Author + information
- Received May 3, 2013
- Revision received July 12, 2013
- Accepted July 17, 2013
- Published online December 1, 2013.
- Francesco Liistro, MD∗∗ (, )
- Simone Grotti, MD∗,†,
- Italo Porto, MD∗,
- Paolo Angioli, MD∗,
- Lucia Ricci, MD‡,
- Kenneth Ducci, MD∗,
- Giovanni Falsini, MD∗,
- Giorgio Ventoruzzo, MD∗,
- Filippo Turini, MD∗,
- Guido Bellandi, MD∗ and
- Leonardo Bolognese, MD∗
- ∗Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy
- †Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy
- ‡Diabetes Unit, San Donato Hospital, Arezzo, Italy
- ↵∗Reprint requests and correspondence:
Dr. Francesco Liistro, Cardiovascular and Neurologic Department, San Donato Hospital, Via Pietro Nenni 20, 52100 Arezzo, Italy.
Objectives 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)
All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received May 3, 2013.
- Revision received July 12, 2013.
- Accepted July 17, 2013.
- American College of Cardiology Foundation