Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

IN.PACT Global Study Investigators

doi:10.1016/j.jcin.2018.02.019

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

IN.PACT Global Study Investigators

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

59 Citations (Scopus)

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

Original language	English
Pages (from-to)	945-953
Number of pages	9
Journal	JACC: Cardiovascular Interventions
Volume	11
Issue number	10
DOIs	https://doi.org/10.1016/j.jcin.2018.02.019
Publication status	Published - 2018 May 28

Bibliographical note

Funding Information:
This research was supported by Medtronic. Prof. Micari is a compensated consultant for Medtronic and Boston Scientific. Prof. Brodmann has received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and Viva Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Prof. Tepe has received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr. Frost and Dr. Wang are full-time employees of Medtronic. Prof. Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, W.L. Gore & Associates, Medtronic, and Spectranetics; and his clinic has received study funds or funds for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, Cardiovascular Systems, Inc., W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Publisher Copyright:
© 2018 The Authors

All Science Journal Classification (ASJC) codes

Cardiology and Cardiovascular Medicine

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10.1016/j.jcin.2018.02.019

Cite this

@article{1c72486c98ff451fa6ecaf66b0287000,

title = "Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study",

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",

author = "{IN.PACT Global Study Investigators} and Antonio Micari and Marianne Brodmann and Koen Keirse and Patrick Peeters and Gunnar Tepe and Martin Frost and Hong Wang and Thomas Zeller and Thomas Zeller and Giovanni Torsello and Gunnar Tepe and Patrick Peeters and Dierk Scheinert and Marc Bosiers and Lieven Maene and Antonio Micari and Do, {Dai Do} and Jeroen Hendriks and Koen Keirse and Marianne Brodmann and Bela Merkely and Lardenoije, {Jan Willem} and Zoltan Ruzsa and Britta Vogel and Pierfrancesco Veroux and {Albuquerque e Castro}, Joao and Daniel Periard and Tomasz Ludyga and Dominique Midy and Donghoon Choi and Wouter Lansink and Dominik Ketelsen and Steven Dubenec and Martin Banyai and Nabil Chakfe and Roithinger, {Franz Xaver} and Carlo Trani and Hossam Mansour and Rha, {Seung Woon} and Frank Vermassen and Alexander Belenky and Lubomir Spak and Nicholas Chalmers and Andrew Benko and Steven Kum and Won, {Je Hwan} and Matej Vozar and Tan, {Kong Teng} and Mamdouh Labib and {de Borst}, {Gert Jan}",

note = "Funding Information: This research was supported by Medtronic. Prof. Micari is a compensated consultant for Medtronic and Boston Scientific. Prof. Brodmann has received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and Viva Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Prof. Tepe has received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr. Frost and Dr. Wang are full-time employees of Medtronic. Prof. Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, W.L. Gore & Associates, Medtronic, and Spectranetics; and his clinic has received study funds or funds for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, Cardiovascular Systems, Inc., W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2018 The Authors",

year = "2018",

month = may,

day = "28",

doi = "10.1016/j.jcin.2018.02.019",

language = "English",

volume = "11",

pages = "945--953",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

number = "10",

}

TY - JOUR

T1 - Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain

T2 - 2-Year Results From the IN.PACT Global Study

AU - IN.PACT Global Study Investigators

AU - Micari, Antonio

AU - Brodmann, Marianne

AU - Keirse, Koen

AU - Peeters, Patrick

AU - Tepe, Gunnar

AU - Frost, Martin

AU - Wang, Hong

AU - Zeller, Thomas

AU - Torsello, Giovanni

AU - Tepe, Gunnar

AU - Peeters, Patrick

AU - Scheinert, Dierk

AU - Bosiers, Marc

AU - Maene, Lieven

AU - Micari, Antonio

AU - Do, Dai Do

AU - Hendriks, Jeroen

AU - Keirse, Koen

AU - Brodmann, Marianne

AU - Merkely, Bela

AU - Lardenoije, Jan Willem

AU - Ruzsa, Zoltan

AU - Vogel, Britta

AU - Veroux, Pierfrancesco

AU - Albuquerque e Castro, Joao

AU - Periard, Daniel

AU - Ludyga, Tomasz

AU - Midy, Dominique

AU - Choi, Donghoon

AU - Lansink, Wouter

AU - Ketelsen, Dominik

AU - Dubenec, Steven

AU - Banyai, Martin

AU - Chakfe, Nabil

AU - Roithinger, Franz Xaver

AU - Trani, Carlo

AU - Mansour, Hossam

AU - Rha, Seung Woon

AU - Vermassen, Frank

AU - Belenky, Alexander

AU - Spak, Lubomir

AU - Chalmers, Nicholas

AU - Benko, Andrew

AU - Kum, Steven

AU - Won, Je Hwan

AU - Vozar, Matej

AU - Tan, Kong Teng

AU - Labib, Mamdouh

AU - de Borst, Gert Jan

N1 - Funding Information: This research was supported by Medtronic. Prof. Micari is a compensated consultant for Medtronic and Boston Scientific. Prof. Brodmann has received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and Viva Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Prof. Tepe has received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr. Frost and Dr. Wang are full-time employees of Medtronic. Prof. Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, Cook Medical, W.L. Gore & Associates, Medtronic, and Spectranetics; and his clinic has received study funds or funds for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, Cardiovascular Systems, Inc., W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: © 2018 The Authors

PY - 2018/5/28

Y1 - 2018/5/28

N2 - 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

AB - 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

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VL - 11

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ER -

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

Abstract

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