Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
Cardiovascular and Neurologic Department, San Donato Hospital, Arezzo, Italy.
J Am Coll Cardiol. 2019 Jul 16;74(2):205-215. doi: 10.1016/j.jacc.2019.04.057.
Drug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available.
The aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis.
Patients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation.
A total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50).
DCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630).
药物洗脱技术改善了股腘动脉（FP）介入治疗的 12 个月血管造影结果，但关于药物涂层球囊（DCB）和药物洗脱支架（DES）之间比较的数据很少。
本研究旨在比较在球囊预扩张后，对高 FP 再狭窄风险患者，DCB 后序贯临时自膨式镍钛诺裸金属支架植入的策略与系统 DES 植入的策略。
接受 FP 介入治疗的间歇性跛行或严重肢体缺血患者，在成功的目标病变预扩张后，按 1:1 随机分配至 DCB 或 DES 组。主要终点是 12 个月时的目标病变二分类再狭窄，采用多普勒超声评估。次要终点是无目标病变血运重建和免于主要截肢。
共纳入 192 例患者，96 例 DCB 组，96 例 DES 组，225 条肢体 240 处病变。两组均有>50%的患者合并糖尿病和严重肢体缺血。平均病变长度为 14cm，基线时目标病变闭塞率约为两组的 60%。与 DCB 相比，系统 DES 策略可获得更大的术后最小管腔直径，且残余夹层的发生率较低，而 DCB 仅在 21%的病变中使用镍钛诺支架。12 个月时，DCB 组有 22%的患者和 DES 组有 21%的患者出现目标病变再狭窄（p=0.90）。DCB 组有 14%的患者和 DES 组有 17%的患者需要进行临床驱动的目标病变血运重建（p=0.50）。
在高危人群中，DCB 并不优于 DES 治疗复杂的 FP 病变，其再狭窄和临床驱动的目标病变血运重建发生率相似。（紫杉醇洗脱球囊血管成形术联合临时使用镍钛诺支架与系统植入紫杉醇洗脱支架治疗股腘动脉新发病变；NCT01969630）
