Department of Cardiology, Kokura Memorial Hospital, Kitakyushu, Japan.
J Vasc Surg. 2011 Oct;54(4):1058-66. doi: 10.1016/j.jvs.2011.03.286. Epub 2011 Aug 31.
The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA).
This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group.
The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001).
New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.
本研究旨在探讨评估自膨式镍钛诺支架治疗股浅动脉（SFA）后原发性通畅率的临床分类方案的预测价值。
这是一项多中心回顾性研究，纳入了前瞻性数据库。2004 年 4 月至 2009 年 12 月，共纳入 1001 条肢体（807 例患者），这些肢体均因新发 SFA 病变而行成功的自膨式镍钛诺支架植入术。原发性通畅定义为治疗血管无再狭窄（定义为双功能超声检查的峰值收缩速度比>2.4）和重复血运重建。分类中包括 6 项：女性、糖尿病、透析、严重肢体缺血（CLI）、病变长度>150mm 和流出道不良；FeDCLIP 评分。病变长度>150mm 记为 2 分。其余每项记 1 分。0 至 2 分、3 至 4 分和≥5 分分别归类为低危、中危和高危患者。观察指标为每组患者的 6 年原发性和继发性通畅率以及全因死亡率。
平均随访时间为 26.8±14.6 个月。低危组、中危组和高危组患者的 1 年、3 年和 5 年原发性通畅率分别为 85.7%、77.3%和 74.2%；71.5%、54.7%和 51.9%；53.0%、24.3%和 20.8%。低危组、中危组和高危组患者的 1 年、3 年和 5 年继发性通畅率分别为 94.6%、92.3%和 90.8%；89.5%、83.1%和 83.1%；82.7%、73.1%和 73.1%。三组间原发性和继发性通畅率差异均有统计学意义（P<0.0001 和 P<0.0001）。低危组、中危组和高危组患者的 1 年、3 年和 5 年总生存率分别为 96.8%、89.5%和 81.8%；91.5%、74.4%和 68.7%；78.2%、63.2%和 48.7%。三组间死亡率差异也有统计学意义（P<0.0001）。
基于 FeDCLIP 评分的新分类方案可用于评估自膨式镍钛诺支架治疗 SFA 疾病后的血管通畅率和死亡率的风险分层。
