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
Abstract
Background
Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians.
Methods
A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC).
Results
AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months.
Conclusion
Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.
Get full access to this article
View all access and purchase options for this article.
References
1. Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, et al. Writing group for the joint guidelines of the society for vascular surgery (svs), european society for vascular surgery (esvs), and world federation of vascular societies (wfvs). global vascular guidelines on the management of chronic limb-threatening ischemia. Eur J Vasc Endovasc Surg. 2019;58(1S):S1–S109.
2. Aboyans V, Ricco JB, Bartelink MEL, Björck M, Brodmann M, Cohnert T, et al. ESC scientific document group. 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(9):763–816.
3. Reinecke H, Unrath M, Freisinger E, Bunzemeier H, Meyborg M, Lüders F, et al. Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. Eur Heart J. 2015;36(15):932–938.
4. Varetto G, Gibello L, Boero M, Frola E, Peretti T, Spalla F, et al. Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis. J Cardiovasc Surg (Torino). 2019;60(5):546–556.
5. Braga SF, Neves JR, Ferreira J, Carrilho C, Simões JC, Mesquita A. Neointimal hyperplasia. Rev Port Cir Cardiotorac Vasc. 2019;26(3):213–217.
6. Feldman DN, Armstrong EJ, Aronow HD, Gigliotti OS, Jaff MR, Klein AJ, et al. SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions. Catheter Cardiovasc Interv. 2018;92(1):124–140.
7. Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, et al. INPACT DEEP Trial Investigators. INPACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014;15:63.
8. 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(2):207–217.
9. Brodmann M, Moscovic M, Wang JCC, Nano G, Dahm J, Zeller T, et al. Real-world experience with a paclitaxel-coated balloon in critical limb ischemia: 24-month subgroup outcomes of biolux p-III. JACC Cardiovasc Interv. 2020;13(19):2289–2299.
10. Hobbs SD, Wilmink AB, Bradbury AW. Ethnicity and peripheral arterial disease. Eur J Vasc Endovasc Surg. 2003;25(6):505–12.
11. Cappuccio FP. Hypertension and ethnicity: prevalence and level of detection and management in the community in England. Am J Hypertension, 1997;10: 22A.
12. Bhopal R, Unwin N, White M, Yallop J, Walker L, Alberti KG et al. Heterogeneity of coronary heart disease risk factors in Indian, Pakistani, Bangladeshi, and European origin populations: cross sectional study. BMJ. 1999;319(7204):215–220.
13. Robbs JV. Atherosclerotic peripheral arterial disease in blacks–an established problem. S Afr Med J. 1985;67(20):797–801.
14. Soon SXY, Patel A, Chong TT, Yap CJQ, Tay HT, Tay KH, Sivanathan C, Tang TY. 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.
15. Gupta R, Misra A. Epidemiology of microvascular complications of diabetes in South Asians and comparison with other ethnicities. J Diabetes. 2016;8(4):470–82.
16. Fanelli F, Cannavale A, Gazzetti M, Lucatelli P, Wlderk A, Cirelli C, d'Adamo A, Salvatori FM. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37(4):898–907.
17. 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(24):e011245.
18. Schneider PA, Brodmann M, Mauri L, Laird J, Soga Y, Micari A, Ansel G, Shishehbor MH, Krishnan P, Gao Q, Ouriel K, Zeller T. Paclitaxel exposure: Long-term safety and effectiveness of a drug-coated balloon for claudication in pooled randomized trials. Catheter Cardiovasc Interv. 2020;96(5):1087–1099.
19. Böhme T, Noory E, Beschorner U, Jacques B, Bürgelin K, Macharzina R, Kuhn LM, Nührenberg T, Neumann FJ, Zeller T. Evaluation of mortality following paclitaxel drug-coated balloon angioplasty of femoropopliteal lesions in patients with ulcerations and gangrene - a single center experience. Vasa. 2021;50(2):132–138.
20. Schahab N, Prengel AK, Mahn T, Schaefer C, Fimmers R, Nickenig G, Zimmer S. Long-term clinical outcome and mortality risks after paclitaxel-coated balloon angioplasty in patients with peripheral artery disease: An observational clinical study. Health Sci Rep. 2021;4(1):e236.
21. Dinh K, Gomes ML, Thomas SD, Paravastu SCV, Holden A, Schneider PA, Varcoe RL. Mortality after paclitaxel-coated device use in patients with chronic limb-threatening ischemia: a systematic review and meta-analysis of randomized controlled trials. J Endovasc Ther. 2020;27(2):175–185.
Cite article
Cite article
Cite article
OR
Download to reference manager
If you have citation software installed, you can download article citation data to the citation manager of your choice
Information, rights and permissions
Information
Published In
Article first published online: April 11, 2022
Issue published: August 2023
Keywords
PubMed: 35410542
Authors
Metrics and citations
Metrics
Article usage*
Total views and downloads: 89
*Article usage tracking started in December 2016
Articles citing this one
Receive email alerts when this article is cited
Web of Science: 0 view articles Opens in new tab
Crossref: 0
There are no citing articles to show.
Figures and tables
Figures & Media
Tables
View Options
Access options
If you have access to journal content via a personal subscription, university, library, employer or society, select from the options below:
I am signed in as:
View my profileSign out
I can access personal subscriptions, purchases, paired institutional access and free tools such as favourite journals, email alerts and saved searches.
loading institutional access options
Alternatively, view purchase options below:
Purchase 24 hour online access to view and download content.
Access journal content via a DeepDyve subscription or find out more about this option.
