Multivariable prediction model to estimate the probability of restenosis at proximal edge after 2nd-generation drug-eluting-stent implantation: development and internal validation using a quantitative coronary angiography from the post-marketing surveillance studies of everolimus-eluting stent in Japan

Author(s):  
Kayoko Kozuma ◽  
◽  
Ken Kozuma ◽  
Tomohiro Shinozaki ◽  
Kosuke Kashiwabara ◽  
...  
BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e052215
Author(s):  
Pil Hyung Lee ◽  
Soon Jun Hong ◽  
Hyun-Sook Kim ◽  
Young won Yoon ◽  
Jong-Young Lee ◽  
...  

IntroductionAngiography remains the gold standard for guiding percutaneous coronary intervention (PCI). However, it is prone to suboptimal stent results due to the visual estimation of coronary measurements. Although the benefit of intravascular ultrasound (IVUS)-guided PCI is becoming increasingly recognised, IVUS is not affordable for many catheterisation laboratories. Thus, a more practical and standardised angiography-based approach is necessary to support stent implantation.Methods and analysisThe Quantitative Coronary Angiography versus Intravascular Ultrasound Guidance for Drug-Eluting Stent Implantation trial is a randomised, investigator-initiated, multicentre, open-label, non-inferiority trial comparing the quantitative coronary angiography (QCA)-guided PCI strategy with IVUS-guided PCI in all-comer patients with significant coronary artery disease. A novel, standardised, QCA-based PCI protocol for the QCA-guided group will be provided to all participating operators, while the PCI optimisation criteria will be predefined for both strategies. A total of 1528 patients will be randomised to either group at a 1:1 ratio. The primary endpoint is the 12-month cumulative incidence of target-lesion failure defined as a composite of cardiac death, target-vessel myocardial infarction or ischaemia-driven target-lesion revascularisation. Clinical follow-up assessments are scheduled at 1, 6 and 12 months for all patients enrolled in the study.Ethics and disseminationEthics approval for this study was granted by the Institutional Review Board of Asan Medical Center (no. 2017-0060). Informed consent will be obtained from every participant. The study findings will be published in peer-reviewed journal articles and disseminated through public forums and academic conference presentations. Cost-effectiveness and secondary imaging analyses will be shared in secondary papers.Trial registration numberNCT02978456.


Author(s):  
Sanda Jēgere ◽  
Inga Narbute ◽  
Indulis Kumsārs ◽  
Iveta Mintāle ◽  
Iļja Zakke ◽  
...  

Comparison of Intravascular Imaging and Quantitative Coronary Angiography to Evaluate Neointimal Proliferation after Complex Lesion Stenting Unlike quantitative coronary angiography (QCA), intravascular imaging methods allow direct visualisation of the arterial wall. Our goal was to determine several intravascular ultrasound (IVUS) and optical coherence tomography (OCT) parameters of neointimal proliferation and stent endothelisation after complex lesion intervention compared to QCA. We examined 261 patients who had underwent percutaneous intervention with bare metal (BMS) or drug eluting stent (DES) implantation for complex coronary lesions and had IVUS or OCT images at six-month follow-up. Percent diameter stenosis (QCA) was 25.2 ± 16.0 in BMS vs 21.7 ± 17.4 in DES (P < 0.05). Percent neointimal volume obstruction (IVUS) was 19.5 ± 14.4 in BMS vs. 5.8 ± 7.7 in DES (P < 0.001). A moderate correlation was observed between QCA and IVUS with an r value of 0.384 overall, 0.472 for BMS and 0.416 for DES (P < 0.001 for all). In patients with chronic total occlusions (n = 161) QCA was similar in BMS and DES patients (P > 0.05) while IVUS showed less neointima in DES (P < 0.05). Total number of uncovered stent struts per OCT image was 0.4 ± 0.8 while per IVUS image 1.2 ± 1.5 (P < 0.001). In conclusion, angiographic indexes correlate with volumetric intravascular parameters. Although IVUS was more sensitive than QCA to assess neointimal proliferation, the assessment of stent endothelisation was more precise using OCT.


2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
Y Nakano ◽  
M Suzuki ◽  
K Waseda ◽  
T Niwa ◽  
H Ando ◽  
...  

Abstract Background Triglyceride deposit cardiomyovasculopathy (TGCV) is a novel disease concept characterized by the excessive accumulation of triglyceride in cardiomyocytes and vascular smooth muscle cells, leading to coronary artery disease (CAD), heart failure, and arrhythmia. However, it is rarely known whether TGCV contributes to the increased risk of vascular failure after drug eluting stent (DES) implantation. Purpose The aim of this study was to evaluate vascular failure after 2nd generation DES implantation in patients with TGCV. Methods Among 637 consecutive patients suspected of having CAD who underwent both coronary angiography and iodine-123-β-methyliodophenyl-pentadecanoic acid (BMIPP) scintigraphy between 2010 and 2018, we analyzed the data from 92 patients who met the inclusion criteria (shown in Table and Figure). Ninety-two patients were allocated to the presence (TGCV group, 11 patients) or absence (control group, 81 patients) of TGCV. All of 92 patients were implanted 2nd generation DES and underwent planned follow up coronary angiography. Control patients were diagnosed of diabetes mellitus. Binary restenosis (ISR), defined as angiographic luminal diameter ≥50% by quantitative coronary angiography, target lesion revascularization (TLR), In-stent late loss and restenosis morphology were assessed in 23 stents of TGCV group and 120 stents of control group. Results There were no significant differences in baseline characteristics between the two groups except for the prevalence of hypertension. In-stent late loss was greater in TGCV than in control (0.45 (−0.04 to 3.33) vs. 0.15 (−0.18 to 2.75), p=0.ehz748.10067), resulting in greater incidence of ISR and TLR in TGCV than in control (34.8% vs. 10.0%, p=0.0017; 21.7% vs. 6.7%, p=0.021, respectively). On multivariable logistic regression analysis, TGCV was found to be a significant and independent predictor for ISR after 2nd generation DES implantation. Regarding restenosis morphology, diffuse and occlusive pattern of ISR, were more frequently observed in TGCV than control (87.5% and 33.3%, Fisher's exact test p=0.028). Table 1.The 4th edition diagnostic criteria for TGCV Items Clinical findings 2 points I) BMIPP scintigraphy Wash-Out Rare <10% II) Diffuse narrowng coronary arteries 1 point III) Jordans anomaly in peripheral blood smear IV) Diabetes Decision 4 points or more → Definite TGCV Figure 1 Conclusion Patients with TGCV showed the greater incidence of vascular failure even after 2nd generation DES implantation, contributing to the novel risk factor for coronary intervention even in the 2nd DES era.


2015 ◽  
Vol 42 (4) ◽  
pp. 327-332 ◽  
Author(s):  
Takaaki Komatsu ◽  
Isao Yaguchi ◽  
Sachiko Komatsu ◽  
Shiro Nakahara ◽  
Sayuki Kobayashi ◽  
...  

Percutaneous coronary intervention is established as an effective treatment for patients with ischemic heart disease; in particular, drug-eluting stent implantation is known to suppress in-stent restenosis. Diabetes mellitus is an independent risk factor for restenosis, so reducing insulin resistance is being studied as a new treatment approach. In this prospective study, we sought to clarify the factors associated with in-stent restenosis after percutaneous coronary intervention, and we evaluated the homeostasis model assessment of insulin resistance (HOMA-IR) index as a predictor of restenosis. We enrolled 136 consecutive patients who underwent elective percutaneous coronary intervention at our hospital from February 2010 through April 2013. All were implanted with a 2nd-generation drug-eluting stent. We distributed the patients in accordance with their HOMA-IR index values into insulin-resistant Group P (HOMA-IR, ≥2.5; n=77) and noninsulin-resistant Group N (HOMA-IR, &lt;2.5; n=59). Before and immediately after stenting, we measured reference diameter, minimal lumen diameter, and percentage of stenosis, and after 8 months we measured the last 2 factors and late lumen loss, all by means of quantitative coronary angiography. After 8 months, the mean minimal lumen diameter was smaller in Group P than that in Group N (1.85 ± 1.02 vs 2.37 ± 0.66 mm; P=0.037), and the mean late lumen loss was larger (0.4 ± 0.48 vs 0.16 ± 0.21 mm; P=0.025). These results suggest that insulin resistance affects neointimal tissue proliferation after 2nd-generation drug-eluting stent implantation.


2017 ◽  
Vol 69 (4) ◽  
pp. 632-639 ◽  
Author(s):  
Yohsuke Honda ◽  
Masahiro Yamawaki ◽  
Shinsuke Mori ◽  
Shigemitsu Shirai ◽  
Kenji Makino ◽  
...  

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