Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany.
Division of Angiology, Department of Internal Medicine, Universitätsklinikum LKH Graz, Graz, Austria.
JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361. doi: 10.1016/j.jcin.2021.04.010.
The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease.
Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification.
The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting.
In patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups.
IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).
本研究旨在比较股腘动脉钙化患者在接受药物涂层球囊（DCB）治疗前，接受血管内碎石术（IVL）或经皮腔内血管成形术（PTA）行血管准备的短期治疗效果，这些患者患有症状性外周动脉疾病。
在外周动脉钙化病变的血管内治疗中，血管扩张效果并不理想，且并发症风险增加。尽管已经有关于 IVL 单臂研究的初步结果，但在存在严重钙化的情况下，大多数设备的随机试验对比证据仍缺乏。
Disrupt PAD III（冲击波医学外周碎石系统治疗 PAD 研究）是一项随机试验，纳入了股腘动脉中有中度或重度钙化的患者，这些患者在接受 DCB 或支架置入术前行 IVL 或 PTA 血管准备。主要终点是在 DCB 或支架置入术前，经核心实验室判定的程序成功（残余狭窄率≤30%，无血流限制夹层）。
在接受 IVL（n=153）或 PTA（n=153）治疗的患者中，IVL 组的手术成功率更高（65.8% vs. 50.4%；p=0.01），残余狭窄率≤30%的病变比例也更高（66.4% vs. 51.9%；p=0.02），而 PTA 组的血流限制夹层更为常见（1.4% vs. 6.8%；p=0.03）。PTA 组的后扩张（5.2% vs. 17.0%；p=0.001）和支架置入（4.6% vs. 18.3%；p<0.001）也更多。两组 30 天主要不良事件（IVL：0% vs. PTA：1.3%；p=0.16）和临床驱动的靶病变血运重建率（IVL：0.7% vs. PTA：0.7%；p=1.0）相当。
IVL 是一种有效的血管准备策略，可促进外周动脉疾病患者钙化股腘动脉的确定性血管内治疗。（冲击波医学外周碎石系统治疗 PAD 研究[Disrupt PAD III]；NCT02923193）。
