A new paclitaxel-eluting balloon for angioplasty of femoropopliteal obstructions: acute and midterm results.
OBJECTIVE
To evaluate safety and results of the Freepac drug-eluting balloon (DEB) technology for the treatment of chronic femoropopliteal steno-occlusions.


RESULTS
In a multicentre registry we enrolled 66 patients with symptomatic femoropopliteal stenosis and/or occlusion <15 cm (Rutherford stages 2 to 4). Patients were treated first with an undersized uncoated balloon and then with an appropriate sized DEB. In case of unsatisfactory results, nitinol stents were implanted. Clinical evaluations and echo-duplex were performed at baseline, at discharge, and at three months after intervention. Procedural success was 100%. Stents were implanted in 10.8% of the patients. At three months follow-up, the mean ankle-brachial index (ABI) significantly improved from 0.58 ± 0.13 to 0.82 ± 0.25, thus resulting in a Rutherford class improvement (p <0.01) and amelioration of the claudication distance (102 ± 87 vs. 403 ± 160 meters) (p<0.001). No serious adverse events occurred during the follow-up.


CONCLUSIONS
The results of this registry demonstrate the safety of mediated paclitaxel elution for the prevention of restenosis in the superficial femoral and popliteal arteries after angioplasty. This technique was associated with encouraging results in terms of clinical improvement as well as a lack of adverse events, including target lesion revascularisation, at three months.
GVM Care and Research, Palermo, Italy. antoniomicari@tiscali.it
Antonio
A
Micari
Angelo
A
Cioppa
Giuseppe
G
Vadalà
Eugenio
E
Stabile
Fausto
F
Castriota
Paolo
P
Pantaleo
Chiara
C
Grattoni
Alberto
A
Cremonesi
Alfredo
A
Marchese
Paolo
P
Rubino
Giancarlo
G
Biamino
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
D000497:Alloys; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; C013616:nitinol; D017239:Paclitaxel