Use of a New Hybrid Heparin-Bonded Nitinol Ring Stent in the Popliteal Artery: Procedural and Mid-term Clinical and Anatomical Outcomes.

Abstract

PURPOSE:

To report the immediate and mid-term clinical and anatomical outcomes of a novel, hybrid, heparin-bonded, nitinol ring stent (TIGRIS; Gore Medical) when used for the treatment of lesions located in the popliteal artery.

MATERIALS AND METHODS:

This was a prospective single-centre registry. Patients eligible for inclusion were individuals suffering from symptomatic popliteal arterial occlusive disease (Rutherford-Becker stage 3-6; P1-P3 segments) and treated with placement of the TIGRIS stent(s). Patients were prospectively scheduled for clinical review and duplex ultrasound follow-up after 6 and 12 months. Outcome measures included immediate technical success, primary vessel patency, in-stent binary restenosis (evaluable by Duplex at 50 % threshold; PSVR > 2.0), freedom from target lesion revascularization (TLR) and amputation-free survival (AFS) estimated by Kaplan-Meier (K-M) survival analysis. Cox proportional-hazards regression analysis was also performed to adjust for confounders and search for independent predictors of outcomes.

RESULTS:

From August 2012 to March 2014, a total of 54 popliteal TIGRIS stents were implanted in 50 limbs of 48 patients (27 men and 21 women; mean age 76.0 ± 1.7 years). Median Rutherford-Becker stage was five at baseline and 37/50 (74.0%) were chronic total occlusions. Technical success was achieved in all cases (100%). Stented lesion length was 114.2 ± 36.9 mm (range 6-20 cm). Median follow-up was 11.8 ± 0.8 months. After 12 months, primary patency of the TIGRIS stent was 69.5 ± 10.2% with an 86.1 ± 5.9% freedom from TLR and 87 ± 5.0% AFS (K-M estimates).

CONCLUSION:

The TIGRIS hybrid heparin-bonded nitinol ring stent is a safe and effective endovascular option for complex occlusive disease of the popliteal artery.

• Authors: Aneeta Parthipun, Athanasios Diamantopoulos, Panagiotis Kitrou, Soundrie Padayachee, Narayan Karunanithy, Irfan Ahmed, Hany Zayed, Konstantinos Katsanos
• Journal: Cardiovascular and interventional radiology (Cardiovasc Intervent Radiol) Vol. 38 Issue 4 Pg. 846-54 (Aug 2015) ISSN: 1432-086X [Electronic] United States
• PMID: 25962990 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Alloys
• Anticoagulants
• nitinol
• Heparin

Topics

• Aged
• Alloys
• Anticoagulants (administration & dosage)
• Arterial Occlusive Diseases (diagnostic imaging, surgery)
• Female
• Follow-Up Studies
• Heparin (administration & dosage)
• Humans
• Kaplan-Meier Estimate
• Male
• Popliteal Artery (anatomy & histology, diagnostic imaging, surgery)
• Proportional Hazards Models
• Prospective Studies
• Prosthesis Design
• Radiography, Interventional
• Stents
• Treatment Outcome
• Vascular Patency