Objectives: To establish a grading model on prognosis of drug-coated balloon (DCB) treatment on femoropopliteal de novo lesions, and assess whether patients at high risk could benefit from combination of directional atherectomy(DA). Methods: The clinical data of 114 patients with femoropopliteal de novo lesions admitted to Department of Vascular Surgery, Peking University People's Hospital from October 2015 to January 2019 were collected retrospectively. There were 95 patients(108 limbs) underwent DCB treatment, including 66 males and 29 females, aged 71.9 years old(range:48 to 91 years), and 19 patients (21 limbs) underwent DA combined with DCB treatment, including 13 males and 6 females, aged 69.5 years old(range: 62 to 80 years). The demographic data, intraoperative and postoperative conditions of the patients were collected. Cox regression model was performed for modeling and then goodness of fit was tested. Kaplan-Meier estimate was carried out between the two groups for patients at high risk and low risk, respectively. Results: All patients were followed up for more than 24 months. Restenosis occurred on 34 limbs in DCB group and 3 limbs in DA+DCB group. Severe calcification(HR=3.804, 95%CI:2.460 to 5.883), popliteal artery involvement (HR=2.104, 95%CI:1.368 to 3.236), long lesion (HR=1.824, 95%CI:1.196 to 2.780), poor runoff(HR=1.736, 95%CI:1.025 to 2.940), chronic kidney disease(HR=1.601, 95%CI:1.040 to 2.463) were independent risk factors of restenosis after DCB treatment, and were defined 3, 2, 1, 1 and 1 points, respectively. Total points≥3 was regarded as high risk group. Kaplan-Meier analysis showed that patients in low risk group did not benefit from DA+DCB comparing with DCB with regard to primary patency at 24 months (77.78% vs. 90.31%, P=0.271) while patients benefited from DA+DCB comparing with DCB in high risk group(88.26% vs. 20.80%, P<0.01). Conclusions: The grading model shows satisfying clinical value. The clinical effect of DA+DCB is better than DCB along in high risk group. Patients at high risk are supposed to receive aggressive vessel preparation like DA.
目的： 构建药物涂层球囊（DCB）治疗原发性股腘动脉硬化性闭塞症的预后评分模型，并探讨高危患者从联合定向经皮腔内斑块旋切术（DA）中的获益。 方法： 回顾性分析2015年10月至2019年1月北京大学人民医院血管外科收治的114例原发性股腘动脉硬化性闭塞症患者的临床资料。接受单纯DCB治疗患者95例（108条患肢），其中男性66例，女性29例，平均年龄71.9岁（范围：48~91岁）；接受DCB联合DA治疗患者19例（21条患肢），男性13例，女性6例，平均年龄69.5岁（范围：62~80岁）。收集患者的一般资料、术中及术后情况等。应用单因素Cox回归分析筛选可能影响患者DCB治疗后再狭窄的相关因素，应用多因素Cox回归分析构建评分模型并进行拟合优度检验，随后用Kaplan-Meier生存分析模型及Log-rank检验比较高危组和低危组患者行DCB联合DA治疗的一期通畅率情况。 结果： 114例患者均获得>24个月随访，单纯DCB治疗组发生靶病变狭窄（≥50%直径）34例次，DCB联合DA组发生靶病变狭窄3例次。多因素分析结果显示，重度钙化（HR=3.804，95%CI：2.460~5.883）、腘动脉受累（HR=2.104，95%CI：1.368~3.236）、病变长度≥15 cm（HR=1.824，95%CI：1.196~2.780）、流出道评分≥7分（HR=1.736，95%CI：1.025~2.940）及慢性肾脏病（HR=1.601，95%CI：1.040~2.463）是单纯DCB治疗后再狭窄的独立预后因素，分别赋予3、2、1、1、1分，若患肢的总评分≥3分则被定义为高危组。生存分析结果显示，低危组患肢中，单纯DCB治疗术后24个月的一期通畅率为90.31%，DA+DCB治疗术后24个月的一期通畅率为77.78%，差异无统计学意义（P=0.271）；高危组患肢中，单纯DCB治疗术后24个月的一期通畅率为20.80%，DA+DCB治疗术后24个月的一期通畅率为88.26%，差异有统计学意义（P<0.01）。 结论： 该评分模型有较好的临床应用价值，高危组患者应用DCB联合DA治疗，效果优于单纯DCB治疗，应积极考虑开展高危患者的联合治疗。.