Purpose: To evaluate the efficacy and safety of the
EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive
disease.
Methods: The prospective, multicenter,
nonrandomized SUMMIT study (ClinicalTrials.gov identifier NCT01336101) enrolled 100
patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal
disease undergoing angioplasty and subsequent implantation of EPIC stents from
April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29
of the lesions were total occlusions. Clinical examination and duplex sonography
were prospectively performed after 6 and 12 months. The primary endpoint was
in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity
ratio ≥2.5). Further outcome measures were patency rates, improvement in
the Rutherford category and ankle-brachial index (ABI), as well as stent
integrity based on plain radiography.
Results: A residual stenosis <30% was
achieved in all procedures. The primary patency rates were 96.8% after 6
months and 85.1% at 1 year. The secondary patency rates were 97.9%
and 91.2% at the same intervals. The 1-year binary >50%
restenosis rate was 15.7%. Freedom from target lesion revascularization
at 1 year was 92.3%. Between baseline and the 12-month follow-up, the
mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased
from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86
patients at the 12-month examination confirmed the absence of stent
fractures.
Conclusion: The outcome of the SUMMIT registry
demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and
effective device for treating peripheral artery disease in the femoropopliteal
segment.
HirschATHaskalZJHertzerNR. 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.
Circulation.
2006;113:e463–654.
2.
NorgrenLHiattWRDormandyJA. Inter-Society Consensus for the
Management of Peripheral Arterial Disease (TASC II).
J Vasc Surg. 2007;45 Suppl S:
S5–67.
3.
SchillingerMSabetiSLoeweC. Balloon angioplasty versus
implantation of nitinol stents in the superficial femoral
artery. N Engl J Med.
2006;354:1879–1888.
4.
BosiersMTorselloGGisslerHM. Nitinol stent implantation in long
superficial femoral artery lesions: 12-month results of the DURABILITY I
study. J Endovasc Ther.
2009;16:261–269.
5.
LairdJRKatzenBTScheinertD. 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.
6.
ScheinertDGrummtLPiorkowskiM. A novel self-expanding interwoven
nitinol stent for complex femoropopliteal lesions: 24-month results of the
SUPERA SFA registry. J Endovasc Ther.
2011;18:745–752.
7.
RutherfordRBBakerJDErnstC. Recommended standards for reports
dealing with lower extremity ischemia: revised version.
J Vasc Surg.
1997;26:517–538.
8.
HiattWRRegensteinerJGHargartenME. Benefit of exercise conditioning for
patients with peripheral arterial disease.
Circulation.
1990;81:602–609.
9.
RankeCCreutzigAAlexanderK.
Duplex scanning of the peripheral arteries: correlation of
the peak velocity ratio with angiographic diameter
reduction. Ultrasound Med Biol.
1992;18:433–440.
KrankenbergHSchluterMSteinkampHJ. 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.
ZellerTTiefenbacherCSteinkampHJ. Nitinol stent implantation in TASC A
and B superficial femoral artery lesions: the Femoral Artery Conformexx
Trial (FACT). J Endovasc Ther.
2008;15:390–398.
17.
DakeMDAnselGMJaffMR. Paclitaxeleluting 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.
18.
SchulteKLKraljIGisslerHM. MISAGO 2: one-year outcomes after
implantation of the Misago self-expanding nitinol stent in the superficial
and popliteal arteries of 744 patients. J Endovasc
Ther.
2012;19:774–784.
