Cardiovascular Department, San Donato Hospital, via Pietro Nenni 20, 52100, Arezzo, Italy.
Cardiovasc Intervent Radiol. 2022 Jun;45(6):761-769. doi: 10.1007/s00270-022-03104-3. Epub 2022 Mar 21.
The aim of this study is to evaluate the 5-year clinical outcome of the DEBATE-BTK (Drug-eluting balloon for below-the-knee angioplasty evaluation) trial.
The DEBATE-BTK was a single-center, randomized trial that enrolled 132 diabetic patients with critical limb ischemia. Subjects were randomized 1:1 to DCB or plain old balloon angioplasty (POBA). Major clinical endpoints were, freedom from all-cause death, freedom from clinically driven target lesion revascularization (CDTLR) and the occurrence of major amputation. Additional analysis were conducted to assess overall survival in patients treated with DCB compared to those treated with only POBA in the entire 5-years period and to test the correlation between paclitaxel dose exposure (in terciles) and overall survival.
Freedom from all-cause death at 5 years was 63.1% (41/65) in DCB vs. 53.7%(35/67) POBA patients (p = 0.4). Freedom from CDTLR was 82% in DCB and 63% in POBA patients (p = 0.002) at 1 year and 63 versus 54% at 5 years respectively P = 0.07. One patient in DCB and 2 patients in POBA underwent a major amputation of the target limb. During the 5-year follow-up, 24 patients originally randomized to POBA received DCB treatment for additional limb revascularization. According to DCB treatment in all the 5 years period, overall survival was 66.3.% (30/89) in DCB versus 40%(26/43) in POBA patients, p = 0.003.
Overall survival at 5-year was similar in DCB treated patients compared to POBA. Moreover, survival was higher in patients that received DCB angioplasty at any time of the 5 years period.
Level 1b, Individual inception cohort study with > 80% follow-up.
本研究旨在评估 DEBATE-BTK（用于膝下血管成形术评估的药物洗脱球囊）试验的 5 年临床结果。
DEBATE-BTK 是一项单中心、随机试验，共纳入 132 例糖尿病合并严重肢体缺血患者。将受试者按 1:1 随机分为 DCB 组或普通球囊血管成形术（POBA）组。主要临床终点为全因死亡、无临床驱动的靶病变血运重建（CDTLR）和主要截肢的发生率。还进行了额外的分析，以评估在整个 5 年期间接受 DCB 治疗的患者的总生存率与仅接受 POBA 治疗的患者相比，以及测试紫杉醇剂量暴露（分为 3 个等分位）与总生存率之间的相关性。
DCB 组 5 年全因死亡率为 63.1%（41/65），POBA 组为 53.7%（35/67）（p=0.4）。DCB 组 1 年 CDTLR 为 82%，POBA 组为 63%（p=0.002），5 年时分别为 63%和 54%（p=0.07）。DCB 组中有 1 例患者和 POBA 组中有 2 例患者发生目标肢体的主要截肢。在 5 年随访期间，24 例最初随机分配至 POBA 组的患者因额外的肢体血运重建而接受了 DCB 治疗。根据 DCB 在 5 年期间的所有治疗情况，DCB 组的总生存率为 66.3%（30/89），POBA 组为 40%（26/43）（p=0.003）。
与 POBA 相比，5 年时 DCB 治疗患者的总生存率相似。此外，在 5 年期间任何时间接受 DCB 血管成形术治疗的患者生存率更高。
1b 级，个体起始队列研究，随访率超过 80%。
