DEB Promising in Critical Limb Ischemia, Femoropopliteal Arterial Disease

SAN FRANCISCO, CALIF.—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 vessels, according to results of separate abstracts from an Italian registry and the DEBATE-BTK trial.

“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,” said Antonio Micari, MD, of Villa Maria Eleonora Hospital, Palermo, Italy, who examined use of the balloons in treating femoropopliteal lesions.

Newer balloon succeeds where conventional one failed

Micari and colleagues looked at 12-month outcomes with the In.Pact Admiral paclitaxel-eluting balloon (Medtronic-Invatec) in 105 patients (114 lesions) enrolled in a prospective, observational, multicenter Italian registry who had Rutherford class 2, 3 or 4 femoropopliteal arterial disease.

Overall, the device was successfully deployed in all patients, with only 12.3% of lesions requiring stenting. At one year, target lesion revascularization (TLR) was 8.7% and quality of life and functional status were substantially improved at all time points with 88% of patients achieving Rutherford class 0 or 1. Researchers also reported a mean ankle-brachial index of 0.81 ± 0.4 at 12 months.

As a result of these findings, Micari said, “A new mindset is required by interventionalists to limit ‘liberal’ stenting. A strict provisional stent approach is needed, mainly limited to true flow limiting dissections.”

A response to the DEBATE

In the DEBATE-BTK study, Francesco Liistro, MD, of the San Donato Hospital, Arezzo, Italy, and fellow researchers examined diabetic patients with critical limb ischemia undergoing angioplasty of below-the-knee lesions. Patients were either treated with a paclitaxel-eluting balloon (In.Pact Amphirion, Invatec) or a conventional uncoated balloon (Amphirion Deep, Invatec).

Although slated to enroll patients with a total of 150 lesions, study researchers presented one-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. At one year, mortality was higher in the conventional balloon group (5 vs. 3), as was restenosis, which was assessed by angiography in 53 lesions and by Duplex Ultrasound in 10 lesions. Overall, restenosis occurred in 27% in the paclitaxel-eluting balloon group compared with 63% in the conventional balloon group (P=.01). Similarly, re-occlusion 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 [below-the-knee] intervention, and re-intervention will be significantly decreased,” Liistro told TCT Daily.

Disclosures
  • Drs. Liistro and Micari report no relevant conflicts of interest.

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