Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial.

BACKGROUND: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance. METHODS AND RESULTS: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients. CONCLUSIONS: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270.

Comparison of cryothermia and radiofrequency current in safety and efficacy of catheter ablation within the canine coronary sinus close to the left circumflex coronary artery.

INTRODUCTION: A canine model was used to compare cryoablation and radiofrequency ablation (RFA) within the coronary sinus (CS) in the ability to create a transmural CS myocardial (Trans-CSM) lesion and risk of coronary artery stenosis. METHODS: After CS and left circumflex (LCx) coronary angiography, an intravascular ultrasound (IVUS) probe was placed in LCx in 29 dogs. An irrigated RFA catheter (8 dogs) or N(2)O cryoablation catheter (21 dogs) was inserted into the CS and positioned within 2 mm of LCx, confirmed by IVUS. RF (30-50W) was applied for 60 seconds at 10 CS sites. Cryoablation (-75 degrees C) was performed with one (n = 7) or two (n = 14) 4-minute applications. Dogs were sacrificed at 1 week (8 RFA and 13 cryoablation) or 3 months (8 cryoablation). RESULTS: During RFA, IVUS showed wall thickening and LCx narrowing in 9 of 10 sites. Angiography at 5-minute post-RFA identified LCx narrowing (25-90%) at 6 of 10 sites and 25-75% narrowing at 4 of 9 sites at 1-week post-RFA. During cryoablation, IVUS showed reversible ice ball compression of LCx, and no LCx narrowing by angiography at 5 minutes, 1 week, or 3 months. Histology showed Trans-CSM lesion at 10 of 10 RFA sites and 20 of 21 cryoablation sites. RFA produced LCx medial necrosis at 7 of 10 sites, involving 20-50%(median 32.5%) of LCx circumference with loss of intima at 5 of 7 sites. Single and twice 4-minute cryoablation produced LCx medial necrosis at 2 of 7 and 8 of 14 sites (5-40%, median 25% circumference). Intima was preserved at 1 week (13/13) with minor proliferation (without narrowing) at 2 of 8 sites at 3 months. CONCLUSIONS: Cryoablation in CS within 2 mm of LCx produces Trans-CSM lesions similar to RFA with lower risk of LCx stenosis than RFA.