient with most patients returning home that day.
"It is extremely safe," Roubin said. "We can relieve incredible discomfort and improve the quality of life dramatically. The ability to treat these blockages is one of the great triumphs of endovascular therapy. The only down side was that the blockages tended to come back. And now we can prevent that."
Patients who meet the requirements of the trial include those with leg pain from blocked arteries. "We also enroll patients with small wounds because of bad circulation," Skowronski said. "We welcome referrals for consideration to participate in the study. And although some patients may not fit guidelines for inclusion, they may have conditions that can be repaired outside of the study."
Study subjects return to CVA at one month, six months, a year and two years following the procedure, followed by phone check-ins at three, four, and five years.
"The patients in the study are exceptional patients," said Suzanne Frew, research coordinator with CVA. "This requires a commitment on their part to follow the regime. We need a buy-in from the patient."
"The follow-up is not onerous," Roubin said. "We follow a standard of care that includes a Doppler study, but patients are not subjected to a lot of additional testing. The quality of care that is required and the detailed adherence to best practice protocols were built into these trials.
"I believe that the reason CVA is number one in enrolling patients in this study is because there has been a commitment on the part of our entire group. We do everything we can to offer these patients state-of-the-art care. We want to bring this technology to patients as soon as possible, assuming it is, as we think it is, a superior way to treat peripheral artery disease."