Predictors and outcomes of restenosis following tibial artery endovascular interventions for critical limb ischemia.

OBJECTIVE: Restenosis following tibial artery endovascular interventions (TAEIs) is thought to be benign but is not well characterized. This study examines the consequences and predictors of recurrent stenosis of TAEIs for critical limb ischemia.

METHODS: All TAEIs for critical limb ischemia performed between 2004 and 2010 were retrospectively reviewed. Restenosis was detected by noninvasive imaging and angiography when indicated. Restenoses were identified and the limb outcomes recorded. Tibial reinterventions were performed only for persistent, worsening, or recurrent tissue loss or rest pain with evidence of recurrence on duplex ultrasound or hemodynamic imaging. The χ test and logistic regression were applied as indicated. One-year patency rates were calculated using the Kaplan-Meier method.

RESULTS: A total of 235 limbs in 210 patients were treated for critical limb ischemia (70% tissue loss, 30% rest pain). Tissue loss included gangrene (49%) and ulcers (51%), and involved the forefoot (80%), the heel (14%), or both (6%). Seventy-eight percent of limbs had Trans-Atlantic InterSociety Consensus C/D lesions, with mean preoperative runoff score of 12. Interventions were isolated tibial (45%) or multilevel (55%) (including tibial). Mean postoperative runoff score improved to 6.6, but restenosis occurred in 96 limbs (41%) at a mean of 4 months. The 1-year primary patency was 59% with a mean follow-up of 9 months. Restenosis presented with a persistent wound (32%), worsened wound (42%), rest pain (16%), or no symptoms (10%). A repeat TAEI was performed in 42 (44%), major amputation in 26 (27%), open bypass in 20 (21%), and observation in eight (8%). The overall amputation rate was 13%, but limb loss was significantly higher in patients with restenosis (n = 26 [27%]) than in patients with no restenosis (n = 5 [4%]; P < .001). Patients with restenosis and tissue loss were more likely to have presented with gangrene (63% vs 38%; P = .0003) but had comparable wound distribution (P = NS). There was a trend toward a higher restenosis rate in patients with renal insufficiency (odds ratio, 5.57; P = .08), but this was unaffected by diabetes, statin therapy, or smoking (P = NS). The rate of repeat intervention after the first reintervention was 36%, with an 87% overall limb salvage rate.

CONCLUSIONS: TAEIs can be used successfully to treat patients with critical limb ischemia with acceptable limb salvage rates. Special attention should be given to patients with extensive tissue loss or gangrene because they are at risk for early restenosis and subsequent limb loss. Strict wound and hemodynamic surveillance, wound care, and timely reinterventions are crucial to achieve successful outcomes in this patient population. Amputation or alternative revascularization options, when feasible, should be considered in patients with restenosis and tissue loss given the high rate of limb loss with tibial reinterventions.