Hypothesis: Patency after primary percutaneous transluminal angioplasty (PTA) and stenting of superficial femoral artery (SFA) occlusions is better than 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 limbs having chronic atherosclerotic SFA occlusion with suprageniculate reconstitution and patent tibial runoff. Critical ischemia (Society for Vascular Surgery [SVS] category, 4-6) was present in 7 (10%), the remainder had intermittent claudication only (SVS, 1-3).
Interventions: Guidewire recanalization followed by PTA, Wallstent deployment, and adjunctive thrombolysis as necessary; 19 limbs (27%) required thrombolysis 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 stented 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 patencies 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 35.7% +/- 12.5% compared with 70.6% +/- 7.4% for limbs not requiring periprocedural thrombolysis (P=.02); the differences in occlusion length and severity of ischemia were not significant between these 2 groups. Limbs undergoing adjunctive 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 requiring PTA at 6 to 12 months angiography (P=.046). Periprocedural mortality and morbidity were 2.8% and 15.5%, respectively. Three of the 7 limbs with 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 higher patency rates than historical controls undergoing PTA alone. When periprocedural thrombolysis is required, subsequent patency appears to be significantly worse. Poor results after PTA and stenting of limbs with critical ischemia and the need for additional endovascular therapy limit the technique's utility.