Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial

Circ Cardiovasc Interv. 2016 Jun;9(6):e002930. doi: 10.1161/CIRCINTERVENTIONS.115.002930.

Abstract

Background: 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.

Methods and results: 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.

Conclusions: 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.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02163863.

Keywords: nitinol; peripheral arterial disease; peripheral vascular diseases; prospective studies; stents.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alloys
  • Amputation
  • Disease-Free Survival
  • Endovascular Procedures / adverse effects
  • Endovascular Procedures / instrumentation*
  • Endovascular Procedures / mortality
  • Female
  • Femoral Artery* / diagnostic imaging
  • Femoral Artery* / physiopathology
  • Germany
  • Graft Occlusion, Vascular / etiology
  • Graft Occlusion, Vascular / physiopathology
  • Humans
  • Kaplan-Meier Estimate
  • Limb Salvage
  • Male
  • Middle Aged
  • Peripheral Arterial Disease / diagnostic imaging
  • Peripheral Arterial Disease / mortality
  • Peripheral Arterial Disease / physiopathology
  • Peripheral Arterial Disease / therapy*
  • Popliteal Artery* / diagnostic imaging
  • Popliteal Artery* / physiopathology
  • Prospective Studies
  • Prosthesis Design
  • Recurrence
  • Risk Factors
  • Stents*
  • Time Factors
  • Treatment Outcome
  • Vascular Patency*

Substances

  • Alloys
  • nitinol

Associated data

  • ClinicalTrials.gov/NCT02163863