Antonio Micari1, Marianne Brodmann2, Koen Keirse3, Patrick Peeters4, Gunnar Tepe5, Martin Frost6, Hong Wang7, Thomas Zeller8. 1. GVM Care and Research, Maria Cecilia Hospital, Cotignola, Italy. Electronic address: micariantonio@gmail.com. 2. Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria. 3. Department of Vascular Surgery, Regional Hospital Heilig Hart Tienen, Tienen, Belgium. 4. Imelda Hospital, Bonheiden, Belgium. 5. RoMed Klinikum, Department of Diagnostic and Interventional Radiology, Rosenheim, Germany. 6. Medtronic, Bakken Research Center BV, Maastricht, the Netherlands. 7. Medtronic, Santa Rosa, California. 8. Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.
Abstract
OBJECTIVES: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296).
OBJECTIVES: The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND: Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS: The IN.PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS: Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS: This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (IN.PACT Global Clinical Study; NCT01609296).
Authors: John A Laird; Peter A Schneider; Michael R Jaff; Marianne Brodmann; Thomas Zeller; D Chris Metzger; Prakash Krishnan; Dierk Scheinert; Antonio Micari; Hong Wang; Michele Masters; Gunnar Tepe Journal: Circ Cardiovasc Interv Date: 2019-06-14 Impact factor: 6.546
Authors: Gary M Ansel; Marianne Brodmann; Koen Keirse; Antonio Micari; Michael R Jaff; Krishna Rocha-Singh; Eric J Fernandez; Hong Wang; Thomas Zeller Journal: J Endovasc Ther Date: 2018-10-03 Impact factor: 3.487
Authors: Gunnar Tepe; Thomas Zeller; Matej Moscovic; Jean-Marc Corpataux; Johnny Kent Christensen; Koen Keirse; Giovanni Nano; Henrik Schroeder; Christoph A Binkert; Marianne Brodmann Journal: Cardiovasc Intervent Radiol Date: 2020-10-20 Impact factor: 2.740