药物涂层球囊与标准经皮腔内血管成形术治疗股浅和近Pop动脉动脉粥样硬化病变：MDT-2113 SFA日本随机试验的一年结果。,Journal of Endovascular Therapy

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药物涂层球囊与标准经皮腔内血管成形术治疗股浅和近Pop动脉动脉粥样硬化病变：MDT-2113 SFA日本随机试验的一年结果。
Journal of Endovascular Therapy ( IF 1.7 ) Pub Date : 2017-12-22 , DOI: 10.1177/1526602817745565
Osamu Iida ₁ , Yoshimitsu Soga ₂ , Kazushi Urasawa ₃ , Shigeru Saito ₄ , Michael R Jaff ₅ , Hong Wang ₆ , Hiroko Ookubo ₇ , Hiroyoshi Yokoi ₈ ,

Affiliation

目的评估MDT-2113（IN.PACT海军上将）药物涂层球囊（DCB）与经皮腔内血管成形术（PTA）相比，治疗股浅及pop小动脉新生和天然动脉再狭窄病变的安全性和有效性），并在日本队列中使用未镀膜的气球。方法MDT-2113 SFA Japan（ClinicalTrials.gov标识符NCT01947478）是一项独立裁决，前瞻性，随机，单盲试验，对来自11个日本中心的100例患者（平均年龄73.6±7.0岁； 76例男性患者）进行了随机分组（2：1）。用DCB（n = 68）或PTA（n = 32）治疗。两组之间的基线特征相似，包括平均病变长度（DCB组和PTA组分别为9.15±5.85和8.89±6.01 cm）。主要疗效结果是在12个月时通畅，定义为无临床驱动靶病变血运重建（CD-TLR）和无再狭窄（通过双工超声检查确定）。安全终点是在12个月内30天与设备和手术相关的死亡和目标肢大截肢以及临床驱动的目标血管血运重建的综合结果。结果与使用PTA治疗的患者（48％，p <0.001）相比，使用DCB治疗的患者表现出更好的12个月初次通畅（89％）。DCB的12个月CD-TLR率为3％，而PTA为19％（p = 0.012）。两组均无与装置或手术相关的死亡，大截肢或血栓形成。两组生活质量指标均显示从基线到12个月持续改善。结论MDT-2113 SFA日本试验的结果表明，DCB优于PTA，具有出色的通畅性和较低的CD-TLR率。这些结果与其他IN.PACT SFA DCB试验一致，并证明了该DCB在该日本队列中治疗股pop病变的安全性和有效性。

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Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial.

PURPOSE To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. METHODS MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. RESULTS Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. CONCLUSION Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.

更新日期：2019-11-01

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