Background: Given the characteristic differences between intravascular ultrasound (IVUS) and optical frequency domain imaging (OFDI), their approach to therapeutic guidance during percutaneous coronary interventions (PCIs) and arterial healing response after stenting may also vary. Methods: MISTIC-1 (The Multimodality Imaging Study in Cardiology cohort 1) is a multicenter, randomized-controlled, noninferiority trial that compared imaging end points between OFDI- and IVUS-guided PCI. Patients with stable coronary artery disease were randomly assigned to either OFDI- or IVUS-guided PCI using a Biolimus A9-eluting stent according to a prespecified protocol for imaging guidance. Stent sizing was based on external elastic lamina in IVUS-guided PCI while lumen up-size in OFDI-guided PCI. Postprocedural OFDI was investigated regardless of randomization, while operators in IVUS-guided PCI arm were blinded to the images. The primary end point was in-segment minimum lumen area assessed using OFDI at 8 months, while the secondary end point was a composite of cardiovascular mortality, target-vessel myocardial infarction, or target-lesion revascularization (device-oriented composite end point). Patients were followed up to 3 years after the index procedure. Results: A total of 109 patients (mean age 70 years, male 78%) with 126 lesions were enrolled. Postprocedural minimum stent area was 6.31±1.89 and 6.72±2.08 mm 2 in OFDI and IVUS group, respectively ( P =0.26). At the 8-month follow-up, in-segment minimum lumen area was 4.56±1.94 and 4.13±1.86 mm 2 in OFDI and IVUS group, respectively ( P non-inferiority <0.001). Both groups had comparable neointimal healing score (median 0.16 [interquartile range, 0.00–3.14] versus 0.90 [0.00–3.30], respectively; P =0.43). The incidence rate of device-oriented composite end point at 3 years was 7.4% and 7.3% in OFDI and IVUS group, respectively (hazard ratio, 1.05 [95% CI, 0.26–4.18]; P =0.95). Conclusions: OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was acknowledged, OFDI could be an alternative to IVUS when considering intracoronary imaging-guided PCI in selected populations with coronary artery diseases. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03292081.
Background: While the utilization of integrated backscatter intravascular ultrasound (IB-IVUS) for the quantitative in vivo assessment of coronary plaque continues to grow, the validity of IB-IVUS images obtained from newly developed and conventional systems remains uncertain. Methods and Results:To assess the accuracy and reliability of a newly developed IB-IVUS system (VISIWAVE) as compared to the conventional system (Clearview), we compared quantitative IB-IVUS plaque characteristics in the 2 systems using 125 post-mortem specimens from 26 coronary arteries in 11 cadavers, as well as using 200 clinical plaques in 32 patients undergoing coronary intervention. The overall agreement between the histological and IB-IVUS diagnoses using VISIWAVE (Cohen's κ=0.82, 95%CI: 0.73-0.90) was similar to that using Clearview (Cohen's κ=0.80, 95%CI: 0.71-0.89). The 2 systems also demonstrated comparably high sensitivity and specificity. In the direct comparison, the overall agreement between IB-IVUS diagnoses using VISIWAVE and Clearview was also excellent (Cohen's κ=0.87, 95%CI: 0.78-0.95). In the clinical comparison, measured plaque dimensions were similar (VISIWAVE: 8.27±3.46 mm 2 vs. Clearview; 8.31±3.46 mm 2 , P=0.44) and there was strong concordance between both greyscale and IB-IVUS parameters. Conclusions:There was close agreement of analyzed results in both systems when compared with the gold standard of histology. Both systems are able to reliably and accurately characterize coronary plaque and thereby make a valuable contribution to our understanding of atherosclerosis. (Circ J 2012; 76: 1678 - 1686
Background Elective percutaneous coronary intervention (PCI) using second generation drug-eluting stent (DES) has been dramatically reduced restenosis rate. Recently, it has been reported that plaque characterization in nontarget lesion is associated with cardio-vascular events in ischemic heart disease patients undergoing elective PCI. However, it is unclear whether plaque characterization in target lesion is predictor of MACEs (major adverse cardiac events) after elective PCI. Purposes The aim of this study is whether plaque characterization detected integrated-backscatter intravascular ultrasound (IB-IVUS) in the target lesion is associated with MACEs in patients with PCI after second generation DES implantation. Methods and results Of 700 patients with ischemic heart disease, 552 patients were excluded for chronic totally occlusion, severe calcification hindering precise intracoronary imaging, tortuous lesions, ostial or left main stem lesions and ST-elevated myocardial infarction patients. Finally, 148 consecutive patients who consented to repeated IB-IVUS prior to undergoing elective PCI were recruited in the study.Plaque characterization in target lesion was identified for three-dimensional IB-IVUS technology using the mechanical IVUS catheter (ViewIT, 40 MHz, 2.5 Fr; Terumo, Tokyo, Japan). The median of percentage lipid volume in all target lesions was 47.6%. Furthermore, lipid rich plaque (LRP) group was defined as the lesions consisting of percentage lipid volume greater than the median. And, non-lipid rich plaque (non-LRP) group was defined as the lesions consisting of percentage lipid volume less than the median. MACEs were defined as cardiovascular death, target vessel myocardial infarction, target lesion revascularization and stent thrombosis. The median of follow up period was 60 months. Of the 148 patients, 106 patients had stable angina pectoris. The remaining 42 patients are acute coronary syndrome (NSTE-ACS). 74 patients were classified LRP groups and 74 patients were non-LRP groups. No significant differences were observed between the two groups with respect to age, sex and coronary risk factors. While plaque and vessel volume were greater in the LRP group (216.9±116.3mm3, p<0.001) than non-LRP group (322.5±144.0mm3, p p<0.001). Remodeling index was greater in LRP group (1.02±0.18) than non-LRP group (0.93±0.18, p<0.003). Although MACEs were no significant differences between the two groups, the number of MACEs tend to be more in patients with LRP group (8.1±27.4%) than small lipid group (2.7±16.3, p<0.147). Especially, cardiac death tend to be more in LRP group (6.7±25.2% than non-LRP group (1.3±11.6, p<0.096). Conclusions In conclusion, lipid rich plaque detected by three dimensional IB-IVUS system in target lesion with patients undergoing elective PCI may be associated with clinical outcomes for five years after second generation DES implantation. Acknowledgement/Funding None
Objectives We sought to examine associations between plaque characteristics by intravascular ultrasound (IVUS) and detectability of external elastic lamina (EEL) by optical frequency domain imaging (OFDI) in human coronary arteries. Background It is often challenging to detect EEL which represents vessel size by light‐based imaging modalities due to light intensity attenuation through atherosclerotic plaque. Methods IVUS and OFDI prior to stent implantation were sequentially investigated per protocol. We identified corresponding cross‐sections by minimum lumen area (MLA) or just distally to side branches as anatomical landmarks. Plaque characterization was determined by integrated backscatter IVUS analysis. We categorized detectable EEL arc by OFDI into four groups: 0≤ and <1 quadrant (group 1), 1≤ and <2 quadrants (group 2), 2≤ and <3 quadrants (group 3), or 3≤ and <4 quadrants (group 4). Results We prospectively studied 103 vessels in 93 patients with stable coronary artery disease. Corresponding 711 cross‐sections were analyzed. Cross‐sections with detectable EEL arc <2 quadrants (group 1 or 2) were observed in 86.1% of MLA sites but only in 29.3% of non‐MLA sites (p < .05). Percentage plaque area (%PA) appeared to be the strongest predictor to detect EEL arc <2 quadrants with the cut‐off of 60.3% (AUC 0.90; sensitivity 79.8%, specificity 85.5%). Lipid pool and calcification remained statistically significant in predicting detectable EEL arc <2 quadrants after adjustment with %PA. Conclusions Presence of large plaque burden, lipid pool, and calcification significantly predicts the detectability of EEL by OFDI assessment. Locations with detectable EEL arc <2 quadrants should thus be avoided for optimal stent landing zone.
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