“DEBELLUM”——药物洗脱球囊治疗下肢多节段病变——随机试验：1年结果
The "DEBELLUM"--lower limb multilevel treatment with drug eluting balloon--randomized trial: 1-year results.
作者信息
Fanelli F, Cannavale A, Corona M, Lucatelli P, Wlderk A, Salvatori F M
机构信息
Unit of Vascular and Interventional Radiology Department of Radiological Sciences "Sapienza" University of Rome, Rome, Italy -
出版信息
J Cardiovasc Surg (Torino). 2014 Apr;55(2):207-16.
AIM
The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial.
METHODS
From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group.
RESULTS
One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05).
CONCLUSION
Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.
目的
本文旨在报告DEBELLUM（药物洗脱球囊评估下肢多级治疗）随机试验的12个月临床结果。
方法
2010年9月至2011年3月，50例患者被随机分为药物洗脱球囊组（DEB，n = 25）和传统血管成形术球囊组（PTA，n = 25）。患者有间歇性跛行和严重肢体缺血症状，股腘动脉（SFA）和腘以下动脉（BTK）区域有新发狭窄或闭塞。仅在SFA允许进行初次支架置入，并根据分配的组用DEB或PTA进行后扩张。
结果
共治疗122处病变：92处（75.4%）在SFA，30处（24.6%）在BTK。20例（40%）患者同时存在股腘动脉和腘以下动脉多级病变。DEB组晚期管腔丢失（LLL）为0.64±0.9mm，对照组为1.81±0.1mm（P = 0.01）。在非支架段，LLL为0.63±0.9mm（DEB） vs. 1.70±0.6mm（PTA），P<0.01。在支架亚组中，LLL为0.65±0.2mm（DEB） vs. 1.91±0.3mm（PTA），P<0.01。在股腘动脉区域，DEB的总体LLL为0.61±0.8mm，PTA为1.84±0.3mm（P = 0.02）。在BTK，总体LLL为0.66±0.9mm（DEB） vs. 1.69±0.5mm（PTA）（P = 0.03）。总体靶病变血运重建率（TLR），DEB为12.2%，PTA为35.3%（P<0.05）。截肢率，DEB为4%，PTA为12%，P = 0.36。血栓形成率，DEB为4%，PTA为8%，P≥0.05。主要不良事件，DEB为24%，PTA为60%，P<0.05。DEB组踝肱指数（ABI）改善更明显：0.81±0.3 vs. 0.68±0.13（P = 0.02）。Fontaine分期改善（从IIb期升至I期），DEB组为80%，PTA组为56%（P<0.05）。
结论
结果证实并强化了最初6个月的结果。In.Pact DEB球囊可被认为能有效降低再狭窄率。
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