February 2020 brings another paclitaxel device meta-analysis of randomized controlled trials in chronic limb-threatening ischemia (CLTI) patients. Krystal Dinh, BMed, of Westmead Hospital, Sydney, Australia, et al report online ahead of print that the risk of all-cause mortality after treatment with paclitaxel-coated devices vs. uncoated controls in patients with CLTI in the Journal of Endovascular Therapy (JEVT) very differently than did Konstantinos Katsanos, MD, and colleagues earlier this year. In fact, Dinh et al, due to the clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, “recommend their continued use in this high-risk patient population.”
Dinh and colleagues, including Ramon Varcoe, MBBS, of Prince of Wales Hospital, Sydney, Australia, Andrew Holden, MBChB, of Auckland Hospital, Auckland, New Zealand, and Peter Schneider, MD, of University of California San Francisco, San Francisco, performed a systematic review on Nov. 5, 2019, to identify randomized controlled trials using intention-to-treat analysis to compare a paclitaxel-coated device to an uncoated device in peripheral arterial disease patients having clinical follow-up of at least six months. Half of the study population had to have CLTI, or extractable data on the CLTI subgroup, if this constituted less than 50%, write the authors.
The search revealed 11 trials with 1,450 patients who were randomized to treatment with a paclitaxel-coated device (n=866) or an uncoated control (n=584). The group included 94.3% (1,367) patients with CLTI. The single endpoint was all-cause mortality, which was analyzed by pooling the mortality data in a random effects model. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI).
Importantly, Varcoe clarified that this meta-analysis included the five-year IN.PACT DEEP results that were overlooked by Katsanos and colleagues. Further, they included only studies that were published, or those that authors were able to confirm had been accepted for publication and were in press.
As described in JEVT, the mean follow-up was 25.6 months (range 6–60) and 10 of 11 studies reported a minimum 12-month follow-up. There were 18.6% (161) deaths in the 866 patients in the paclitaxel device group and 19.9% (116) deaths in 584 patients who received treatment with a non-coated devices (RR 0.93, 95% CI 0.78 to 1.12, p=0.45).
This led the investigators to conclude that “there was no observed difference in short- to mid-term mortality among a pooled patient population of predominately CLTI patients treated with paclitaxel-coated balloons or stents compared with uncoated controls.”
They write: “This meta-analysis has demonstrated that there is no increased risk of all-cause mortality in a predominately CLTI patient population treated with paclitaxel-coated vs. uncoated devices. With clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, we recommend their continued use in this high-risk patient population.”