Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy; Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy.
JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.
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.
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.
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.
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.
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).
本研究旨在比较紫杉醇洗脱球囊（PEB）与传统经皮腔内血管成形术（PTA）在易发生再狭窄的患者中的疗效，前者在 PTA 后序贯植入自膨式镍钛诺裸金属支架（BMS）。
PTA 是治疗股腘动脉（FPA）粥样硬化的有效策略。虽然 PEB 在治疗单纯病变方面优于无涂层球囊，但尚不清楚这些结果是否适用于 FPA 粥样硬化的复杂程度。
共纳入 104 例患者（110 条肢体 110 处 FPA 病变），随机分为 PEB+BMS 组或 PTA+BMS 组。主要终点为 12 个月时的二元再狭窄。次要终点为免于靶病变血运重建和主要截肢。进行了亚组分析，比较了长病变（≥100mm）与短病变，以及真腔与内膜下技术。
PEB+BMS 组和 PTA+BMS 组的平均病变长度分别为 94±60mm 和 96±69mm（p=0.8）。PEB+BMS 组和 PTA+BMS 组的主要终点发生率分别为 9（17%）例和 26（47.3%）例（p=0.008）。PEB+BMS 组 1 年免于靶病变血运重建的优势接近显著（p=0.07）。无主要截肢。根据病变特征或技术方法，未观察到显著差异。
与 PTA+BMS 相比，在复杂的 FPA 病变中，在 BMS 植入前先行 PEB 血管成形术预扩张，可降低 12 个月时的再狭窄和靶病变血运重建发生率。再狭窄减少的效果保持不变，与病变长度和再通技术无关。（药物洗脱球囊在股浅动脉外周介入中的应用[DEBATE-SFA]；NCT01556542）。
