Korean Journal of Radiology

  • 제25권6호
  • /
  • Pages.565-574
  • /
  • 2024
  • /
  • 1229-6929(pISSN)
  • /
  • 2005-8330(eISSN)
대한영상의학회 (The Korean Society of Radiology)
권호 표지
DOI QR코드

DOI QR Code

Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

  • Tae Won Choi (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine) ;
  • Je Hwan Won (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine) ;
  • Hwan Jun Jae (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Yong Sun Jeon (Department of Radiology, Inha University Hospital, Inha University School of Medicine) ;
  • Sang Woo Park (Department of Radiology, Konkuk University Hospital, Konkuk University School of Medicine) ;
  • Gi-Young Ko (Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Nam Yeol Yim (Department of Radiology, Chonnam National University Hospital, Chonnam National University Medical School) ;
  • Jong Yun Won (Department of Radiology, Severance Hospital, Yonsei University College of Medicine) ;
  • Chang Won Kim (Department of Radiology, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Jinoo Kim (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine)
  • 투고 : 2023.11.18
  • 심사 : 2024.04.04
  • 발행 : 2024.06.01
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

키워드

과제정보

The present study was supported by BIOTRONIK through the research grant number G1714. The funding source was not involved in collecting, monitoring, or analyzing study data and writing the manuscript.

참고문헌

  1. Fowkes FG, Rudan D, Rudan I, Aboyans V, Denenberg JO, McDermott MM, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 2013;382:1329-1340
  2. Criqui MH, Aboyans V. Epidemiology of peripheral artery disease. Circ Res 2015;116:1509-1526
  3. Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO) the task force for the diagnosis and treatment of peripheral arterial diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J 2018;39:763-816
  4. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 2007;45(Suppl S):S5-S67
  5. Abu Dabrh AM, Steffen MW, Undavalli C, Asi N, Wang Z, Elamin MB, et al. The natural history of untreated severe or critical limb ischemia. J Vasc Surg 2015;62:1642-1651.e3
  6. Kim MH, Ahn S, Kim JY, Jun KW, Yun SS, Won YS. Current trends of major arterial diseases in Korea: based on data from the Health Insurance Review and Assessment Service. Ann Surg Treat Res 2016;90:218-223
  7. Cho S, Lee SH, Joh JH. Risk factors for asymptomatic peripheral arterial disease in Korean population: lessons from a community-based screening. Ann Surg Treat Res 2019;97:210-216
  8. Axel DI, Kunert W, Goggelmann C, Oberhoff M, Herdeg C, Kuttner A, et al. Paclitaxel inhibits arterial smooth muscle cell proliferation and migration in vitro and in vivo using local drug delivery. Circulation 1997;96:636-645
  9. Herdeg C, Oberhoff M, Baumbach A, Blattner A, Axel DI, Schroder S, et al. Local paclitaxel delivery for the prevention of restenosis: biological effects and efficacy in vivo. J Am Coll Cardiol 2000;35:1969-1976
  10. Scheinert D, Schulte KL, Zeller T, Lammer J, Tepe G. Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial. J Endovasc Ther 2015;22:14-21
  11. Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med 2015;373:145-153
  12. Tepe G, Zeller T, Albrecht T, Heller S, Schwarzwalder U, Beregi JP, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008;358:689-699
  13. Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, et al. Stellarex drug-coated balloon for treatment of femoropopliteal disease: twelve-month outcomes from the randomized ILLUMENATE pivotal and pharmacokinetic studies. Circulation 2017;136:1102-1113
  14. Tepe G, Laird J, Schneider P, Brodmann M, Krishnan P, Micari A, et al. Drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of superficial femoral and popliteal peripheral artery disease: 12-month results from the IN.PACT SFA randomized trial. Circulation 2015;131:495-502
  15. Tepe G, Gogebakan O, Redlich U, Tautenhahn J, Ricke J, Halloul Z, et al. Angiographic and clinical outcomes after treatment of femoro-popliteal lesions with a novel paclitaxel-matrix-coated balloon catheter. Cardiovasc Intervent Radiol 2017;40:1535-1544
  16. Scheinert D, Duda S, Zeller T, Krankenberg H, Ricke J, Bosiers M, et al. The LEVANT I (Lutonix paclitaxel-coated balloon for the prevention of femoropopliteal restenosis) trial for femoropopliteal revascularization: first-in-human randomized trial of low-dose drug-coated balloon versus uncoated balloon angioplasty. JACC Cardiovasc Interv 2014;7:10-19
  17. Werk M, Albrecht T, Meyer DR, Ahmed MN, Behne A, Dietz U, et al. Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty: evidence from the randomized PACIFIER trial. Circ Cardiovasc Interv 2012;5:831-840
  18. Wittig T, Schmidt A, Kabelitz M, Hukauf M, Pflug T, Scheinert D, et al. Safety and efficacy of all comers treated with a paclitaxel coated balloon for below knee intervention. Eur J Vasc Endovasc Surg 2022;64:516-525
  19. Liistro F, Reccia MR, Angioli P, Ducci K, Ventoruzzo G, Falsini G, et al. Drug-eluting balloon for below the knee angioplasty: five-year outcome of the DEBATE-BTK randomized clinical trial. Cardiovasc Intervent Radiol 2022;45:761-769
  20. Zeller T, Micari A, Scheinert D, Baumgartner I, Bosiers M, Vermassen FEG, et al. The IN.PACT DEEP clinical drug-coated balloon trial: 5-year outcomes. JACC Cardiovasc Interv 2020;13:431-443
  21. Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, et al. Paclitaxel-coated balloon in infrapopliteal arteries: 12-month results from the BIOLUX P-II randomized trial (BIOTRONIK'S-first in man study of the Passeo-18 LUX drug releasing PTA balloon catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv 2015;8:1614-1622
  22. Tepe G, Zeller T, Moscovic M, Corpataux JM, Christensen JK, Keirse K, et al. Paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of BIOLUX P-III global registry. Cardiovasc Intervent Radiol 2021;44:207-217
  23. Ahmad N, Thomas GN, Chan C, Gill P. Ethnic differences in lower limb revascularisation and amputation rates. Implications for the aetiopathology of atherosclerosis? Atherosclerosis 2014;233:503-507
  24. Chen P, Patel PB, Ding J, Krimbill J, Siracuse JJ, O'Donnell TFX, et al. Asian race is associated with peripheral arterial disease severity and postoperative outcomes. J Vasc Surg 2023;78:175-183.e3
  25. Loja MN, Brunson A, Li CS, Carson JG, White RH, Romano PS, et al. Racial disparities in outcomes of endovascular procedures for peripheral arterial disease: an evaluation of California hospitals, 2005-2009. Ann Vasc Surg 2015;29:950-959
  26. Linn YL, Wang JC, Pua U, Yahaya SA, Choke ET, Chong TT, et al. Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population - 24-month outcome data from the BIOLUX P-III global registry 24-month Asian outcomes of BIOLUX P-III. Vascular 2023;31:767-776
  27. Stoner MC, Calligaro KD, Chaer RA, Dietzek AM, Farber A, Guzman RJ, et al. Reporting standards of the Society for Vascular Surgery for endovascular treatment of chronic lower extremity peripheral artery disease. J Vasc Surg 2016;64:e1-e21
  28. Langhoff R, Arjumand J, Waliszewski M, Reimer P, Hartel D, Hohl C, et al. The real-world CONSEQUENT ALL COMERS study: predictors for target lesion revascularization and mortality in an unselected patient population. Angiology 2021;72:724-732
  29. Soon SXY, Patel A, Chong TT, Yap CJQ, Tay HT, Tay KH, et al. Distribution of peripheral arterial disease in patients undergoing endovascular revascularization for chronic limb threatening ischaemia: insights from the vascular quality initiative in Singapore. Vasc Specialist Int 2021;37:13
  30. Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines. Circulation 2017;135:e686-e725
  31. Ko YG, Choi D, Rha SW, Won JH, Do YS, Lee SW, et al. Long-term outcomes after paclitaxel-coated balloon angioplasty of femoropopliteal arteries in Asian patients of the IN.PACT global study. Catheter Cardiovasc Interv 2022;100:1273-1283
  32. Tang TY, Yap CJ, Chan SL, Soon SX, Lee CT, Chong TT, et al. Safety and efficacy of LuminorTM balloon and AngioliteTM stent on TASC C/D tibial occlusive lesions in CLI patients: 12-month results. The MERLION trial. Int Angiol 2021;40:335-344
  33. Soga Y, Iida O, Fujihara M, Kawasaki D, Saito S, Urasawa K, et al. Real-world clinical outcomes of IN.PACT admiral drug-coated balloon for femoropopliteal artery disease-12-month results from Japan post-market surveillance study. Circ J 2021;85:2149-2156
  34. Yang J, Yue J, Chen X, Wang H, Jiang W, Huang X, et al. Safety and efficacy of the Passeo-18 Lux drug-coated balloon catheter in atherosclerotic femoropopliteal lesions: the multicenter BIOLUX P-IV China study. Ann Vasc Surg 2023;93:275-282
  35. Tepe G, Wang J, Corpataux JM, Pua U, Binkert CA, Moscovic M, et al. BIOLUX P-III Passeo-18 Lux all-comers registry: 24-month results in below-the-knee arteries. Cardiovasc Intervent Radiol 2021;44:10-18
  36. Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN.PACT DEEP randomized trial. J Am Coll Cardiol 2014;64:1568-1576
  37. Teichgraber U, Lehmann T, Thieme M, Wahl KU, Stelzner C, Bormann A, et al. Drug-coated balloon angioplasty of infrapopliteal lesions in patients with critical limb ischaemia: 1-year results of the APOLLO trial. Cardiovasc Intervent Radiol 2019;42:1380-1390
  38. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018;7:e011245
  39. Rocha-Singh KJ, Duval S, Jaff MR, Schneider PA, Ansel GM, Lyden SP, et al. Mortality and paclitaxel-coated devices: an individual patient data meta-analysis. Circulation 2020;141:1859-1869
  40. Klumb C, Lehmann T, Aschenbach R, Eckardt N, Teichgraber U. Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: a systematic review and meta-analysis of randomised controlled trials. EClinicalMedicine 2019;16:42-50
  41. Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, et al. Mortality with paclitaxel-coated devices in peripheral artery disease. N Engl J Med 2020;383:2538-2546
  42. Albrecht T, Schnorr B, Kutschera M, Waliszewski MW. Two-year mortality after angioplasty of the femoro-popliteal artery with uncoated balloons and paclitaxel-coated balloons-a pooled analysis of four randomized controlled multicenter trials. Cardiovasc Intervent Radiol 2019;42:949-955
  43. Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol 2019;73:2550-2563
  44. Dinh K, Limmer AM, Chen AZL, Thomas SD, Holden A, Schneider PA, et al. Mortality rates after paclitaxel-coated device use in patients with occlusive femoropopliteal disease: an updated systematic review and meta-analysis of randomized controlled trials. J Endovasc Ther 2021;28:755-777
  45. Zhang C, Yin G. Safety of paclitaxel-coated devices in the femoropopliteal arteries: a systematic review and meta-analysis. PLoS One 2022;17:e0275888