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 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.
Background It has been reported that intravascular ultrasound (IVUS) guided PCI reduced a risk of major adverse cardiac event compared to conventional angiography guided PCI, while comparison between IVUS-guided and optical frequency domain imaging (OFDI)-guided PCI specifically in long-term clinical outcomes (>1 year) has been unexplored. Purpose We sought to compare imaging surrogates at 8 months and clinical outcomes beyond 1 year after drug-eluting stent implantation between IVUS and OFDI guidance. Methods The MISTIC-1 is a prospective, multi-centre, single-blinded, randomised-controlled, non-inferiority trial comparing OFDI-guided and IVUS-guided PCI using Biolimus A9 eluting Nobori stent. We enrolled patients with stable coronary artery disease who have symptoms or clinically relevant myocardial ischemia. Stent landing zones were selected in the most normal looking sites with largest lumen and without percentage plaque area >50% in IVUS group while without lipidic plaque of >2 quadrants or suggestive thin-cap fibroatheroma in OFDI group. Stent sizing was based on external elastic lamina (EEL) in IVUS group, while by taking 10% or 0.25mm larger than mean lumen diameter at reference sites in OFDI group. Stent optimisation with in-stent minimum lumen area ≥80% of the average lumen area at proximal and distal reference sites was encouraged in both groups. Primary efficacy endpoint is in-segment minimum lumen area (MLA) assessed by OFDI at 8 months. Secondary safety endpoint is a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation. Based on the assumption that mean in-segment MLA at follow-up was 4.5mm2 with a standard deviation of 2.0mm2 in the control (IVUS) group and a non-inferiority limit of 1.2mm2 for OFDI group, sample size was estimated as 48 cases in each group with 5% type I error and 90% statistical power. Results Since June-2014 and August-2016, we prospectively enrolled 109 patients (mean age 70 years, male 78%) with 126 lesions. Baseline patient and lesion characteristics were well balanced and average nominal size and length of stent used did not differ between OFDI-guided and IVUS-guided PCI (3.0 and 19.1mm vs. 3.1 and 19.3mm, respectively). Post-procedural minimum stent area was 6.24mm2 in OFDI group and 6.72mm2 in IVUS group (p=0.20). At 8-month follow-up, in-segment MLA was 4.56mm2 in OFDI group and 4.13mm2 in IVUS group (P for non-inferiority <0.001). During the follow-up (median 4.5 years [1654 days]), incidence rates of major adverse cardiac event were comparable between the two groups (7.4% in OFDI group and 7.3% in IVUS group, hazard ratio 0.96, 95% CI 0.24–3.83, p=0.95). No definite or probable stent thrombosis were documented in both groups. Conclusion OFDI-guided PCI demonstrated comparable results in achieving satisfactory imaging surrogates as well as long-term clinical outcomes after newer generation DES implantation as compared to IVUS-guided PCI. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Suzuken Memorial Foundation
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.