Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort
Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease The IN.PACT Global Study De Novo In-Stent Restenosis Imaging Cohort
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DOI：
10.1016/j.jcin.2017.06.018
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发表时间：
2017-10-23
影响因子：
11.3
通讯作者：
Zeller, Thomas
中科院分区：
文献类型：
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作者：
Brodmann, Marianne;Keirse, Koen;Zeller, Thomas
本研究旨在评价紫杉醇涂层药物涂层球囊（DCB）治疗新发支架内再狭窄（ISR）患者的安全性和有效性。目前的策略受到再狭窄复发率高和需要再次介入的困扰。ISR的最佳干预措施仍有待阐明。PACT Global研究是一项独立裁定的多中心、前瞻性、单组研究，入组了1，535例患有股浅动脉和/或腘动脉症状性动脉粥样硬化疾病（包括新发ISR病变）的受试者。在12个月的随访期内，对入选预先指定的ISR成像队列的患者进行血管通畅性和再介入评估。队列的平均年龄为67.8岁。平均病变长度为17.17 ± 10.47 cm，包括34.0%的完全闭塞和59.1%的钙化病变。一期通畅率的12个月Kaplan-Meier估计值为88.7%。12个月时临床驱动的靶病变血运重建（CD TLR）率为7.3%。主要安全性结局（30天内无器械和手术相关死亡率以及12个月内无重大靶肢体截肢和CD TLR的复合终点）为92.7%。没有主要的目标肢体截肢，没有死亡，血栓形成率低（0.8%）conclusions结果从ISR成像队列显示高通畅率和低率的CD TLR在12个月。这些数据证实了IN的安全性和有效性。PACT Admiral DCB（Medtronic，都柏林，爱尔兰）用于复杂股腘动脉病变，包括该具有挑战性的子集。(C)2017作者由Elsevier代表美国心脏病学会基金会发布。
OBJECTIVES This study sought to evaluate the safety and effectiveness of a paclitaxel-coated drug-coated balloon (DCB) for the treatment of patients with de novo in-stent restenosis (ISR).BACKGROUND Treatment of patients with ISR remains a challenge. Current strategies are plagued by high rates of recurrent restenosis and need for reintervention. The best intervention for ISR remains to be elucidated.METHODS The IN. PACT Global study is an independently adjudicated multicenter, prospective, single-arm study that enrolled 1,535 subjects with symptomatic atherosclerotic disease of the superficial femoral and/or popliteal arteries, including de novo ISR lesions. Patients enrolled in the pre-specified ISR imaging cohort were evaluated for vessel patency and reintervention within the 12-month follow-up period.RESULTS A total of 131 subjects with 149 ISR lesions were included for analysis. The mean age of the cohort was 67.8 years. Mean lesion length was 17.17 +/- 10.47 cm, including 34.0% total occlusions and 59.1% calcified lesions. The 12-month Kaplan-Meier estimate of primary patency was 88.7%. The rate of clinically driven target lesion revascularization (CD TLR) at 12 months was 7.3%. The primary safety outcome, a composite of freedom from device-and procedure-related mortality through 30 days and freedom from major target limb amputation and CD TLR within 12 months, was 92.7%. There were no major target limb amputations, no deaths, and a low (0.8%) thrombosis rate.CONCLUSIONS Results from the ISR imaging cohort demonstrate high patency and a low rate of CD TLR at 12 months. These data confirm the safety and effectiveness of the IN. PACT Admiral DCB (Medtronic, Dublin, Ireland) in complex femoropopliteal lesions, including this challenging subset. (C) 2017 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.