Outcomes of drug-coated balloon endovascular angioplasty in the treatment of chronic femoropopliteal artery stenosis and occlusion

Duy Tan Nguyen1, Huu Duc Pham, Ngoc Hai Dang Nguyen2, Minh Bao Luan Tran2,3,
1 Thong Nhat Hospital
2 University of Medicine and Pharmacy at HCMC
3 University Medical Center HCMC

Main Article Content

Abstract

Background: Endovascular intervention has become the preferred treatment strategy for chronic femoropopliteal arterial stenosis and occlusion owing to its minimally invasive nature, low complication rate, rapid recovery, and long-term efficacy that is equivalent or superior to conventional open surgery. However, plain old balloon angioplasty (POBA) and metallic stent implantation still have significant limitations. Drug-coated balloons (DCB) were developed with the “leave nothing behind” strategy, preserving the vessel wall’s natural physiological structure after recanalization and avoiding the long-term risks associated with metallic implants.


Objective: To evaluate the 12-month short-term outcomes of endovascular paclitaxel-coated balloon angioplasty in the treatment of chronic femoropopliteal arterial stenosis and occlusion at Thong Nhat Hospital.


Patients and Methods: Retrospective descriptive case series of


Results: from June 2022 to June 2024, there were 122 patients underwent endovascular drug-coated balloon intervention for chronic femoropopliteal arterial stenosis and occlusion at Thong Nhat Hospital. Periprocedural clinical symptom improvement reached 93.4%. Immediately after the procedure, 54.1% of patients became completely asymptomatic, 4.1% had residual mild intermittent claudication, and 1.6% had residual moderate pain; no patients remained in Rutherford category 3 or 4. Hemodynamically, the mean ankle-brachial index (ABI) increased from 0.58 to 0.98 post-intervention, and triphasic flow was restored in 58.5% of cases. At 12-month follow-up, treatment efficacy remained high, with a primary patency rate of 74.2% and a limb salvage rate of 91.8%.


Conclusion: the “preferred endovascular intervention with drug-coated balloon” strategy is both reasonable and feasible in patients with chronic femoropopliteal arterial stenosis and occlusion, sustained long-term results, and reduced need for reintervention compared with alternative approaches.

Article Details

References

1. Krishnappa S., Rachaiah J. M., Mariappa H. M., Doddamadaiah C., Nanjappa M. C. Endovascular Interventions to Superficial Femoral Artery Occlusion: Different Approaches, Technique, and Follow-up. Heart Views. 2020;21(2):65-74. Epub 2020/10/06. doi: 10.4103/heartviews.Heartviews_34_19. PubMed PMID: 33014298; PubMed Central PMCID: PMCPMC7507906.
2. Norgren L., Hiatt W. R., Dormandy J. A., Nehler M. R., Harris K. A., Fowkes F. G. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45 Suppl S:S5-67. Epub 2007/01/16. doi: 10.1016/j.jvs.2006.12.037. PubMed PMID: 17223489.
3. Tepe G., Laird J., Schneider P., 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(5):495-502. Epub 2014/12/05. doi: 10.1161/circulationaha.114.011004. PubMed PMID: 25472980; PubMed Central PMCID: PMCPMC4323569.
4. 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):145-53. Epub 2015/06/25. doi: 10.1056/NEJMoa1406235. PubMed PMID: 26106946.
5. 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. Epub 2018/12/19. doi: 10.1161/jaha.118.011245. PubMed PMID: 30561254; PubMed Central PMCID: PMCPMC6405619.
6. 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):2550-63. Epub 2019/01/29. doi: 10.1016/j.jacc.2019.01.013. PubMed PMID: 30690141.