Helical Centerline Stent Improves Patency: Two-Year Results From the Randomized Mimics Trial.
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.
['Zeller|Thomas|T|', 'Gaines|Peter A|PA|', 'Ansel|Gary M|GM|', 'Caro|Colin G|CG|']
D000368:Aged D000497:Alloys D000671:Amputation D018572:Disease-Free Survival D057510:Endovascular Procedures D005260:Female D005263:Femoral Artery D005858:Germany D006083:Graft Occlusion, Vascular D006801:Humans D053208:Kaplan-Meier Estimate D023821:Limb Salvage D008297:Male D008875:Middle Aged D058729:Peripheral Arterial Disease D011150:Popliteal Artery D011446:Prospective Studies D011474:Prosthesis Design D012008:Recurrence D012307:Risk Factors D015607:Stents D013997:Time Factors D016896:Treatment Outcome D014654:Vascular Patency
stents nitinol peripheral arterial disease peripheral vascular diseases prospective studies