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 all, 28
RCT
s with 4663 patients (89% intermittent claudication) were analyzed. All‐cause patient death at 1 year (28
RCT
s 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
RCT
s 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
RCT
s 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:
CRD
42018099447.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.