Giannopoulos Stefanos, Strobel Aaron, Rudofker Eric, Kovach Christopher, Kokkosis Angela A, Armstrong Ehrin J
Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado Denver, Denver, CO, USA.
Division of Vascular and Endovascular Surgery, Department of Surgery, Stony Brook University Hospital, Stony Brook, NY, USA.
J Endovasc Ther. 2023 Apr;30(2):194-203. doi: 10.1177/15266028221079770. Epub 2022 Feb 18.
Drug-coated balloon (DCB) angioplasty has been increasingly used for the treatment of lower limb peripheral artery disease (PAD). However, bail-out stenting may be necessary in cases of suboptimal angioplasty. This study investigated the outcomes of femoropopliteal disease treated with DCB with/without bail-out stenting.
This was a single-center retrospective study enrolling 166 consecutive patients (DCB+stent: n=81 vs DCB: n=85) with 253 femoropopliteal lesions (DCB+stent: n=99 vs DCB: n=154) treated with DCB with/without stenting. Bail-out stenting was performed at the operator discretion for postangioplasty dissections or otherwise suboptimal angiographic result (>30% residual stenosis). Cox regression analysis was performed to examine the outcomes of DCB with/without stenting during 2-year follow-up.
The baseline clinical characteristics were similar between the 2 groups. About half of the patients presented with critical limb ischemia, with most of the lesions located at the superficial femoral artery. The overall mean lesion length was 147±67 mm. The most frequent bail-out stent types were bare metal stents (BMS) (53.5%) followed by drug-eluting stents (DES) (41.4%). Lesions requiring bail-out stenting were on average longer (177±67 mm vs 127±59 mm; p<0.01) and on average had higher prevalence of flow-limiting postangioplasty dissections. The overall procedural success rate was 94% without any differences between the 2 groups. Both the stented and nonstented treatment modalities were effective and safe, demonstrating similar rates of 2-year freedom from major adverse limb event (stented: 71.3% vs nonstented: 64.4%) and 2-year freedom from target lesion revascularization (stented: 77.1% vs nonstented: 72.3%) during following up. The use of DES as bail-out therapy was associated with a lower risk of 2-year death compared with the use of BMS (DES: 97.2% vs BMS: 75.8%; p=0.01).
Drug-coated balloon with bail-out stenting is a viable treatment option for cases of suboptimal DCB results, promising similar efficacy with DCB-alone procedures. However, as the patency of stents at the femoropopliteal segment may be a challenge due to the biomechanical stress of the artery, the efficacy of DCB+bail-out stenting should be further evaluated. In addition, future studies are needed to determine which grades of post-DCB dissections should be treated and optimize current bail-out strategies.
药物涂层球囊（DCB）血管成形术已越来越多地用于治疗下肢外周动脉疾病（PAD）。然而，在血管成形术效果欠佳的情况下，可能需要补救性支架置入术。本研究调查了采用DCB治疗伴或不伴补救性支架置入术的股腘动脉疾病的疗效。
这是一项单中心回顾性研究，纳入了166例连续患者（DCB+支架组：n=81 vs DCB组：n=85），其253个股腘动脉病变（DCB+支架组：n=99 vs DCB组：n=154）接受了伴或不伴支架置入术的DCB治疗。补救性支架置入术由术者根据血管成形术后夹层情况或其他血管造影结果欠佳（残余狭窄>30%）自行决定实施。进行Cox回归分析以检验伴或不伴支架置入术的DCB在2年随访期间的疗效。
两组的基线临床特征相似。约一半患者表现为严重肢体缺血，大多数病变位于股浅动脉。病变的总体平均长度为147±67mm。最常用的补救性支架类型是裸金属支架（BMS）（53.5%），其次是药物洗脱支架（DES）（41.4%）。需要补救性支架置入术的病变平均更长（177±67mm vs 127±59mm；p<0.01），血管成形术后夹层导致血流受限的发生率平均更高。总体手术成功率为94%，两组之间无差异。支架置入和非支架置入治疗方式均有效且安全，在随访期间显示出相似的2年无主要肢体不良事件发生率（支架置入组：71.3% vs 非支架置入组：64.4%）和2年无靶病变血运重建率（支架置入组：77.1% vs 非支架置入组：72.3%）。与使用BMS相比，使用DES作为补救治疗与较低的2年死亡率相关（DES：97.2% vs BMS：75.8%；p=0.01）。
对于DCB效果欠佳的病例，药物涂层球囊联合补救性支架置入术是一种可行的治疗选择，有望与单纯DCB手术具有相似的疗效。然而，由于动脉的生物力学应力，股腘段支架的通畅性可能是一个挑战，DCB+补救性支架置入术的疗效应进一步评估。此外，需要未来的研究来确定哪些等级的DCB术后夹层应接受治疗并优化当前的补救策略。
