Department of Angiology, Universitäts Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany.
Swiss Cardiovascular Center, Division of Angiology, University Hospital, Inselspital, Bern, Switzerland.
J Am Coll Cardiol. 2014 Oct 14;64(15):1568-76. doi: 10.1016/j.jacc.2014.06.1198.
Drug-eluting balloons (DEB) may reduce infrapopliteal restenosis and reintervention rates versus percutaneous transluminal angioplasty (PTA) and improve wound healing/limb preservation.
The goal of this clinical trial was to assess the efficacy and safety of IN.PACT Amphirion drug-eluting balloons (IA-DEB) compared to PTA for infrapopliteal arterial revascularization in patients with critical limb ischemia (CLI).
Within a prospective, multicenter, randomized, controlled trial with independent clinical event adjudication and angiographic and wound core laboratories 358 CLI patients were randomized 2:1 to IA-DEB or PTA. The 2 coprimary efficacy endpoints through 12 months were clinically driven target lesion revascularization (CD-TLR) and late lumen loss (LLL). The primary safety endpoint through 6 months was a composite of all-cause mortality, major amputation, and CD-TLR.
Clinical characteristics were similar between the 2 groups. Significant baseline differences between the IA-DEB and PTA arms included mean lesion length (10.2 cm vs. 12.9 cm; p = 0.002), impaired inflow (40.7% vs. 28.8%; p = 0.035), and previous target limb revascularization (32.2% vs. 21.8%; p = 0.047). Primary efficacy results of IA-DEB versus PTA were CD-TLR of 9.2% versus 13.1% (p = 0.291) and LLL of 0.61 ± 0.78 mm versus 0.62 ± 0.78 mm (p = 0.950). Primary safety endpoints were 17.7% versus 15.8% (p = 0.021) and met the noninferiority hypothesis. A safety signal driven by major amputations through 12 months was observed in the IA-DEB arm versus the PTA arm (8.8% vs. 3.6%; p = 0.080).
In patients with CLI, IA-DEB had comparable efficacy to PTA. While primary safety was met, there was a trend towards an increased major amputation rate through 12 months compared to PTA. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
药物洗脱球囊（DEB）可能降低经皮腔内血管成形术（PTA）治疗的下肢动脉再狭窄和再介入率，并改善伤口愈合/肢体保存。
本临床试验的目的是评估 IN.PACT Amphirion 药物洗脱球囊（IA-DEB）与 PTA 治疗下肢严重缺血（CLI）患者的下肢动脉再血管化的疗效和安全性。
在一项前瞻性、多中心、随机、对照临床试验中，采用独立的临床事件裁决以及血管造影和伤口核心实验室，358 例 CLI 患者按 2:1 随机分为 IA-DEB 或 PTA 组。12 个月时的 2 个主要疗效终点为临床驱动的靶病变血运重建（CD-TLR）和晚期管腔丢失（LLL）。6 个月时的主要安全性终点为全因死亡率、大截肢和 CD-TLR 的复合终点。
两组的临床特征相似。IA-DEB 与 PTA 组之间存在显著的基线差异，包括平均病变长度（10.2cm 对 12.9cm；p=0.002）、流入受限（40.7%对 28.8%；p=0.035）和先前的靶肢体血运重建（32.2%对 21.8%；p=0.047）。IA-DEB 与 PTA 的主要疗效结果为 CD-TLR 分别为 9.2%和 13.1%（p=0.291）和 LLL 分别为 0.61±0.78mm 和 0.62±0.78mm（p=0.950）。主要安全性终点分别为 17.7%和 15.8%（p=0.021），符合非劣效性假设。IA-DEB 组的主要截肢术安全性终点在 12 个月时高于 PTA 组（8.8%对 3.6%；p=0.080）。
在 CLI 患者中，IA-DEB 与 PTA 的疗效相当。虽然主要安全性得到满足，但与 PTA 相比，12 个月时主要截肢术的发生率呈上升趋势。（IN.PACT Amphirion 药物洗脱球囊与标准 PTA 治疗膝下严重肢体缺血的研究[INPACT-DEEP]；NCT00941733）。
