title: Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial.
abstract: Reintervention in the femoropopliteal artery is frequent and a major driver of cost-effectiveness. High wall shear generated by swirling blood flow is associated with reduced occurrence of atherosclerosis and restenosis. This trial investigated the clinical and hemodynamic outcomes of the BioMimics 3D self-expanding tubular nitinol stent with helical centerline geometry compared with a straight stent in the femoropopliteal artery.
  
  
  
  In a prospective, multicenter, randomized controlled trial, 76 patients with symptomatic peripheral arterial disease were randomized 2:1 to receive a helical or a straight stent. An independent core laboratory adjudicated angiographic and ultrasound parameters. The primary safety end point was freedom from a composite of all death, target limb amputation, and target lesion revascularization at 30 days. The primary effectiveness end point was freedom from clinically driven target lesion revascularization at 6 months. Patency was a secondary end point. Subjects were followed up for 2 years from intervention. The primary safety (1-sided P<0.01) and efficacy (1-sided P<0.001) end points for the helical stent were met. The proportion of patients treated with the helical stent who maintained patency at 12 and 24 months was 80% and 72%, respectively, compared with 71% and 55% for the control group. The difference was significant through 24 months (P=0.05). Freedom from clinically driven target lesion revascularization for the helical compared with straight stent was 91% versus 92% at 12 months and 91% versus 76% at 24 months.
  
  
  
  Both groups had similar safety outcomes and clinically driven target lesion revascularization to 2 years. However, after placement of a BioMimics 3D helical stent, there was improved patency to 2 years.
  
  
  
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.
authors.affiliation: From the Department of Angiology, Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.).
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: From the Department of Angiology, Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.). p.a.gaines@sheffield.ac.uk.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Gaines
authors.affiliation: From the Department of Angiology, Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.).
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.affiliation: From the Department of Angiology, Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany (T.Z.); Sheffield Vascular Institute, Northern General Hospital, Sheffield, United Kingdom (P.A.G.); Center for Critical Limb Care, Riverside Methodist Hospital, Columbus, OH (G.M.A.); and Department of Bioengineering, Imperial College, London, United Kingdom (C.G.C.).
authors.forename: Colin G
authors.initials: CG
authors.lastname: Caro
mesh_terms: D000368:Aged; D000497:Alloys; D000671:Amputation, Surgical; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D005858:Germany; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; C013616:nitinol
keywords: nitinol; peripheral arterial disease; peripheral vascular diseases; prospective studies; stents