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

The IN.PACT Global Study Investigators

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)E940-E948
Issue number11
Publication statusPublished - 2022 Dec

Bibliographical note

Funding Information:
This study was sponsored by Medtronic. The authors received no specific funding for this work or preparation of the manuscript.

Publisher Copyright:
© Europa Digital & Publishing 2022. All rights reserved.

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine


Dive into the research topics of 'Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study'. Together they form a unique fingerprint.

Cite this