Clinical Outcomes of Drug-Coated Balloon Angioplasty in Peripheral Artery Disease Patients With End-Stage Renal Disease

Abstract

Purpose:

The objective was to determine the effectiveness and safety of paclitaxel-coated balloon angioplasty in hemodialysis patients with diabetic nephropathy (DN).

Materials and Methods:

The outcomes of end-stage renal disease (ESRD) patients with peripheral artery disease (PAD) and treated with drug-coated balloon (DCB) angioplasty were retrospectively evaluated. The effectiveness outcomes were clinical improvement of the Rutherford classification and target lesion revascularization (TLR). Safety outcomes were all-cause mortality and amputation.

Results:

Ninety-seven patients were treated with DCB angioplasty between December 2018 and December 2020. 87 (63.8±10.1 years) achieved technical success. Most patients had a Rutherford classification of at least grade 4. The mean lesion length was 169.8±73.8 mm, almost all had arterial calcification, and 31.0% had annular calcification. Wounds were present in 73.6% of the target limbs. The mean follow-up in this cohort was 13.4±7.4 months. The wound healing rate was 61.5% at the 12-month follow-up. All-cause mortality during 12 months of follow-up was 35.6%, amputation-free survival was 58.6%, and TLR was observed in 13 (15.3%) patients. At 3 and 12 months of follow-up, the Rutherford grade significantly improved (p<0.001). The Cox proportional hazards model revealed that wounds (hazard ratio [HR]=1.404, p=0.023) and annular calcification (HR=2.076, p=0.031) were independent predictors of amputation-free survival.

Conclusions:

Drug-coated balloon angioplasty in ESRD patients was effective and safe over the medium term. Wounds and annular calcification were independent predictors of amputation-free survival.

Clinical Impact

The effectiveness of DCB angioplasty in ESRD patients and the factors affecting major outcome prognosis in this population remain limited. This study contributes valuable insights into the effectiveness and safety of paclitaxel-coated balloon angioplasty for PAD in hemodialysis patients. Medical professionals can now regard DCB angioplasty as a viable treatment. Identifying wound presence and annular calcification as predictors of amputation-free survival equips medical practitioners with a more tailored approach to patient management, potentially resulting in enhanced outcomes and more precise treatment strategies.

Keywords

drug-coated balloon angioplasty end-stage renal disease calcification wound ischemia foot infection

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References

Song

Rudan

Zhu

, et al. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Global Health. 2019;7(8):e1020–e1030. doi:10.1016/s2214-109x(19)30255-4.

Selvin

Erlinger

. Prevalence of and risk factors for peripheral arterial disease in the United States: results from the National Health and Nutrition Examination Survey, 1999–2000. Circulation. 2004;110(6):738–743. doi:10.1161/01.cir.0000137913.26087.f0.

Bakken

Palchik

Hart

Rhodes

Saad

Davies

. Impact of diabetes mellitus on outcomes of superficial femoral artery endoluminal interventions. J Vasc Surg. 2007;46(5):946–958; discussion 958. doi:10.1016/j.jvs.2007.06.047.

Hakaim

Gordon

Scott

. Early outcome of in situ femorotibial reconstruction among patients with diabetes alone versus diabetes and end-stage renal failure: analysis of 83 limbs. J Vasc Surg. 1998;27(6):1049–1054; discussion 1054–1055. doi:10.1016/s0741-5214(98)70008-4.

Morooka

Tanaka

Inaguma

Maruyama

. Peripheral artery disease at the time of dialysis initiation and mortality: a prospective observational multicenter study. BMJ Open. 2020;10(12):e042315. doi:10.1136/bmjopen-2020-042315.

Okamoto

Iida

Mano

. Current perspective on hemodialysis patients with peripheral artery disease. Ann Vasc Dis. 2017;10(2):88–91. doi:10.3400/avd.ra.17-00034.

O’Hare

Johansen

. Lower-extremity peripheral arterial disease among patients with end-stage renal disease. J Am Soc Nephrol. 2001;12(12):2838–2847. doi:10.1681/asn.v12122838.

Rajagopalan

Dellegrottaglie

Furniss

, et al. Peripheral arterial disease in patients with end-stage renal disease: observations from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Circulation. 2006;114(18):1914–1922. doi:10.1161/circulationaha.105.607390.

Garimella

Hirsch

. Peripheral artery disease and chronic kidney disease: clinical synergy to improve outcomes. Adv Chronic Kidney Dis. 2014;21(6):460–471. doi:10.1053/j.ackd.2014.07.005.

10.

Kumada

Aoyama

Ishii

, et al. Long-term outcome of percutaneous transluminal angioplasty in chronic haemodialysis patients with peripheral arterial disease. Nephrol Dial Transplant. 2008;23(12):3996–4001. doi:10.1093/ndt/gfn378.

11.

Shanmugasundaram

Murugapandian

Truong

Lotun

Banerjee

. Drug-coated balloon in peripheral artery disease. Cardiovasc Revasc Med. 2019;20(4):338–343. doi:10.1016/j.carrev.2018.04.017.

12.

Jia

Zhang

Zhuang

, et al. Acotec drug-coated balloon catheter: randomized, multicenter, controlled clinical study in femoropopliteal arteries: evidence from the AcoArt I Trial. JACC Cardiovasc Interv. 2016;9(18):1941–1949. doi:10.1016/j.jcin.2016.06.055.

13.

Schroeder

Werner

Meyer

, et al. Low-dose paclitaxel-coated versus uncoated percutaneous transluminal balloon angioplasty for femoropopliteal peripheral artery disease: one-year results of the ILLUMENATE European Randomized Clinical Trial (randomized trial of a novel paclitaxel-coated percutaneous angioplasty balloon). Circulation. 2017;135(23):2227–2236. doi:10.1161/circulationaha.116.026493.

14.

Jia

Zhuang

Wang

, et al. Drug-coated balloon angioplasty compared with uncoated balloons in the treatment of infrapopliteal artery lesions (AcoArt II-BTK). J Endovasc Ther. 2021;28(2):215–221. doi:10.1177/1526602820969681.

15.

Iiya

Hikita

Yoshikawa

, et al. Clinical outcomes after endovascular therapy among hemodialysis patients with peripheral artery disease stratified by the primary kidney disease. Ann Vasc Surg. 2021;73:197–204. doi:10.1016/j.avsg.2020.11.046.

16.

Anantha-Narayanan

Sheikh

Nagpal

, et al. Systematic review and meta-analysis of outcomes of lower extremity peripheral arterial interventions in patients with and without chronic kidney disease or end-stage renal disease. J Vasc Surg. 2021;73(1):331–340.e4. doi:10.1016/j.jvs.2020.08.032.

17.

Zuo

Chen

, et al. Modified glomerular filtration rate estimating equation for Chinese patients with chronic kidney disease. J Am Soc Nephrol. 2006;17(10):2937–2944. doi:10.1681/asn.2006040368.

18.

Fanelli

Cannavale

Gazzetti

, et al. Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease. Cardiovasc Intervent Radiol. 2014;37(4):898–907. doi:10.1007/s00270-014-0904-3.

19.

Mills

Conte

Armstrong

, et al. The Society for Vascular Surgery lower extremity threatened limb classification system: risk stratification based on Wound, Ischemia, and Foot Infection (WIfI). J Vasc Surg. 2014;59(1):220–234.e2. doi:10.1016/j.jvs.2013.08.003.

20.

Darling

McCallum

Soden

, et al. Predictive ability of the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system after first-time lower extremity revascularizations. J Vasc Surg. 2017;65(3):695–704. doi:10.1016/j.jvs.2016.09.055.

21.

Garimella

Hart

O’Hare

DeLoach

Herzog

Hirsch

. Peripheral artery disease and CKD: a focus on peripheral artery disease as a critical component of CKD care. Am J Kidney Dis. 2012;60(4):641–654. doi:10.1053/j.ajkd.2012.02.340.

22.

Smilowitz

Bhandari

Berger

. Chronic kidney disease and outcomes of lower extremity revascularization for peripheral artery disease. Atherosclerosis. 2020;297:149–156. doi:10.1016/j.atherosclerosis.2019.12.016.

23.

Matsuzawa

Aoyama

Yoshida

. Clinical characteristics of patients on hemodialysis with peripheralarterial disease. Angiology. 2015;66(10):911–917. doi:10.1177/0003319715572678.

24.

Lacroix

Aboyans

Desormais

, et al. Chronic kidney disease and the short-term risk of mortality and amputation in patients hospitalized for peripheral artery disease. J Vasc Surg. 2013;58(4):966–971. doi:10.1016/j.jvs.2013.04.007.

25.

Margolis

Hofstad

Feldman

. Association between renal failure and foot ulcer or lower-extremity amputation in patients with diabetes. Diabetes Care. 2008;31(7):1331–1336. doi:10.2337/dc07-2244.

26.

Kim

Park

Choi

, et al. Different association between renal dysfunction and clinical outcomes according to the presence of diabetes in patients undergoing endovascular treatment for peripheral artery disease. J Vasc Surg. 2020;71(1):132–140.e1. doi:10.1016/j.jvs.2019.03.071.

27.

Stavroulakis

Schwindt

Torsello

, et al. Directional atherectomy with antirestenotic therapy vs drug-coated balloon angioplasty alone for isolated popliteal artery lesions. J Endovasc Ther. 2017;24(2):181–188. doi:10.1177/1526602816683933.