Objective
To examine the impact of re‐entry device (RED) use on 1‐ and 5‐year outcomes after endovascular treatment of common iliac artery (CIA) chronic total Occlusions (CTOs).
Background
There are not enough data regarding the long‐term safety and efficacy of RED.
Methods
We performed a two‐center retrospective study of 115 patients (140 lesions) undergoing CIA CTO endovascular intervention between 2006 and 2016. Baseline characteristics and long‐term outcomes were described. A Cox proportional hazard model was developed to determine if REDs were associated with target lesion revascularization (TLR) or major adverse limb events (MALE) after 1 and 5 years.
Results
Among 140 lesions, 43 (31%) required use of a RED. The mean age was 63.9 years and the majority (n = 80) of patients were male. An antegrade crossing approach and treatment of restenotic lesions were less common in the RED group (10% vs. 29%, P < .05 and 0% vs. 21%, P < .05, respectively). There were no significant differences in Rutherford class, pre‐procedure ABI, or patient presentation. The procedural complication rates were similar between the two groups. The 1‐ and 5‐year TLR rates for lesions treated with re‐entry device vs. standard approaches were 11% vs. 9%; P = 0.8 and 29% vs. 29%; P = 0.9 respectively. The 1 and 5‐year MALE rates for lesions treated with re‐entry device were 5% vs. 6%; P = 0.8 and 11% vs. 11%; P = 0.9 respectively.
Conclusions
This retrospective analysis found that recanalization of CIA occlusions using a RED is safe and is associated with long‐term clinical outcomes similar to that of standard crossing techniques.