Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

on behalf of the IN.PACT Global Investigators

doi:10.1177/1526602820931477

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

on behalf of the IN.PACT Global Investigators

Department of Internal Medicine

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

25 Citations (Scopus)

Abstract

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p'0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Original language	English
Pages (from-to)	693-705
Number of pages	13
Journal	Journal of Endovascular Therapy
Volume	27
Issue number	5
DOIs	https://doi.org/10.1177/1526602820931477
Publication status	Published - 2020 Oct 1

Bibliographical note

Funding Information:
The authors would like to thank Megan Fox, MBA, and Eric Fernandez, MD, for clinical support; Pei Li, PhD, for statistical review; Bridget Wall, PhD, and Kathleen Cahill, MS, for technical review of the manuscript; and Sangeeta Yendrembam, PhD, for assistance in its preparation. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The IN.PACT Global Study was sponsored by Medtronic.

Funding Information:
The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giovanni Torsello received speaking honoraria from W.L. Gore & Associates and Medtronic. Konstantinos Stavroulakis received honoraria from Medtronic, Boston Scientific Corp, Philips, and Biotronik. Marianne Brodmann 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. Antonio Micari is a compensated consultant for Medtronic and Boston Scientific Corp. Gunnar Tepe received research grants from Medtronic and is a compensated advisory board member for Medtronic. Pierfrancesco Veroux received research and clinical trial funds and honoraria from Medtronic, Abbott Vascular, Terumo Medical Corp, Cook Medical, W.L. Gore & Associates, and Bolton Medical. Andrew Benko received speaking honoraria from Medtronic, Boston Scientific Corp, and Cordis and research funding from Medtronic, Boston Scientific Corp, and Soundbite Medical. Frank E.G. Vermassen received speaking honoraria from Abbott Vascular, Boston Scientific Corp, Medtronic, and Philips and is a consultant for Medtronic and Philips. Michael R. Jaff is a noncompensated advisor for Abbott Vascular; a part-time employee of Boston Scientific; an advisor for Biotronik, Medtronic, Philips, Sanofi, Vactronix, and Vascular Therapies; and an equity investor in Embolitech, Gemini, and PQ Bypass. Thomas Zeller received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; he is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp, 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, CSI, W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. Jia Guo and Reka Dobranszki are full-time employees of Medtronic.

Publisher Copyright:
© The Author(s) 2020.

All Science Journal Classification (ASJC) codes

Surgery
Radiology Nuclear Medicine and imaging
Cardiology and Cardiovascular Medicine

Access to Document

10.1177/1526602820931477

Cite this

@article{894063aecf2a46f89460e8194433d692,

title = "Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort",

abstract = "Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p'0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.",

author = "{on behalf of the IN.PACT Global Investigators} and Giovanni Torsello and Konstantinos Stavroulakis and Marianne Brodmann and Antonio Micari and Gunnar Tepe and Pierfrancesco Veroux and Andrew Benko and Donghoon Choi and Vermassen, {Frank E.G.} and Jaff, {Michael R.} and Jia Guo and Reka Dobranszki 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 {Xaver Roithinger}, Franz 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",

note = "Funding Information: The authors would like to thank Megan Fox, MBA, and Eric Fernandez, MD, for clinical support; Pei Li, PhD, for statistical review; Bridget Wall, PhD, and Kathleen Cahill, MS, for technical review of the manuscript; and Sangeeta Yendrembam, PhD, for assistance in its preparation. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The IN.PACT Global Study was sponsored by Medtronic. Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giovanni Torsello received speaking honoraria from W.L. Gore & Associates and Medtronic. Konstantinos Stavroulakis received honoraria from Medtronic, Boston Scientific Corp, Philips, and Biotronik. Marianne Brodmann 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. Antonio Micari is a compensated consultant for Medtronic and Boston Scientific Corp. Gunnar Tepe received research grants from Medtronic and is a compensated advisory board member for Medtronic. Pierfrancesco Veroux received research and clinical trial funds and honoraria from Medtronic, Abbott Vascular, Terumo Medical Corp, Cook Medical, W.L. Gore & Associates, and Bolton Medical. Andrew Benko received speaking honoraria from Medtronic, Boston Scientific Corp, and Cordis and research funding from Medtronic, Boston Scientific Corp, and Soundbite Medical. Frank E.G. Vermassen received speaking honoraria from Abbott Vascular, Boston Scientific Corp, Medtronic, and Philips and is a consultant for Medtronic and Philips. Michael R. Jaff is a noncompensated advisor for Abbott Vascular; a part-time employee of Boston Scientific; an advisor for Biotronik, Medtronic, Philips, Sanofi, Vactronix, and Vascular Therapies; and an equity investor in Embolitech, Gemini, and PQ Bypass. Thomas Zeller received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; he is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp, 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, CSI, W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. Jia Guo and Reka Dobranszki are full-time employees of Medtronic. Publisher Copyright: {\textcopyright} The Author(s) 2020.",

year = "2020",

month = oct,

day = "1",

doi = "10.1177/1526602820931477",

language = "English",

volume = "27",

pages = "693--705",

journal = "Journal of Endovascular Therapy",

issn = "1526-6028",

publisher = "International Society of Endovascular Specialists",

number = "5",

}

TY - JOUR

T1 - Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

AU - on behalf of the IN.PACT Global Investigators

AU - Torsello, Giovanni

AU - Stavroulakis, Konstantinos

AU - Brodmann, Marianne

AU - Micari, Antonio

AU - Tepe, Gunnar

AU - Veroux, Pierfrancesco

AU - Benko, Andrew

AU - Choi, Donghoon

AU - Vermassen, Frank E.G.

AU - Jaff, Michael R.

AU - Guo, Jia

AU - Dobranszki, Reka

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 - Xaver Roithinger, Franz

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

N1 - Funding Information: The authors would like to thank Megan Fox, MBA, and Eric Fernandez, MD, for clinical support; Pei Li, PhD, for statistical review; Bridget Wall, PhD, and Kathleen Cahill, MS, for technical review of the manuscript; and Sangeeta Yendrembam, PhD, for assistance in its preparation. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The IN.PACT Global Study was sponsored by Medtronic. Funding Information: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Giovanni Torsello received speaking honoraria from W.L. Gore & Associates and Medtronic. Konstantinos Stavroulakis received honoraria from Medtronic, Boston Scientific Corp, Philips, and Biotronik. Marianne Brodmann 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. Antonio Micari is a compensated consultant for Medtronic and Boston Scientific Corp. Gunnar Tepe received research grants from Medtronic and is a compensated advisory board member for Medtronic. Pierfrancesco Veroux received research and clinical trial funds and honoraria from Medtronic, Abbott Vascular, Terumo Medical Corp, Cook Medical, W.L. Gore & Associates, and Bolton Medical. Andrew Benko received speaking honoraria from Medtronic, Boston Scientific Corp, and Cordis and research funding from Medtronic, Boston Scientific Corp, and Soundbite Medical. Frank E.G. Vermassen received speaking honoraria from Abbott Vascular, Boston Scientific Corp, Medtronic, and Philips and is a consultant for Medtronic and Philips. Michael R. Jaff is a noncompensated advisor for Abbott Vascular; a part-time employee of Boston Scientific; an advisor for Biotronik, Medtronic, Philips, Sanofi, Vactronix, and Vascular Therapies; and an equity investor in Embolitech, Gemini, and PQ Bypass. Thomas Zeller received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; he is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp, 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, CSI, W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. Jia Guo and Reka Dobranszki are full-time employees of Medtronic. Publisher Copyright: © The Author(s) 2020.

PY - 2020/10/1

Y1 - 2020/10/1

N2 - Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p'0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

AB - Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p'0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

UR - http://www.scopus.com/inward/record.url?scp=85088581168&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85088581168&partnerID=8YFLogxK

U2 - 10.1177/1526602820931477

DO - 10.1177/1526602820931477

M3 - Article

C2 - 32583749

AN - SCOPUS:85088581168

SN - 1526-6028

VL - 27

SP - 693

EP - 705

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

IS - 5

ER -

Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Abstract

Bibliographical note

All Science Journal Classification (ASJC) codes

Access to Document

Other files and links

Fingerprint

Cite this