Introduction: Endovascular therapy (EVT) for aorto-iliac (AI) artery disease is widely accepted. However, recanalization of chronic total occlusion (CTO) is still challenging and technical success rate for intraluminal and subintimal angioplasty is unknown. To investigate the safety of intraluminal and subintimal endovascular technique and primary outcome for the EVT treatment of de novo AI CTO lesions.
Hypothesesis: Subintimal angioplasty for AI artery disease is comparable safety as intraluminal angioplasty.
Methods: This was a Sub - Analysis of OMOTENASHI Registry Prospective Multicenter Observational Study, Japanese 65 clinical sites were enrolled and registering patients who presented with AI artery disease treated with the EVT treatment. The primary endpoint was Technical success rate (angiographical success; residual stenosis was less than 30%, clinical success; without major adverse events, improvement of ABI ≧ 0.15, symptomatic success; improvement Rutherford class) . The secondary endpoints were 30days primary patency and peri-procedural complications.
Result: Between April 2014 and April 2016, a total 267 patients, 334 CTO lesions were registered. In 60 patients, 78 lesions were treated with subintimal angioplasty in 207 patients, 256 lesions were treated with intraluminal angioplasty. Baseline lesion TASCII (B/C/D) was 8/20/50 in the subintimal group versus 69/48/139 in the intraluminal group (P=0.004). Angiographical success was 94% versus 96% (P=0.459), clinical success was 94% versus 95% (P=0.555), symptomatic success was 94% versus 96% (P=0.369). 30 days primary patency was 88% versus 92% (P=0.623). Major adverse events and peri-procedural complications were comparable.
Conclusion: Both subintimal and intraluminal approach for AI CTO lesions are feasible and can be performed safely and effectively.