Division of Angiology, Department of Internal Medicine, Neurology and Dermatology, University Hospital Leipzig, Leipzig, Germany.
Department of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
J Am Coll Cardiol. 2019 Feb 19;73(6):667-679. doi: 10.1016/j.jacc.2018.11.039.
Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing.
The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months.
Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes.
More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months.
Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441).
与标准球囊血管成形术相比，药物洗脱支架（DES）和药物涂层球囊（DCB）治疗股腘动脉病变的随机试验报告显示这两种策略的通畅率均更高。迄今为止，尚缺乏头对头比较。
作者旨在通过 36 个月的时间比较股腘动脉病变中 DES 与 DCB 的疗效。
在一项多中心、随机试验中，150 例有症状的股腘动脉疾病患者根据病变长度（≤10 cm、>10 cm 至≤20 cm 和>20 cm 至≤30 cm）分层后，随机分配至初次 DES 植入或 DCB 血管成形术联合保肢支架置入。主要有效性终点为 12 个月时通过 Kaplan-Meier 评估的一期通畅率。次要终点包括主要不良事件，包括死亡、主要截肢和临床驱动的靶病变血运重建，以及临床结局。
超过一半的病变为完全闭塞，DCB 组的支架置入率为 25.3%。DES 和 DCB 的 12 个月 Kaplan-Meier 估计一期通畅率分别为 79%和 80%（p=0.96），但 36 个月时分别降至 54%和 38%（p=0.17）。12 个月时，两组的临床驱动的靶病变血运重建率均>90%，但 36 个月时均降至 70%左右。总体而言，36 个月时的死亡率为 7.3%，DCB 组有 1 例与操作相关的死亡。36 个月时临床结局持续改善。
12 个月的通畅率表明，DES 与 DCB 加保肢支架置入治疗股腘动脉病变的疗效和安全性相当；DES 至 36 个月时呈有利趋势。（随机评估 Zilver PTX 支架与紫杉醇洗脱球囊治疗症状性外周动脉疾病股腘动脉病变的疗效[REAL PTX]；NCT01728441）。
