Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Abstract

Purpose

To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease.

Materials and Methods

The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported.

Results

The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture.

Conclusion

Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

Keywords

ankle-brachial index femoropopliteal lesions major adverse events nitinol stents objective performance goal peripheral artery disease stent patency superficial femoral artery target lesion revascularization

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References

Jukema

Verschuren

Ahmed

, et al. Restenosis after PCI. Part 1: pathophysiology and risk factors. Nat Rev Cardiol. 2011;9:53–62.

Ni Ghriallais

Heraty

Smouse

, et al. Deformation of the femoropopliteal segment: effect of stent length, location, flexibility, and curvature. J Endovasc Ther. 2016;23:907–918.

Nikanorov

Smouse

Osman

, et al. Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions. J Vasc Surg. 2008;48:435–440.

Arena

FJ.

Arterial kink and damage in normal segments of the superficial femoral and popliteal arteries abutting nitinol stents—a common cause of late occlusion and restenosis? A single-center experience. J Invasive Cardiol. 2005;17:482–486.

Caro

CG.

Discovery of the role of wall shear in atherosclerosis. Arterioscler Thromb Vasc Biol. 2009;29:158–161.

Caro

Doorly

Tarnawski

, et al. Non-planar curvature and branching of arteries and non-planar-type flow. Proc R Soc Lond A. 1996;452:185–197.

Zeller

Gaines

Ansel

, et al. Helical centerline stent improves patency: two-year results from the randomized MIMICS trial. Circ Cardiovasc Interv. 2016;9(6):e002930.

Rocha-Singh

Jaff

Crabtree

, et al. Performance goals and endpoint assessments for clinical trials of femoropopliteal bare nitinol stents in patients with symptomatic peripheral arterial disease. Catheter Cardiovasc Interv. 2007;69:910–919.

Rocha-Singh

Zeller

Jaff

MR.

Peripheral arterial calcification: prevalence, mechanism, detection, and clinical implications. Catheter Cardiovasc Interv. 2014;83:E212–E220.

10.

Matsumura

Yamanouchi

Goldstein

, et al. The United States StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex NitInol STent SYstem II (DURABILITY II). J Vasc Surg. 2013;58:73–83.e1.

11.

Laird

Jain

Zeller

, et al. Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-month results from the complete SE multicenter trial. J Endovasc Ther. 2014;21:202–212.

12.

Gray

Feiring

Cioppi

, et al. S.M.A.R.T. self-expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery (STROLL): 1-year outcomes. J Vasc Interv Radiol. 2015;26:21–28.

13.

Garcia

Jaff

Metzger

, et al. Wire-interwoven nitinol stent outcome in the superficial femoral and proximal popliteal arteries: twelve-month results of the SUPERB trial. Circ Cardiovasc Interv. 2015;8(5):e000937.

14.

Ohki

Angle

Yokoi

, et al. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study). J Vasc Surg. 2016;63:370–376.e1.

15.

Dake

Ansel

Jaff

, et al. 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. 2013;61:2417–2427.

16.

Müller-Hülsbeck

Keirse

Zeller

, et al. Long-term results from the MAJESTIC trial of the Eluvia paclitaxel-eluting stent for femoropopliteal treatment: 3-year follow-up. Cardiovasc Intervent Radiol. 2017;40:1832–1838.

17.

Laird

Schneider

Tepe

, et al. Durability of treatment effect using a drug-coated balloon for femoropopliteal lesions: 24-month results of IN.PACT SFA. J Am Coll Cardiol. 2015;66:2329–2338.

18.

Sullivan

Zeller

Nakamura

, et al. Swirling flow and wall shear: evaluating the BioMimics 3D helical centerline stent for the femoropopliteal segment. Int J Vasc Med. 2018:9795174.

19.

Wood

Zhao

Zambanini

, et al. Curvature and tortuosity of the superficial femoral artery: a possible risk factor for peripheral arterial disease. J Appl Physiol (1985). 2006;101:1412–1418.

20.

Carlier

van Damme

Blommerde

, et al. Augmentation of wall shear stress inhibits neointimal hyperplasia after stent implantation: inhibition through reduction of inflammation? Circulation. 2003;107:2741–2746.

21.

Caro

Seneviratne

Heraty

, et al. Intimal hyperplasia following implantation of helical-centreline and straight-centreline stents in common carotid arteries in healthy pigs: influence of intraluminal flow. J R Soc Interface. 2013;10:20130578.

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