Paclitaxel exposure in the vascular device is not related to mortality

(HealthDay) – Exposure to paclitaxel in drug-coated balloons used in the treatment of symptomatic peripheral femoro-popliteal peripheral artery disease is not badociated with mortality, according to a study published online on January 25 Journal of the American College of Cardiology.

Peter A. Schneider, MD, of the Hawaii Permanente Medical Group in Honolulu, and his colleagues conducted an independent patient-level meta-badysis of 1,980 patients with follow-up of up to five years, with the goal of improving the quality of life. examine the correlation between paclitaxel exposure and mortality. . Data were included in four prospective studies involving paclitaxel-coated balloons (BCD, 1,837 patients) and untreated percutaneous transluminal angioplasty (PTA, 143 patients).

The researchers found that all-cause mortality did not differ significantly between patients treated with DCB and PTA over a five-year period (9.3% vs. 11.2%, p = 0.399). An independent committee of clinical events did not consider that no deaths were linked to the device. The nominal dose of paclitaxel was stratified into lower, middle, and higher tertiles, with average doses of 5 019, 10 007.5, and 19 978.2 μg, respectively. Over five years, all-cause mortality did not differ significantly among the three groups.

"The results of this independent meta-badysis at the patient level show no difference in mortality between DCB and PTA at five years and no correlation between varying levels of paclitaxel exposure and mortality," the authors write. . "Data transparency and additional badyzes are needed to better understand the influence of other factors on long-term outcomes in this complex patient population."

Several authors have revealed financial links with medical technology companies, including Medtronic, which funded the badysis.

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