Jang Shih-Jung, Hsieh Chien-An, Chang Yao-Ting, Chen I-Chih, Liu Kuan-Liang, Tzeng I-Shiang, Chou Hsin-Hua, Ko Yu-Lin, Chang Heng-Chia, Huang Hsuan-Li
Division of Cardiology, Department of Internal Medicine, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, New Taipei City.
School of Medicine, Tzu Chi University, Hualien.
Acta Cardiol Sin. 2023 Mar;39(2):331-342. doi: 10.6515/ACS.202303_39(2).20220815B.
A recent meta-analysis reported late excess mortality in patients treated with paclitaxel-coated devices (PCDs) for symptomatic femoropopliteal disease. However, this finding is controversial.
To investigate the impact on mortality and predictors of repeat exposure to PCDs in patients with lower extremity peripheral arterial disease (LE-PAD).
We analyzed registry patient-level data from two centers. A total of 214 patients were enrolled, and stratified based on terciles of cumulative dose of paclitaxel. We treated 134 patients with a single PCD exposure and 80 with multiple PCD exposures. We used the follow-up index (FUI) in Kaplan-Meier survival estimates to minimize potential selection bias. We used Cox proportional hazard and splines models to determine the predictors of mortality and assess their relationships with mortality.
The mean cumulative dose of paclitaxel was significantly different among groups (6.40 mg vs. 15.06 mg vs. 38.57 mg, p < 0.001). The 5-year FUI (0.93 ± 0.19 vs. 0.94 ± 0.18 vs. 0.95 ± 0.15, p = 0.836) and survival rates were not different (65.4% vs. 51.9% vs. 72.0%, p = 0.148). There was no dose-response association between paclitaxel dosage and death (p = 0.297). The predictors of death were congestive heart failure, stroke, dialysis dependence, neutrophil-lymphocyte ratio (NLR) > 3, age > 71 years, and body mass index (BMI) < 20 kg/m. Spline model analysis validated the non-linear associations between mortality, age, BMI, and NLR.
Repeated PCD exposure for LE-PAD did not result in excess late mortality. Predictors of mortality might change over time, and continuous variables had non-linear relationships with death.
最近一项荟萃分析报告称，使用紫杉醇涂层器械（PCD）治疗症状性股腘动脉疾病的患者存在晚期额外死亡率。然而，这一发现存在争议。
研究下肢外周动脉疾病（LE-PAD）患者重复接触PCD对死亡率的影响及预测因素。
我们分析了来自两个中心的登记患者水平数据。共纳入214例患者，并根据紫杉醇累积剂量的三分位数进行分层。我们对134例单次接触PCD的患者和80例多次接触PCD的患者进行了治疗。我们在Kaplan-Meier生存估计中使用随访指数（FUI）以尽量减少潜在的选择偏倚。我们使用Cox比例风险模型和样条模型来确定死亡率的预测因素并评估它们与死亡率的关系。
各组间紫杉醇的平均累积剂量有显著差异（6.40mg对15.06mg对38.57mg，p<0.001）。5年随访指数（0.93±0.19对0.94±0.18对0.95±0.15，p=0.836）和生存率无差异（65.4%对51.9%对72.0%，p=0.148）。紫杉醇剂量与死亡之间不存在剂量反应关联（p=0.297）。死亡的预测因素为充血性心力衰竭、中风、透析依赖、中性粒细胞与淋巴细胞比值（NLR）>3、年龄>71岁和体重指数（BMI）<20kg/m²。样条模型分析验证了死亡率、年龄、BMI和NLR之间的非线性关联。
LE-PAD患者重复接触PCD并未导致额外的晚期死亡率。死亡率的预测因素可能随时间变化，且连续变量与死亡存在非线性关系。
