Pooled Analysis of Four Trials Shows No Increase in 2-Year Mortality With Paclitaxel-Coated Balloons
March 6, 2019—Thomas Albrecht, MD, et al conducted a patient-level pooled analysis of four multicenter, randomized controlled trials (RCTs) to determine the 2-year mortality after angioplasty of the femoropopliteal artery with uncoated balloons and paclitaxel-coated balloons. The four RCTs were THUNDER, FEMPAC, PACIFIER, and CONSEQUENT.
The investigators concluded that there was no increase in 2-year mortality in patients treated with paclitaxel-coated balloons compared to control patients treated with uncoated balloons. They reported that causes of death were well balanced between patients treated with paclitaxel-coated balloons versus control patients. The findings are available online in CardioVascular and Interventional Radiology (CVIR).
The investigators noted that the study was conducted in response to the recently published meta-analysis that suggested that there were higher rates of 2- and 5-year mortality in patients with peripheral artery disease (PAD) treated with paclitaxel-delivering devices. Findings from that systematic review and meta‐analysis of RCTs evaluating paclitaxel-coated balloons and paclitaxel-eluting stents in the femoral and/or popliteal arteries were published online by Konstantinos Katsanos, MD, et al online in Journal of the American Heart Association.
As summarized in CVIR, the clinical data of the four RCTs were pooled to assess 2-year mortality after paclitaxel-coated balloon angioplasty compared to angioplasty without paclitaxel (control group). A logistic regression model was applied to identify potential predictors of mortality.
The investigators reported the following:
- At 2 years, mortality rates were 7% (13 of 185 patients) in the control group versus 8.7% (16 of 184 patients) in the paclitaxel-coated balloon group (P = .55).
- Kaplan-Meier analysis revealed no significant difference from all-cause death at 2 years (log rank P = .54).
- Causes of death were well balanced between the groups, with no pattern or trend in favor of any specific causes in the paclitaxel-coated balloon group.
- Logistic regression revealed that treatment groups (controls or paclitaxel-coated balloons) were not a predictor of 2-year mortality.
- The only predictor for mortality was patient age ≥ 75 years.
The delivered paclitaxel doses per patient were not significantly different in patients who died and patients who did not die during the 24-month follow-up (5.300 ± 4.224 μg vs 6.248 ± 4.629 μg; P = .433), noted the investigators in CVIR.
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