Drug-coated balloon angioplasty in peripheral arterial disease
DOI: 10.32364/2587-6821-2022-6-4-177-181
S.A. Papoyan1–3, A.A. Shchegolev1, D.G. Gromov1,2, K.S. Asaturyan2
2F.I. Inozemtsev City Clinical Hospital, Moscow, Russian Federation
1Pirogov Russian National Research Medical University, Moscow, Russian Federation
3Research Institute of Public Health Organization and Medical Management, Moscow, Russian Federation
The prevalence of peripheral arterial disease requires the search for an optimal solution for preserving blood flow by using devices of various modifications. Drug-coated balloons are widely used in the surgical treatment of peripheral arterial disease. The article aims at the summarization of the study results on the efficacy and safety of the various drug-coated balloons, in particular, with paclitaxel, in the treatment of steno-occlusive lesions in the peripheral arterial disease. Comparing the study results is fraught with certain difficulties, given the differences in the study endpoints, the demographic characteristics of patients and the lesion patterns. Nevertheless, the study results of percutaneous transluminal angioplasty (PTA) with drug-eluting ballons on the femoropopliteal segment are superior to the results obtained using conventional PTA and other endovascular interventions in the same vascular bed. PTA with drug-eluting balloons has a Class 1 recommen dation in accordance with the issued recommendations of the SCAI (Society for Cardiovascular Angiography and Interventions). However, conducting PTA with paclitaxel-eluting balloons requires further determination of the possibilities of its use.
Keywords: drug-coated balloons, paclitaxel, percutaneous transluminal angioplasty, angioplasty, atherosclerosis, peripheral arterial disease.
For citation: Papoyan S.A., Shchegolev A.A., Gromov D.G., Asaturyan K.S. Drug-coated balloon angioplasty in peripheral arterial disease. Russian Medical Inquiry. 2022;6(4):177–181 (in Russ.). DOI: 10.32364/2587-6821-2022-6-4-177-181.
About the authors:
Simon A. Papoyan — C. Sc. (Med.), Head of the Department of Vascular Surgery, F.I. Inozemtsev City Clinical Hospital; 1 Fortunatovskaya str., Moscow, 105187, Russian Federation; Associate Professor of the Department of Hospital Surgery, Pirogov Russian National Research Medical University; 1 Ostrovityanova str., Moscow, 117997, Russian Federation; Head of the Organizational and Methodological Department for Cardiovascular Surgery, Research Institute of Public Health Organization and Medical Management; 9 Sharikopodshipnikovskaya str., Moscow, 115088, Russian Federation; ORCID iD 0000-0002-6207-4174.
Alexander A. Shchegolev — Dr. Sc. (Med.), Professor, Head of the Department of Hospital Surgery of the Pediatric Faculty, Pirogov Russian National Research Medical University; 1 Ostrovityanova str., Moscow, 117997, Russian Federation; ORCID iD 0000-0001-6427-4295.
Dmitry G. Gromov — Dr. Sc. (Med.), Head of the Department endovascular diagnostics and treatment, F.I. Inozemtsev City Clinical Hospital; 1 Fortunatovskaya str., Moscow, 105187, Russian Federation; Head of the Department of X-ray Endovascular Diagnostics and Treatment, Pirogov Russian National Research Medical University; 1 Ostrovityanova str., Moscow, 117997, Russian Federation; ORCID iD 0000-0001-7500-4987.
Karen S. Asaturyan — cardiovascular surgeon, F.I. Inozemtsev City Clinical Hospital; 1 Fortunatovskaya str., Moscow 105187, Russian Federation; ORCID iD 0000-0003-2389-058X.
Contact information: Karen S. Asaturyan, e-mail: karasaturyan@mail.ru.
Financial Disclosure: no authors have a financial or property interest in any material or method mentioned.
There is no conflict of interests.
Received 18.02.2022.
Revised 18.03.2022.
Accepted 12.04.2022.
2. Katsanos K., Spiliopoulos S., Karunanithy N. et al. Bayesian network meta-analysis of nitinol stents, covered stents, drug-eluting stents, and drug-coated balloons in the femoropopliteal artery. J Vasc Surg. 2014;59(4):1123–1133.e8. DOI: 10.1016/j.jvs.2014.01.041.
3. Jaff M.R., Nelson T., Ferko N. et al. Endovascular Interventions for Femoropopliteal Peripheral Artery Disease: A Network Meta-Analysis of Current Technologies. J Vasc Interv Radiol. 2017;28(12):1617–1627.e1. DOI: 10.1016/j.jvir.2017.08.003.
4. Tepe G., Schnorr B., Albrecht T. et al. Angioplasty of femoral-popliteal arteries with drug-coated balloons: 5-year follow-up of the THUNDER trial. JACC Cardiovasc Interv. 2015;8(1 Pt A):102–108. DOI: 10.1016/j.jcin.2014.07.023.
5. Dake M.D., Ansel G.M., Jaff M.R. et al. Durable Clinical Effectiveness With Paclitaxel-Eluting Stents in the Femoropopliteal Artery: 5-Year Results of the Zilver PTX Randomized Trial. Circulation. 2016;133(15):1472–1483; discussion 1483. DOI: 10.1161/CIRCULATIONAHA.115.016900.
6. Kruse R.R., Poelmann F.B., Doomernik D. et al. Five-Year Outcome of Self-Expanding Covered Stents for Superficial Femoral Artery Occlusive Disease and an Analysis of Factors Predicting Failure. J Endovasc Ther. 2015;22(6):855–861. DOI: 10.1177/1526602815610583.
7. Crimi G., Gritti V., Galiffa V.A. et al. Drug eluting stents are superior to bare metal stents to reduce clinical outcomeand stent-related complications in CKD patients, a systematic review, meta-analysis and network meta-analysis. J Interv Cardiol. 2018;31(3):319–329. DOI: 10.1111/joic.12473.
8. Mills J.L., Conte M.S., Murad M.H. Critical review and evidence implications of paclitaxel drug-eluting balloons and stents in peripheral artery disease. J Vasc Surg. 2019;70(1):3–7. DOI: 10.1016/j.jvs.2019.05.002.
9. Haldar S., Chintapalli J., Croce C.M. TAXOL induces bcl2 phosphorylation and death of pros-tate cancer cells. Cancer Res 1996;56(6):1253–1255. PMID: 8640809.
10. Belotti D., Vergani V., Drudis T. et al. The microtubule-affecting drug paclitaxel has antiangio-genic activity. Clin Cancer Res. 1996;2(11):1843–1849. PMID: 9816139.
11. Speck U., Scheller B., Abramjuk C. et al. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006;240(2):411–418. DOI: 10.1148/радиол.2402051248.
12. Scheller B., Speck U., Abramjuk C. et al. Paclitaxel balloon coating, a novel method for pre-vention and therapy of restenosis. Circulation. 2004;110(7):810–814. DOI: 10.1161/01.CIR.0000138929.71660.E0.
13. Scheller B., Speck U., Romeike B. et al. Contrast media as carriers for local drug delivery: successful inhibition of neointimal proliferation in the porcine coronary stent model. Eur Heart J. 2003;24(15):1462–1467. DOI: 10.1016/s0195-668x(03)00317-8.
14. Scheller B., Speck U., Schmitt A. et al. Acute cardiac tolerance of current contrast media and the new taxane protaxel using iopromide as carrier during porcine coronary angiography and stenting. Invest Radiol. 2002;37(1):29–34. DOI: 10.1097/00004424-200201000-00006.
15. Albrecht T., Speck U., Beier C.l. et al. B. Reduction of stenosis due to intimal hyperplasia af-ter stent supported angioplasty of peripheral arteries by local administration of paclitaxel in swine. Invest Radiol. 2007;42(8):579–585. DOI: 10.1097/RLI.0b013e31804f5a60.
16. Tepe G., Zeller T., Albrecht T. et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med. 2008;358(7):689–699. DOI: 10.1056/NEJMoa0706356.
17. Teichgräber U.K., Klumb C. Drug-coated Balloon Angioplasty in Femoropopliteal Arteries — Is There a Class Effect? Zentralbl Chir. 2017;142(5):470–480 (in German). DOI: 10.1055/s-0043-119895.
18. Aboyans V., Ricco J.B., Bartelink M.E.L. et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascu-lar Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and verte-bral, mesenteric, renal, upper and lower extremity arteries. Endorsed 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. DOI: 10.1093/eurheartj/ehx095.
19. Morice M.C., Colombo A., Meier B. et al. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006;295(8):895–904. doi: 10.1001/jama.295.8.895.
20. Scheller B., Speck U., Schmitt A. et al. Addition of paclitaxel to contrast media prevents restenosis after coronary stent implantation. J Am Coll Cardiol. 2003;42(8):1415–1420. DOI: 10.1016/s0735-1097(03)01056-8.
21. Rosenfield K., Jaff M.R., White C.J. et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373(2):145–153. DOI: 10.1056/NEJMoa1406235.
22. Schneider P.A., Laird J.R., Doros G. 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(20):2550–2563. DOI: 10.1016/j.jacc.2019.01.013.
23. Randomized Trial of IN.PACT Admiral Drug Eluting Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850. (Electronic resource.) URL: https://clinicaltrials.gov/ct2/show/NCT01175850 (access date: 23.01.2022).
24. IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461. (Electronic resource.) URL: https://clinicaltrials.gov/ct2/show/NCT01566461. (access date: 23.01.2022).
25. Ott I., Cassese S., Groha P. et al. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conven-tional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): a randomized trial. J Am Heart Assoc. 2017;6(7):e006321. DOI: 10.1161/JAHA.117.006321.
26. Krishnan P., Faries P., Niazi K. et al. Stellarex Drug-Coated Balloon for Treatment of Fem-oropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017;136(12):1102–1113. DOI: 10.1161/CIRCULATIONAHA.117.028893.
27. Gray W.A., Jaff M.R., Parikh S.A. et al. Mortality assessment of paclitaxel-coated balloons: pa-tient-level meta-analysis of the ILLUMENATE clinical program at 3 years. Circulation 2019;140(14):1145–1155. DOI: 10.1161/CIRCULATIONAHA.119.040518.
28. Katsanos K., Spiliopoulos S., Kitrou P. et al. 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. DOI: 10.1161/JAHA.118.011245.
29. Holden A., Varcoe R.L., Jaff M.R. et al. Paclitaxel and mortality: the dose argument is critical. J Endovasc Ther. 2019;26(4):467–470. DOI: 10.1177/1526602819857241.
30. Ducasse E., Caradu C. Rigorous focus on paclitaxel-related mortality in femoropopliteal artery disease. J Vasc Surg. 2020;71(1):216–219. DOI: 10.1016/j.jvs.2019.10.010.
31. FDA Executive Summary. Circulatory System Devices Panel Meeting June 19 and 20, 2019. (Electronic resource.) URL: https://www.fda.gov/media/127698/download (access date: 23.01.2022).
32. Teichgräber U., Lehmann T., Aschenbach R. et al. Drug-coated Balloon Angioplasty of Femoropopliteal Lesions Maintained Superior Efficacy over Conventional Balloon: 2-year Results of the Randomized EffPac Trial. Radiology. 2020;295(2):478–487. DOI: 10.1148/radiol.2020191619.
33. Laird J.R., Schneider P.A., Tepe G. et al. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015;66(21):2329–2338. DOI: 10.1016/j.jacc.2015.09.063.
34. Xu Y., Jia X., Zhang J. et al. Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of 200 Chinese Patients With Severe Femoropopliteal Lesions: 24-Month Results of AcoArt I. JACC Cardiovasc Interv. 2018;11(23):2347–2353. DOI: 10.1016/j.jcin.2018.07.041.
35. Brodmann M., Werner M., Meyer D.R. et al. Sustainable Antirestenosis Effect With a Low-Dose Drug- Coated Balloon: The ILLUMENATE European Randomized Clinical Trial 2-Year Results. JACC Cardiovasc Interv. 2018;11(23):2357–2364. DOI: 10.1016/j.jcin.2018.08.034.
36. Albrecht T., Waliszewski M., Roca C. et al. Two-Year Clinical Outcomes of the CONSE-QUENT Trial: Can Femoropopliteal Lesions Be Treated with Sustainable Clinical Results That Are Economically Sound? Cardiovasc Intervent Radiol. 2018;41(7):1008–1014. DOI: 10.1007/s00270-018-1940-1.
37. Scheinert D., Duda S., Zeller T. 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(1):10–19. DOI: 10.1016/j.jcin.2013.05.022.
38. Edwards C.T., Schneider P.A., Huynh C. Paclitaxel Exposure and Dosage of Drug-coated Devices for the Treatment of Femoropopliteal Peripheral Artery Disease. Vascular & Endovascular Review. 2021;4:e05. DOI: 10.15420/ver.2020.14.
39. Koifman E., Lipinski M.J., Buchanan K. et al. Comparison of treatment strategies for femoropopliteal disease: a network meta-analysis. Catheter Cardiovasc Interv. 2018;91(7):1320–1328. DOI: 10.1002/ccd.27484.
40. Feldman D.N., Armstrong E.J., Aronow H.D. et al. SCAI consensus guidelines for device selection in femoral-popliteal arterial interventions. Catheter Cardiovasc Interv. 2018;92(1):124–140. DOI: 10.1002/ccd.27635.
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