Background: Data are mixed concerning the safety and effectiveness of drug-coated balloons (DCBs) for treating below-the-knee (BTK) lesions.

Aims: The aim of this study was to assess the safety and effectiveness of the IN.PACT 014 paclitaxel-coated balloon catheter versus conventional percutaneous transluminal angioplasty (PTA) for infrapopliteal chronic total occlusions (CTOs) in patients with chronic limb-threatening ischaemia (CLTI).

Methods: The IN.PACT BTK randomised study is a prospective, multicentre, randomised pilot study. Fifty CLTI participants (Rutherford clinical category 4-5) with BTK CTOs were randomised 1:1 to DCB (N=23) or PTA (N=27). The primary effectiveness endpoint was late lumen loss (LLL) at 9 months post procedure. Safety outcomes up to 9 months included all-cause mortality, major target limb amputation, and clinically driven target lesion revascularisation (CD-TLR).

Results: Mean lesion length was 215.41±83.81 mm in the DCB group and 218.19±80.43 mm for PTA (p=0.806). The 9-month angiographic LLL was 0.892±0.774 mm for the DCB group and 1.312±0.720 mm for the PTA group (p=0.070) in a classic analysis, and 0.592±0.944 mm for DCB and 1.260±0.810 mm for PTA (p=0.017) in a subsegmental analysis. The Kaplan-Meier estimated freedom from CD-TLR up to 9 months was 91.1% for DCB and 91.8% for PTA (log-rank p=0.942). At 9 months, 1 patient died in the DCB group and 2 in the PTA group (p=1.000); there were no major target limb amputations in either arm.

Conclusions: The 9-month subsegmental LLL was lower after treatment with the IN.PACT 014 DCB compared with PTA with no differences in safety or revascularisation events in a small complex population of patients with BTK CTOs. ClinicalTrials.gov Identifier: NCT02963649. https://clinicaltrials.gov/ct2/show/NCT02963649

背景：关于药物涂层球囊 (DCB) 治疗膝下 (BTK) 病变的安全性和有效性的数据不一。

目的：本研究的目的是评估 IN.PACT 014 紫杉醇涂层球囊导管与传统经皮腔内血管成形术 (PTA) 相比，治疗慢性肢体威胁性缺血患者腘下慢性完全闭塞 (CTO) 的安全性和有效性。 CLTI）。

方法： IN.PACT BTK 随机研究是一项前瞻性、多中心、随机试点研究。50 名具有 BTK CTO 的 CLTI 参与者（卢瑟福临床类别 4-5）按 1:1 随机分配至 DCB（N=23）或 PTA（N=27）。主要有效性终点是术后 9 个月的晚期管腔丢失 (LLL)。长达 9 个月的安全性结果包括全因死亡率、主要目标肢体截肢和临床驱动的目标病变血运重建 (CD-TLR)。

结果： DCB 组的平均病灶长度为 215.41±83.81 mm，PTA 为 218.19±80.43 mm (p=0.806)。在经典分析中，DCB 组的 9 个月血管造影 LLL 为 0.892±0.774 mm，PTA 组为 1.312±0.720 mm (p=0.070)，DCB 为 0.592±0.944 mm，PTA 为 1.260±0.810 mm (p=0.070) =0.017) 在一个细分分析中。Kaplan-Meier 估计 DCB 长达 9 个月免于 CD-TLR 为 91.1%，PTA 为 91.8%（对数秩 p=0.942）。9 个月时，DCB 组 1 例患者死亡，PTA 组 2 例患者死亡（p=1.000）；任何一只手臂都没有大的目标肢体截肢。

结论：与 PTA 相比，IN.PACT 014 DCB 治疗后 9 个月的亚节段 LLL 较低，在 BTK CTO 的小型复杂人群中，安全性或血运重建事件没有差异。ClinicalTrials.gov 标识符：NCT02963649。https://clinicaltrials.gov/ct2/show/NCT02963649