A study of almost 65,000 people has found that using paclitaxel-based drug-eluting devices (DEDs) for endovascular revascularisation (EVR) of the lower limbs is not linked with an increase in mortality.
The findings, published this week in the European Heart Journal, contradict recent research, which suggested an almost two-fold increased long-term mortality in patients treated with paclitaxel-based DEDs.
As part of this latest study, researchers analysed data on 64,771 real-world patients who underwent 107,112 EVR procedures of the lower limbs from 2007 up to 2015, using data from German BARMER health insurance claims. Participants were assigned to one of four sub-groups: drug-eluting stents (DES), drug-coated balloon (DCB), bare metal stent or plain balloon angioplasty. They were followed for more than 11 years.
The authors reported that neither paclitaxel-based DES or DCB were associated with increased mortality. DCB use was actually associated with decreased mortality in the first year, which became irrelevant in subsequent years.
“Our work provides a solid base of evidence that will be difficult to rebut. We expect the FDA and other regulatory authorities will very likely amend their statements on safety concerns on paclitaxel-based devices,” said author, Dr Eva Freisinger, of the University Hospital Münster, Germany.