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

Giovanni Torsello; Konstantinos Stavroulakis; Marianne Brodmann; Antonio Micari; Gunnar Tepe; Pierfrancesco Veroux; Andrew Benko; Donghoon Choi; Frank E. G. Vermassen; Michael R. Jaff; Jia Guo; Reka Dobranszki; 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; 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:10.1177/1526602820931477

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

Giovanni Torsello, Konstantinos Stavroulakis, Marianne Brodmann, Antonio Micari, Gunnar Tepe, Pierfrancesco Veroux, Andrew Benko, Donghoon Choi, Frank E. G. Vermassen, Michael R. Jaff, Jia Guo, Reka Dobranszki, Thomas Zeller, Thomas Zeller, Giovanni Torsello, Gunnar Tepe, Patrick Peeters, Dierk Scheinert, Marc Bosiers, Lieven MaeneAntonio 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, 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 in rivista

6 Citazioni (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.

Lingua originale	English
pagine (da-a)	693-705
Numero di pagine	13
Rivista	Journal of Endovascular Therapy
Volume	27
DOI	https://doi.org/10.1177/1526602820931477
Stato di pubblicazione	Pubblicato - 2020

Keywords

angioplasty
drug-coated balloon
femoropopliteal segment
mortality
peripheral artery disease
popliteal artery
superficial femoral artery
target lesion revascularization

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10.1177/1526602820931477

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Torsello, G., Stavroulakis, K., Brodmann, M., Micari, A., Tepe, G., Veroux, P., Benko, A., Choi, D., Vermassen, F. E. G., Jaff, M. R., Guo, J., Dobranszki, R., Zeller, T., Zeller, T., Torsello, G., Tepe, G., Peeters, P., Scheinert, D., Bosiers, M., ... Lundberg, G. (2020). Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort. Journal of Endovascular Therapy, 27, 693-705. https://doi.org/10.1177/1526602820931477

@article{540cc6a4983e41de8e4e5d8ab237a6e0,

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.",

keywords = "angioplasty, drug-coated balloon, femoropopliteal segment, mortality, peripheral artery disease, popliteal artery, superficial femoral artery, target lesion revascularization, angioplasty, drug-coated balloon, femoropopliteal segment, mortality, peripheral artery disease, popliteal artery, superficial femoral artery, target lesion revascularization",

author = "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 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 {Xaver Roithinger}, Franz 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 Won, {Je Hwan} and Matej Vozar and {Teng Tan}, Kong and Mamdouh Labib and Borst, {Gert-Jan De} 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 Vries, {Jean-Paul De} 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 = "2020",

doi = "10.1177/1526602820931477",

language = "English",

volume = "27",

pages = "693--705",

journal = "Journal of Endovascular Therapy",

issn = "1526-6028",

publisher = "Alliance Communication Group:810 East 10th Street:Lawrence, KS 66044:(800)627-0629, (785)843-1235, EMAIL: [email protected], Fax: (785)843-1274",

}

Torsello, G, Stavroulakis, K, Brodmann, M, Micari, A, Tepe, G, Veroux, P, Benko, A, Choi, D, Vermassen, FEG, Jaff, MR, Guo, J, Dobranszki, R, 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, Xaver Roithinger, F, Trani, C, Mansour, H, Rha, S-W, Vermassen, F, Belenky, A, Spak, L, Chalmers, N, Benko, A, Kum, S, Won, JH, Vozar, M, Teng Tan, K, Labib, M, Borst, G-JD, Do, Y-S, Teijink, J, Gomez, JF, Falkowski, A, Ferreira, L, Matela, J, Lee, S-W, Verhoeven, B, Mannheim, D, Nessi, F, Vulev, I, Vries, J-PD, Maly, R, Kavteladze, Z, Turner, D, Mendiz, O, Kolvenbach, R, Karnabatidis, D, Cuellar, C, Venermo, M, Velicka, L & Lundberg, G 2020, 'Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort', Journal of Endovascular Therapy, vol. 27, pagg. 693-705. https://doi.org/10.1177/1526602820931477

TY - JOUR

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

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

AU - Won, Je Hwan

AU - Vozar, Matej

AU - Teng Tan, Kong

AU - Labib, Mamdouh

AU - Borst, Gert-Jan De

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 - Vries, Jean-Paul De

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 - 2020

Y1 - 2020

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.

KW - angioplasty

KW - drug-coated balloon

KW - femoropopliteal segment

KW - mortality

KW - peripheral artery disease

KW - popliteal artery

KW - superficial femoral artery

KW - target lesion revascularization

KW - angioplasty

KW - drug-coated balloon

KW - femoropopliteal segment

KW - mortality

KW - peripheral artery disease

KW - popliteal artery

KW - superficial femoral artery

KW - target lesion revascularization

UR - http://hdl.handle.net/10807/168229

U2 - 10.1177/1526602820931477

DO - 10.1177/1526602820931477

M3 - Article

SN - 1526-6028

VL - 27

SP - 693

EP - 705

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

ER -

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

Abstract

Keywords

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