Universitaets-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Department of Cardiology, Humanitas Gavazzeni Hospital, Bergamo, Italy.
JACC Cardiovasc Interv. 2020 Feb 24;13(4):431-443. doi: 10.1016/j.jcin.2019.10.059.
The goal of this study was to evaluate the 5-year follow-up data of the IN.PACT DEEP (Randomized IN.PACT Amphirion Drug-Coated Balloon [DCB] vs. Standard Percutaneous Transluminal Angioplasty [PTA] for the Treatment of Below-the-Knee Critical Limb Ischemia [CLI]) trial.
Initial studies from randomized controlled trials have shown comparable short-term outcomes of DCB angioplasty versus PTA in patients with CLI with infrapopliteal disease. However, the long-term safety and effectiveness of DCB angioplasty remain unknown in this patient population.
IN.PACT DEEP was an independently adjudicated prospective, multicenter, randomized controlled trial that enrolled 358 subjects with CLI. Subjects were randomized 2:1 to DCB angioplasty or PTA. Assessments through 5 years included freedom from clinically driven target lesion revascularization, amputation, and all-cause death. Additional assessments were conducted to identify risk factors for death and major amputation, including paclitaxel dose tercile.
Freedom from clinically driven target lesion revascularization through 5 years was 70.9% and 76.0% (log-rank p = 0.406), and the incidence of the safety composite endpoint was 59.8% and 57.5% (log-rank p = 0.309) in the DCB angioplasty and PTA groups, respectively. The rate of major amputation was 15.4% for DCB angioplasty compared with 10.6% for PTA (log-rank p = 0.108). Given the recent concern regarding a late mortality signal in patients treated with paclitaxel-coated devices, additional analyses from this study showed no increase in all-cause mortality with DCB angioplasty (39.4%) compared with PTA (44.9%) (log-rank p = 0.727). Predictors of mortality included age, Rutherford category >4, and previous revascularization but not paclitaxel by dose tercile.
Tibial artery revascularization in patients with CLI using DCB angioplasty resulted in comparable long-term safety and effectiveness as PTA. Paclitaxel exposure was not related to increased risk for amputation or all-cause mortality at 5-year follow-up. (Study of IN.PACT Amphirion™ Drug Eluting Balloon vs. Standard PTA for the Treatment of Below the Knee Critical Limb Ischemia [INPACT-DEEP]; NCT00941733).
本研究旨在评估 IN.PACT DEEP（随机 IN.PACT Amphirion 药物涂层球囊 [DCB] 与标准经皮腔内血管成形术 [PTA] 治疗膝下严重肢体缺血 [CLI]）试验的 5 年随访数据。
最初来自随机对照试验的研究表明，在患有膝下病变的 CLI 患者中，DCB 血管成形术与 PTA 的短期结果相当。然而，在这一患者群体中，DCB 血管成形术的长期安全性和有效性仍不清楚。
IN.PACT DEEP 是一项独立评估的前瞻性、多中心、随机对照试验，共纳入 358 例 CLI 患者。患者按 2:1 的比例随机分为 DCB 血管成形术或 PTA 组。通过 5 年的评估包括无临床驱动的靶病变血运重建、截肢和全因死亡。进行了其他评估，以确定死亡和主要截肢的风险因素，包括紫杉醇剂量三分位数。
5 年无临床驱动的靶病变血运重建率分别为 70.9%和 76.0%（对数秩检验 p=0.406），DCB 血管成形术组和 PTA 组的安全性复合终点发生率分别为 59.8%和 57.5%（对数秩检验 p=0.309）。DCB 血管成形术组的主要截肢率为 15.4%，而 PTA 组为 10.6%（对数秩检验 p=0.108）。鉴于最近有报道称紫杉醇涂层器械治疗患者存在晚期死亡率信号，本研究的额外分析显示，DCB 血管成形术组（39.4%）与 PTA 组（44.9%）的全因死亡率无增加（对数秩检验 p=0.727）。死亡率的预测因素包括年龄、Rutherford 分类>4 级和既往血管重建术，但与紫杉醇剂量三分位数无关。
在 CLI 患者中使用 DCB 血管成形术进行胫骨动脉血运重建的长期安全性和有效性与 PTA 相当。在 5 年随访时，紫杉醇暴露与截肢或全因死亡率的增加无关。（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）。
