Mortality Assessment of Paclitaxel-Coated Balloons Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years
Mortality Assessment of Paclitaxel-Coated Balloons Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years
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DOI：
10.1161/circulationaha.119.040518
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发表时间：
2019-10-01
期刊：
影响因子：
37.8
通讯作者：
Lyden, Sean P.
中科院分区：
文献类型：
--
作者：
Gray, William A.;Jaff, Michael R.;Lyden, Sean P.
背景：最近的一项汇总水平的荟萃分析包括对紫杉醇涂层球囊和支架介入的随机对照试验(RCT)，发现紫杉醇治疗患者的晚期死亡率过高。方法：我们对Stellarex股动脉临床计划中所有患者的患者水平数据进行了一项独立的荟萃分析，以评估Stellarex药物涂层球囊(DCB)治疗股动脉疾病的安全性。为了比较DCB和非涂层经皮腔内血管成形术(PTA)后的死亡率，我们收集了2个随机对照试验的数据，其中419名患者接受了DCB治疗，170名患者接受了PTA治疗。在另一项分析中，数据来自6项可合并的Stellarex DCB研究(2项随机对照试验、3项单臂研究和1项登记)。所有严重不良事件，包括死亡，都由一个盲目的、第三方的、独立的临床事件委员会裁决。将随机对照试验中的Kaplan-Meier估计值与限制的平均生存时间进行比较。死亡预测因素用风险比(HRs)和COX比例风险模型进行评估。结果：在合并RCT分析中，接受DCB和PTA治疗的患者的基线特征相似，除了DCB队列更年轻(67.4+/-9.7岁比69.4+/-9.4岁，P=0.02)，吸烟更频繁(86.6%比78.8%，P=0.02)，以及较少因复发病变接受治疗(8.8%比14.7%，P=0.04)。在随机对照试验中，接受DCB治疗的患者与接受PTA治疗的患者的全因死亡率没有差异(Kaplan-Meier估计，1年、2年和3年的全因死亡率分别为1.8+/-0.7%比1.3+/-0.9%、6.5+/-1.2%比5.9+/-1.9%、9.3+/-1.5%比9.9+/-2.4%，P=0.86)。在1906名患者的非随机DCB数据集中，全原因死亡率相似(Kaplan-Meier估计1、2和3年分别为2.1%、4.9%和7.0%)。临床事件委员会--DCB和PTA队列中已判定的死亡原因是平衡的。多变量COX模型显示年龄(HR，1.06；95%CI，1.04-1.08；P
Background: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. Methods: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling. Results: Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4 +/- 9.7 versus 69.4 +/- 9.4 years, P=0.02), smoked more frequently (86.6% versus 78.8%, P=0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P=0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8 +/- 0.7% versus 1.3 +/- 0.9%, 6.5 +/- 1.2% versus 5.9 +/- 1.9%, and 9.3 +/- 1.5% versus 9.9 +/- 2.4% at 1, 2, and 3 years, respectively, P=0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P