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Toshifumi Kudo, MD, PhD, Samuel S. Ahn, MD.
UCLA Gonda Vascular Center, Los Angeles, CA, USA.
OBJECTIVE: To evaluated a 10-year experience of our treatment strategy -primary iliac angioplasty with selective stent placement in patients with iliac artery occlusive disease.
METHODS: From August 1993 to March 2004, 136 iliac lesions (134 stenoses, 2 occlusions; 28 common iliac, 25 external iliac artery, and 83 both arteries) in 94 patients with disabling claudication (68 [50%]), rest pain (37 [27%]), and ulcer/gangrene (31 [23%]) were treated by percutaneous transluminal angioplasty (PTA). Forty-five limbs had concomitant infrainguinal endovascular (32 limbs) or open procedures (13 limbs). Thirty-one limbs (23%) had one or more stents placed for primary PTA failure including residual stenosis (> 30%), pressure gradient (> 5 mmHg), or dissection (Stent group) while 105 limbs (77%) underwent PTA alone (PTA group). All analysis were performed according to intent-to-treat basis and recommended standards for reports (Society for Vascular Surgery/International Society for Cardiovascular Surgery).
RESULTS: There were no perioperative death. Total complication rate was 1.5% (one groin hematoma and one stroke). Mean follow-up was 19.6 months (range, 1 to 94 months). Only 4 limbs (2.9%) in PTA group had stents placed subsequently for recurrent stenosis. The lesion was more extensive in Stent group than in PTA group (P < .001). The technical success rate was 97.8% and the initial clinical success rate was 94.1%. Over all, the cumulative primary patency rates±SE at 6 months, 1, 3, and 6 years were 89.1%±3.1%, 75.9%±4.7%, 59.4%±6.3%, and 54.8%±7.3%, and continued clinical improvement rates±SE at 6 months, 1, 3, and 5 years were 82.5%±3.6%, 66.4%±5.0%, 47.1%±6.5%, and 43.7%±6.9% (Kaplan-Meier). There was no significant difference of primary patency rates (Kaplan-Meier, log-rank test, P=.53) nor clinical success rates (P=.86) between in PTA group and in Stent group. The cumulative assisted primary patency, the secondary patency, and limb salvage rates at 6 years were 98.1%±1.3%, 99.3%±.73%, and 93.4±3.2%, respectively. Of 13 predictable variables studied in 136 iliac lesions, primary patency rates were significantly decreased in patients with TransAtlantic Inter-Society Consensus (TASC) type B or C/D vs. patients with TASC type A (P < .01), lesion length 3-5cm or > 5cm vs. < 3cm (P < .05), stenotic SFA vs. patent/bypassed/PTA SFA or occluded SFA (P < .01), and smoker vs. non-smoker (P < .01). Clinical success rates were significantly decreased in patients with gangrene/ulcer vs. patients with claudication or rest pain (P < .01), TASC type C/D vs. TASC type A (P = .016), and lesion length > 5 cm vs. < 3 cm (P = .021).
CONCLUSIONS: Although primary patency rates were not high, assisted primary patency rates were excellent for both groups. Careful follow-up could prevent iliac occlusion after PTA and selective stenting. Routine primary stenting is not necessary for patients with iliac occlusive disease.