Meta-Analysis Observes Increased Mortality Trend in Trials of Paclitaxel‐Coated SFA Devices, But No Definitive Cause


December 6, 2018—A systematic review and meta‐analysis of randomized controlled trials (RCTs) evaluating paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries concluded that there is an increased risk of death after application of these devices in this anatomy. Konstantinos Katsanos, MD, et al published the study online in Journal of the American Heart Association (JAHA). Although the authors postulated that late paclitaxel toxicity may be the reason for the observed increased death rate, a specific cause or plausible mechanism between paclitaxel and patient death could not be established. Further investigations are urgently warranted, advised the authors.

The study is registered with PROSPERO, the international prospective register of systematic reviews.

The investigators analyzed 28 RCTs composed of 4,663 patients (89% with intermittent claudication). The primary safety measure was all‐cause patient death. Risk ratios (RRs) and risk differences were pooled with a random effects model.

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