Medtronic Invatec's DEBs Show Promise for Treating Lower Limb Arteries

November 9, 2011—According to data presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, use of drug-eluting balloons resulted in positive 1-year outcomes in patients with femoropopliteal arterial disease and diabetic patients with critical limb ischemia in below-the-knee (BTK) vessels. The results from an Italian registry and the DEBATE-BTK trial were presented in abstracts at the conference and summarized in TCT Daily.

As reported by TCT Daily, Antonio Micari, MD, et al examined use of the balloons in treating femoropopliteal lesions. Dr. Micari commented, “For years, the medical community has hoped for a therapy that could deliver patency while leaving nothing behind. The drug-eluting balloon fulfills this and constitutes a tremendous tool in the hands of physicians for the benefit of their patients.”

The investigators analyzed 12-month outcomes with the In.Pact Admiral paclitaxel-eluting balloon (Medtronic Invatec, Frauenfeld, Switzerland). The study was composed of 105 patients (114 lesions) enrolled in a prospective, observational, multicenter Italian registry who had Rutherford class 2, 3, or 4 femoropopliteal arterial disease. The device was successfully deployed in all patients, with only 12.3% of lesions requiring stenting.

At 1 year, target lesion revascularization was 8.7%, and quality of life and functional status were substantially improved at all time points, with 88% of patients improving to Rutherford class 0 or 1. The investigators also reported a mean ankle-brachial index of 0.81 ± 0.4 at 12 months. Based on these findings, Dr. Micari concluded, “A new mindset is required by interventionists to limit ‘liberal' stenting. A strict provisional stent approach is needed, mainly limited to true flow-limiting dissections.”

In the DEBATE-BTK study, Francesco Liistro, MD, et al examined diabetic patients with critical limb ischemia undergoing angioplasty of BTK lesions. Patients were either treated with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic Invatec) or a conventional uncoated balloon (Amphirion Deep, Medtronic Invatec).

As reported in TCT Daily, the study was designed to enroll patients with a total of 150 lesions. At the TCT meeting, the investigators presented 1-year follow-up data on 51 patients with 66 lesions, including 30 lesions in the paclitaxel-eluting balloon arm and 36 lesions in the conventional balloon group. The two groups were similar with regard to Rutherford class as well as clinical and procedural characteristics.


The investigators found that at 1 year, mortality was higher in the conventional balloon group (five deaths) versus the paclitaxel-coated balloon (three deaths), as was restenosis, which was assessed by angiography in 53 lesions and by duplex ultrasound in 10 lesions. Overall, restenosis occurred in 27% of patients in the paclitaxel-eluting balloon group compared with 63% in the conventional balloon group (P = .01). Similarly, reocclusion was present in significantly more patients in the conventional balloon arm (44% vs 19%; P = .02). No major amputations were required in either group.

“If our results [are] confirmed by the end of the study, drug-eluting balloon angioplasty could be the standard treatment for [BTK] intervention, and reintervention will be significantly decreased,” Dr. Liistro stated to TCT Daily.