Paclitaxel DCB safe for long-term in femoropopliteal PAD:IN.PACT Global Study

Germany: A paclitaxel-based drug-coated balloon (DCB) showed safe and durable outcomes in real-world patients with femoropopliteal peripheral arterial disease (PAD), according to 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study. 

Numerous randomized controlled trials (RCTs) have shown paclitaxel drug-coated balloons (DCBs) to be superior to non-coated angioplasty balloons for treating femoropopliteal peripheral arterial disease. However, there is a lack of clinical evidence in more complex patients who are often excluded from RCTs. Also, there is very limited long-term data up to 5 years in PAD revascularisation studies. 

Thomas Zeller, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany, and colleagues in their study, published in the EuroIntervention report on the 5-year outcomes from the IN.PACT Global Study. The evaluation of IN.PACT Admiral DCB was done for the treatment of femoropopliteal atherosclerotic diseasein a real-world patient population. 

A total of 1,535 patients were enrolled at 64 international sites. The prespecified clinical cohort included 1,406 patients with claudication or rest pain. Evaluation of the patients for the occurrence of adverse events and clinically driven target lesion revascularisations (CD-TLR) was done for up to 5 years.