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In PENDULUM mono, Japanese patients with high bleeding risk (HBR) received short-term dual antiplatelet therapy (DAPT) followed by single antiplatelet therapy (SAPT) with prasugrel after percutaneous coronary intervention (PCI). One-year data from PENDULUM mono showed better outcomes with prasugrel monotherapy after short-term DAPT compared with matched patients in the PENDULUM registry with longer DAPT durations according to guidelines at that time. This study presents 2-year results.Methods and Results: We compared 24-month data from PENDULUM mono (n=1,107; de-escalation strategy group) and the PENDULUM registry (n=2,273; conventional strategy group); both were multicenter, non-interventional, prospective registry studies, using the inverse probability of treatment weighting (IPTW) method. In the PENDULUM mono group, the cumulative incidence of clinically relevant bleeding (CRB) at 24 months post-PCI (primary endpoint) was 6.8%, and that of major adverse cardiac and cerebrovascular events (MACCE) was 8.9%. After IPTW adjustment, the cumulative incidence of CRB was 5.8% and 7.2% in PENDULUM mono and the PENDULUM registry, respectively (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.57-1.04; P=0.086), and that of MACCE was 8.0% and 9.5%, respectively (HR 0.77; 95% CI 0.59-1.01; P=0.061).Japanese PCI patients with HBR prescribed prasugrel SAPT after short-term DAPT had a lower ischemic event risk than those prescribed long-term DAPT, and this was particularly relevant for ischemic events after 1 year.

Background Although diastolic flow reversal (DFR) in the descending aorta, assessed via transesophageal echocardiography (TEE), is a simple and easy indicator for evaluating aortic regurgitation, the association between DFR pattern and clinical outcomes following transcatheter aortic valve implantation (TAVI) is unclear. The purpose of this study was to evaluate the effect of DFR patterns on clinical outcomes following TAVI.Methods and Results:Two-hundred and eleven patients (mean age, 83.6±5.7 years; 69% female) who underwent TAVI were retrospectively assessed via intraprocedural TEE. DFR was evaluated using pulsed-wave Doppler in the descending aorta before and after TAVI. The primary endpoint was major adverse cardio-cerebrovascular events (MACCEs). Although only 7 patients (3.3%) had moderate or severe paravalvular leak, as assessed by color Doppler echocardiography, holo-DFR (HDFR) was observed in 33 patients (16.0%) after TAVI. MACCEs occurred in 40 patients during the median follow up of 282 days (interquartile range: 160-478 days). The estimated cumulative MACCE-free survival at 1 year was significantly lower in patients with HDFR than in those without HDFR. A Cox proportional hazards analysis revealed that HDFR after TAVI was independently associated with MACCEs. Conclusions HDFR was associated with an increased risk of MACCEs after TAVI. DFR evaluated by intraprocedural echocardiography could serve as a simple and easy method for predicting clinical outcomes.

Background Outcomes with prasugrel single antiplatelet therapy (SAPT) vs. dual antiplatelet therapy (DAPT) in Japanese percutaneous coronary intervention (PCI) patients with high bleeding risk (HBR) are currently unknown.Methods and Results:Data from 1,173 SAPT and 2,535 DAPT patients from the PENDULUM mono and PENDULUM registry studies (respective median DAPT durations: 108 vs. 312 days) were compared. The adjusted cumulative incidence of Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding from 1 to 12 months after PCI (primary endpoint) was 2.8% (95% confidence interval [CI], 1.9-4.2) and 4.1% (95% CI, 3.3-5.1), respectively (hazard ratio [HR], 0.69; 95% CI, 0.45-1.06; P=0.090). The adjusted cumulative incidences of BARC 2, 3, or 5 bleeding from 0 to 12 months after PCI (secondary endpoint) were 3.8% (95% CI, 2.7-5.3) and 5.6% (95% CI, 4.7-6.7), respectively (HR, 0.68; 95% CI, 0.47-0.98; P=0.039). There was no significant difference in major adverse cardiac and cerebrovascular events (MACCE) from 1 to 12 months after PCI (HR, 0.93; 95% CI, 0.63-1.37; P=0.696) and at 12 months after PCI (HR, 0.85; 95% CI, 0.61-1.19; P=0.348) between the groups. Conclusions Prasugrel SAPT may reduce BARC 2, 3, or 5 bleeding, without increasing MACCE, in Japanese patients with HBR.

BACKGROUND Characteristics and treatment outcomes of acute myocardial infarction (AMI) patients have been studied; however, those of recent myocardial infarction (RMI) patients remain unclear. This study aimed to clarify characteristics, treatment strategy, and in-hospital outcomes of RMI patients in the Tokyo CCU network database.Methods and Results:In total, 1,853 RMI and 12,494 AMI patients from the Tokyo CCU network database during 2013-2016 were compared. Both RMI and AMI were redefined by onset times of 2-28 days and ≤24 h, respectively. The RMI group had a higher average age (70.4±12.9 vs. 68.0±13.4 years, P

Background:This study directly compared optical coherence tomography (OCT) and histopathology for the assessment of vascular response to first- and second-generation drug-eluting stents.Methods and Results:Sirolimus-, everolimus-, and biolimus-eluting stents (SES, EES, and BES, respectively) were randomly implanted into the coronary arteries of 12 porcine. OCT was conducted after implantation: at 1, 3, and 6 months; histopathology was assessed at 3 and 6 months. At 1-month OCT, EES had the highest neointimal area (NA) and lowest neointimal unevenness score (NUS). At 6 months, NA and NUS were equivalent among the stent types. ∆NA from 1 to 6 months was lowest for EES, and ∆NA correlated with the histopathological inflammation score at 6 months, which was highest for SES (P

Previous reports have shown potential disadvantages of limus-derivative drugs for the stenting treatment of patients with diabetes mellitus (DM). METHODS AND RESULTS: We studied 159 coronary artery lesions (DM: n=72, non-DM: n=87) in 123 patients treated with everolimus-eluting stent (EES) and who underwent scheduled 9-month follow-up angiography with optical coherence tomography (OCT) regardless of symptoms. In addition to standard OCT variables, neointimal unevenness score (maximum/average neointimal thickness) and stent eccentricity index (minimum/maximum stent diameter) were calculated for each cross-section. To investigate a potential baseline difference between DM and non-DM lesions, pre- and post-interventional intravascular ultrasound (IVUS) images were also evaluated as an IVUS subgroup analysis. The average neointimal thickness and neointimal coverage did not differ between DM and non-DM patients. DM patients had, however, greater asymmetric stent expansion and variability of neointimal thickness than non-DM patients. There was a weak, but significant association between average stent eccentricity index and neointimal unevenness score. The IVUS substudy showed that the culprit plaque volume and plaque eccentricity in DM patients were significantly greater than in non-DM patients.Although EES provided a similar level of average neointimal thickness and coverage both in the presence and absence of DM, uneven neointimal suppression occurred in DM patients. A larger plaque volume of the culprit lesion may hamper symmetric stent expansion, possibly explaining the non-uniform neointimal suppression in DM patients.

Background:Nobori is a novel biolimus A9-eluting stent (BES) coated with a biodegradable polymer only on the abluminal side, which degrades over 6–9 months post-stent deployment. The course of vessel reaction after deployment at these time points remains unclear.Methods and Results:We serially evaluated 28 BES implanted in de novo coronary lesions of 23 patients using optical coherence tomography (OCT) at 6 and 12 months post-stenting. Standard OCT variables, the percentage of stent with peri-strut low-intensity area (PLIA, a region around stent struts homogenously showing lesser intensity than the surrounding tissue, suggesting fibrin deposition or impaired neointima maturation) and that with in-stent thrombi were evaluated. There was a significant, but small increase in neointimal thickness (72±23 to 82±25 µm, P=0.006) from the 6- to the 12-month follow-up, without a significant decrease in minimum lumen area (P=0.30). The incidences of uncovered and malapposed struts were low at 6 months and reduced further at 12 months (3.96±3.97% to 1.51±1.63%, P=0.001, and 0.50±1.84% to 0.06±0.24%, P=0.20, respectively). The frequency of stent with PLIA decreased during the follow-up (57% to 32%, P=0.05) and that with in-stent thrombi also numerically decreased (7% to 0%, P=0.24).Conclusions:Neointimal hyperplasia was persistently suppressed following BES implantation up to 12 months. Simultaneously, favorable vessel healing was achieved at 6 months without a delaying adverse reaction for up to 12 months. (Circ J 2014; 78: 1882–1890)

Although both optical coherence tomography (OCT) and angioscopy are robust tools for detecting intrastent thrombi and neoatherosclerosis in vivo, whether OCT findings are comparable with angioscopy findings remains unclear.22 patients presenting with de novo lesions underwent 26 sirolimus-eluting stent (SES) implantations, with follow-up OCT and angioscopy at 10 months post-implantation for segmental assessment of the proximal, mid-, and distal SES segments (66 segments). The mean signal intensity index (signal intensity of the neointima/signal intensity of fibrous intimal hyperplasia) was quantified for angioscopically detected in-stent yellow and white segments. The detection rate for red thrombi was numerically higher with angioscopy than with OCT (17% vs. 9%; P=0.053). Angioscopically detected in-stent yellow segments were categorized into 3 OCT patterns: "high-attenuation tissue covering struts" (OCT-defined neoatherosclerosis), "high-attenuation tissue underneath struts," and "low-attenuation and low-intensity tissue covering struts"; further, macrophage-like appearance was most frequently observed with OCT-defined neoatherosclerosis (56%, 6.3%, and 0%, respectively, P0.001). The mean signal intensity index of neoatherosclerosis was significantly lower than that of angioscopically detected in-stent white segments (0.929 vs. 0.997, P=0.004).Current OCT-based definitions for thrombus detection may underestimate the presence of subclinical red thrombi. Qualitative and quantitative OCT assessments of the neointima may enhance the detection of neoatherosclerosis over SES in vivo.

Background The Taxus Express™ paclitaxel-eluting stent (Express-PES) and Taxus Liberte™ PES (Liberte-PES) have identical drugs, drug doses, and polymers, but different stent platforms. The Liberte-PES platform has thinner struts, specifically designed for more uniform drug elution. Methods and results Fifty-four patients who underwent 6-month follow-up optical coherence tomography (OCT) after Express-PES (n=27) or Liberte-PES (n=27) implantation were enrolled. Longitudinal and circumferential uniformity of neointimal distribution was evaluated in 3-D by computing mean neointimal thickness (NIT) within 360 equally spaced radial sectors for every 1-mm cross-section. After stenting, intravascular ultrasound showed that Liberte-PES had a significantly smaller maximum angle between adjacent struts, with a tendency toward a lower incidence of % length of the segment with maximum angle >90° than Express-PES. Liberte-PES had a significantly thinner mean NIT than the Express-PES with comparable frequency of uncovered struts. Longitudinal and circumferential absolute variation of NIT expressed by standard deviation of NIT from each sector was significantly smaller for Liberte-PES than for Express-PES. Liberte-PES had a tendency toward a decreased incidence of thrombus and peri-strut low-intensity areas (findings suggestive of delayed arterial healing), compared to Express-PES. Conclusions Stent design and thickness appeared to affect neointima suppression of PES. The stent platform of the Liberte-PES may offer greater and more homogeneous reduction of neointimal proliferation spatially across the full length of the PES.

Background: The cytochrome P450 (CYP) 2C19*2 polymorphism is associated with reduced responsiveness to clopidogrel and poor clinical outcome after stent implantation. Despite the high frequency of this polymorphism in Japanese patients, its contribution to cardiac events and stent thrombi after drug-eluting stent (DES) implantation is not clear in this population. Methods and Results: One hundred Japanese patients received clopidogrel and underwent follow-up optical coherence tomography (OCT) after DES implantation. The patients were divided into 2 groups: those with at least one CYP2C19*2 allele (*2 carriers) and non-carriers. The incidence of stent thrombosis and major adverse cardiac events (MACE; ie, death, myocardial infarction, and target vessel revascularization) was compared between the 2 groups. In addition, OCT was used to evaluate the incidence of intra-stent thrombus, defined as a mass protruding into the lumen with significant attenuation. Of the 100 patients, 42 were *2 carriers. No remarkable differences in the baseline characteristics were noted. Although MACE did not differ significantly between the 2 groups, a subclinical intra-stent thrombus was detected more frequently in *2 carriers than in non-carriers (52.3% vs. 15.5%, P=0.0002). Multivariate logistic regression analysis showed that the presence of the CYP2C19*2 polymorphism was the only independent predictive factor for intra-stent thrombus (P=0.00006). Conclusions: From these results it is suggested that CYP2C19*2 polymorphism is associated with subclinical thrombus formation among Japanese patients receiving clopidogrel. (Circ J 2011; 75: 99-105)

Differences between paclitaxel-eluting stents (PES) and sirolimus-eluting stent (SES) in neointimal proliferation under strictly matched conditions remain to be clarified by optical coherence tomography (OCT).Between May and December 2007, 27 patients were implanted with a PES and a SES, randomized to either the proximal or distal site in a single coronary artery, and underwent follow-up angiography and OCT examination at 6 months. The frequency of vessel wall apposition with neointima was greater for PES than for SES (92.6% vs 85.8%, P0.01). The median (25th, 75th percentiles) neointimal thickness (NIT) in PES was significantly greater than that in SES (90 microm [25th: 40 microm; 75th: 200 microm] vs 50 microm [25th: 20 microm; 75th: 140 microm]; P0.01). Both the average difference between the maximum and minimum NIT in each cross-section and the average difference between the maximum and minimum NIT in the longitudinal axis were larger in PES than in SES (206+/-88 vs 131+/-57 microm; P0.001, 607+/-243 vs 400+/-185 microm; P0.001). Low-density spots were significantly more frequently observed in PES than in SES (30.9% vs 17.0%, P=0.001).Compared with SES, PES had a non-uniform and larger neointimal thickness with fewer uncovered struts, and more peri-strut low-density areas.

Factors influencing measurements and accurate evaluation of stent apposition by optical coherence tomography (OCT) are not established.Phantom models of known luminal sizes and lengths were evaluated by OCT under various conditions and measurements were compared with actual values. Stents implanted into phantom models were examined by OCT to validate the measurement point on the stent strut surface for accurate evaluation of stent apposition. Strut thickness was measured at 3 points (midpoint, inner and outer surfaces of the stent shadow). The precision of OCT measurements of lumen diameter and area was satisfactory when the image wire was positioned in the center, but the error and deviation were unsatisfactory when the image wire was positioned eccentrically using a low frame acquisition rate. Longitudinal OCT measurements were close to actual values under all conditions examined. Measurements from the midpoint of the stent shadow to the adjacent vessel wall surface coincided with actual stent thickness.Significant measurement error can occur if the image wire is positioned eccentrically with a lower frame acquisition rate than specified by the manufacturer. To accurately evaluate stent apposition, the stent surface should be measured from the center of the stent reflection.

Background: Although cardiac output index (CI), stroke volume index (SVI), and total systemic vascular resistance (TSVR) are important hemodynamic parameters for the prognosis of chronic heart failure (CHF), they are difficult to measure in an outpatient setting. Whole body bioimpedance monitoring using a Non-Invasive Cardiac System (NICaS) allows for easy, non-invasive estimation of these parameters. Here, whether NICaS-derived hemodynamic parameters are clinically significant was investigated by relating them to other conventional car diovascular functional indices, and by evaluating their predictive accuracy for CHF readmission. Methods and Results: Study subjects of 68 patients with CHF were enrolled in the study immediately upon discharge from the hospital. NICaS-derived CI, -SVI, and -TSVR values obtained at an outpatient clinic were significantly related with left ventricular ejection fraction (LVEF) measured by echocardiography, serum B-type natriuretic peptide (BNP), and exercise tolerance. During the 100±98 days follow-up, 15 patients were readmitted to our hospital for CHF recurrence. Multivariate analysis indicated that LVEF, NICaS-derived CI, NICaS-derived SVI, and plasma BNP were significant indicators (receiver operating characteristic curve cut-off point, LVEF: 37%, NICaS-derived CI: 2.49 L · min–1 · m–2, NICaS-derived SVI: 27.2 ml/m2, plasma BNP: 344 pg/ml) for readmission. Conclusions: Hemodynamic parameters derived by NICaS are applicable for the non-invasive assessment of cardiac function in outpatient CHF follow up. (Circ J 2009; 73: 1074 – 1079)

Background: Sirolimus-eluting stents (SES) have incomplete neointimal coverage at 6-month follow up as determined with optical coherence tomography (OCT). The long-term detailed changes of neointima in SES remains to be clarified. Methods and Results: Serial changes in neointimal coverage of SES from 6 months to 12 months using OCT were examined. Of 21 SES in 13 patients, OCT was used to visualize 2,321 stent struts at 6 months and 2,285 stent struts at 12 months. The frequency of struts without neointimal coverage decreased from 6 months to 12 months (from 10.4 to 5.7%). The frequency of malapposed struts decreased from 6 months to 12 months (from 1.7 to 0.2%). The average thickness of the neointima increased (from 112 ±123 to 120 ±130 μm). The frequency of struts located at the side branch orifice without neointima decreased (from 4 out of 17 (24%) to 0 out of 17 (0%)). Complete coverage with neointima was observed in 14% (3 of 21 SES) at 6 months, and 24% (5 of 21 SES) at 12 months. Conclusions: Additional neointimal coverage was observed between 6 and 12 months, with a small increase in the neointimal thickness. The incidence of complete coverage, however, was still low at 12 months. These findings suggest delayed neointimalization on SES. (Circ J 2009; 73: 1033-1037)

A 76-year-old man presented with an anterior myocardial infarction. Coronary angiography showed 99% stenosis in the left anterior descending artery and total occlusion in the left circumflex artery (LCX). After successful percutaneus coronary intervention (PCI) for segment 7, a staged PCI to the LCX with a distal protection system was attempted, but the wire entered the subintima, creating a large dissection and intramural hematoma. Three sirolimus-eluting stents (SES) were implanted to cover the entire hematoma, but 2 weeks later intravascular ultrasound revealed stent malapposition, with healing of the residual hematoma, and vessel enlargement. Optical coherence tomography (OCT) showed the malapposition more clearly. Balloon dilatation successfully achieved apposition of the SES to the vessel wall, but 6 months later it revealed recurrence of malapposition, with the struts covered by thrombus-like tissue. This case suggests that SES implantation treatment of a long intramural hematoma can potentially cause late malapposition because of persistent vessel enlargement related to arterial wall injury and inhibition of neointimal hyperplasia by the SES. OCT is useful in showing the precise condition of the stent struts.

Non-invasive measurement of cardiac output (CO) may become an important modality for the treatment of heart failure. Among the several methods proposed, impedance cardiography (ICG) has gained particular attention. There are 2 basic technologies of ICG: thoracic and whole-body ICG whereby the electrodes are applied either to the chest or to the limbs. The present study is aimed to test the effectiveness of the Non-Invasive Cardiac System (NICaS), a new ICG device working with a wrist-to-ankle configuration.To evaluate the reliability of NICaS derived CO (NI-CO), 50 CO measurements were taken simultaneously with thermodilution (TD-CO) and modified Fick (Fick-CO) in 35 cardiac patients, with the TD-CO serving as the gold-standard for the evaluation. Overall, 2-tailed Pearson's correlation and Bland-Altman limits of agreement between NI-CO and TD-CO were r=0.91 and -1.06 and 0.68 L/min and between Fick-CO and TD-CO, r=0.80 and -1.52 and 0.88 L/min, respectively. Good correlation was observed in patients with loading conditions altered by nitroglycerin and also in patients with moderate valvular diseases.Agreement between NI-CO and TD-CO is within the boundaries of the FDA guidelines of bio-equivalence. NI-CO is applicable for non-invasive assessment of cardiac function.