Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study

DOI: 10.4244/EIJ-D-21-01098

Thomas Zeller
Thomas Zeller1, MD, PhD; Marianne Brodmann2, MD; Gary M. Ansel3, MD; Dierk Scheinert4, MD; Donghoon Choi5, MD, PhD; Gunnar Tepe6, MD; Jeremiah Menk7, MS; Antonio Micari8, MD, PhD
1. Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 2. Division of Angiology, Medical University, Graz, Austria; 3. Healthcare Insights, Columbus, OH, USA; 4. University Hospital Leipzig, Leipzig, Germany; 5. Yonsei University, Yongin Severance Hospital, Yongin, South Korea; 6. RoMed Clinic, Rosenheim, Germany; 7. Medtronic, Santa Rosa, CA, USA; 8. Cardiology Unit, University of Messina, Messina, Italy

Background: Numerous randomised controlled trials (RCTs) have demonstrated the superiority of paclitaxel drug-coated balloons (DCBs) over non-coated angioplasty balloons for treatment of femoropopliteal peripheral arterial disease (PAD). There is a paucity of clinical evidence in more complex patients who are often excluded from RCTs and long-term data up to 5 years are very limited in PAD revascularisation studies.

Aims: This is a report of the 5-year outcomes from the prospective, single-arm, international IN.PACT Global Study. The IN.PACT Admiral DCB was evaluated for femoropopliteal atherosclerotic disease treatment in a real-world patient population.

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

Results: 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 (p=0.602). 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.

Conclusions: The IN.PACT Admiral DCB demonstrated safe and durable outcomes in real-world participants with complex femoropopliteal disease. ClinicalTrials.gov: NCT01609296

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calcified stenosisdrug-eluting balloonfemoropopliteal diseasein-stent restenosisTotal occlusion
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