Results of a study investigating the use of a drug-eluting balloon for below-the-knee revascularisation were presented at the TCT symposium in San Francisco in November. The preliminary results show that a paclitaxel-eluting balloon seems to provide better results in terms of 12-month restenosis and re-occlusion compared to conventional balloon angioplasty.
In the DEBATE-BTK study, Francesco Liistro et al, from the San Donato Hospital, Arezzo, Italy, examined diabetic patients with critical limb ischaemia undergoing angioplasty of tibial vessel lesions. Patients were either treated with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic Invatec) or a conventional uncoated balloon.
The study was designed to enrol patients with a total of 150 lesions. Up to November, 93 patients with 118 lesions had been enrolled in the study, including 57 lesions in the paclitaxel-eluting balloon arm and 61 lesions in the conventional balloon group. One-year follow-up was available for 82 lesions – 46 lesions in the conventional angioplasty group and 36 with the drug-eluting balloon. The two groups were similar with regard to Rutherford class as well as clinical and procedural characteristics.
The investigators found that at one year, mortality occurred in eight of the enrolled patients, three in the paclitaxel-eluting balloon group and five in the conventional balloon group (p=0.2). Restenosis was assessed by angiography in 65 lesions and by duplex ultrasound in 17 lesions.
Overall, restenosis occurred in 27% of patients in the paclitaxel-eluting balloon group compared with 65% in the conventional balloon group (p=0.0004). Similarly, re-occlusion was present in significantly more patients in the conventional balloon arm (53% vs. 16%; p=0.0006). No major amputations were required in either group.
“By provisional results, a paclitaxel-eluting balloon seems to provide better results in terms of one-year restenosis compared to conventional angioplasty. If our results are confirmed by the end of the study, drug-eluting balloon angioplasty could be the standard treatment for below-the-knee intervention, and re-intervention will be significantly decreased,” Liistro said.
Liistro told Vascular News that the implications of the study concern the possibility to reduce target lesion revascularisation and foot lesion recurrences in diabetic patients with critical limb ischaemia. “We have to keep in mind that repeat intervention in these patients could result in kidney insufficiency and vascular complications related to the procedure,” he said.
Asked about the key challenges that still need to be overcome in the use of drug-eluting balloons in peripheral arterial disease, Liistro said that, as anatomical pattern of vascular disease in tibial districts in critical limb ischaemia diabetic patients is characterised by long occlusions, angioplasty of such lesions is frequently associated with dissection which may ultimate in abrupt vessel closure. “The results in below-the-knee angioplasty should take in consideration a 48-hour vessel patency which is fundamental for the drug released to act. Moreover, before addressing a failure of drug-eluting balloons we have to be sure that the device had the opportunity to work.
Stent implantation in below-the-knee intervention has limitations regarding the particular anatomy not suitable for the present devices,” he said.
The next step in the drug-eluting balloon investigation will be to compare the different drug-eluting balloons which may differ significantly in terms of efficacy, Liistro concluded.