Department of Vascular Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, PR China.
Department of Vascular Surgery, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, PR China.
Int J Surg. 2017 Jun;42:72-82. doi: 10.1016/j.ijsu.2017.04.057. Epub 2017 Apr 29.
Several prospective controlled trials have assessed the safety and efficacy of drug-coated balloon angioplasty (DCBA) versus standard balloon angioplasty (POBA) for femoropopliteal in-stent restenosis (ISR). We therefore performed a meta-analysis of prospective controlled trials to pool the results of these trials and obtain more reliable conclusions.
Prospective controlled trials comparing DCBA versus POBA were searched through PubMed, EMBASE, the Cochrane Central Register of Controlled Trials, ISI Web of Knowledge, and relevant websites without language or publication date restrictions. The keywords were "drug-eluting balloon," "angioplasty," "femoropopliteal," and "in-stent restenosis." We selected recurrent ISR, freedom from clinically driven target lesion revascularization (TLR), clinical improvement, ankle-brachial index (ABI), and major adverse events (MAEs) as the outcomes of this meta-analysis. Based on the inclusion criteria, we identified 3 prospective clinical trials. The one-year outcomes of DCBA and POBA were as follows: recurrent ISR (34.8% versus 73.1%, respectively; OR, 0.18; 95% CI, 0.10-0.32, Z = 5.56, P < 0.00001), freedom from clinically driven TLR (82.2% versus 54.1%, respectively; OR, 4.20; 95% CI, 2.05-8.61, Z = 3.92, P < 0.0001), clinical improvement (76.2% versus 55.7%, respectively; OR, 2.58; 95% CI, 1.41-4.72, Z = 3.07, P = 0.002), ABI (MD, -0.04; 95% CI, -0.13-0.04, Z = 1.01, P = 0.31), and MAEs (11.0% versus 18.3%, respectively; OR, 0.54; 95% CI, 0.25-1.15, Z = 1.60, P = 0.002).
For femoropopliteal ISR, DCBA is associated with superior efficacy outcomes compared with POBA, with the same safety outcome after a one-year follow-up. In the future, multicenter and large-scale prospective controlled trials comparing DCBA with other endovascular strategies are required to further assess the efficacy and safety profiles of DCBA in the treatment of femoropopliteal ISR.
已有几项前瞻性对照试验评估了药物涂层球囊血管成形术（DCBA）与标准球囊血管成形术（POBA）治疗股腘段支架内再狭窄（ISR）的安全性和疗效。因此，我们进行了一项荟萃分析，以汇总这些试验的结果，得出更可靠的结论。
通过 PubMed、EMBASE、Cochrane 对照试验中心注册库、ISI Web of Knowledge 和相关网站，无语言或出版日期限制，检索比较 DCBA 与 POBA 的前瞻性对照试验。关键词为“药物洗脱球囊”、“血管成形术”、“股腘”和“支架内再狭窄”。我们选择再狭窄、无临床驱动的靶病变血运重建（TLR）、临床改善、踝肱指数（ABI）和主要不良事件（MAE）作为该荟萃分析的结果。根据纳入标准，我们确定了 3 项前瞻性临床试验。DCBA 和 POBA 的一年结果如下：再狭窄（分别为 34.8%和 73.1%；OR，0.18；95%CI，0.10-0.32，Z=5.56，P<0.00001）、无临床驱动的 TLR（分别为 82.2%和 54.1%；OR，4.20；95%CI，2.05-8.61，Z=3.92，P<0.0001）、临床改善（分别为 76.2%和 55.7%；OR，2.58；95%CI，1.41-4.72，Z=3.07，P=0.002）、ABI（MD，-0.04；95%CI，-0.13-0.04，Z=1.01，P=0.31）和 MAE（分别为 11.0%和 18.3%；OR，0.54；95%CI，0.25-1.15，Z=1.60，P=0.002）。
对于股腘段 ISR，与 POBA 相比，DCBA 具有更好的疗效，一年随访后安全性相当。未来需要多中心、大规模的前瞻性对照试验比较 DCBA 与其他血管内治疗策略，以进一步评估 DCBA 治疗股腘段 ISR 的疗效和安全性。
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