THUNDER: Paclitaxel-Coated Balloon Lowers Restenosis
Patients receiving coated balloons experienced reduced late lumen loss.
The paclitaxel-coated balloon catheter Paccocath was safe and reduced restenosis in the superficial femoral artery, according to six-month data from the prospective, randomized THUNDER trial.
Gunnar Tepe, MD, of the department of diagnostic radiology at the Eberhard-Karls-University of Tubingen in Germany, presented primary and secondary data from THUNDER.
In the trial, patients were randomized to receive an uncoated balloon, an uncoated balloon in combination with paclitaxel, or the Paccocath catheter, manufactured by Bavaria Medizin Technologie GmbH.
Mean late lumen loss at six-month follow-up was significantly reduced in the Paccocath arm (P < .01) when compared with those receiving uncoated balloons (see Figure). During the same follow-up period, patients in the Paccocath arm also had a significantly better binary restenosis rate (P < .01).
Secondary endpoints
Patients in the uncoated balloon arm had mean Rutherford scores of 3.1 at baseline and 1.6 at six-month follow-up, compared with 3.4 and 2.0 in the uncoated balloon-plus-paclitaxel arm and 3.4 and 1.2 in the Paccocath arm, respectively. The target lesion revascularization rate at six months was 29.6% in the uncoated balloon arm, 25% in the uncoated balloon-plus-paclitaxel arm and 6.3% in the Paccocath arm.
“This gives us the first proof that drug-coated balloons reduce restenosis in the superficial femoral artery,” Tepe said.
Further analysis merited
In an accompanying commentary, Ivan De Scheerder, MD, PhD, of the University Hospital Leuvens in Belgium, noted the approximate 20% study dropout rate and the lack of a comparison group of patients treated with paclitaxel-coated stents as possible critiques. DeScheerder was satisfied with the design of the trial, however, concluding that “local short-time paclitaxel delivery using a paclitaxel-coated balloon seems to be safe and effective in preventing restenosis in peripheral artery disease, and may be as effective as stent-mediated paclitaxel delivery,” he said.
“I have some concerns about the reproducibility of local paclitaxel delivery using this balloon system,” he said. “Furthermore, the bulk release of paclitaxel, which we know can result in vessel wall toxicity, late restenosis and especially late thrombosis, is a concern.”
Study design
The THUNDER trial enrolled 154 patients, 54 receiving uncoated balloons, 52 receiving uncoated balloons in combination with paclitaxel, and 48 receiving the Paccocath. Among other inclusion criteria, patients had an occlusion or stenosis of greater than 2 cm and a Rutherford score of 3 to 5.
All treatment groups were well balanced for patient characteristics. Those in the uncoated balloon arm had an average pre-procedure lesion length of 7.3 cm, compared with 6.7 and 6.5 for the uncoated balloon-plus-paclitaxel and the Paccocath arms, respectively. Study participants had 1.7 lesions treated on average, and the mean degree of stenosis ranged from 87.7% to 90.7% between the three arms.
