Abstract
To examine clinical outcomes for combination therapy of heparin-bonded covered stent [VIABAHN™ stent (VIA)] and bare-nitinol stent (BNS), and to determine independent predictors of restenosis after VIA implantation assessed by intravascular ultrasound (IVUS). A retrospective analysis was conducted on VIA use in the femoropopliteal artery of 71 patients (81 lesions) treated between June 2012 and November 2018. We divided the treated lesions into two groups; that is, whether BNS was added at the proximal site of the VIA or not (combination of VIA and BNS group [COM; n = 21] vs. VIA group [n = 60]). The median follow-up duration was 21.6 months (interquartile range, 13.2–28.8 months). Restenosis at 2 years was observed in 5 lesions (33%) in COM group and 17 lesions (38%) in VIA group (log-rank, P = 0.74). In VIA group, 14 lesions developed restenosis within 12 months. Multivariate logistic regression analysis of VIA group revealed that the proximal plaque burden was an independent predictor of restenosis within 12 months after VIA implantation (odds ratio 1.15, 95% confidence interval 1.01–1.30, P = 0.01), with the optimal cutoff value of 43% (area under the receiver operator characteristic curve 0.79, sensitivity 91%, specificity 69%). A remaining plaque of > 43% at the proximal reference segment was an independent predictor of restenosis after VIA implantation. When residual stenosis is observed at the proximal site of SFA after VIA implantation, combination therapy of VIA and BNS would be an optimal management.
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Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Ristl R, Schoder M (2013) Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease). J Am Coll Cardiol 62:1320–1327
Lammer J, Zeller T, Hausegger KA, Schaefer PJ, Gschwendtner M, Mueller-Huelsbeck S, Rand T, Funovics M, Wolf F, Rastan A, Gschwandtner M, Puchner S, Beschorner U, Ristl R, Schoder M (2015) Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial. Cardiovasc Intervent Radiol 38:25–32
Lin TC, Huang CY, Chen PL, Lee CY, Shih CC, Chen IM (2018) Edge stenosis after covered stenting for long superficial femoral artery occlusive disease: risk factor analysis and prevention with drug-coated balloon angioplasty. J Endovasc Ther 25:313–319
Iida O, Takahara M, Soga Y, Suzuki K, Hirano K, Kawasaki D, Shintani Y, Suematsu N, Yamaoka T, Nanto S, Uematsu M (2014) Efficacy of intravascular ultrasound in femoropopliteal stenting for peripheral artery disease with TASC II class A to C lesions. J Endovasc Ther 21:485–492
Miki K, Fujii K, Kawasaki D, Shibuya M, Fukunaga M, Imanaka T, Tamaru H, Sumiyoshi A, Nishimura M, Horimatsu T, Saita T, Okada K, Kimura T, Honda Y, Fitzgerald PJ, Masuyama T, Ishihara M (2016) Intravascular ultrasound-derived stent dimensions as predictors of angiographic restenosis following nitinol stent implantation in the superficial femoral artery. J Endovasc Ther 23:424–432
Mori S, Hirano K, Nakano M, Muramatsu T, Tsukahara R, Ito Y, Ishimori H (2015) Intravascular ultrasound measurements after drug-eluting stent placement in femoropopliteal lesions: determining predictors of restenosis. J Endovasc Ther 22:341–349
Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG, O’Rourke RA, Abrams J, Bates ER, Brodie BR, Douglas PS, Gregoratos G, Hlatky MA, Hochman JS, Kaul S, Tracy CM, Waters DD, Winters WL (2001) American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (ivus)31When citing this document, the American College of Cardiology would appreciate the follow. J Am Coll Cardiol 37:1478–1492
Cheneau E, Leborgne L, Mintz GS, Kotani J-I, Pichard AD, Satler LF, Canos D, Castagna M, Weissman NJ, Waksman R (2003) Predictors of subacute stent thrombosis. Circulation 108:43–47
Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW (2015) Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol 65:931–941
Tomoi Y, Soga Y, Takahara M, Fujihara M, Iida O, Kawasaki D, Ando K (2019) Spot stenting versus full coverage stenting after endovascular therapy for femoropopliteal artery lesions. J Vasc Surg 70:1166–1176
Rocha-Singh KJ, Zeller T, Jaff MR (2014) Peripheral arterial calcification: Prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv 83:E212–220
Soga Y, Iida O, Hirano K, Suzuki K, Tosaka A, Yokoi H, Nobuyoshi M (2011) Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery. J Vasc Surg 54:1058–1066
Ranke C, Creutzig A, Alexander K (1992) Duplex scanning of the peripheral arteries: correlation of the peak velocity ratio with angiographic diameter reduction. Ultrasound Med Biol 18:433–440
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, TASCII Working Group (2007) Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 45:S5–67
Saxon RR, Chervu A, Jones PA, Bajwa TK, Gable DR, Soukas PA, Begg RJ, Adams JG, Ansel GM, Schneider DB, Eichler CM, Rush MJ (2013) Heparin-bonded, expanded polytetrafluoroethylene-lined stent graft in the treatment of femoropopliteal artery disease: 1-year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) trial. J Vasc Interv Radiol 24:165–173
Zeller T, Peeters P, Bosiers M, Lammer J, Brechtel K, Scheinert D, Rastan A, Noory E, Beschorner U (2014) Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther 21:765–774
Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P (2015) Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther 22:1–10
Reijnen M, van Walraven LA, Fritschy WM, Lensvelt MMA, Zeebregts CJ, Lemson MS, Wikkeling ORM, Smeets L, Holewijn S (2017) 1-year results of a multicenter randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. JACC Cardiovasc Interv 10:2320–2331
Kruse RR, Poelmann FB, Doomernik D, Burgerhof HGM, Fritschy WM, Moll FL, Reijnen MMPJ (2015) Five-year outcome of self-expanding covered stents for superficial femoral artery occlusive disease and an analysis of factors predicting failure. J Endovasc Ther 22:855–861
Schneider JR, Verta MJ, Alonzo MJ, Hahn D, Patel NH, Kim S (2011) Results with Viabahn-assisted subintimal recanalization for TASC C and TASC D superficial femoral artery occlusive disease. Vasc Endovasc Surg 45:391–397
McQuade K, Gable D, Hohman S, Pearl G, Theune B (2009) Randomized comparison of ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg 49:109–116.e9
Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D (2018) 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 7:e011245
Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T (2019) Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol 73:2550–2563
Katsuki T, Takahara M, Soga Y, Okamoto S, Iida O, Fujihara M, Kawasaki D, Ando K (2019) Mortality risk following application of a paclitaxel-coated stent in femoropopliteal lesions. J Endovasc Ther 26:593–599
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The authors would like to thank CE. Hiroki Kobayashi at Kokura Memorial Hospital for his excellent assistance during the study.
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Katsuki, T., Tomoi, Y., Yamaji, K. et al. Combination therapy of heparin-bonded covered stent and bare-nitinol stent assessed by intravascular ultrasound. Heart Vessels 35, 1502–1509 (2020). https://doi.org/10.1007/s00380-020-01631-y
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DOI: https://doi.org/10.1007/s00380-020-01631-y