Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty

Mohammad Alsagheer Alhewy; Abdelaziz Ahmed Abdelhafez; Ehab Abdelmoneim Ghazala

doi:doi:10.11648/j.ccr.20210504.17

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Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty

Mohammad Alsagheer Alhewy, Abdelaziz Ahmed Abdelhafez, Ehab Abdelmoneim Ghazala

Published in Cardiology and Cardiovascular Research (Volume 5, Issue 4)

Received: 4 November 2021 Accepted: 24 November 2021 Published: 2 December 2021

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Abstract

Backgroud: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. Objective: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. Patients and Methods: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. Results: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. Conclusion: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.

Published in	Cardiology and Cardiovascular Research (Volume 5, Issue 4)
DOI	10.11648/j.ccr.20210504.17
Page(s)	198-203
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2021. Published by Science Publishing Group

Keywords

Femoropopliteal Occlusive Disease, TASC II C, D, Drug-coated Balloons, Conventional Un-coated Balloon Angioplasty

References

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[2]	Roh J, Young-GukKo, Chul-MinAhn et al. (2019): Risk Factors for Restenosis after Drug-coated Balloon Angioplasty for Complex Femoropopliteal Arterial Occlusive Disease. annals of vasc surg; 55: 45-54.
[3]	Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG (2006); TASC II Working Group. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007; 45 (suppl S): S5–67. doi: 10.1016/j.jvs.12.037.
[4]	Caradu, C, Lakhlifi, E, Colacchio, EC, et al. (2019): Systematic review and updated meta-analysis of the use of drug-coated balloon angioplasty versus plain old balloon angioplasty for femoropopliteal arterial disease. J Vasc Surg.; 70: 981–995.e10.
[5]	Giannopoulos, S, Varcoe, RL, Lichtenberg, M, et al. (2020): Balloon angioplasty of infrapopliteal arteries: a systematic review and proposed algorithm for optimal endovascular therapy. J Endovasc Ther.; 27: 547–564.
[6]	Salisbury, AC, Li, H, Vilain, KR, et al. (2016): Cost-effectiveness of endovascular femoropopliteal intervention using drug-coated balloons versus standard percutaneous transluminal angioplasty: results from the IN. PACT SFA II Trial. JACC Cardiovasc Interv; 9: 2343–2352.
[7]	Donas, KP, Sohr, A, Pitoulias, GA, et al. (2020): Long-term mortality of matched patients with intermittent claudication treated by high-dose paclitaxel-coated balloon versus plain balloon angioplasty: a real-world study. Cardiovasc Intervent Radiol.; 43: 2–7.
[8]	Anantha-Narayanan, M, Shah, SM, Jelani, QU, et al. (2019) Drug-coated balloon versus plain old balloon angioplasty in femoropopliteal disease: an updated meta-analysis of randomized controlled trials. Catheter Cardiovasc Interv.; 94: 139–148.
[9]	Mohapatra A, Saadeddin Z Daniel J. Bertges et al (2020): Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries. J Vasc Surg; 71: 560-566.
[10]	Roh JW, Ko YG, Ahn CM, Hong SJ, Shin DH, Kim JS, et al. (2019): Risk factors for restenosis after drug-coated balloon angioplasty for complex femoropopliteal arterial occlusive disease. Ann Vasc Surg; 55: 45–54.
[11]	S. Steiner, A. Willfort-Ehringer, H. Sievert, V. Geist, M. Lichtenberg, C. Del Giudice, et al. (2018): 12-Month results from the first-in-human randomized study of the Ranger paclitaxel-coated balloon for femoropopliteal treatment JACC Cardiovasc Interv, 11, pp. 934-941.
[12]	Klein AJ, Chen SJ, Messenger JC, Hansgen AR, Plomondon ME, Carroll JD, Casserly IP. (2019): Quantitative assessment of the conformational change in the femoropopliteal artery with leg movement. Catheter Cardiovasc Interv.; 74: 787–798. doi: 10.1002/ccd.22124.
[13]	Fanelli F, Cannavale A, Gazzetti M, et al. (2014): Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol.; 37: 898-907.
[14]	Ihnat, DM, Duong, ST, Taylor, ZC (2008): Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg; 47: 967–974.
[15]	Grus T, Lukas L, Gabriela G, Peter L, Jan H and Jaroslav L (2017): Branched crural bypass has no advantage over simple crural bypass in the treatment of peripheral arterial disease, Int J Clin Exp Med., 10 (5): 7859-7866.
[16]	Stein R, Hriljac I, Halperin JL et al. (2006): Limitation of the resting ankle-brachial index in symptomatic patients with peripheral arterial disease. Vasc Med., 11: 29-33.
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[18]	Laird JR, Yeo KK. (2012): The treatment of femoropopliteal in-stent restenosis: back to the future. J Am Coll Cardiol; 59: 24–25. doi: 10.1016/j. jacc.2011.09.037.

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Mohammad Alsagheer Alhewy, Abdelaziz Ahmed Abdelhafez, Ehab Abdelmoneim Ghazala. (2021). Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiology and Cardiovascular Research, 5(4), 198-203. https://doi.org/10.11648/j.ccr.20210504.17

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Mohammad Alsagheer Alhewy; Abdelaziz Ahmed Abdelhafez; Ehab Abdelmoneim Ghazala. Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiol. Cardiovasc. Res. 2021, 5(4), 198-203. doi: 10.11648/j.ccr.20210504.17

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AMA Style

Mohammad Alsagheer Alhewy, Abdelaziz Ahmed Abdelhafez, Ehab Abdelmoneim Ghazala. Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiol Cardiovasc Res. 2021;5(4):198-203. doi: 10.11648/j.ccr.20210504.17

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@article{10.11648/j.ccr.20210504.17,
  author = {Mohammad Alsagheer Alhewy and Abdelaziz Ahmed Abdelhafez and Ehab Abdelmoneim Ghazala},
  title = {Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty},
  journal = {Cardiology and Cardiovascular Research},
  volume = {5},
  number = {4},
  pages = {198-203},
  doi = {10.11648/j.ccr.20210504.17},
  url = {https://doi.org/10.11648/j.ccr.20210504.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ccr.20210504.17},
  abstract = {Backgroud: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. Objective: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. Patients and Methods: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. Results: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. Conclusion: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.},
 year = {2021}
}

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TY  - JOUR
T1  - Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty
AU  - Mohammad Alsagheer Alhewy
AU  - Abdelaziz Ahmed Abdelhafez
AU  - Ehab Abdelmoneim Ghazala
Y1  - 2021/12/02
PY  - 2021
N1  - https://doi.org/10.11648/j.ccr.20210504.17
DO  - 10.11648/j.ccr.20210504.17
T2  - Cardiology and Cardiovascular Research
JF  - Cardiology and Cardiovascular Research
JO  - Cardiology and Cardiovascular Research
SP  - 198
EP  - 203
PB  - Science Publishing Group
SN  - 2578-8914
UR  - https://doi.org/10.11648/j.ccr.20210504.17
AB  - Backgroud: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. Objective: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. Patients and Methods: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. Results: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. Conclusion: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.
VL  - 5
IS  - 4
ER  -

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Author Information

Mohammad Alsagheer Alhewy

Departments of Vascular Surgery, Faculty of Medicine, Al-Azhar University, Assiut, Egypt
Abdelaziz Ahmed Abdelhafez

Departments of Vascular Surgery, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
Ehab Abdelmoneim Ghazala

Departments of Vascular Surgery, Faculty of Medicine, Al-Azhar University, Assiut, Egypt

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Mohammad Alsagheer Alhewy, Abdelaziz Ahmed Abdelhafez, Ehab Abdelmoneim Ghazala. (2021). Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiology and Cardiovascular Research, 5(4), 198-203. https://doi.org/10.11648/j.ccr.20210504.17

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ACS Style

Mohammad Alsagheer Alhewy; Abdelaziz Ahmed Abdelhafez; Ehab Abdelmoneim Ghazala. Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiol. Cardiovasc. Res. 2021, 5(4), 198-203. doi: 10.11648/j.ccr.20210504.17

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AMA Style

Mohammad Alsagheer Alhewy, Abdelaziz Ahmed Abdelhafez, Ehab Abdelmoneim Ghazala. Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty. Cardiol Cardiovasc Res. 2021;5(4):198-203. doi: 10.11648/j.ccr.20210504.17

Copy | Download

@article{10.11648/j.ccr.20210504.17,
  author = {Mohammad Alsagheer Alhewy and Abdelaziz Ahmed Abdelhafez and Ehab Abdelmoneim Ghazala},
  title = {Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty},
  journal = {Cardiology and Cardiovascular Research},
  volume = {5},
  number = {4},
  pages = {198-203},
  doi = {10.11648/j.ccr.20210504.17},
  url = {https://doi.org/10.11648/j.ccr.20210504.17},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.ccr.20210504.17},
  abstract = {Backgroud: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. Objective: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. Patients and Methods: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. Results: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. Conclusion: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.},
 year = {2021}
}

Copy | Download

TY  - JOUR
T1  - Multicenter Long Term Experience with Management of TASC II C, D Femoropopliteal Occlusive Disease Drug Coated Versus Uncoated Ballon Angioplasty
AU  - Mohammad Alsagheer Alhewy
AU  - Abdelaziz Ahmed Abdelhafez
AU  - Ehab Abdelmoneim Ghazala
Y1  - 2021/12/02
PY  - 2021
N1  - https://doi.org/10.11648/j.ccr.20210504.17
DO  - 10.11648/j.ccr.20210504.17
T2  - Cardiology and Cardiovascular Research
JF  - Cardiology and Cardiovascular Research
JO  - Cardiology and Cardiovascular Research
SP  - 198
EP  - 203
PB  - Science Publishing Group
SN  - 2578-8914
UR  - https://doi.org/10.11648/j.ccr.20210504.17
AB  - Backgroud: The use of drug-coated balloons for the treatment of TransAtlantic Inter-Society Consensus TASC-II C, D femoro-popliteal lesions has become widespread in recent years. Drug-coated balloons promise to minimize the rates of restenosis by effective delivery of antiproliferative agent (paclitaxel) directly to vessel wall without the need for a permanent implant. Reinterventions with drug coated balloons are lower and easier to perform because we leave no stent behind. Objective: The aim of this retrospective study was to investigate the efficacy of drug‐coated balloon (DCB) and comparing it with conventional un-coated balloon (UCB) angioplasty for the treatment of femoropopliteal occlusive disease TASC II C, D in critical lower limb ischemia. Patients and Methods: Thirty patients were included and presented to vascular surgery department of Al-Azhar University hospitals and Sednawy hospitals in Cairo, Elaraby Specialized Hospital in Monofia and Albahah hospital in KSA with TASC II C, D femoro-popliteal lesions, distributed into two equal groups; Group I was treated with DCB for femoropopliteal lesions while group II was treated with UCB during the period from December 2017 to November 2020. Primary end point was wound healing, limb salvage or amputation. All patients were monitored with 0, 3, 6 and 12 months’ serial postoperative duplex scanning surveillance. Results: Twenty-five patients (83%) reached the end point of healing and limb salvage (14 patients with ‘DCB’ technique and 11 patients with ‘UCB’ technique), whereas 5 patients underwent major amputations (2 with ‘DCB’ technique and 3 with ‘UCB’ technique). The early patency rate at 1 and 3 months was 93.34% in the group with ‘DCB’, and 89.93% in the group with ‘UCB’. While the late patency rate at one year post-operatively was 88.86% in the ‘DCB’ group with, and 53.33% in the ‘UCB’ group. Conclusion: Both DCB and UCB were effective for treatment of femoro-popliteal occlusive disease TASC II C, D, and there was nearly no difference regarding wound healing and limb salvage while DCB appeared to be superior on UCB regarding high patency and low re-intervention rates.
VL  - 5
IS  - 4
ER  -

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