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Edge restenosis has still been reported after second-generation drug-eluting stent (DES) implantation. It was more likely attributable to post-procedural angiographic results than to the patient's background. The aim of this study was to develop and internally validate a prediction model for restenosis in proximal edge after 2nd-generation DES stent implantation using angiographic data. Data were obtained from several post-marketing surveillance (PMS) studies of the cobalt-chromium everolimus-eluting stent (CoCr-EES) and platinum-chromium everolimus-eluting stent (PtCr-EES), second-generation DES, in Japan. Angiographic analysis was conducted at baseline and after 8 or 12 months. We focused on the proximal edge of angiographic analysis. The main outcome was restenosis defined as ≥ 50% diameter stenosis at follow-up. The predictive performance of the prediction model based on multivariable logistic regression was assessed in terms of discrimination and calibration, which were internally validated by the bootstrap method. We also performed decision curve analysis to assess threshold of predicted probability of restenosis at which additional intervention was considered. Among 2053 lesions in 1860 patients, restenosis rates in proximal edge was 2.8%. The final model was constructed with % post-procedural diameter stenosis (DS) and post-procedural reference diameter (RD) as strong predictors for edge restenosis. Discrimination and calibration were satisfactory with optimism-corrected C-statistics 0.75. Predicted probability between 0.03 and 0.24 was preferable threshold for restenosis treatments. Our prediction model can be used to obtain valid prediction for restenosis in proximal edge, assisting to know complete stent coverage of lesion.

The impact of dual antiplatelet therapy (DAPT) with adjusted-dose (3.75 mg/day) prasugrel for Japanese patients has not been fully investigated in terms of local arterial healing following the elective percutaneous coronary intervention (PCI). The ROUTE-01 elective study was a prospective, 12-center and single-arm registry that enrolled 123 patients who underwent elective PCI with everolimus-eluting stents (EESs) under DAPT with a combination of adjusted-dose prasugrel and aspirin. Serial optical coherence tomography (OCT) was performed at the index PCI and 9-month follow-up to assess the relationship between in-stent thorombus (IST) and residual platelet reactivity measuring platelet reactivity unit (PRU). The patients were classified as extensive, intermediate, and poor metabolizers by cytochrome P450 2C19 (CYP2C19) loss-of-function polymorphisms. The prevalence of IST was 9.0% by 9-month OCT, with no difference amongst the three groups (p = 0.886). The incidences of malapposed and uncovered struts were not different among the groups. PRU was not statistically different among the groups. In multivariate logistic regression analysis, the independent predictor for IST on 9-month OCT was irregular protrusion (odds ratio = 8.952, p = 0.037) on post-PCI OCT, not CYP2C19 loss-of-function polymorphisms. An adequate anti-thrombotic effect with an acceptable incidence of IST was observed irrespective of CYP2C19 loss-of-function polymorphisms. Our data suggests that adjusted-dose prasugrel and aspirin is a feasible treatment option in Japanese patients treated with EESs in elective PCI.

Cobalt-chromium everolimus-eluting stent (CoCr EES) is associated with a lower rate of stent thrombosis even in patients with ST-elevation myocardial infarction (STEMI). However, the time-serial changes of endothelial coverage of the stent struts in the extremely early period have never been reported, especially in patients with STEMI. The aim of this study was to compare the vessel healing process between CoCr EES and cobalt-chromium bare metal stent (CoCr BMS) implantations using optical coherence tomography (OCT) in patients with STEMI. Sixty-three patients who had primary emergent percutaneous coronary intervention (PCI) with CoCr EES (42 patients) or CoCr BMS (21 patients) were enrolled in this study for 3 years. OCT was performed just after, 2 and 12 weeks after EES or BMS implantations. Time-serial changes in the neointimal coverage (NIC), the neointimal thickness, and malapposition of stent struts were evaluated. NIC of stent struts did not differ between CoCr EES (23.2%, 99.4%) and CoCr BMS (24.0%, 97.8%) at 2 weeks and 12 weeks after PCI, respectively. Thicknesses of the neointima on the stent strut was significantly thinner in CoCr EES (34.0 ± 13.8, 107.0 ± 32.4 µm) than in CoCr BMS (40.0 ± 14.6, 115.7 ± 33.8 µm) at 2 weeks and 12 weeks after PCI (p = 0.011, p = 0.008), respectively. The malapposition did not differ just after PCI, and was completely resolved at 12 weeks after PCI in both groups. Thrombus was significantly less in CoCr EES than in CoCr BMS at 2 weeks (19.0% vs 42.9%, p < 0.01), and decreased over time in both groups, but at 12 weeks, disappeared only in CoCr EES (CoCr EES: 0% vs. CoCr BMS: 4.8%, p = 0.56). This study demonstrated that NIC and apposition of the stent struts almost completed at 12 weeks after EES and BMS implantations, while the neointimal thickness on the stent struts were thinner in EES than in BMS. Moreover, thrombus was significantly less in EES than in BMS implantations 2 weeks after PCI, which may explain the lower rate of acute and subacute stent thrombosis of EES compared with BMS.

Background: Chronic kidney disease (CKD) and inflammation play critical roles in atherosclerosis. There is limited evidence regarding the relationship between CKD and patients receiving second-generation drug-eluting stents for coronary artery disease., Objective: This study aimed to investigate the effect of CKD on cardiovascular and renal events in patients undergoing percutaneous coronary intervention (PCI) with everolimus-eluting stents (EES)., Methods: We analyzed 504 consecutive patients with stable angina pectoris and significant coronary artery stenosis treated with EES. CKD was defined as an estimated glomerular filtration rate < 60 mL/min/1.73 m2 before coronary angiography. The primary outcome was the occurrence of major adverse renal and cardiovascular events (MARCE) including cardiac death, revascularization, heart failure, cerebral infarction, worsening renal function > 25% from baseline, and renal replacement therapy at 1 year., Results: Patients were divided into the a MARCE (n = 126) and a non-MARCE (n = 378) group. The incidence of CKD was 51% in all subjects (including those on hemodialysis) and was significantly higher in the MARCE group than in the non-MARCE group (p = 0.00001). Multivariate logistic regression analysis identified that CKD was independently associated with MARCE (adjusted odds ratio 2.03, 95% confidence interval 1.21-3.39, p = 0.007). Patients were divided into four groups based on CKD and C-reactive protein (CRP) level prior to initial coronary angiography. Cox proportional hazards analysis revealed that patients with CKD and high CRP (≥0.3 mg/dL) had the worst prognosis (hazard ratio 4.371, 95% confidence interval 2.634-7.252, p = 0.00001) compared to patients without CKD and with low CRP., Conclusion: CKD combined with CRP predicted more clinical events in patients undergoing PCI with EES., (© 2018 S. Karger AG, Basel.)