Tetsuya Fusazaki

Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): one-year angiographic and clinical results

Abstract Aims Optical frequency domain imaging (OFDI) is a recently developed, light-based, high-resolution intravascular imaging technique. Intravascular ultrasound (IVUS) is a widely used, conventional imaging technique for guiding percutaneous coronary intervention (PCI). We aimed to demonstrate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. Methods and results We did a prospective, multicentre, randomized (ratio 1:1), active-controlled, non-inferiority study to compare head-to-head OFDI vs. IVUS in patients undergoing PCI with a second generation drug-eluting stent. The primary endpoint was target vessel failure defined as a composite of cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularization until 12 months after the PCI. The major secondary endpoint was angiographic binary restenosis at 8 months. We randomly allocated 829 patients to receive OFDI-guided PCI (n = 414) or IVUS-guided PCI (n = 415). Target vessel failure occurred in 21 (5.2%) of 401 patients undergoing OFDI-guided PCI, and 19 (4.9%) of 390 patients undergoing IVUS-guided PCI, demonstrating non-inferiority of OFDI-guided PCI to IVUS-guided PCI (hazard ratio 1.07, upper limit of one-sided 95% confidence interval 1.80; Pnon-inferiority = 0.042). With 89.8% angiographic follow-up, the rate of binary restenosis was comparable between OFDI-guided PCI and IVUS-guided PCI (in-stent: 1.6% vs. 1.6%, P = 1.00; and in-segment: 6.2% vs. 6.0%, P = 1.00). Conclusion The 12-month clinical outcome in patients undergoing OFDI-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI. Both OFDI-guided and IVUS-guided PCI yielded excellent angiographic and clinical results, with very low rates of 8-month angiographic binary restenosis and 12-month target vessel failure. Clinical registration ClinicalTrials.gov, number NCT01873027.

Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial

BACKGROUND Optical coherence tomography is becoming increasingly widespread as an adjunctive intravascular diagnostic technique in percutaneous coronary intervention (PCI), because of its ability to visualize coronary structures at high resolution. Several studies have reported that intravascular ultrasound (IVUS) guidance in PCI might be helpful to reduce subsequent stent thrombosis, restenosis, repeat revascularization, myocardial infarction, and cardiac death. The OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial is aimed at evaluating the impact of optical frequency domain imaging (OFDI) guidance in PCI on clinical outcomes compared with IVUS guidance. METHODS AND DESIGN The OPINION trial is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. The eligible patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. PCI is performed using the biolimus-eluting stent in accordance with a certain criteria of OFDI and IVUS for optimal stent deployment. All patients will undergo a follow-up angiography at 8 months. The primary endpoint is target vessel failure composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization at 12 months. CONCLUSION When completed, the OPINION trial will contribute to define the clinical value of the OFDI guidance in PCI.

Angioscopy and OCT in repeated in-stent restenosis in saphenous vein graft.

The morphological characteristics of in-stent restenosis (ISR) that occur in multiple layers of stents (stent in stent) are not well described. We used multimodality imaging in a 69-year-old man in whom repeated episodes of restenosis developed in a 9-year-old saphenous vein graft (SVG) to the left

Clinical and pathological characteristics of homogeneous and nonhomogeneous tissue of in-stent restenosis visualized by optical coherence tomography.

BackgroundAlthough it is known that in-stent restenosis (ISR) patterns appear homogeneous or nonhomogeneous by optical coherence tomography (OCT), interpretations of the ISR inflammatory response, of the OCT image, and its pathological implications are unclear. The aim of this study was to use OCT to characterize ISR and its inflammatory index in patients after coronary stenting. MethodsOCT was performed at follow-up in 100 angiographic ISR lesions. ISR lesions were divided into two groups: (a) homogeneous (n=48) and (b) nonhomogeneous (n=52) image groups. We assessed the ISR images produced by OCT for tissue heterogeneity and neo-intimal hyperplasia using the normalized standard deviation of OCT signal-intensity (OCT-NSD) observed in neo-intimal hyperplasia tissue. In some patients with a nonhomogeneous OCT image, we collected pathological tissue. ResultsThe prevalence of drug-eluting stents was 48% in the nonhomogeneous group and 29% in the homogeneous group (P=0.05). The OCT-NSD value in the nonhomogeneous group (0.223±0.019) was significantly higher than that in the homogeneous group (0.203±0.025; P<0.0001). Pathological tissue showed fibrin thrombi with infiltrating macrophage in 12 cases of nonhomogeneous ISR. The area under the receiver operating characteristic curve for the prediction of a nonhomogeneous image was 0.73 for OCT-NSD (95% confidence interval: 0.62–0.83: P<0.0001). The odds ratio for the prediction of a nonhomogeneous image was 3.47 (95% confidence interval: 1.18–10.2: P=0.02) for smoking by logistic regression analysis. ConclusionNonhomogeneous ISR visualized by OCT showed a high OCT-NSD value, which was a useful predictor for nonhomogeneous images. Moreover, the nonhomogeneous ISR image visualized by OCT may show chronic inflammation and fibrin thrombi.

A honeycomb-like structure in the right coronary artery visualized by three-dimensional optical coherence tomography.

A 66-year-old Japanese man with hypertension, diabetes, dyslipidemia, ischemic cardiomyopathy with left ventricular (LV) dysfunction, and sustained ventricular tachycardia was treated with the oral medicine in another hospital from 2011. He was transferred from the satellite hospital to our hospital for catheter treatment of ischemic cardiomyopathy in 2012. Myocardial perfusion imaging (MPI) of this patient indicated previous myocardial infarction at the inferoposterior wall and partial ischemia at the inferior wall after an ergometer stress test (Fig. 1). Coronary angiography showed two significant lesions at the right coronary artery (RCA) and the left circumflex artery (LCX). The distal LCX was occluded and angiographic haziness was present in the middle RCA and the proximal LCX (Fig. 2). Thrombolysis in myocardial infarction (TIMI) grade of the RCA was grade 3. There was no viability at the posterior wall according to MPI and a small perfusion territory of LCX from angiography. Therefore, a percutaneous coronary intervention was performed on the middle RCA. We assessed the segment of haziness by intravascular ultrasound (IVUS) and optical coherence tomography (OCT) before percutaneous coronary intervention. Initially, there were some low echoic lesions that were separated by partitions using IVUS imaging (Fig. 3); as a result, it was considered to be a ruptured plaque or recanalized thrombus. By contrast, OCT imaging indicated a honeycomb-like structure with multiple channels in at least 10 lumens (Fig. 4) (Supplemental digital content 1, http://links.lww.com/ MCA/A27). After contrast enhancement, a complex lesion was shown by OCT, although blood could not be replaced by contrast completely at first. Multiple channels were separated by high signal intensity tissue and each of the lumens was connected in the distal lumen and the proximal lumen. There was no evidence of atherosclerotic changes and lipid pool by OCT. White thrombus characterized as without backscattering protrusions was observed in the distal site of a honeycomb lesion. It was assumed to be spontaneous recanalization of the old thrombus. Finally, this site was treated with an everolimus-eluting stent (Xience Prime 3.5/28mm; Abbott Vascular, Santa Clara, California, USA). Although almost all channels were crushed by the stent, some outside channels remained on OCT imaging (Fig. 5). As expansion and apposition of the stent were good, it was decided that further extension was unnecessary. Furthermore, we performed 3D-OCT imaging of the honeycomb structure using free software (Blender, Ver. 2.5, Amsterdam, the Netherlands). A more detailed structure could be easily observed by actually using 3D animation. According to the 3D image, there was no occluded lumen and almost all lumens were connected to the distal site and the proximal site (Fig. 6).

A unique stenosis in saphenous vein graft visualized by optical coherence tomography.

We present a case of a unique stenosis in a 12-year-old saphenous vein graft (SVG), to the right coronary artery, which was visualized by optical coherence tomography (OCT), before percutaneous coronary intervention. The patient was an 80-year-old man in whom the stenosis was documented by area-detector coronary computed tomography. OCT imaging demonstrated that the culprit lesion was a venous valve containing a thrombus before preintervention imaging. Coronary stenting was performed with a distal protection device, and pathologic examination of the aspirate verified the OCT findings. Coronary angiography 12 years previously, just after coronary artery bypass surgery (CABG), had shown a completely normal SVG without any suspicion of a venous valve. These OCT images suggested the possibility that the culprit lesion was an “upside down” venous valve that was not visualized by angiography just after surgery, but could be a cause of late SVG stenosis following CABG. OCT imaging is very useful for clarifying the etiology of the stenosis in cases of ambiguous angiographic lesions.

“Intracoronary Whirling Current Phenomenon” and Thrombus Formation After Sirolimus-Eluting Stent Implantation Visualized by Optical Coherence Tomography

We present a case of imaged “intracoronary whirling current phenomenon.” A 60-year-old Japanese man was treated with 2 sirolimus-eluting stents (SES; 3.0×18 and 3.5×33 mm) in the right coronary artery (RCA) for chronic total occlusion in October 2007. After percutaneous coronary intervention, he was taking 200 mg of aspirin and 200 mg of ticlopidine. However, he had recurrent transient ischemic chest pain beginning at 7 months. A second coronary angiography at 8 months after SES implantation showed reocclusion at a site just proximal to the SES. A repeat percutaneous coronary intervention was performed for RCA chronic total occlusion (Figure 1). After crossing the guide wire to the distal portion of the RCA, the target lesion was dilated using a 1.25×10 mm balloon catheter. After minimum balloon dilatation, optical coherence tomography (OCT) was performed to evaluate in-stent reocclusion from the distal portion to the proximal portion (Figure 2). Two different types of tissue coverage (may be consistent with thrombus formations of different ages) were observed in the stent reocclusion.1 Moreover, in the patent distal portion of the RCA, an intracoronary whirling current …

Very late stent thrombosis after paclitaxel-eluting stent implantation with full neointimal tissue coverage visualized by optical coherence tomography

We present findings of a very late stent thrombosis (VLST) involving paclitaxel-eluting stents (PESs) that were fully covered by thin neointima, visualized by optical coherence tomography (OCT) in a patient receiving dual antiplatelet therapy. A 69-year-old Japanese man had been treated with 2 overlapping PESs for chronic coronary artery disease in the proximal right coronary artery. A follow-up coronary computed tomography angiography showed no restenosis in the stent site, and the result of stress myocardial perfusion imaging showed no ischemic changes. Seventeen months after the percutaneous coronary intervention, he was transported to our clinic with a diagnosis of acute myocardial infarction. Emergency coronary angiography showed a total occlusion at the overlapping site of the 2 PESs. After thrombus aspiration therapy, the OCT image revealed a thin layer of neointimal tissue covering the stent struts with no stent malapposition or fracture. There was no plaque rupture site or intracoronary thrombus. Histopathologic study of an aspirated red thrombus revealed massive amounts of inflammatory infiltrates including eosinophils and neutrophils within the fibrin clot. These findings suggested the possibility that the patients allergic and inflammatory reactions may have caused the onset of VLST. <Learning objective: To recognize the relationship between in stent OCT findings of neointima and pathological findings of the thrombus at the VLST after PES implantation.>.

Chronic thrombus occlusion after bare metal stenting in a patient with acute coronary syndrome visualized by optical coherence tomography

We present a case of chronic thrombus occlusion visualized by optical coherence tomography (OCT) in a patient following bare metal stent (BMS) implantation. A 74-year-old Japanese man was treated with single BMS implantation for acute coronary syndrome. The second follow-up angiography demonstrated no restenosis at the BMS site in the convalescent phase before discharge. A third coronary angiography at 6 months after BMS implantation showed sub-total occlusion at a site just proximal to the BMS. OCT was performed to evaluate in-stent restenosis. OCT demonstrated an organized thrombus-like image containing a micro-channel in the target lesion. Repeat percutaneous coronary intervention (PCI) was performed with a distal protection device and we were able to aspirate some tissue from the culprit lesion. Pathological examination of this tissue revealed an organized fibrin thrombus with angiogenesis. Phosphotungstic acid hematoxylin staining and CD68 immunological staining were positive in this tissue. Moreover, immunological staining for CD34 was positive in the micro-channel of this tissue, suggesting chronic build up. This case demonstrated that chronic, organized thrombus formation is a possible cause of restenosis after BMS implantation in the convalescent phase, and that OCT is a useful modality to discriminate thrombus formation from regular neo-intimal hyperplasia in in-stent restenosis lesions.

Late stent thrombosis after discontinuation of dual anti-platelet therapy in off-label use of paclitaxel-eluting stent visualized by optical coherence tomography—3-vessel OCT study

We observed late stent thrombosis image by optical coherence tomography (OCT) in vessels with off-label paclitaxel-eluting stents (PES) implantation. A 59-year-old Japanese man was treated with a single on-label PES for chronic coronary artery disease in the left circumflex artery. After 9 months, he was implanted with two linked PESs in the left anterior descending artery (LAD) and a single PES in the right coronary artery (RCA). He was examined for suspicion of a colon tumor by fiberscope after discontinuation of dual anti-platelet therapy without consultation. He complained of chest pain and was transferred to our center. Emergency coronary angiography demonstrated thrombotic total occlusion of the proximal LAD in the two linked PESs. After thrombus aspiration therapy, OCT was performed to evaluate the stents in the 3 vessels. The off-label two linked PESs demonstrated the same average neo-intimal hyperplasia (NIH) thickness and percentage of uncovered stent struts compared with the on-label PES in the RCA by visualized OCT image. However, the heterogeneity of NIH in the LAD stent was significantly higher than the stents in the other two vessels. The implantation of the two linked off-label and the heterogeneity of NIH may increase hyperplatelet coagulability more than on-label single PES use.