New meta-analysis finds “no observed difference” in mortality between paclitaxel and uncoated device use in CLTI patients

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February 2020 brings another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et al report online ahead of print the risk of all-cause mortality after treatment with paclitaxel-coated devices vs. uncoated controls in patients with CLTI in the Journal of Vascular and Endovascular Therapy (JEVT) very differently than did Katsanos and colleagues earlier this year.

Dinh and colleagues, including Ramon Varcoe (Prince of Wales Hospital, Sydney, Australia), Andrew Holden (Auckland Hospita, Auckland, New Zealand) and Peter Schneider (University of California San Francisco, San Francisco, USA) performed a systematic review on 5 November 2019 to identify randomised 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 randomised 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 analysed 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).

Ramon Varcoe
Ramon Varcoe

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”.


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