Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease.
BACKGROUND
This is a randomized prospective study comparing the treatment of superficial femoral artery occlusive disease percutaneously with an expanded polytetrafluoroethylene (ePTFE)/nitinol self-expanding stent graft (stent graft) versus surgical femoral to above-knee popliteal artery bypass with synthetic graft material.


METHODS
One hundred limbs in 86 patients with superficial femoral artery occlusive disease were evaluated from March 2004 to May 2005. Patient symptoms included both claudication and limb threatening ischemia with or without tissue loss. Trans-Atlantic InterSociety Consensus (TASC II) A (n = 18), B (n = 56), C (n = 11), and D (n = 15) lesions were included. Patients were randomized prospectively into one of two treatment groups; a percutaneous treatment group (group A; n = 50) with angioplasty and placement of one or more stent grafts, or a surgical treatment group (group B; n = 50) with a femoral to above-knee popliteal artery bypass using synthetic conduit (Dacron or ePTFE). Patients were followed for 48 months. Follow-up evaluation included clinical assessment, physical examination, ankle-brachial indices, and color flow duplex sonography at 3, 6, 9, 12, 18, 24, 36, and 48 months.


RESULTS
Mean total lesion length of the treated arterial segment in the stent graft group was 25.6 cm (SD = 15 cm). The stent graft group demonstrated a primary patency of 72%, 63%, 63%, and 59% with a secondary patency of 83%, 74%, 74%, and 74% at 12, 24, 36, and 48 months, respectively. The surgical femoral-popliteal group demonstrated a primary patency of 76%, 63%, 63%, and 58% with a secondary patency of 86%, 76%, 76%, and 71% at 12, 24, 36, and 48 months, respectively. No statistical difference was found between the two groups with respect to primary (P = .807) or secondary (P = .891) patency.


CONCLUSIONS
Management of superficial femoral artery occlusive disease with percutaneous stent grafts exhibits similar primary patency at 4-year (48 month) follow up when compared with conventional femoral-popliteal artery bypass grafting with synthetic conduit. This treatment method may offer an alternative to treatment of the superficial femoral artery segment for revascularization when prosthetic bypass is being considered or when autologous conduit is unavailable.
McQuade
Karen
K
Department of Vascular Surgery, Baylor University Medical Center, Dallas, TX 75226, USA.
Gable
Dennis
D
Pearl
Greg
G
Theune
Brian
B
Black
Steve
S
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D017130:Angioplasty / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D001807:Blood Vessel Prosthesis; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology / Q000628:therapy; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011093:Polyethylene Terephthalates; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery*; D011446:Prospective Studies; D011474:Prosthesis Design; D012086:Reoperation; D012720:Severity of Illness Index; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D014481:United States; D014654:Vascular Patency
D000497:Alloys; D011093:Polyethylene Terephthalates; C013616:nitinol; D011138:Polytetrafluoroethylene