Optical Coherence Tomography Guided Percutaneous Coronary Intervention With Nobori Stent Implantation in Patients With Non–ST-Segment–Elevation Myocardial Infarction (OCTACS) Trial

Abstract

BACKGROUND: Incomplete strut coverage has been documented an important histopathologic morphometric predictor for later thrombotic events. This study sought to investigate whether optical coherence tomography (OCT)-guided percutaneous coronary intervention with Nobori biolimus-eluting stent implantation in patients with non-ST-segment-elevation myocardial infarction would provide improved strut coverage at 6 months in comparison with angiographic guidance only. METHODS AND RESULTS: One hundred patients were randomized 1:1 to either OCT-guided or angio-guided Nobori biolimus-eluting stent implantation. Postprocedure OCT was performed in all patients. In the OCT-guided group, prespecified criteria indicating additional intervention were related to (1) stent underexpansion, (2) strut malapposition, (3) edge dissection(s), and (4) residual stenosis at the distal or proximal reference segment(s). A final OCT was performed in case of reintervention. Six-month OCT follow-up was available in 85 patients. Twenty-three (46%) OCT-guided patients had additional postdilation or stenting. The percentage of acutely malapposed struts was substantially lower in the OCT-guided group (3.4% [interquartile range, 0.3-7.6] versus 7.8% [interquartile range, 2.3-19.4]; P<0.01). At 6-month follow-up, the OCT-guided group had a significantly lower proportion of uncovered struts; 4.3% [interquartile range, 1.2-9.8] versus 9.0% [interquartile range, 5.5-14.5], P<0.01. Furthermore, OCT-guided patients had significantly more completely covered stents: 17.5% versus 2.2%, P=0.02. The percentages of malapposed struts and struts being both uncovered and malapposed at follow-up were comparable between groups. CONCLUSIONS: OCT-guided optimization of Nobori biolimus-eluting stent implantation improves strut coverage at 6-month follow-up in comparison with angiographic guidance alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02272283.