1 Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
2 Department of Biomedical Statistics, Osaka University Graduate School of Medicine, Osaka, Japan.
J Endovasc Ther. 2018 Jun;25(3):306-312. doi: 10.1177/1526602818771358. Epub 2018 Apr 30.
To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy.
The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test.
The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95).
These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.
研究西洛他唑治疗经血管内治疗的间歇性跛行患者的中期安全性和有效性。
西洛他唑充分治疗外周介入（STOP-IC）研究（ClinicalTrials.gov 标识符 NCT00912756；大学医院医疗信息网络标识符 UMIN000002091）纳入了 200 名（平均年龄 73 岁；131 名男性）于 2009 年 3 月至 2011 年 4 月在日本 13 个心血管中心接受股腘疾病治疗的患者。参与者以 1:1 的比例随机接受口服阿司匹林加或不加西洛他唑。在被分配到 2 个治疗组的 100 名患者中，西洛他唑组的 7 名患者和无西洛他唑组的 2 名患者在未进行血管内治疗的情况下退出了研究，留下西洛他唑组的 93 名患者和无西洛他唑组的 98 名患者进行随访分析。主要终点为原发性通畅率；次要终点为无临床驱动的靶病变血运重建（CD-TLR）和总生存率。采用 Kaplan-Meier 法进行意向治疗分析；估计值采用对数秩检验进行比较。
中位随访时间为 38.1 个月（四分位距 25.1，47.7）。在西洛他唑组的 93 名患者中，7 人死亡，26 人在血管内手术后 1 年停止用药。停用西洛他唑不是再狭窄的显著因素。西洛他唑组的原发性通畅率显著高于无西洛他唑组（69%比 54%，p=0.026），3 年时差异仍有统计学意义。西洛他唑组 3 年无 CD-TLR 的比例也较好（78%比 63%，p=0.014），尽管总生存率的估计值无显著差异（p=0.95）。
这些结果表明，西洛他唑治疗股腘疾病血管内治疗患者的安全性和有效性得以维持。
