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01-02-2016 | Original Article

Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease

Authors: Masahiko Fujihara, Makoto Utsunomiya, Akihiro Higashimori, Yoshiaki Yokoi, Masato Nakamura

Published in: Heart and Vessels | Issue 2/2016

Abstract

The purpose of this study was to evaluate the efficacy of Zilver PTX, the first drug-eluting stent, in patients with complex femoropopliteal (FP) artery disease. Between July 2012 and March 2013, 60 consecutive patients (39 males; mean age: 72.5 ± 8.6 years) with complex risk factors including TASC II C/D lesions, in-stent restenosis (ISR) and/or on haemodialysis underwent successful Zilver PTX implantation for symptomatic FP artery disease. The primary outcome was primary patency, which was defined as freedom from restenosis at 12 months, as verified by duplex ultrasound. Secondary outcomes included the technical success rate, the freedom from target lesion revascularisation (TLR) rate and the amputation-free survival (AFS) rate. The average follow-up period was 13.2 ± 5.3 months. 62 % of the patients had TASC II C/D lesions, 35.0 % experienced ISR, and 41.6 % were on haemodialysis. The mean lesion length was 188 ± 96 mm. The technical success rate was 98.3 %. The primary patency rate was 50.2 %, the freedom from clinically driven TLR rate was 68.6 %, and the AFS rate was 83.2 % at 12 months. In conclusion, Zilver PTX stent implantation for complex FP artery disease did not affect long-term durability.

Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E (2006) Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 354:1879–1888CrossRefPubMed

Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E (2007) Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation 115:2745–2749CrossRefPubMed

Krankenberg H, Schluter M, Steinkamp HJ, Bürgelin K, Scheinert D, Schulte KL, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F, Tübler T, Zeller T (2007) Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation 116:285–292CrossRefPubMed

Bosiers M, Torsello G, Gissler HM, Ruef J, Müller-Hülsbeck S, Jahnke T, Peeters P, Daenens K, Lammer J, Schroë H, Mathias K, Koppensteiner R, Vermassen F, Scheinert D (2009) Nitinol stent implantation in long superficial femoral artery lesions: 12 month results of the durability I study. J Endovasc Ther 16:261–269CrossRefPubMed

Laird JR, Katzen BT, Scheinert D, Lammer J, Carpenter J, Buchbinder M, Dave R, Ansel G, Lansky A, Cristea E, Collins TJ, Goldstein J, Jaff MR, RESILIENT Investigators (2010) Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve month results from the resilient randomized trial. Circ Cardiovasc Interv 3:267–276CrossRefPubMed

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Zeller T, Roubin GS, Burket MW, Khatib Y, Snyder SA, Ragheb AO, White JK, Machan LS, Zilver PTX Investigators (2011) 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 4:495–504CrossRefPubMed

Norgren L, Hiatt WR, Dormandy JA, Nehler, Harris KA, Fowkes FG, TASC II Working Group (2007) Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg 45(Suppl S):S5–67CrossRefPubMed

Rutherford RB, Becker GJ (1991) Standards for evaluating and reporting the results of surgical and percutaneous therapy for peripheral arterial disease. J Vasc Interv Radiol 2:169–174CrossRefPubMed

Zeller T, Tiefenbacher C, Steinkamp HJ, Langhoff R, Wittenberg G, Schlüter M, Buergelin K, Rastan A, Krumsdorf U, Sixt S, Schulte C-L, Tübler T, Krankenberg H (2008) Nitinol stent implantation in TASC A and B superficial femoral artery lesions: the femoral artery conformexx trial (FACT). J Endovasc Ther 15:390–398CrossRefPubMed

10.

Duda SH, Bosiers M, Lammers J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP (2006) Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther 13:701–710CrossRefPubMed

11.

Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB (2011) First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg 54:394–401CrossRefPubMed

12.

Naito R, Miyauchi K, Konishi H, Tsuboi S, Ogita M, Kasai T, Tamura H, Okazaki S, Daida H (2014) Comparison of long-term clinical outcomes between sirolimus- and paclitaxel-eluting stents in real-world clinical practice. Heart Vessels. doi:10.1007/s00380-014-0560-1

13.

Dake MD, Ansel GM, Jaff MR, Ohki T, Saxon RR, Smouse HB, Snyder SA, O’Leary EE, Tepe G, Scheinert D, Zeller T, Zilver PTX Investigators (2013) 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 61:2417–2427CrossRefPubMed

14.

Siracuse JJ, Giles KA, Pomposelli FB, Hamdan AD, Wyers MC, Chaikof EL, Nedeau AE, Schermerhorn ML (2012) Results for primary bypass versus primary angioplasty/stent for intermittent claudication due to superficial femoral artery occlusive disease. J Vasc Surg 55:1001–1007PubMedCentralCrossRefPubMed

15.

Kumada Y, Aoyama T, Ishii H, Tanaka M, Kawamura Y, Takahashi H, Toriyama T, Aoyama T, Yuzawa Y, Maruyama S, Matsuo S, Murohara T (2008) Long-term outcome of percutaneous transluminal angioplasty in chronic haemodialysis patients with peripheral arterial disease. Nephrol Dial Transplant 23:3996–4001CrossRefPubMed

16.

Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, Yokoi H, Nanto S, Nobuyoshi M (2012) Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol 59(1):16–23CrossRefPubMed

17.

Dick P, Sabeti S, Mlekusch W, Schlager O, Amighi J, Haumer M, Cejna M, Minar E, Schillinger M (2008) Conventional balloon angioplasty versus peripheral cutting balloon angioplasty for treatment of femoropopliteal artery in-stent restenosis: initial experience. Radiology 248(1):297–302CrossRefPubMed

18.

Dake MD, Scheinert D, Tepe G, Tessarek J, Fanelli F, Bosiers M, Ruhlmann C, Kavteladze Z, Lottes AE, Ragheb AO, Zeller T, Zilver PTX Single-Arm Study Investigators (2011) Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther 18:613–623CrossRefPubMed

19.

Stabile E, Virga V, Salemme L, Cioppa A, Ambrosini V, Sorropago G, Tesorio T, Cota L, Popusoi G, Pucciarelli A, Biamino G, Rubino P (2012) Drug-eluting balloon for treatment of superficial femoral artery in-stent restenosis. J Am Coll Cardiol 60(18):1739–1742CrossRefPubMed

20.

Zeller T, Rastan A, Sixt S, Schwarzwälder U, Schwarz T, Frank U, Bürgelin K, Müller C, Rothenpieler U, Flügel PC, Tepe G, Neumann FJ (2006) Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol 48(8):1573–1578CrossRefPubMed

21.

Laird JR Jr, Yeo KK, Rocha-Singh K, Das T, Joye J, Dippel E, Reddy B, Botti C, Jaff MR (2012) Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study. Catheter Cardiovasc Interv 80(5):852–859CrossRefPubMed

22.

Werner M, Scheinert D, Henn M, Scheinert S, Bräunlich S, Bausback Y, Friedenberger J, Schuster J, Hertting K, Piorkowski M, Rosner C, Schmidt A, Ulrich M, Gutberlet M (2012) Endovascular brachytherapy using liquid Beta-emitting rhenium-188 for the treatment of long-segment femoropopliteal in-stent stenosis. J Endovasc Ther 19(4):467–475CrossRefPubMed

Title: Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease
Authors: Masahiko Fujihara
Makoto Utsunomiya
Akihiro Higashimori
Yoshiaki Yokoi
Masato Nakamura
Publication date: 01-02-2016
Publisher: Springer Japan
Published in: Heart and Vessels / Issue 2/2016
Print ISSN: 0910-8327
Electronic ISSN: 1615-2573
DOI: https://doi.org/10.1007/s00380-014-0596-2

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