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

Antonio Micari; Marianne Brodmann; Koen Keirse; Patrick Peeters; Gunnar Tepe; Martin Frost; Hong Wang; Thomas Zeller; Thomas Zeller; Giovanni Torsello; Gunnar Tepe; Patrick Peeters; Dierk Scheinert; Marc Bosiers; Lieven Maene; Antonio Micari; Dai-Do Do; Jeroen Hendriks; Koen Keirse; Marianne Brodmann; Bela Merkely; Jan-Willem Lardenoije; Zoltan Ruzsa; Britta Vogel; Pierfrancesco Veroux; Joao Albuquerque E Castro; Daniel Periard; Tomasz Ludyga; Dominique Midy; Donghoon Choi; Wouter Lansink; Dominik Ketelsen; Steven Dubenec; Martin Banyai; Nabil Chakfe; Franz Xaver Roithinger; Carlo Trani; Hossam Mansour; Seung-Woon Rha; Frank Vermassen; Alexander Belenky; Lubomir Spak; Nicholas Chalmers; Andrew Benko; Steven Kum; Kumar Seerangan; Je Hwan Won; Matej Vozar; Kong Teng Tan; Mamdouh Labib; Gert-Jan De Borst; Young-Soo Do; Joep Teijink; Juan Fernando Gomez; Aleksander Falkowski; Luis Ferreira; Jozef Matela; Seung-Whan Lee; Bart Verhoeven; Dalit Mannheim; Franco Nessi; Ivan Vulev; Jean-Paul De Vries; Radovan Maly; Zaza Kavteladze; Douglas Turner; Oscar Mendiz; Ralf Kolvenbach; Dimitrios Karnabatidis; Cesar Cuellar; Maarit Venermo; Linas Velicka; Goran Lundberg

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

Antonio Micari
, Marianne Brodmann
, Koen Keirse
, Patrick Peeters
, Gunnar Tepe
, Martin Frost
, Hong Wang
, Thomas Zeller
, Thomas Zeller
, Giovanni Torsello
, Gunnar Tepe
, Patrick Peeters
, Dierk Scheinert
, Marc Bosiers
, Lieven Maene
, Antonio Micari
, Dai-Do Do
, Jeroen Hendriks
, Koen Keirse
, Marianne Brodmann

Bela Merkely, Jan-Willem Lardenoije, Zoltan Ruzsa, Britta Vogel, Pierfrancesco Veroux, Joao Albuquerque E Castro, Daniel Periard, Tomasz Ludyga, Dominique Midy, Donghoon Choi, Wouter Lansink, Dominik Ketelsen, Steven Dubenec, Martin Banyai, Nabil Chakfe, Franz Xaver Roithinger, Carlo Trani, Hossam Mansour, Seung-Woon Rha, Frank Vermassen, Alexander Belenky, Lubomir Spak, Nicholas Chalmers, Andrew Benko, Steven Kum, Kumar Seerangan, Je Hwan Won, Matej Vozar, Kong Teng Tan, Mamdouh Labib, Gert-Jan De Borst, Young-Soo Do, Joep Teijink, Juan Fernando Gomez, Aleksander Falkowski, Luis Ferreira, Jozef Matela, Seung-Whan Lee, Bart Verhoeven, Dalit Mannheim, Franco Nessi, Ivan Vulev, Jean-Paul De Vries, Radovan Maly, Zaza Kavteladze, Douglas Turner, Oscar Mendiz, Ralf Kolvenbach, Dimitrios Karnabatidis, Cesar Cuellar, Maarit Venermo, Linas Velicka, Goran Lundberg

Risultato della ricerca: Contributo in rivista › Articolo

40 Citazioni (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 Global Clinical Study; NCT01609296)

Lingua originale	Inglese
pagine (da-a)	945-953
Numero di pagine	9
Rivista	JACC: Cardiovascular Interventions
Volume	11
DOI	https://doi.org/10.1016/j.jcin.2018.02.019
Stato di pubblicazione	Pubblicato - 2018

Keywords

Aged
Angioplasty, Balloon
Cardiovascular Agents
Coated Materials, Biocompatible
Constriction, Pathologic
Female
Femoral Artery
Humans
Intermittent Claudication
Ischemia
Male
Middle Aged
Paclitaxel
Peripheral Arterial Disease
Popliteal Artery
Prospective Studies
Recurrence
Time Factors
Treatment Outcome
Vascular Access Devices
Vascular Patency
angioplasty
drug-coated balloon
femoropopliteal artery
peripheral artery disease
target lesion revascularization

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10.1016/j.jcin.2018.02.019

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Micari, A., Brodmann, M., Keirse, K., Peeters, P., Tepe, G., Frost, M., Wang, H., Zeller, T., Zeller, T., Torsello, G., Tepe, G., Peeters, P., Scheinert, D., Bosiers, M., Maene, L., Micari, A., Do, D.-D., Hendriks, J., Keirse, K., ... Lundberg, G. (2018). 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. JACC: Cardiovascular Interventions, 11, 945-953. https://doi.org/10.1016/j.jcin.2018.02.019

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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 Global Clinical Study; NCT01609296)",

keywords = "Aged, Angioplasty, Balloon, Cardiovascular Agents, Coated Materials, Biocompatible, Constriction, Pathologic, Female, Femoral Artery, Humans, Intermittent Claudication, Ischemia, Male, Middle Aged, Paclitaxel, Peripheral Arterial Disease, Popliteal Artery, Prospective Studies, Recurrence, Time Factors, Treatment Outcome, Vascular Access Devices, Vascular Patency, angioplasty, drug-coated balloon, femoropopliteal artery, peripheral artery disease, target lesion revascularization, Aged, Angioplasty, Balloon, Cardiovascular Agents, Coated Materials, Biocompatible, Constriction, Pathologic, Female, Femoral Artery, Humans, Intermittent Claudication, Ischemia, Male, Middle Aged, Paclitaxel, Peripheral Arterial Disease, Popliteal Artery, Prospective Studies, Recurrence, Time Factors, Treatment Outcome, Vascular Access Devices, Vascular Patency, angioplasty, drug-coated balloon, femoropopliteal artery, peripheral artery disease, target lesion revascularization",

author = "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 Dai-Do Do and Jeroen Hendriks and Koen Keirse and Marianne Brodmann and Bela Merkely and Jan-Willem Lardenoije 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 Seung-Woon Rha and Frank Vermassen and Alexander Belenky and Lubomir Spak and Nicholas Chalmers and Andrew Benko and Steven Kum and Kumar Seerangan and Won, \{Je Hwan\} and Matej Vozar and Tan, \{Kong Teng\} and Mamdouh Labib and \{De Borst\}, Gert-Jan and Young-Soo Do and Joep Teijink and Gomez, \{Juan Fernando\} and Aleksander Falkowski and Luis Ferreira and Jozef Matela and Seung-Whan Lee and Bart Verhoeven and Dalit Mannheim and Franco Nessi and Ivan Vulev and \{De Vries\}, Jean-Paul and Radovan Maly and Zaza Kavteladze and Douglas Turner and Oscar Mendiz and Ralf Kolvenbach and Dimitrios Karnabatidis and Cesar Cuellar and Maarit Venermo and Linas Velicka and Goran Lundberg",

year = "2018",

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.",

}

Micari, A, Brodmann, M, Keirse, K, Peeters, P, Tepe, G, Frost, M, Wang, H, Zeller, T, Zeller, T, Torsello, G, Tepe, G, Peeters, P, Scheinert, D, Bosiers, M, Maene, L, Micari, A, Do, D-D, Hendriks, J, Keirse, K, Brodmann, M, Merkely, B, Lardenoije, J-W, Ruzsa, Z, Vogel, B, Veroux, P, Albuquerque E Castro, J, Periard, D, Ludyga, T, Midy, D, Choi, D, Lansink, W, Ketelsen, D, Dubenec, S, Banyai, M, Chakfe, N, Roithinger, FX, Trani, C, Mansour, H, Rha, S-W, Vermassen, F, Belenky, A, Spak, L, Chalmers, N, Benko, A, Kum, S, Seerangan, K, Won, JH, Vozar, M, Tan, KT, Labib, M, De Borst, G-J, Do, Y-S, Teijink, J, Gomez, JF, Falkowski, A, Ferreira, L, Matela, J, Lee, S-W, Verhoeven, B, Mannheim, D, Nessi, F, Vulev, I, De Vries, J-P, Maly, R, Kavteladze, Z, Turner, D, Mendiz, O, Kolvenbach, R, Karnabatidis, D, Cuellar, C, Venermo, M, Velicka, L & Lundberg, G 2018, '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', JACC: Cardiovascular Interventions, vol. 11, pagg. 945-953. https://doi.org/10.1016/j.jcin.2018.02.019

TY - JOUR

T1 - 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

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 - Seerangan, Kumar

AU - Won, Je Hwan

AU - Vozar, Matej

AU - Tan, Kong Teng

AU - Labib, Mamdouh

AU - De Borst, Gert-Jan

AU - Do, Young-Soo

AU - Teijink, Joep

AU - Gomez, Juan Fernando

AU - Falkowski, Aleksander

AU - Ferreira, Luis

AU - Matela, Jozef

AU - Lee, Seung-Whan

AU - Verhoeven, Bart

AU - Mannheim, Dalit

AU - Nessi, Franco

AU - Vulev, Ivan

AU - De Vries, Jean-Paul

AU - Maly, Radovan

AU - Kavteladze, Zaza

AU - Turner, Douglas

AU - Mendiz, Oscar

AU - Kolvenbach, Ralf

AU - Karnabatidis, Dimitrios

AU - Cuellar, Cesar

AU - Venermo, Maarit

AU - Velicka, Linas

AU - Lundberg, Goran

PY - 2018

Y1 - 2018

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 Global Clinical Study; NCT01609296)

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 Global Clinical Study; NCT01609296)

KW - Aged

KW - Angioplasty, Balloon

KW - Cardiovascular Agents

KW - Coated Materials, Biocompatible

KW - Constriction, Pathologic

KW - Female

KW - Femoral Artery

KW - Humans

KW - Intermittent Claudication

KW - Ischemia

KW - Male

KW - Middle Aged

KW - Paclitaxel

KW - Peripheral Arterial Disease

KW - Popliteal Artery

KW - Prospective Studies

KW - Recurrence

KW - Time Factors

KW - Treatment Outcome

KW - Vascular Access Devices

KW - Vascular Patency

KW - angioplasty

KW - drug-coated balloon

KW - femoropopliteal artery

KW - peripheral artery disease

KW - target lesion revascularization

KW - Aged

KW - Angioplasty, Balloon

KW - Cardiovascular Agents

KW - Coated Materials, Biocompatible

KW - Constriction, Pathologic

KW - Female

KW - Femoral Artery

KW - Humans

KW - Intermittent Claudication

KW - Ischemia

KW - Male

KW - Middle Aged

KW - Paclitaxel

KW - Peripheral Arterial Disease

KW - Popliteal Artery

KW - Prospective Studies

KW - Recurrence

KW - Time Factors

KW - Treatment Outcome

KW - Vascular Access Devices

KW - Vascular Patency

KW - angioplasty

KW - drug-coated balloon

KW - femoropopliteal artery

KW - peripheral artery disease

KW - target lesion revascularization

UR - http://hdl.handle.net/10807/157339

U2 - 10.1016/j.jcin.2018.02.019

DO - 10.1016/j.jcin.2018.02.019

M3 - Article

SN - 1936-8798

VL - 11

SP - 945

EP - 953

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

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

Keywords

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