Data from an unselected, real-world cohort of 64,000 claimants of the German BARMER Health Insurance reveals no signal of increased long-term mortality when paclitaxel-based devices are used in the femoropopliteal arteries, Eva Freisinger (Münster, Germany) told BLearning Peripheral at LINC 2020.
She explained that as German law mandates the mortality of every insurance holder be reported directly to the healthcare insurance provider, the investigators knew the exact date of death for every patient included in the analysis. “This is why we have no loss of follow-up on this important end-point,” Freisinger imparted.
“In 2020, I would consider these devices to not harm patients in the long-term, as was suggested by the Katsanos work,” she concluded, referencing the 2018 meta-analysis by Konstantinos Katsanos (Patras, Greece) et al that reported an increased association with mortality with paclitaxel-based devices in the leg. Freisinger believes these findings should “reassure physicians [that] we do not see an increased long-term mortality signal for paclitaxel-based devices”.
Bolstering the evidence-base for proponents of paclitaxel-based devices, Thomas Zeller (Bad Krozingen, Germany) also reported positive results for drug-coated balloons (DCBs) at LINC.
In an analysis of approximately 1,600 patients at his own institution treated with either a paclitaxel-coated balloon or through a paclitaxel-naïve method (either bare metal stenting, atherectomy, or plain balloon angioplasty), and with a follow-up of at least three years, Zeller and colleagues “found a mortality benefit of around 10% over time favouring the treatment with DCB angioplasty”.
He added that, despite being a single-centre, retrospective study, he believes “this is very high-level scientific data, because we enrolled really all-comers, we did not exclude any patient”. Additionally, an advantage of the single-centre setting is to exclude any confounding variables that may arise if patients are treated at different hospitals.
Based on both large, real-world data sets from insurance companies and this single-centre data analysis, Zeller concluded that his team “could not confirm” the 2018 findings that treatment with paclitaxel-coated devices in the femoropopliteal segment poses a greater risk to long-term mortality.
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