Concerns about paclitaxel-coated stents and balloons removed
28 October 2019
The use of drug-coated stent and balloon catheters is an established standard in the endovascular therapy of peripheral arterial occlusive disease. Millions of patients worldwide have been treated with these medical devices to date. Paclitaxel is by far the most frequently used drug for the coating, inhibiting cell division and thus preventing the reocclusion of the treated extremities. However, a meta-analysis published in December 2018 was critical of the paclitaxel-coated catheter products.
A new analysis comes to a different conclusion: “In our analysis, there is no evidence of increased mortality over 11 years in connection with paclitaxel-based DED. The study results disprove the data of Katsanos at least for Germany and could contribute to a rehabilitation of the successful therapy with coated catheters”. The general prognosis of PAVK patients is unfavourable. In a median follow-up period of 92 months, 42% of all patients died. The patients with DES or according to DCB had a slightly reduced mortality risk in the first year. Thereafter, the risk of DES carriers increased slightly. However, the hazard ratios were not significant at any time. Therefore, the study cannot confirm the concerns of the drug authorities. In view of the poor prognosis, however, it is not possible to speak of a therapy breakthrough through the stents.
|Zylka-Menhorn V, Meyer R||Dtsch Ärztebl 2019; 116(43): A-1954 / B-1601 / C-1569|
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