SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment.

Abstract

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.

• Authors: Martin Werner, Michael Piorkowski, Markus Thieme, Thomas Nanning, Ulrich Beschorner, Aljoscha Rastan, Thomas Zeller, Dierk Scheinert
• Journal: Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists (J Endovasc Ther) Vol. 20 Issue 6 Pg. 759-66 (Dec 2013) ISSN: 1545-1550 [Electronic] United States
• PMID: 24325691 (Publication Type: Journal Article)

Chemical References

• Alloys
• nitinol

Topics

• Aged
• Alloys
• Angioplasty, Balloon (adverse effects, instrumentation)
• Ankle Brachial Index
• Constriction, Pathologic
• Female
• Femoral Artery (diagnostic imaging, physiopathology)
• Germany
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Peripheral Arterial Disease (diagnosis, therapy)
• Popliteal Artery (diagnostic imaging, physiopathology)
• Prospective Studies
• Prosthesis Design
• Radiography
• Recurrence
• Registries
• Stents
• Time Factors
• Treatment Outcome
• Ultrasonography, Doppler, Duplex
• Vascular Patency