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SCAI Issues Statement on the Association Between Paclitaxel Devices and Mortality

from SCAI

On Dec. 6, 2018, the Journal of the American Heart Association (JAHA) published a meta-analysis by Katsanos et al that revealed an increase in long-term mortality with paclitaxel-coated balloons and paclitaxel-eluting stents. Briefly, the study evaluated 28 randomized control trials across 12 devices for the treatment of femoropopliteal disease.

Experts from the Society for Cardiovascular Angiography and Interventions (SCAI) Vascular Disease Council have reviewed this meta-analysis and have concluded that the methods are appropriate and within constraints of trial-level meta-analysis. However, it is important to note that SCAI believes the associations are hypothesis-generating and require further investigation with patient-level data.

“At present, SCAI concurs with FDA that the benefits of paclitaxel devices continue to outweigh any potential risks,” says David A. Cox, M.D., MSCAI, SCAI President. “However, we strongly encourage our members to discuss the findings of the meta-analysis with their patients and to report any safety concerns to FDA.”

Read the full statement here.

Access full media coverage here:
New Data Add Fuel to Paclitaxel-Device Firestorm in PAD (Medscape)
IN.PACT Admiral Data Show No Death Difference at 5 Years for Paclitaxel DCBs Versus PTA in Femoropopliteal Disease (TCTMD)
SCAI: Benefits of paclitaxel-coated devices outweigh risks (Healio)
Study Upholds Safety of Paclitaxel Balloon in PAD Amid FDA Probe (MedPage Today)
Safety of Paclitaxel-eluting Stents and Balloons Called Into Question (Diagnostic and Interventional Cardiology)
Paclitaxel devices for the legs still recommended, but (Star Tribune)
SCAI chimes in on concerns about paclitaxel devices (Cardiovascular Business) more


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