Risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta‐analysis of …

K Katsanos, S Spiliopoulos, P Kitrou… - Journal of the …, 2018 - Am Heart Assoc
Journal of the American Heart Association, 2018Am Heart Assoc
Background Several randomized controlled trials (RCT s) have already shown that
paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and
target lesion revascularization after lower extremity interventions. Methods and Results A
systematic review and meta‐analysis of RCT s investigating paclitaxel‐coated devices in the
femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause
patient death. Risk ratios and risk differences were pooled with a random effects model. In …
Background
Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions.
Methods and Results
A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All‐cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel‐coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72–1.61). All‐cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15–2.47; —number‐needed‐to‐harm, 29 patients [95% CI, 19–59]). All‐cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27–2.93; —number‐needed‐to‐harm, 14 patients [95% CI, 9–32]). Meta‐regression showed a significant relationship between exposure to paclitaxel (dose‐time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg‐year; P<0.001). Trial sequential analysis excluded false‐positive findings with 99% certainty (2‐sided α, 1.0%).
Conclusions
There is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted.
Clinical Trial Registration
URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447.
Am Heart Assoc