1 Patras University Hospital Rion Greece.
2 Attikon University Hospital Athens Greece.
J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
Background Several randomized controlled trials ( RCT s) have already shown that paclitaxel-coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta-analysis of RCT s investigating paclitaxel-coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all-cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCT s with 4663 patients (89% intermittent claudication) were analyzed. All-cause patient death at 1 year (28 RCT s with 4432 cases) was similar between paclitaxel-coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72-1.61). All-cause death at 2 years (12 RCT s with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15-2.47; -number-needed-to-harm, 29 patients [95% CI , 19-59]). All-cause death up to 5 years (3 RCT s with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI , 1.27-2.93; -number-needed-to-harm, 14 patients [95% CI , 9-32]). Meta-regression showed a significant relationship between exposure to paclitaxel (dose-time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg-year; P<0.001). Trial sequential analysis excluded false-positive findings with 99% certainty (2-sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL : www.crd.york.ac.uk/PROSPERO . Unique identifier: CRD 42018099447.
几项随机对照试验（ RCT ）已经表明，紫杉醇涂层球囊和支架可显著降低下肢介入治疗后血管再狭窄和靶病变血运重建的发生率。
对股动脉和/或腘动脉紫杉醇涂层装置进行的 RCT 进行了系统评价和荟萃分析。主要安全性指标为全因患者死亡。采用随机效应模型汇总风险比和风险差异。共分析了 28 项 RCT ，共纳入 4663 例患者（ 89%间歇性跛行）。1 年时全因患者死亡（ 28 项 RCT ， 4432 例）紫杉醇涂层装置与对照组之间无差异（ 2.3%与 2.3%的粗死亡率；风险比， 1.08；95%置信区间， 0.72-1.61）。紫杉醇组与对照组相比，2 年时全因死亡显著增加（ 7.2%与 3.8%的粗死亡率；风险比， 1.68；95%置信区间， 1.15-2.47；-需要治疗的患者数， 29 例[95%置信区间， 19-59]）。紫杉醇组全因死亡（ 3 项 RCT ， 863 例）进一步增加至 5 年时，风险比（ 1.93；95%置信区间， 1.27-2.93；-需要治疗的患者数， 14 例[95%置信区间， 9-32]）。Meta 回归显示，紫杉醇暴露（剂量时间乘积）与全因死亡的绝对风险之间存在显著关系（每紫杉醇毫克年增加 0.4±0.1%的死亡超额风险； P<0.001）。试验序贯分析以 99%的把握度排除了假阳性结果（双侧α， 1.0%）。
在下肢股腘动脉应用紫杉醇涂层球囊和支架后，死亡风险增加。迫切需要进一步的研究。
www.crd.york.ac.uk/PROSPERO 。唯一标识符：CRD42018099447。
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