Skip to main content
Erschienen in: Heart and Vessels 2/2016

01.02.2016 | Original Article

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

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

Erschienen in: Heart and Vessels | Ausgabe 2/2016

Einloggen, um Zugang zu erhalten

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.
Literatur
1.
Zurück zum Zitat 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, 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
2.
Zurück zum Zitat 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 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
3.
Zurück zum Zitat 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 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
4.
Zurück zum Zitat 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 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
5.
Zurück zum Zitat 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 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
6.
Zurück zum Zitat 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 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
7.
Zurück zum Zitat 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 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
8.
Zurück zum Zitat 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 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
9.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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.
Zurück zum Zitat 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 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
Metadaten
Titel
Outcomes of Zilver PTX stent implantation for the treatment of complex femoropopliteal artery disease
verfasst von
Masahiko Fujihara
Makoto Utsunomiya
Akihiro Higashimori
Yoshiaki Yokoi
Masato Nakamura
Publikationsdatum
01.02.2016
Verlag
Springer Japan
Erschienen in
Heart and Vessels / Ausgabe 2/2016
Print ISSN: 0910-8327
Elektronische ISSN: 1615-2573
DOI
https://doi.org/10.1007/s00380-014-0596-2

Weitere Artikel der Ausgabe 2/2016

Heart and Vessels 2/2016 Zur Ausgabe

Screening-Mammografie offenbart erhöhtes Herz-Kreislauf-Risiko

26.04.2024 Mammografie Nachrichten

Routinemäßige Mammografien helfen, Brustkrebs frühzeitig zu erkennen. Anhand der Röntgenuntersuchung lassen sich aber auch kardiovaskuläre Risikopatientinnen identifizieren. Als zuverlässiger Anhaltspunkt gilt die Verkalkung der Brustarterien.

Niedriger diastolischer Blutdruck erhöht Risiko für schwere kardiovaskuläre Komplikationen

25.04.2024 Hypotonie Nachrichten

Wenn unter einer medikamentösen Hochdrucktherapie der diastolische Blutdruck in den Keller geht, steigt das Risiko für schwere kardiovaskuläre Ereignisse: Darauf deutet eine Sekundäranalyse der SPRINT-Studie hin.

Therapiestart mit Blutdrucksenkern erhöht Frakturrisiko

25.04.2024 Hypertonie Nachrichten

Beginnen ältere Männer im Pflegeheim eine Antihypertensiva-Therapie, dann ist die Frakturrate in den folgenden 30 Tagen mehr als verdoppelt. Besonders häufig stürzen Demenzkranke und Männer, die erstmals Blutdrucksenker nehmen. Dafür spricht eine Analyse unter US-Veteranen.

Adipositas-Medikament auch gegen Schlafapnoe wirksam

24.04.2024 Adipositas Nachrichten

Der als Antidiabetikum sowie zum Gewichtsmanagement zugelassene Wirkstoff Tirzepatid hat in Studien bei adipösen Patienten auch schlafbezogene Atmungsstörungen deutlich reduziert, informiert der Hersteller in einer Vorab-Meldung zum Studienausgang.

Update Kardiologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.