Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery).
OBJECTIVE
This study sought to compare paclitaxel-eluting balloon (PEB) with conventional percutaneous transluminal angioplasty (PTA), followed by systematic implantation of a self-expanding nitinol bare-metal stent (BMS) in patients at risk for restenosis.


BACKGROUND
PTA is an effective strategy for treating atherosclerosis of the femoropopliteal axis (FPA). Whereas PEB have shown advantage over uncoated balloons in the treatment of simple lesions, it is unknown whether these results are applicable to complex degrees of FPA atheroma.


METHODS
A total of 104 patients (110 FPA lesions in 110 limbs) were randomly assigned to either PEB + BMS or PTA + BMS. The primary endpoint was 12-month binary restenosis. Secondary endpoints were freedom from target lesion revascularization and major amputation. Post hoc subanalyses were performed for the comparison of long (≥100 mm) versus short lesions and true lumen versus subintimal approach.


RESULTS
Mean lesion length was 94 ± 60 versus 96 ± 69 mm in the PEB + BMS and PTA + BMS groups (p = 0.8), respectively. The primary endpoint occurred in 9 (17%) versus 26 (47.3%) of lesions in the PEB + BMS and PTA + BMS groups (p = 0.008), respectively. A near-significant (p = 0.07) 1-year freedom from target lesion revascularization advantage was observed in the PEB + BMS group. No major amputation occurred. No significant difference was observed according to lesion characteristics or technical approach.


CONCLUSIONS
Pre-dilation with PEB angioplasty prior to BMS implantation, as compared to PTA + BMS in complex FPA lesions, reduces restenosis and target lesion revascularization at 12-month follow-up. Restenosis reduction is maintained irrespective of lesion length and recanalization technique. (Drug Eluting Balloon in Peripheral Intervention for the Superficial Femoral Artery [DEBATE-SFA]; NCT01556542).
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy. Electronic address: francescoliistro@hotmail.com.
Francesco
F
Liistro
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy; Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy.
Simone
S
Grotti
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Italo
I
Porto
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Paolo
P
Angioli
Diabetes Unit, San Donato Hospital, Arezzo, Italy.
Lucia
L
Ricci
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Kenneth
K
Ducci
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Giovanni
G
Falsini
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Giorgio
G
Ventoruzzo
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Filippo
F
Turini
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Guido
G
Bellandi
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Leonardo
L
Bolognese
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000671:Amputation, Surgical; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011859:Radiography; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
D000497:Alloys; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; C013616:nitinol; D017239:Paclitaxel
BMS; CLI; DAPT; DEB; DES; DUS; FPA; ISR; LLL; PEB; PTA; TLR; bare-metal stent(s); critical limb ischemia; drug-eluting balloon; drug-eluting balloon(s); drug-eluting stent(s); dual antiplatelet therapy; duplex ultrasonography; femoropopliteal axis; in-stent restenosis; late lumen loss; paclitaxel-eluting balloon(s); percutaneous transluminal angioplasty; peripheral arterial disease; restenosis stent(s); target lesion revascularization(s)