SUPERA interwoven nitinol Stent Outcomes in Above-Knee IntErventions (SAKE) study.
OBJECTIVE
To report experience with the novel interwoven-wire self-expanding nitinol SUPERA stent (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Texas) for the treatment of severely diseased superficial femoral and popliteal arteries.


METHODS
Consecutive patients with severely diseased superficial femoral and popliteal arteries who received SUPERA stents (n = 80 patients [98 limbs]; mean age, 70.8 y; 80% male) were retrospectively identified. Patients were followed for an average of 14.3 months after intervention.


RESULTS
Total occlusions were present in 39% of the lesions, 21% had tissue loss, and 61% demonstrated calcification on fluoroscopy. Patients were prescribed dual antiplatelet therapy (aspirin and clopidogrel) for at least 30 days unless contraindicated, followed by aspirin alone indefinitely. The mean (± SD) lesion length was 143 mm (± 98). Based on need for clinical intervention, primary patency was 96.9% at 6 months and 85.8% at 12 months (Kaplan-Meier estimates). Assisted primary patency and secondary patency rates at 12 months were 96.8% and 100%, respectively. Ankle-brachial index increased from 0.60 at baseline to 0.83 at last follow-up (P < .001). No stent fractures were found by fluoroscopy inspection in 19 limbs (16 patients) that required reintervention.


CONCLUSIONS
Based on experience with multiple operators at a single clinical center, the interwoven nitinol stent design provides a viable option for high-grade obstructive disease in the femoropopliteal artery.
Division of Interventional Cardiology & Endovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ 08015. Electronic address: jcgeorgemd@hotmail.com.
Jon C
JC
George
Division of Interventional Cardiology & Endovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ 08015.
Eric S
ES
Rosen
Division of Interventional Cardiology & Endovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ 08015.
Jonathan
J
Nachtigall
Division of Interventional Cardiology & Endovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ 08015.
Aaron
A
VanHise
Division of Interventional Cardiology & Endovascular Medicine, Deborah Heart and Lung Center, 200 Trenton Road, Browns Mills, NJ 08015.
Richard
R
Kovach
D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D055109:Ankle Brachial Index; D001241:Aspirin / Q000008:administration & dosage; D000077144:Clopidogrel; D003251:Constriction, Pathologic; D004359:Drug Therapy, Combination; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011237:Predictive Value of Tests; D011474:Prosthesis Design; D011859:Radiography; D012189:Retrospective Studies; D012720:Severity of Illness Index; D015607:Stents; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
D000497:Alloys; D010975:Platelet Aggregation Inhibitors; C013616:nitinol; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin