■评估慢性威胁肢体缺血(CLTI)患者的腹膜下病变的药物涂层球囊(DCB)血管成形术的6个月结果。
■我们分析了来自10个中心的PRIME-WIFI前瞻性注册的300名连续CLTI患者(33.000%女性)的6个月随访数据,这些患者接受了DCB血管成形术治疗膝下动脉病变。主要结果是无重大不良事件(MAE),严重截肢的复合材料,全因死亡,和临床驱动的目标肢体再干预(CD-TLR)。次要结局包括无截肢生存率(AFS),不受每个主要结果成分的影响,主要的持续临床改善,和生活质量(QOL)评分。采用Cox比例风险回归分析确定MAE的独立危险因素。
■用DCB治疗312个肢体的409个膝下病变,54.167%的四肢接受孤立的膝下病变治疗。通过Kaplan-Meier分析,术后6个月(随访率,85.000%),MAE的自由度为86.353%;AFS为90.318%;免于严重截肢的自由度,全因死亡,CD-TLR为96.429%,93.480%,和95.079%,分别。在6个月的随访中,83.590%的患者表现出主要的持续临床改善,QOL评分(4.902±1.388)较术前(2.327±1.109;p<0.001)改善。慢性肾功能不全,慢性阻塞性肺疾病,卢瑟福等级,术后膝下径流评分是6个月内MAE的独立危险因素。
■在CLTI中,膝下病变的DCB血管成形术可产生可接受的早期疗效和安全性。
结论:本研究通过分析多中心前瞻性数据,评估了DCB血管成形术在CLTI患者膝下病变中的6个月结局,显示可以在可接受的无MAE率的情况下进行膝下DCB血管成形术,无截肢生存率,免于严重截肢率,存活率,和不受CD-TLR率的影响。无患者经历DCB相关术中远端栓塞。慢性肾功能不全,慢性阻塞性肺疾病,卢瑟福分级和术后膝下径流评分是6个月内MAE的独立危险因素。需要比较现实世界的研究。
UNASSIGNED: To evaluate 6-month outcomes of drug-coated balloon (DCB) angioplasty of infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI).
UNASSIGNED: We analyzed 6-month follow-up data from the 10-center PRIME-WIFI prospective registry on 300 consecutive patients (33.000% female) with CLTI who underwent DCB angioplasty for infrapopliteal arterial lesions. The primary outcome was freedom from major adverse event (MAE), a composite of major amputation, all-cause death, and clinically-driven target limb reintervention (CD-TLR). Secondary outcomes included amputation-free survival (AFS), freedom from each primary outcome component, primary sustained clinical improvement, and quality of life (QOL) score. Independent risk factors of MAE were determined using Cox proportional hazards regression analysis.
UNASSIGNED: A total of 409 infrapopliteal lesions in 312 limbs were treated with DCB, with 54.167% of the limbs being treated for isolated infrapopliteal lesions. By Kaplan-Meier analysis, at 6 months post- procedure (follow-up rate, 85.000%), freedom from MAE was 86.353%; AFS was 90.318%; and freedom from major amputation, all-cause death, and CD-TLR were 96.429%, 93.480%, and 95.079%, respectively. At 6-month follow-up, 83.590% of patients showed primary sustained clinical improvement, and QOL score (4.902±1.388) improved compared with that before procedure (2.327±1.109; p<0.001). Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade, and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months.
UNASSIGNED: In CLTI, DCB angioplasty of infrapopliteal lesions yields acceptable early efficacy and safety.
CONCLUSIONS: This study evaluated the 6-month outcomes of DCB angioplasty in infrapopliteal lesions in CLTI patients by analyzing multicenter prospective data, showing that infrapopliteal DCB angioplasty can be performed with acceptable freedom from MAE rate, amputation-free survival rate, freedom from major amputation rate, survival rate, and freedom from CD-TLR rate. No patient experienced DCB-related intraoperative distal embolism. Chronic renal insufficiency, chronic obstructive pulmonary disease, Rutherford grade and postoperative infrapopliteal runoff score were independent risk factors for MAE within 6 months. Comparative real-world studies are needed.