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SCAI, Manufacturers Defend Peripheral Paclitaxel Devices Against Doubts

 
• By Reed Miller

The Society for Cardiovascular Angiography and Interventions’ Vascular Disease Council says the recent meta-analysis finding a higher long-term mortality risk with paclitaxel-eluting peripheral devices can only be viewed as hypothesis-generating. The long-term risks of these devices should be investigated with patient-level data, SCAI argues. Several clinical data presentations at the recent LINC meeting in Leipzig showed comparable mortality rates with paclitaxel-eluting devices as comparable non-drug-eluting devices.

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• Source: shutterstock.com

A recent meta-analysis calling into question the safety of paclitaxel-coated balloons and paclitaxel-eluting stents was appropriately conducted within the constraints of trial-level data but the conclusions should only be viewed as hypothesis-generating, says the Society for Cardiovascular Angiography and Interventions (SCAI) Vascular Disease Council.

On Dec. 6, the Journal of the American Heart Association published a meta-analysis of 28 randomized trials with a total of 4,663 patients treated with paclitaxel‐coated balloons and stents to treat vascular disease the lower extremities. The meta-analysis, led by Konstantinos Katsanos of Patras University Hospital in Greece, shows increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs

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