Department of Angiology, University Hospital Leipzig, Germany (D.S.).
GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy (A.M.).
Circ Cardiovasc Interv. 2018 Oct;11(10):e005654. doi: 10.1161/CIRCINTERVENTIONS.117.005654.
Background The IN.PACT Global Study was an international prospective single-arm clinical trial to evaluate the safety and effectiveness of a drug-coated balloon in the treatment of atherosclerotic disease of the superficial femoral and/or popliteal arteries (P1-P3) in subjects with intermittent claudication and/or rest pain. Prespecified subjects were selected for core-laboratory-adjudicated duplex ultrasound imaging, including a subcohort with long lesions (≥15 cm). Methods and Results Subjects were followed for 12 months. The primary safety end point was a composite of freedom from device- and procedure-related mortality through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization through 12 months. An independent Clinical Events Committee adjudicated all adverse events. The primary effectiveness end point was primary patency at 12 months (by duplex ultrasound). The long lesion imaging cohort had 157 subjects (164 lesions). Mean lesion length was 26.40±8.61 cm. Provisional stents were implanted in 39.4% (63/160) of lesions. Primary patency by Kaplan-Meier estimate was 91.1%, and freedom from clinically-driven target lesion revascularization was 94.2% at 12 months. The primary safety composite end point was achieved by 94.0% (126/134) of subjects. There were no device- or procedure-related deaths or major target limb amputations. Conclusions The IN.PACT Admiral drug-coated balloon was safe and highly effective at 12 months after treatment in a rigorous independently adjudicated analysis of real-world subjects with lesions ≥15 cm in the superficial femoral and/or popliteal arteries (P1-P3). CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov . Unique identifier: NCT01609296.
IN.PACT Global 研究是一项国际性前瞻性单臂临床试验，旨在评估药物涂层球囊治疗间歇性跛行和/或静息痛患者股浅动脉和/或腘动脉（P1-P3）动脉粥样硬化病变的安全性和有效性。根据预设标准选择受试者进行核心实验室评估的双功能超声成像，包括一个长病变（≥15cm）亚组。
受试者接受了 12 个月的随访。主要安全性终点为 30 天内无器械和手术相关死亡率，以及 12 个月内无主要靶肢体截肢和临床驱动的靶血管血运重建的复合终点。所有不良事件均由独立临床事件委员会裁定。主要有效性终点为 12 个月时的通畅率（通过双功能超声）。长病变成像队列有 157 例患者（164 个病变）。平均病变长度为 26.40±8.61cm。在 63/160（39.4%）个病变中植入了临时支架。Kaplan-Meier 估计的通畅率为 91.1%，12 个月时无临床驱动的靶病变血运重建率为 94.2%。主要安全性复合终点的达成率为 134/126（94.0%）。无器械或手术相关死亡或主要靶肢体截肢。
在对真实世界≥15cm 的股浅动脉和/或腘动脉（P1-P3）病变患者进行严格的独立裁定分析中，IN.PACT Admiral 药物涂层球囊在 12 个月时的安全性和有效性均较高。
https://www.clinicaltrials.gov 。唯一标识符：NCT01609296。
