A safety shadow cast over paclitaxel-impregnated stents and devices

Paclitaxel-coated balloons and stents reduce restenosis and target lesion revascularization after lower extremity interventions, but what of long term outcomes? A recent systematic review and meta-analysis of RCTs investigating paclitaxel-coated devices in the femoral and/or popliteal arteries did not deliver reassuring news. The primary safety measure was all-cause patient death: although all-cause patient death after one year was similar for paclitaxel 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 mortality after two years was significantly higher with 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]). The effect was also found to be dose-related. The investigators are profoundly understated in their conclusion that “further investigations are urgently warranted.” Read more detail here.