Long-term results of ePTFE stent-graft versus angioplasty in the femoropopliteal artery: single center experience from a prospective, randomized trial.
OBJECTIVE
To describe a single-center experience as part of a U.S. multicenter prospective randomized trial of PTA versus percutaneous transluminal angioplasty (PTA)- and ePTFE (expanded polytetrafluoroethylene)-covered endoprosthesis placement for the treatment of superficial femoral artery (SFA) and proximal popliteal artery stenoses and occlusions.


METHODS
Twenty-eight patients with claudication or ischemia were treated by PTA alone (n = 13) or PTA and endoprosthesis placement (n = 15). Baseline characteristics, including exercise ankle/brachial index (ABI), number of patent runoff vessels, Rutherford-Becker ischemia score, and lesion length, were equivalent. Follow-up included postprocedure, objective, noninvasive vascular evaluation and a clinical status scale for a minimum of 24 months.


RESULTS
Technical success was achieved in 15 of 15 patients (100%) in the endoprosthesis group and 12 of 13 patients (92%) in the PTA group. Complications in the endoprosthesis group included clinically significant embolization (n = 1, successfully treated by thrombolysis) and transient thigh pain that required medication in three patients (20%). Clinical improvement was achieved initially in all patients with a significant increase in exercise ABI in both groups (mean increase from baseline was 0.51 with 95% CI: 0.37-0.64 in endoprosthesis patients and 0.39 with 95% CI: 0.31-0.47 in PTA patients; P =.13). At 6-month follow-up with duplex US, 93% of patients (14 of 15) treated with the Hemobahn endoprosthesis (W.L. Gore & Associates, Flagstaff, AZ) remained primarily patent versus 42% of patients (five of 12) treated with PTA alone. At 2 years follow-up, primary patency remained 87% (13 of 15 patients) in the endoprosthesis group versus only 25% (three of 12 patients) in the PTA group (P =.002). Exercise ABI was >0.15 higher than baseline in 93% of patients (14 of 15) treated with endoprosthesis placement versus 54% of patients (seven of 13) treated by PTA alone. Clinical success was maintained in 87% of patients (13 of 15) in the endoprosthesis group versus 46% of patients (six of 13) in the PTA group.


CONCLUSIONS
This single-center experience with placement of the Hemobahn endoprosthesis (W.L. Gore & Associates) in the SFA demonstrated a statistically significant improvement in both patency and clinical outcome compared with PTA alone.
Saxon
Richard R
RR
San Diego Vascular Institute, Diagnostic Imaging and Interventional Radiology, Tri-City Medical Center, 4002 Vista Way, Oceanside, California 92056, USA. rsaxonmd@nctimes.net
Coffman
Jeanine M
JM
Gooding
Justin M
JM
Natuzzi
Eileen
E
Ponec
Donald J
DJ
D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D001807:Blood Vessel Prosthesis; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy; D007511:Ischemia / Q000628:therapy; D008297:Male; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery; D011446:Prospective Studies; D015607:Stents; D016896:Treatment Outcome; D014654:Vascular Patency
D011138:Polytetrafluoroethylene