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Paclitaxel exposure: Long‐term safety and effectiveness of a drug‐coated balloon for claudication in pooled randomized trials

Catheterization and Cardiovascular Interventions Aug 28, 2020

Schneider PA, Brodmann M, Mauri L, et al. - Researchers assessed how paclitaxel exposure could impact the long‐term safety and efficacy of angioplasty of femoropopliteal artery lesions in the combined IN.PACT randomized trials. Drug‐coated balloons (DCB) were compared with standard percutaneous transluminal angioplasty (PTA) for claudication in the IN.PACT randomized trials (SFA, N = 331 and Japan, N = 100) each. In the IN.PACT SFA trial, increment in the rate of long‐term vital status ascertainment from 81% to 97% for DCB and from 85% to 97% for PTA was evident. Paclitaxel dose (mg) was identified as an independent predictor of attenuated risk of clinically driven target lesion revascularization. Overall, paclitaxel was found to be related to improved efficacy but was not related to increased mortality, in pooled randomized trial data with updated vital status ascertainment.

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