Long-Term Outcomes of a Drug-Eluting Resorbable Scaffold vs Angioplasty in Infrapopliteal Chronic Limb-Threatening Ischemia: 3-Year Results From the LIFE-BTK Trial.

The LIFE-BTK trial previously demonstrated superior efficacy of the Esprit (Abbott Vascular) BTK drug-eluting resorbable scaffold (DRS) over PTA at 1 year, with sustained benefits at 2 years, with comparable safety at both time points.

LIFE-BTK试验先前证明了Esprit（Abbott Vascular）BTK药物洗脱可吸收支架（DRS）在1年时的疗效优于PTA，并在2年时持续保持这些益处，且在这两个时间点的安全性相当。

This report presents the 3-year outcomes.

本报告展示了3年的临床结果。

We aimed to compare the 3-year safety and efficacy of DRS vs PTA in patients with CLTI and infrapopliteal artery disease.

我们的目标是比较在患有慢性下肢缺血（CLTI）和膝下动脉疾病的患者中，直接血栓切除术（DRS）与经皮腔内血管成形术（PTA）3年的安全性和有效性。

Methods

In this randomized trial, 261 patients with CLTI were assigned 2:1 to DRS or PTA.

在这项随机试验中，261名患有慢性肢体缺血（CLTI）的患者按2:1的比例被分配到DRS或PTA治疗。

The primary efficacy endpoint was freedom from above-ankle amputation in the target limb, target vessel occlusion, clinically driven target lesion revascularization (CD-TLR), and binary restenosis of the target lesion.

主要疗效终点是目标肢体远端踝关节以上无截肢、目标血管闭塞、临床驱动的目标病变血运重建（CD-TLR）以及目标病变的二元再狭窄。

The primary safety endpoint was freedom from major adverse limb events and perioperative death.

主要安全性终点是主要不良肢体事件和围手术期死亡的自由度。

Results

A total of 57% of patients completed the 3-year follow-up.

共有57%的患者完成了3年的随访。

By Kaplan-Meier analysis, the 3-year primary efficacy endpoint was higher with DRS than PTA (59.5% vs 44.8%; P = 0.0025), binary restenosis occurred less frequently with DRS (38.0% vs 49.0%), and CD-TLR was numerically lower with DRS (10.2% vs 18.4%).

通过Kaplan-Meier分析，与PTA相比，DRS的3年主要疗效终点更高（59.5%对44.8%；P = 0.0025），二元再狭窄的发生率在DRS中较低（38.0%对49.0%），CD-TLR在DRS中数值上也较低（10.2%对18.4%）。

Limb salvage remained high and comparable (93.8% vs 95.7%), as did the primary safety endpoint (90.8% vs 94.2%).

肢体挽救率保持高位且相当（93.8%对95.7%），主要安全性终点也是如此（90.8%对94.2%）。

In multivariable Cox regression at 3 years, treatment with DRS was associated with a lower hazard of CD-TLR compared with PTA (HR: 0.46 [95% CI: 0.22-0.97]), with previous minor amputation, greater preintervention stenosis, higher residual stenosis after predilatation, and use of postprocedure dual antiplatelet therapy being independent predictors of CD-TLR.

在3年的多变量Cox回归分析中，与PTA相比，DRS治疗与较低的CD-TLR风险相关（HR: 0.46 [95% 置信区间: 0.22-0.97]），既往小截肢、干预前狭窄程度较高、预扩张后残余狭窄较高以及术后使用双联抗血小板治疗是CD-TLR的独立预测因素。

Subgroup analyses showed that outcomes generally favored DRS for patency and reintervention across most patient and lesion characteristics.

亚组分析显示，对于大多数患者和病变特征，DRS在通畅率和再次干预方面通常具有更好的结果。

Conclusions

At 3 years, DRS demonstrated sustained advantages over PTA in preserving vessel patency, with lower restenosis and fewer reinterventions while maintaining a comparable safety profile.

在3年的随访中，DRS在保持血管通畅性方面显示出持续的优势，与PTA相比，其再狭窄率较低，再次干预次数减少，同时保持了相似的安全性。

These findings support the use of DRS in selected patients with CLTI and infrapopliteal disease.

这些发现支持在选定的患有CLTI和下肢动脉疾病的患者中使用DRS。

(Pivotal Investigation of Safety and Efficacy of Drug-Eluting Resorbable Scaffold Treatment-Below the Knee [LIFE-BTK]; NCT04227899).

(关键研究：药物洗脱可吸收支架治疗膝下病变的安全性和有效性研究[LIFE-BTK]; NCT04227899).