Intravascular Ultrasonography Analysis of the Everolimus-Eluting Stent in Coronary Chronic Total Occlusions
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PURPOSE: Chronic total coronary occlusions (CTOs) are challenging to treat in part due to high rates of restenosis after stenting. Drug-eluting stents improve outcomes compared to bare metal stents. The goal of the present study was to evaluate the angiographic, intravascular ultrasonography (IVUS) and clinical outcomes after implantation of the Everolimus-Eluting Stent (EES) in CTOs. METHODS: One hundred consecutive CTO patients who were successfully treated using EES at the Dallas VAMC between 2009-2012 were enrolled in the AngiographiC Evaluation of the Everolimus-Eluting Stent in Chronic Total Occlusions (ACE-CTO trial: NCT01012869). Patients underwent follow-up angiography and IVUS imaging at 8 months and clinical follow-up at 12 months. The primary endpoint of this study, binary angiographic restenosis, was defined as >50% minimum lumen diameter stenosis at 8-month follow-up quantitative coronary angiography. The primary endpoint of the IVUS analysis was 8-month in-stent neointimal hyperplasia (NIH) volume (stent volume-lumen volume). RESULTS: Patients had high prevalence of hypertension (91%), hyperlipidemia (90%), diabetes (47%), prior MI (51%), and prior PCI (21%). Of the 89 patients who underwent follow-up angiography, binary in-stent angiographic restenosis occurred in 41 patients (46%), and IVUS analysis was performed in 61 patients. IVUS was not performed in 24 patients (8 of whom had occlusive in-stent restenosis), and suboptimal image quality precluded analysis in 4 patients. Mean and median neointimal hyperplasia volume were 68 ±100 and 26 (0, 91) mm3, respectively. This corresponded to a mean and median percent volume obstruction of 12% ± 15% and 5% (0%, 24%), respectively. No NIH could be detected in 33% of patients. CONCLUSIONS: EES implantation in CTO patients is associated with high rates of angiographic restenosis as well as revascularization, yet most patients derived significant symptomatic improvement despite focal NIH formation.