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首页> 外文期刊>Journal of the American College of Cardiology >Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the zilver PTX randomized and single-arm clinical studies
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Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the zilver PTX randomized and single-arm clinical studies

机译：紫杉醇洗脱支架治疗股pop部病变的持续安全性和有效性：Zilver PTX随机和单臂临床研究的2年随访

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Objectives A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery lesions. The RCT compared the DES with percutaneous transluminal angioplasty (PTA) and provisional bare-metal stent (BMS) placement. Background Local drug delivery for superficial femoral artery lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the superficial femoral artery are promising, but longer-term benefits have not been established. Methods In the RCT, patients were randomly assigned to primary DES implantation (n = 236) or PTA (n = 238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n = 61) or BMS (n = 59) placement. The single-arm study enrolled 787 patients with DES treatment. Results Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% vs. 77.9%, p = 0.02) and primary patency (74.8% vs. 26.5%, p 0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% vs. 64.1%, p 0.01) and achieved higher sustained clinical benefit (83.9% vs. 68.4%, p = 0.05). Two-year freedom from target lesion revascularization with primary DES placement was 80.5% in the single-arm study and 86.6% in the RCT. Conclusions Two-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal artery disease, including the long-term superiority of the DES to PTA and to provisional BMS placement. (Evaluation of the Zilver PTX Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery; NCT00120406; Zilver? PTX? Global Registry; NCT01094678).
机译：目的一项前瞻性，跨国随机对照试验（RCT）和一项补充性单臂研究评估了紫杉醇涂层药物洗脱支架（DES）在股浅动脉病变患者中的2年安全性和有效性。 RCT将DES与经皮腔内血管成形术（PTA）和临时裸金属支架（BMS）放置进行了比较。背景技术已经研究了针对股浅动脉病变的局部药物递送，其目的与限制用于冠状动脉的DES相似，以限制再狭窄。 DES在股浅动脉的一年结局是有希望的，但尚未建立长期的获益。方法在随机对照试验中，患者被随机分配为一次DES植入（n = 236）或PTA（n = 238）。急性PTA失败发生在120例患者中，他们接受了DES（n = 61）或BMS（n = 59）放置的二次随机分组。单臂研究招募了787例接受DES治疗的患者。结果与对照组相比，初级DES组的2年无事件生存率明显提高（86.6％比77.9％，p = 0.02）和初级通畅性（74.8％对26.5％，p <0.01）。此外，与临时BMS组相比，临时DES组的2年初次通畅率更高（83.4％对64.1％，p <0.01），并获得更高的持续临床获益（83.9％对68.4％，p = 0.05）。 。在单臂研究中，两年期无主要靶点DES的靶病变血运重建的两年率为80.5％，在RCT中为86.6％。结论紫杉醇洗脱支架的两年结局支持其在股pop动脉疾病患者中的持续安全性和有效性，包括DES对PTA和临时BMS的长期优势。 （评估膝上股pop动脉中的Zilver PTX药物洗脱支架; NCT00120406; Zilver™PTX™全球注册; NCT01094678）。

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