Vascular and Interventional Radiology Unit, Department of Radiological Sciences, Sapienza University of Rome, Italy.
J Endovasc Ther. 2012 Oct;19(5):571-80. doi: 10.1583/JEVT-12-3926MR.1.
To report 6-month results of the DEBELLUM (Drug-Eluting Balloon Evaluation for Lower Limb MUltilevel TreatMent) randomized trial to evaluate the efficacy of a drug-eluting balloon (DEB) to reduce restenosis after treatment of multilevel lower limb occlusive disease vs. a conventional angioplasty balloon (AB).
Between September 2010 and March 2011, 50 consecutive patients (37 men; mean age 66±4 years) with 122 lesions (96 stenoses and 26 occlusions) of the femoropopliteal (92, 75.4%) or below-the-knee (BTK) arteries (30, 24.6%) were enrolled and randomly assigned to the DEB (25 patients with 57 lesions) or AB (25 patients with 65 lesions) group. Twenty patients presented multilevel lesions. Mean lesion length was 7.5±3.5 cm. Thirty-one (62%) of the patients were Fontaine stage IIb, while 19 (38%) were stage III or IV. DEBs or ABs were used for dilation of de novo lesions or for postdilation after primary stenting (superficial femoral artery only). Patients requiring provisional stenting after angioplasty secondary to flow-limiting dissection or residual stenosis >50% were ineligible. Primary endpoint was late lumen loss at 6 months. Secondary endpoints were target lesion revascularization (TLR), amputation, and thrombosis.
Late lumen loss was lower in the DEB group (0.5±1.4 vs. 1.6±1.7 mm, p<0.01). TLR was necessary in 6.1% of the DEB group vs. 23.6% of the AB group (p=0.02). Comparing the DEB to AB groups, the thrombosis rates were 3.0% vs. 5.2% (p=0.6), and the amputation rates were 3.0% vs. 7.9% (p=0.36). The binary restenosis rates were 9.1% (3/33 limbs) in the DEB group vs. 28.9% (11/38 limbs) in the control group (p=0.03). The ankle-brachial index improved to a greater degree in the DEB group: 0.87±0.22 vs. 0.70±0.13 (p<0.05). The Fontaine stage improved in both groups but more so in patients treated with DEBs (p=0.04).
The DEBELLUM trial confirmed the ability of paclitaxel-eluting balloons to reduce restenosis vs. conventional balloons at 6 months after treatment of multilevel (femoropopliteal and BTK) arterial disease in patients affected by claudication and CLI. A lower TLR rate and better clinical outcomes appear to be associated with the use of DEBs regardless of stent placement.
报告 DEBELLUM（下肢多水平治疗的药物洗脱球囊评估）随机试验的 6 个月结果，以评估药物洗脱球囊（DEB）在降低多水平下肢闭塞性疾病治疗后的再狭窄率方面的疗效，与传统的血管成形球囊（AB）相比。
2010 年 9 月至 2011 年 3 月，连续纳入 50 例（37 例男性；平均年龄 66±4 岁）122 处（96 处狭窄和 26 处闭塞）股腘或膝下动脉（92 处，75.4%）或（30 处，24.6%）病变患者，并随机分为 DEB（25 例患者 57 处病变）或 AB（25 例患者 65 处病变）组。20 例患者存在多水平病变。平均病变长度为 7.5±3.5cm。31 例（62%）患者为 Fontaine Ⅱb 期，19 例（38%）为Ⅲ或Ⅳ期。DEB 或 AB 用于扩张新发病变或用于初次支架置入后的后扩张（仅股浅动脉）。由于血流受限夹层或残余狭窄>50%导致血管成形术后需要临时支架置入的患者不符合入组条件。主要终点为 6 个月时的晚期管腔丢失。次要终点为靶病变血运重建（TLR）、截肢和血栓形成。
DEB 组晚期管腔丢失较低（0.5±1.4 vs. 1.6±1.7mm，p<0.01）。TLR 在 DEB 组的发生率为 6.1%，AB 组为 23.6%（p=0.02）。与 AB 组相比，DEB 组的血栓形成率为 3.0%vs.5.2%（p=0.6），截肢率为 3.0%vs.7.9%（p=0.36）。DEB 组的二元再狭窄率为 9.1%（3/33 条肢体），对照组为 28.9%（11/38 条肢体）（p=0.03）。DEB 组踝肱指数改善更明显：0.87±0.22 vs. 0.70±0.13（p<0.05）。两组的 Fontaine 分期均有所改善，但 DEB 治疗组改善更明显（p=0.04）。
DEBELLUM 试验证实，与传统球囊相比，紫杉醇洗脱球囊在治疗伴有间歇性跛行和 CLI 的患者的多水平（股腘和膝下）动脉疾病后 6 个月时能够降低再狭窄率。无论是否放置支架，较低的 TLR 率和更好的临床结果似乎与 DEB 的使用相关。
