Peripheral interventions

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

EuroIntervention 2022;18:e940-e948. 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, Republic of 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

Sign in to read and download the full article

Forgot your password?

No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

calcified stenosisdrug-eluting balloonfemoropopliteal diseasein-stent restenosisTotal occlusion
Read next article
Ten-year clinical outcomes of drug-eluting stents with different polymer coating strategies by degree of coronary calcification: a pooled analysis of the ISAR-TEST 4 and 5 randomised trials

Latest news