5 years ago, several prospective randomized studies confirmed paclitaxel coated balloons were safe and effective in femoropopliteal territory. However, a recently published meta-analysis of heterogeneous studies including both paclitaxel coated balloons and drug eluting stents has linked these devices to mortality. In addition, higher doses were associated to higher mortality, both at 2 and 5 years.
This new meta-analysis soon to be published in J Am Coll Cardiol seeks to determine whether this association really exists in 1980 patients followed up at 5 years.
Data from 4 randomized independently adjudicated prospective studies, 2 including 1837 patients receiving paclitaxel coated balloons and 2 including 143 control patients receiving uncoated conventional balloons, were included. A thorough analysis of patient baseline characteristics was carried out and followed at long term to prove whether or not the use of paclitaxel had a positive correlation with mortality. Survival rate and dose tercile were taken into account.
All efforts were coordinated to shed light on this link that both interventionists and patients are so concerned about, seeing as the latter have already been treated with these devices.
There was no significant association between all-cause mortality and paclitaxel coated balloons at 5-year follow-up (9.3% vs. 11.2%; p=0.399). No deaths were independently adjudicated to these devices.
When dividing patients according to dose tercile, there were no differences between patients receiving the higher dose vs. patients with the lower dose of paclitaxel (p=0.7).
This new meta-analysis shows paclitaxel coated balloons are safe and are not liked to increased mortality, even in patients with higher doses.
Original Title: Mortality Not Correlated With Paclitaxel Exposure An Independent Patient-Level Meta-Analysis.
Reference: Peter A. Schneider et al. J Am Coll Cardiol 2019; Article in press.
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