Stent placement versus balloon angioplasty for the treatment of obstructive lesions of the popliteal artery: A prospective, multicenter, randomized trial

Circulation

Volumn 127, Issue 25, 2013, Pages 2535-2541

  Rastan, Aljoscha ^a   Krankenberg, Hans ^b   Baumgartner, Iris ^c   Blessing, Erwin ^d   Müller Hülsbeck, Stefan ^e   Pilger, Ernst ^f   Scheinert, Dierk ^g   Lammer, Johannes ^h   Giler, Martin ⁱ   Noory, Elias ^a   Neumann, Franz Josef ^a   Zeller, Thomas ^a  

^a UNIVERSITY HEART CENTER FREIBURG BAD KROZINGEN   (Germany)

^b UNIVERSITY HEART CENTER HAMBURG   (Germany)

^c UNIVERSITY OF BERN   (Switzerland)

^d UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^e Ev Luth Deaconess Institute   (Germany)

^f INNSBRUCK MEDICAL UNIVERSITY   (Austria)

^g UNIVERSITY OF LEIPZIG HEART CENTER   (Germany)

^h UNIV KLIN FÜR RADIODIAGNOSTIK   (Austria)

ⁱ Institut für Radiologie   (Germany)

Author keywords

angioplasty; arteries; peripheral vascular diseases; stents

Indexed keywords

ADULT; AGED; ARTERY DIAMETER; ARTERY LESION; ARTERY OCCLUSION; ARTICLE; BELOW KNEE AMPUTATION; BODY MASS; BYPASS SURGERY; CAROTID ARTERY DISEASE; CONTROLLED STUDY; DIABETES MELLITUS; DYSLIPIDEMIA; EVENT FREE SURVIVAL; FEMALE; FOLLOW UP; HEART INFARCTION; HOSPITAL READMISSION; HUMAN; HYPERTENSION; ISCHEMIC HEART DISEASE; LIMB SALVAGE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NITINOL STENT; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PERIPHERAL OCCLUSIVE ARTERY DISEASE; POPLITEAL ARTERY; POPLITEAL ARTERY OCCLUSION; POPLITEAL ARTERY STENT; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; REVASCULARIZATION; SEPTIC SHOCK; VASCULAR PATENCY;

ANGIOPLASTY; ARTERIES; PERIPHERAL VASCULAR DISEASES; STENTS;

ADULT; AGED; AGED, 80 AND OVER; ALLOYS; ANGIOPLASTY, BALLOON; ARTERIAL OCCLUSIVE DISEASES; ENDOVASCULAR PROCEDURES; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; POPLITEAL ARTERY; PROSPECTIVE STUDIES; STENTS; SURVIVAL RATE; TREATMENT OUTCOME; VASCULAR PATENCY;

EID: 84879509191     PISSN: 00097322     EISSN: 15244539     Source Type: Journal    
DOI: 10.1161/CIRCULATIONAHA.113.001849     Document Type: Article

References (26)

1. Dormandy JA, Rutherford RB; TASC Working Group. TransAtlantic Inter-Society Consensus (TASC). Management of peripheral arterial disease (PAD). J Vasc Surg. 2000;31(pt 2):S1-S296.
2. Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM, White CJ, White J, White RA, Antman EM, Smith SC, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B. ACC/AHA 2005 guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): executive summary: a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. J Am Coll Cardiol. 2006;47:1239-1312.
3. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clement D, Collet JP, Cremonesi A, De Carlo M, Erbel R, Fowkes FG, Heras M, Kownator S, Minar E Ostergren J, Poldermans D, Riambau V, Roffi M, Rother J, Sievert H, van Sambeek M, Zeller T. ESC guidelines on the diagnosis and treatment of peripheral artery diseases: document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries: the Task Force on the Diagnosis and Treatment of Peripheral Artery Diseases of the European Society of Cardiology (ESC). Eur Heart J. 2011;32:2851-2906.
4. Krankenberg H, Schlüter 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. 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. 2007;116:285-292.
5. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, Schlager O, Cejna M, Lammer J, Minar E. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879-1888.
6. 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. 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. 2010;3:267-276.
7. Babalik E, Gülbaran M, Gürmen T, Oztürk S. Fracture of popliteal artery stents. Circ J. 2003;67:643-645.
8. Müller-Hülsbeck S, Schäfer PJ, Charalambous N, Yagi H, Heller M, Jahnke T. Comparison of second-generation stents for application in the superficial femoral artery: an in vitro evaluation focusing on stent design. J Endovasc Ther. 2010;17:767-776.
9. Nikanorov A, Smouse HB, Osman K, Bialas M, Shrivastava S, Schwartz LB. Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions. J Vasc Surg. 2008;48:435-440.
10. Popma JJ, Tiroch K, Almonacid A, Cohen S, Kandzari DE, Leon MB. A qualitative and quantitative angiographic analysis of stent fracture late following sirolimus-eluting stent implantation. Am J Cardiol. 2009;103:923-929.
11. Ranke C, Creutzig A, Alexander K. Duplex scanning of the peripheral arteries: correlation of the peak velocity ratio with angiographic diameter reduction. Ultrasound Med Biol. 1992;18:433-440.
12. Ranke C, Rieder M, Creutzig A, Alexander K. A nomogram of duplex ultrasound quantification of peripheral arterial stenoses: studies of the cardiovascular model and in angiography patients [in German]. Med Klin (Munich). 1995;90:72-77.
13. 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. 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;4:495-504.
14. Jahnke T, Mueller-Huelsbeck S, Charalambous N, Trentmann J, Jamili A, Huemme TH, Bolte H, Heller M, Schaefer PJ. Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study. J Vasc Interv Radiol. 2010;21:186-194.
15. Semaan E, Hamburg N, Nasr W, Shaw P, Eberhardt R, Woodson J, Doros G, Rybin D, Farber A. Endovascular management of the popliteal artery: comparison of atherectomy and angioplasty. Vasc Endovascular Surg. 2010;44:25-31.
16. Strecker EP, Boos IB, Göttmann D, Vetter S, Haase W. Popliteal artery stenting using flexible tantalum stents. Cardiovasc Intervent Radiol. 2001;24:168-175.
17. Goltz JP, Ritter CO, Kellersmann R, Klein D, Hahn D, Kickuth R. Endovascular treatment of popliteal artery segments P1 and P2 in patients with critical limb ischemia: initial experience using a helical nitinol stent with increased radial force. J Endovasc Ther. 2012;19:450-456.
18. Scheinert D, Werner M, Scheinert S, Paetzold A, Banning-Eichenseer U, Piorkowski M, Ulrich M, Bausback Y, Bräunlich S, Schmidt A. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013;6:65-71.
19. Schulte KL, Kralj I, Gissler HM, Bagnaschino LA, Buschmann I, Pernès JM, Haage P, Goverde P, Beregi JP, Válka M, Boudny J, Geibel T, Velkoborsky M, Zähringer M, Paetzel C, Fanelli F, Müller-Hülsbeck S, Zeller T, Langhoff R. MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther. 2012;19:774-784.
20. Iida O, Soga Y, Hirano K, Suzuki K, Yokoi H, Nobuyoshi M, Muramatsu T, Inoue N, Nanto S, Uematsu M. Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis. J Endovasc Ther. 2011;18:753-761.
21. Soga Y, Iida O, Hirano K, Yokoi H, Nanto S, Nobuyoshi M. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg. 2010;52:608-615.
22. Kröger K, Santosa F, Goyen M. Biomechanical incompatibility of popliteal stent placement. J Endovasc Ther. 2004;11:686-694.
23. Scheinert D, Scheinert S, Sax J, Piorkowski C, Bräunlich S, Ulrich M, Biamino G, Schmidt A. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. J Am Coll Cardiol. 2005;45:312-315.
24. Lammer J, Bosiers M, Zeller T, Schillinger M, Boone E, Zaugg MJ, Verta P, Peng L, Gao X, Schwartz LB. First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease. J Vasc Surg. 2011;54:394-401.
25. 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. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16:261-269.
26. 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. Nitinol stents with polymerfree 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. 2011;18:613-623.