Response by Schneider et al to Letter Regarding Article, “Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial”
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Dan et al describe paclitaxel as the pharmaceutical component of a coronary drug-eluting stent removed from the market because of safety and efficacy concerns. Paclitaxel has demonstrated a different clinical profile in the lower extremity, whether delivered by balloon or stent.
The IN.PACT SFA trial studied the use of the IN.PACT Admiral drug-coated balloon (DCB) in the SFA and proximal popliteal arteries, and IN.PACT DEEP trial used the IN.PACT Amphirion DCB in the infrapopliteal arteries.1,2 These DCBs are completely different devices used in disparate populations for distinct conditions. IN.PACT Admiral is commercially available based on safety and efficacy in rigorously collected and adjudicated clinical trials and is coated with 3.5 μg/mm2 paclitaxel. IN.PACT Amphirion—a DCB with a different balloon material and coating methodology—is no longer on …