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.
Salient findings include:
- The mean lesion length was 12.1±9.5 cm in 1,774 lesions, 18.0% had in-stent restenosis, 35.5% were total occlusions and 68.7% were calcified.
- Per independent clinical events committee adjudication, the Kaplan-Meier estimate of freedom from CD-TLR up to 5 years was 69.4%, and the restricted mean survival time to first CD-TLR was 1,470.1 days.
- Outcomes were similar for males and females; freedom from CD-TLR was 69.1% in females and 69.6% in males.
- The cumulative incidence of major adverse events for the clinical cohort was 45.9% and freedom from all-cause mortality with the vital status update was 78.9% up to 5 years.
"The IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease," the researchers concluded.
Reference:
Zeller T, Brodmann M, Ansel GM, et al. Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study. EuroIntervention. 2022;Epub ahead of print.
