Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.

ABSTRACT:

Aims

Drug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED.

Methods and results

In 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied D

SUBMITTER: Freisinger E 

PROVIDER: S-EPMC7666867 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature