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CardioVascular and Interventional Radiology

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Open Access 01-11-2017 | Clinical Investigation

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan

Authors: Yukihisa Ogawa, Hiroyoshi Yokoi, Takao Ohki, Kimihiko Kichikawa, Masato Nakamura, Kimihiro Komori, Shinsuke Nanto, Erin E. O’Leary, Aaron E. Lottes, Alan T. Saunders, Michael D. Dake

Published in: CardioVascular and Interventional Radiology | Issue 11/2017

Abstract

Purpose

Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF.

Methods

This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency.

Results

Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively.

Conclusion

This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF.

Level of Evidence

Level 3, Post-Market Surveillance Study.

Orimoto Y, Ohta T, Ishibashi H, Sugimoto I, Iwata H, Yamada T, et al. The prognosis of patients on hemodialysis with foot lesions. J Vasc Surg. 2013;58(5):1291–9. doi:10.1016/j.jvs.2013.05.027.CrossRefPubMed

Nathan DP, Tang GL. The impact of chronic renal insufficiency on vascular surgery patient outcomes. Semin Vasc Surg. 2014;27(3–4):162–9. doi:10.1053/j.semvascsurg.2015.01.006.CrossRefPubMed

Fallon JM, Goodney PP, Stone DH, Patel VI, Nolan BW, Kalish JA, et al. Outcomes of lower extremity revascularization among the hemodialysis-dependent. J Vasc Surg. 2015;62(5):1183–91. doi:10.1016/j.jvs.2015.06.203.CrossRefPubMedPubMedCentral

Patel VI, Mukhopadhyay S, Guest JM, Conrad MF, Watkins MT, Kwolek CJ, et al. Impact of severe chronic kidney disease on outcomes of infrainguinal peripheral arterial intervention. J Vasc Surg. 2014;59(2):368–75. doi:10.1016/j.jvs.2013.09.006.CrossRefPubMed

Matsumi J, Tobita K, Shishido K, Mizuno S, Yamanaka F, Murakami M, et al. Comparison of long-term patency after endovascular therapy for superficial femoral artery occlusive disease between patients with and without hemodialysis. Catheter Cardiovasc Interv. 2016;87(6):1142–8. doi:10.1002/ccd.26359.CrossRefPubMed

Meyer A, Lang W, Borowski M, Torsello G, Bisdas T, Collaborators C. In-hospital outcomes in patients with critical limb ischemia and end-stage renal disease after revascularization. J Vasc Surg. 2016;63(4):966–73. doi:10.1016/j.jvs.2015.10.009.CrossRefPubMed

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease: Twelve-month Zilver PTX randomized study results. Circ Cardiovasc Interv. 2011;4(5):495–504. doi:10.1161/circinterventions.111.962324.CrossRefPubMed

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, et al. Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: 2-year follow-up from the Zilver PTX randomized and single-arm clinical studies. J Am Coll Cardiol. 2013;61(24):2417–27. doi:10.1016/j.jacc.2013.03.034.CrossRefPubMed

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, 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):1472–83. doi:10.1161/circulationaha.115.016900.CrossRefPubMedPubMedCentral

10.

Ohki T, Yokoi H, Kichikawa K, Kimura T, Snyder SA, Ragheb AO, et al. Two-year analysis of the Japanese cohort from the Zilver PTX randomized controlled trial supports the validity of multinational clinical trials. J Endovasc Ther. 2014;21(5):644–53. doi:10.1583/14-4753.1.CrossRefPubMed

11.

Iida O, Takahara M, Soga Y, Nakano M, Yamauchi Y, Zen K, et al. 1-year results of the ZEPHYR registry (Zilver PTX for the femoral artery and proximal popliteal artery): predictors of restenosis. J Am Coll Cardiol Interv. 2015;8(8):1105–12. doi:10.1016/j.jcin.2015.03.022.CrossRef

12.

Yokoi H, Ohki T, Kichikawa K, Nakamura M, Komori K, Nanto S, et al. Zilver PTX post-market surveillance study of paclitaxel-eluting stents for treating femoropopliteal artery disease in Japan: 12-month results. J Am Coll Cardiol Interv. 2016;9(3):271–7. doi:10.1016/j.jcin.2015.09.035.CrossRef

13.

Viener A, Aviram M, Better OS, Brook JG. Enhanced in vitro platelet aggregation in hemodialysis patients. Nephron. 1986;43(2):139–43.CrossRefPubMed

14.

Notohamiprodjo M, Andrassy K, Bommer J, Ritz E. Dialysis membranes and coagulation system. Blood Purif. 1986;4(1–3):130–41.PubMed

15.

Ishii H, Kumada Y, Toriyama T, Aoyama T, Takahashi H, Yamada S, et al. Cilostazol improves long-term patency after percutaneous transluminal angioplasty in hemodialysis patients with peripheral artery disease. Clin J Am Soc Nephrol. 2008;3(4):1034–40. doi:10.2215/cjn.05761207.CrossRefPubMedPubMedCentral

16.

Ihnat DM, Duong ST, Taylor ZC, Leon LR, Mills JL Sr, Goshima KR, et al. Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score. J Vasc Surg. 2008;47(5):967–74. doi:10.1016/j.jvs.2007.12.050.CrossRefPubMed

17.

Bakken AM, Protack CD, Saad WE, Hart JP, Rhodes JM, Waldman DL, et al. Impact of chronic kidney disease on outcomes of superficial femoral artery endoluminal interventions. Ann Vasc Surg. 2009;23(5):560–8. doi:10.1016/j.avsg.2008.11.010.CrossRefPubMed

18.

Willenberg T, Baumann F, Eisenberger U, Baumgartner I, Do DD, Diehm N. Impact of renal insufficiency on clinical outcomes in patients with critical limb ischemia undergoing endovascular revascularization. J Vasc Surg. 2011;53(6):1589–97. doi:10.1016/j.jvs.2011.01.062.CrossRefPubMed

19.

Kay M, Rogoveanu R, Hodson J, Tallowin S, Hopkins J, Duddy M, et al. Factors affecting the results of superficial femoral artery stenting. Vasc Endovasc Surg. 2015;49(8):228–35. doi:10.1177/1538574415614405.CrossRef

20.

Simons JP, Goodney PP, Nolan BW, Cronenwett JL, Messina LM, Schanzer A, et al. Failure to achieve clinical improvement despite graft patency in patients undergoing infrainguinal lower extremity bypass for critical limb ischemia. J Vasc Surg. 2010;51(6):1419–24. doi:10.1016/j.jvs.2010.01.083.CrossRefPubMedPubMedCentral

21.

Goodney PP, Nolan BW, Schanzer A, Eldrup-Jorgensen J, Bertges DJ, Stanley AC, et al. Factors associated with amputation or graft occlusion one year after lower extremity bypass in northern New England. Ann Vasc Surg. 2010;24(1):57–68. doi:10.1016/j.avsg.2009.06.015.CrossRefPubMed

22.

Yamamoto S, Hosaka A, Okamoto H, Shigematsu K, Miyata T, Watanabe T. Efficacy of revascularization for critical limb ischemia in patients with end-stage renal disease. Eur J Vasc Endovasc Surg. 2014;48(3):316–24. doi:10.1016/j.ejvs.2014.05.019.CrossRefPubMed

23.

Kawamura Y, Ishii H, Aoyama T, Tanaka M, Takahashi H, Kumada Y, et al. Nitinol stenting improves primary patency of the superficial femoral artery after percutaneous transluminal angioplasty in hemodialysis patients: a propensity-matched analysis. J Vasc Surg. 2009;50(5):1057–62. doi:10.1016/j.jvs.2009.07.017.CrossRefPubMed

24.

Ramdev P, Rayan SS, Sheahan M, Hamdan AD, Logerfo FW, Akbari CM, et al. A decade experience with infrainguinal revascularization in a dialysis-dependent patient population. J Vasc Surg. 2002;36(5):969–74.CrossRefPubMed

25.

Owens CD, Ho KJ, Kim S, Schanzer A, Lin J, Matros E, et al. Refinement of survival prediction in patients undergoing lower extremity bypass surgery: stratification by chronic kidney disease classification. J Vasc Surg. 2007;45(5):944–52. doi:10.1016/j.jvs.2007.01.025.CrossRefPubMed

26.

Young MD, Streicher MC, Beck RJ, van den Bogert AJ, Tajaddini A, Davis BL. Simulation of lower limb axial arterial length change during locomotion. J Biomech. 2012;45(8):1485–90. doi:10.1016/j.jbiomech.2012.02.011.CrossRefPubMedPubMedCentral

27.

Scheinert D, Scheinert S, Sax J, Piorkowski C, Braunlich S, Ulrich M, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45(2):312–5. doi:10.1016/j.jacc.2004.11.026.CrossRefPubMed

28.

Goolsby MJ. National Kidney Foundation Guidelines for chronic kidney disease: evaluation, classification, and stratification. J Am Acad Nurse Pract. 2002;14(6):238–42.CrossRefPubMed

Title: Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan
Authors: Yukihisa Ogawa
Hiroyoshi Yokoi
Takao Ohki
Kimihiko Kichikawa
Masato Nakamura
Kimihiro Komori
Shinsuke Nanto
Erin E. O’Leary
Aaron E. Lottes
Alan T. Saunders
Michael D. Dake
Publication date: 01-11-2017
Publisher: Springer US
Published in: CardioVascular and Interventional Radiology / Issue 11/2017
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI: https://doi.org/10.1007/s00270-017-1673-6

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan

Abstract

Purpose

Methods

Results

Conclusion

Level of Evidence

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

Level of Evidence

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