Department of Vascular Surgery, Xuanwu Hospital, Capital Medical University, Beijing 100053, China.
Biomed Res Int. 2020 Jun 10;2020:3076346. doi: 10.1155/2020/3076346. eCollection 2020.
The purpose of this article was to compare the efficiency and safety of drug-coated balloon angioplasty (DCB) and atherectomy with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal in-stent restenosis (ISR). Pubmed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) (all up to March 2019) were searched systematically. Trial sequential analysis (TSA) was conducted. 5 studies with 599 participants were included. Compared with PTA, DCB significantly increased the rate of patency (6 months: RR 1.65, 95% CI 1.30 to 2.09, < 0.01; 12 months: RR 2.38, 95% CI 1.71 to 3.30, < 0.01) and the rate freedom from target lesion revascularization (TLR) (6 months: RR 1.18, 95% CI 1.09 to 1.28, < 0.01; 12 months: RR 1.56, 95% CI 1.33 to 1.82, < 0.01) at 6 and 12 months follow-up, and the TSA results showed these outcomes were reliable. The rate of clinical improvement by ≥1 Rutherford category in the DCB group was higher than that in the PTA group (6 months: RR 1.35, 95% CI 1.03 to 1.75, = 0.03; 12 months: RR 1.46, 95% CI 1.17 to 1.82, < 0.01) at 6 and 12 months. There is no statistically difference of ABI, all-cause mortality, and incidence of amputation between DCB group and PTA group (MD 0.03, 95% CI -0.03 to 0.08, = 0.40; RR 1.24, 95% CI 0.46 to 3.34, = 0.67; RR 0.32, 95% CI 0.01 to 7.61, = 0.48). Compared with PTA, the rate of patency and freedom from TLR in the laser atherectomy (LD) group was higher than that in the PTA group (patency: 6 months: RR 1.28, 95% CI 1.01 to 1.64, < 0.05, 12 months: RR 2.25, 95% CI 1.14 to 4.44, < 0.05; freedom from TLR: 6 months: RR 1.27, 95% CI 1.05 to 1.53, = 0.01, 12 months: RR 1.59, 95% CI 1.12 to 2.25, = 0.01) at 6 and 12 months follow-up. In conclusion, DCB and LD had superior clinical (freedom from TLR and clinical improvement) and angiographic outcomes (patency rate) compared with PTA for the treatment of femoropopliteal ISR. Moreover, DCB and LD had a low incidence of amputation and mortality and were relatively safe methods.
本文旨在比较药物涂层球囊血管成形术（DCB）与经皮腔内血管成形术（PTA）治疗股腘动脉支架内再狭窄（ISR）的疗效和安全性。系统检索了PubMed、Embase 和 Cochrane 中心对照试验注册库（CENTRAL）（均截至 2019 年 3 月）。进行了试验序贯分析（TSA）。纳入了 5 项研究共 599 名参与者。与 PTA 相比，DCB 显著提高了通畅率（6 个月：RR 1.65，95%CI 1.30 至 2.09，<0.01；12 个月：RR 2.38，95%CI 1.71 至 3.30，<0.01）和免于靶病变血运重建率（TLR）（6 个月：RR 1.18，95%CI 1.09 至 1.28，<0.01；12 个月：RR 1.56，95%CI 1.33 至 1.82，<0.01），6 和 12 个月随访时，TSA 结果表明这些结果是可靠的。DCB 组临床改善≥1 个 Rutherford 级别的比例高于 PTA 组（6 个月：RR 1.35，95%CI 1.03 至 1.75，=0.03；12 个月：RR 1.46，95%CI 1.17 至 1.82，<0.01）。6 和 12 个月时，ABI、全因死亡率和截肢发生率在 DCB 组和 PTA 组之间无统计学差异（MD 0.03，95%CI -0.03 至 0.08，=0.40；RR 1.24，95%CI 0.46 至 3.34，=0.67；RR 0.32，95%CI 0.01 至 7.61，=0.48）。与 PTA 相比，激光动脉粥样斑块切除术（LD）组的通畅率和免于 TLR 率均高于 PTA 组（通畅率：6 个月：RR 1.28，95%CI 1.01 至 1.64，<0.05；12 个月：RR 2.25，95%CI 1.14 至 4.44，<0.05；免于 TLR：6 个月：RR 1.27，95%CI 1.05 至 1.53，=0.01；12 个月：RR 1.59，95%CI 1.12 至 2.25，=0.01）。结论：与 PTA 相比，DCB 和 LD 治疗股腘动脉支架内再狭窄具有更好的临床（免于 TLR 和临床改善）和血管造影结果（通畅率）。此外，DCB 和 LD 截肢和死亡率较低，是相对安全的方法。
