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Zeller, T; Brodmann, M; Ansel, GM; Scheinert, D; Choi, D; Tepe, G; Menk, J; Micari, A; IN PACT Global Study Investigators.
Paclitaxel-coated balloons for femoropopliteal peripheral arterial disease: final five-year results of the IN.PACT Global Study
EUROINTERVENTION. 2022; 18(11): 940-+. Doi: 10.4244/EIJ-D-21-01098 [OPEN ACCESS]
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Co-Autor*innen der Med Uni Graz
Brodmann Marianne
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Abstract:
Background: Numerous randomised controlled trials (RCTs) have demonstrated the superiority of pacli-taxel 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 treat-ment 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 occur-rence 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 sur-vival 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 partici-pants with complex femoropopliteal disease. ClinicalTrials.gov: NCT01609296

Find related publications in this database (Keywords)
calcified stenosis
drug-eluting balloon
femoropopliteal disease
in-stent restenosis
total occlusion
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