Three-year outcome of endovascular treatment of superficial femoral arteryocclusion

Hypothesis: Patency after primary percutaneous transluminal angioplasty (PT A) and stenting of superficial femoral artery (SFA) occlusions is better th an historical experience with PTA alone. Design: Consecutive case series of primary PTA with stenting, and follow-up with duplex imaging every 6 months (mean+/-SD follow-up, 32+/-15 months). Setting: Veterans Affairs medical center. Patients and Methods: Patients were 57 previously untreated men with 71 lim bs having chronic atherosclerotic SFA occlusion with suprageniculate recons titution and patent tibial runoff. Critical ischemia (Society for Vascular Surgery [SVS] category, 4-6) was present in 7 (10%), the remainder had inte rmittent claudication only (SVS, 1-3). Interventions: Guidewire recanalization followed by PTA, Wallstent deployme nt, and adjunctive thrombolysis as necessary; 19 limbs (27%) required throm bolysis to manage periprocedural thrombosis. Main Outcome Measures: Cumulative patency, limb salvage, and complications. Results: Length (mean+/-SD) of occlusion was 14.4+/-9.9 cm. Length of stent ed artery was 24.3+/-11.1 cm. Ankle brachial index increased from 0.59+/-0. 14 to 0.86+/0.16 (P<.001) after stenting. One- and 3-year potencies were as follows: primary, 54.6%+/-6.3% and 29.9%+/-6.6%; assisted primary, 72.3%+/ -5.6% and 59.0%+/-6.8%; and secondary, 81.6%+/-4.8% and 68.3%+/-6.5%. Three -year secondary patency when periprocedural thrombolysis was required was 3 5.7%+/-12.5% compared with 70.6%+/-7.4% for limbs not requiring periprocedu ral thrombolysis (P=.02); the differences in occlusion length and severity of ischemia were not significant between these 2 groups. Limbs undergoing a djunctive PTA during angiography 6 to 12 months after initial stenting had 63.0%+/-13.3% patency at 3 years compared with 100% patency in limbs not re quiring PTA at 6 to 12 months angiography (P=.046). Periprocedural mortalit y and morbidity were 2.8% and 15.5%, respectively. Three of the 7 limbs wit h critical ischemia underwent amputation during follow-up compared with 2 ( 3%) of 64 limbs with functional ischemia (<chi>(2) test, P<.006). A mean of 1.8 endovascular interventions per limb were performed. Conclusions: Percutaneous transluminal angioplasty and stenting yielded hig her patency rates than historical controls undergoing PTA alone. When perip rocedural thrombolysis is required, subsequent patency appears to be signif icantly worse. Poor results after PTA and stenting of limbs with critical i schemia and the need for additional endovascular therapy limit the techniqu e's utility.