Department of Surgery, West Virginia University-Charleston Division, Charleston, WV, USA.
CAMC Institute for Academic Medicine, Charleston, WV, USA.
J Endovasc Ther. 2022 Jun;29(3):350-360. doi: 10.1177/15266028211049339. Epub 2021 Oct 8.
Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center.
PATIENT POPULATIONS/METHODS: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years.
Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A-C lesions. Mean follow-up was 18.4 months (1-76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A-C vs 59% and 59% for D lesions, p=0.001).
Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A-C lesions but inferior/unsatisfactory for TASC D lesions.
在使用药物洗脱支架（DES）治疗股腘动脉疾病方面，很少有行业赞助的试验报告令人满意的结果。本研究分析了来自真实世界的单中心的早期/晚期临床结果。
患者人群/方法：共分析了 115 条接受 Zilver PTX 治疗的肢体：主要不良肢体事件（MALE：踝以上肢体截肢/1 年内主要干预）、主要不良事件（MAE：死亡、截肢和靶病变血栓形成/再介入）、一期通畅率（基于双功超声±踝肱指数）、肢体存活率和 1 年和 2 年时的无截肢生存率（AFS）。
适应证包括跛行 32%和严重肢体缺血（CLI）68%。治疗的病变包括：股浅动脉（SFA）66%，SFA 和腘动脉（PA）均受累 19%，仅 PA 受累 15%。平均病变长度为 21cm，68%为完全闭塞。45%为跨大西洋内科学会共识（TASC）TASC II D 病变，55%为 A-C 病变。平均随访时间为 18.4 个月（1-76 个月）。围手术期主要发病率为 8.7%，无死亡。1 年时 MALE 发生率为 17%（跛行 13.5%，CLI 19.2%，p=0.4499）。MAE 发生率为跛行 30%，CLI 52%（p=0.0392）。1 年和 2 年时的总通畅率分别为 75%和 54%（跛行分别为 86%和 71%，CLI 分别为 70%和 46%，p=0.0213）。1 年和 2 年时 TASC A-C 病变的一期通畅率分别为 94%和 88%，TASC D 病变分别为 50%和 16%（p<0.0001）。1 年和 2 年时的 MALE 无事件生存率分别为 85%和 79%（跛行分别为 86%和 86%，CLI 分别为 84%和 74%，p=0.2391）。TASC A-C 病变分别为 96%和 93%，D 病变分别为 70%和 50%（p<0.0001）。1 年和 2 年时的肢体存活率分别为 93%和 86%（跛行均为 100%，CLI 分别为 89%和 78%，p=0.012）。1 年和 2 年时的总 AFS 率分别为 79%和 71%（TASC A-C 分别为 93%和 82%，D 病变分别为 59%和 59%，p=0.001）。
股腘动脉病变中 DES（Zilver PTX）的临床结果对于 TASC A-C 病变是令人满意的，但对于 TASC D 病变则较差/不满意。
