Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Tex Heart Inst J. 2022 Nov 1;49(6). doi: 10.14503/THIJ-21-7560.
Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice.
A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed.
Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups.
In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.
荟萃分析随机对照试验表明，使用紫杉醇涂层装置进行股腘和膝下血管成形术后，长期死亡率增加。本研究旨在评估真实世界实践中膝下病变使用紫杉醇药物涂层球囊（DCB）和普通球囊血管成形术（POBA）的长期死亡率。
对至少随访 3 年接受膝下病变球囊血管成形术的患者进行回顾性死亡率分析。
研究期间共对 2424 例膝下病变患者进行了治疗。576 例患者符合研究标准。其中 269 例患者接受了无涂层器械治疗，随访期间未转为紫杉醇涂层器械，307 例患者接受了 DCB 血管成形术。平均（SD）随访时间为 46.48（32.77）个月。POBA 后死亡率为 66.9%，DCB 后死亡率为 46.9%（P<0.001）。在配对队列中，164 例接受无涂层治疗的患者死亡（66.7%），119 例接受 DCB 组死亡（48.4%；P<0.001）。DCB 长度与死亡率之间无相关性（P=0.357）。对于整个队列，多变量逻辑回归分析显示治疗类型（无涂层器械与 DCB；P=0.002）、年龄（P<0.001）、中风（P=0.005）、肾功能不全（P=0.014）和严重肢体缺血（P=0.001）是全因死亡率的独立预测因素。紫杉醇暴露组之间的死亡率无显著差异。
在这项真实世界的回顾性分析中，DCB 血管成形术治疗膝下病变的长期死亡率低于 POBA。
