Low-Dose Prasugrel vs. Standard-Dose Clopidogrel for Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Low-dose prasugrel (3.75 mg) is used as maintenance therapy for percutaneous coronary intervention; however, data on long-term outcomes are scarce. METHODS AND RESULTS: We analyzed 5,392 participants in the KiCS-PCI registry who were administered low-dose prasugrel or clopidogrel at discharge between 2008 and 2018 and for whom 2-year follow-up data were available. We adjusted for confounders using matching weight analyses and multiple imputations. Similarly, we used inverse probability- and propensity score-weighted analyses. We also performed instrumental variable analyses. The primary outcomes were acute coronary syndrome (ACS) and bleeding requiring readmission. Secondary outcomes were all-cause death and a composite outcome of ACS, bleeding, heart failure, stroke, coronary bypass requiring admission, and all-cause death. In this cohort, 12.2% of patients were discharged with low-dose prasugrel. Compared with clopidogrel, low-dose prasugrel was associated with a reduced risk of ACS (hazard ratio [HR] 0.58; 95% confidence interval [CI] 0.39-0.85), bleeding (HR 0.62; 95% CI 0.40-0.97), and the composite outcome (HR 0.71; 95% CI 0.59-0.86). Inverse probability-weighted analysis yielded similar results; however, matching weight analysis without multiple imputations and propensity score-matched analyses showed similar outcomes in both groups. Instrumental variable analyses showed reduced risks of ACS and composite outcome for those on low-dose prasugrel. All-cause mortality did not differ in all analyses. CONCLUSIONS: Low-dose prasugrel demonstrates comparable outcomes to clopidogrel in terms of ACS and bleeding.

Catheter ablation for patients with atrial fibrillation and heart failure with reduced and preserved ejection fraction: insights from the KiCS-AF multicentre cohort study.

AIMS: The usefulness of catheter ablation (CA) for atrial fibrillation (AF) across a broad spectrum of heart failure (HF) patients remains to be established. We assessed the association of CA with both health-related quality of life (QoL) and cardiovascular events among HF patients with reduced and preserved left ventricular ejection fraction (LVEF) in an 'all-comer' outpatient-based AF registry. METHODS AND RESULTS: Of 3303 patients with AF consecutively enrolled in a retrospective multicentre registry that mandated the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire at registration and 1-year follow-up, we extracted data from 530 patients complicating clinical HF. The association between CA and both 1-year change in AFEQT Overall Summary (AFEQT-OS) scores and 2-year composite clinical outcomes (including all-cause death, stroke, and HF hospitalization) was assessed by multivariable analyses. The median duration of AF was 108 days (52-218 days), and 83.4% had LVEF >35%. Overall, 75 patients (14.2%) underwent CA for AF within 1-year after registration. At 1-year follow-up, 67.2% in the ablation group showed clinically meaningful improvements of ≥ 5 points in AFEQT-OS score than 47.8% in the non-ablation group {adjusted odds ratio, 2.03 [95% confidence interval (CI): 1.13-3.64], P = 0.017}. Furthermore, the composite endpoint of all-cause death, stroke, and HF hospitalization occurred less frequently in the ablation group than the non-ablation group [adjusted hazard ratio, 0.27 (95% CI: 0.09-0.86), P = 0.027]. CONCLUSION: Among AF-HF patients, CA was associated with improved QoL and lower risk of cardiovascular events against drug therapy alone, even for patients with mildly reduced and preserved LVEF.

Rate versus rhythm control in patients with newly diagnosed atrial fibrillation: Effects of the treatment timing on health status outcomes.

BACKGROUND: Recent randomized clinical trials have demonstrated that applying rhythm control during the early stage of atrial fibrillation (AF) may lead to improved clinical outcomes. However, the effects of this modality on health-related quality of life (HRQoL) have not been fully investigated. We aimed to assess the association between the AF stage, determined by the time between AF diagnosis and referral to the cardiology clinic, and HRQoL outcomes. METHODS: Using an outpatients-based multicenter AF registry (n = 3,313), we analyzed 2,070 patients with AF diagnosed within 5 years. The patients were divided into 2 groups according to AF stage: early and late AF (AF duration ≤1 and >1 year, respectively). All patients had HRQoL information collected at baseline and 1 year after their initial treatment (assessed via the Atrial Fibrillation Effect on Quality-of-Life-overall summary [AFEQT-OS] score, with higher scores reflecting better HRQoL). The change in AFEQT-OS was adjusted for patient characteristics using a generalized linear mixed model. RESULTS: The early AF group (n = 1,644) was older (early, 68.5 ± 11.1, late, 64.4 ± 10.6 years, P < .001) and had more heart failure (early, 19.9%, late, 12.7%, P < .001) than the late AF group (n = 426). At 1 year after treatment, the adjusted changes in AFEQT-OS were similar in patients with rhythm (adjusted difference [SE], early, 8.4 [1.2], late, 7.2 [1.4], P = .15) or rate (early, 4.0 [0.7], late, 2.3 [1.4], P = .16) control, regardless of AF stage. Furthermore, the improvement in HRQoL was similar between early and late AF in patients undergoing catheter ablation (early, 10.2 [2.1], late, 9.8 [2.4], P = .78), whereas a significant difference was observed in those receiving antiarrhythmic drug therapy alone (early, 10.2 [1.4], late, 3.5 [2.2], P < .001). CONCLUSIONS: Rhythm control therapy provided clinically meaningful improvements in HRQoL, regardless of AF stage. For patients with impaired HRQoL, AF duration should not be a deterrent to treatment, especially catheter ablation.

Bleeding avoidance strategies and percutaneous coronary intervention outcomes: A 10-year observation from a Japanese Multicenter Registry.

BACKGROUND: Bleeding avoidance strategies (BASs) are increasingly adopted for patients undergoing percutaneous coronary intervention (PCI) due to bleeding complications. However, their association with bleeding events outside of Western countries remains unclear. In collaboration with the National Cardiovascular Data Registry (NCDR) CathPCI registry, we aimed to assess the time trend and impact of BAS utilization among Japanese patients. METHODS: Our study included 19,656 consecutive PCI patients registered over 10 years. These patients were divided into 4-time frame groups (T1: 2008-2011, T2: 2012-2013, T3: 2014-2015, and T4: 2016-2018). BAS was defined as the use of transradial approach or vascular closure device (VCD) use after transfemoral approach (TFA). Model performance of the NCDR CathPCI bleeding model was evaluated. The degree of bleeding reduction associated with BAS adoption was estimated via multilevel mixed-effects multivariable logistic regression analysis. RESULTS: The NCDR CathPCI bleeding risk score demonstrated good discrimination in the Japanese population (C-statistics 0.79-0.81). The BAS adoption rate increased from 43% (T1) to 91% (T4), whereas the crude CathPCI-defined bleeding rate decreased from 10% (T1) to 7% (T4). Adjusted odds ratios for bleeding events were 0.25 (95% confidence interval, 0.14-0.45, P< .001) for those undergoing TFA with VCD in T4 and 0.26 (95% confidence interval 0.20-0.35, P< .001) for transradial approach in T4 compared to patients that received TFA without VCD in T1. CONCLUSIONS: BAS use over the studied time frames was associated with lower risk of bleeding complications among Japanese. Nonetheless, observed bleeding rates remained higher compared to the US population.

Association of decreasing hemoglobin levels with the incidence of acute kidney injury after percutaneous coronary intervention: a prospective multi-center study.

Acute kidney injury (AKI) is common in patients undergoing percutaneous coronary intervention (PCI). One risk factor for AKI is periprocedural hemoglobin drop level (> 3 g/dL); however, whether the relationship between hemoglobin drop and AKI is linear or nonlinear remains unknown. We aimed to investigate the relationship between periprocedural hemoglobin drop and AKI after PCI. We evaluated 14,273 consecutive patients undergoing PCI between September 2008 and March 2019. AKI was defined as an absolute or a relative increase in serum creatinine level of 0.3 mg/dL or 50%, respectively. Restricted cubic spline was constructed to assess the association between hemoglobin drop and AKI by logistic regression and machine learning (ML) models, which were used to predict the risk of AKI. The patients' mean age was 68.4 ± 11.6 years; the AKI incidence was 10.5% (N = 1499). An absolute > 3 g/dL or 20% relative decrease in hemoglobin level was an independent predictor of AKI incidence (odds ratio, OR [95% confidence interval, CI]: 2.24 [1.92-2.61], P < 0.001; 2.35 [2.04-2.71], P < 0.001, respectively). An adjusted restricted cubic spline demonstrated that absolute/relative decrease in hemoglobin was linearly associated with AKI. Logistic and ML models with absolute/relative hemoglobin changes were comparable while estimating the risk of AKI (absolute area under the curve [AUC] (logistic):0.826, AUC (ML): 0.820; relative AUC (logistic): 0.818, AUC (ML): 0.816). An absolute/relative decrease in periprocedural hemoglobin after PCI was linearly associated with AKI. Detection of a relative/absolute decrease in hemoglobin may help clinicians identify individuals as high risk for AKI after PCI.

Discrepancy in recognition of symptom burden among patients with atrial fibrillation.

Our aim was to investigate the variability in physician recognition of atrial fibrillation (AF)-related symptoms, which greatly contributes to the management of AF patients. METHODS AND RESULTS: A total of 1493 newly-referredAF patients (67 ±â€¯11 y/o, 1057 men) consecutively registered in an outpatient-based Japanese multicenter database (KiCS-AF) from September 2012 to December 2016 were analyzed. Self-reportedAF symptom burden was assessed via symptom and daily activities domains within the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. Physician symptom under-recognition (UR) was defined as no subjective complaints recorded in the medical records despite AFEQT score of <80; and physician's apparent over-recognition (OvR) was defined as documentation of subjective complaints despite total AFEQT score of ≥80. There was poor agreement between patient-reported and physicians-estimated symptom burden (kappa 0.28, 95% CI 0.23 to 0.33). In the logistic regression analysis, age> 75 (odds ratio [OR], 1.72; 95% confidence interval [CI], 1.13-2.62), male sex (OR, 1.82; 95% CI, 1.22-2.74), and persistent/permanent AF (OR 2.54/3.36; CI, 1.63-3.99/1.91-5.89, respectively) were predictors of UR. Conversely, heart failure (OR, 2.46; 95% CI, 1.44-4.25) and treatment in an ablation facility (OR, 1.43; 95% CI, 1.02-2.02) were associated with greater odds of OvR in addition to age, sex, and type of AF. CONCLUSIONS: Discordance in recognition of AF symptom burden by physicians was frequent in AF patients seen in outpatient management and involved both patient- and physician-related factors.

Treatment strategies and subsequent changes in the patient-reported quality-of-life among elderly patients with atrial fibrillation.

BACKGROUND: Rhythm-control strategy, including catheter ablation (CA) application, constitutes an integral part of atrial fibrillation (AF) management. However, elderly patients are underrepresented in clinical trials, and reports on patient-reported outcome of various rhythm-control treatments remain limited. Therefore, we aimed to investigate the application of a rhythm-control strategy for elderly patients with AF. METHODS: Using a prospective, multicenter Japanese registry, we analyzed 733 patients with AF aged ≥70 years who completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire at baseline and 1-year visit. Improvement in patient-reported quality-of-life (QOL) was assessed according to their initial treatment strategy. RESULTS: A total of 321 patients (43.8%) were managed with rhythm-control strategy, of which 125 (17.1%) received treatment with antiarrhythmic drugs (AADs) alone and 196 (26.7%) underwent CA. Compared with the rate-control group, the rhythm-control group was younger and less likely to have comorbid conditions but had lower baseline AFEQT-overall summary (OS) scores (71.8 [standard deviation 20.3] vs. 80.0 [standard deviation 16.1]; P < .001). After the first year, AFEQT-OS scores improved regardless of treatment strategies (ie, rate- or rhythm-control). After adjusting for confounders, CA implementation and a lower baseline AFEQT score were associated with meaningful improvement in QOL (changes in AFEQT-OS score ≥5). QOL improvement among subgroups of rhythm-control patients with AADs alone was not clinically meaningful. CONCLUSIONS: In contemporary Japanese clinical practice, rhythm-control strategy is widely implemented in elderly patients with AF, and CA use is associated with improvement in QOL in carefully selected patients.

Real-world use of intravascular ultrasound in Japan: a report from contemporary multicenter PCI registry.

Clinical trial data suggest that intravascular ultrasound (IVUS) may improve clinical outcomes after PCI. The aim of this study was to investigate the safety of IVUS in its broader use for percutaneous coronary intervention (PCI). A total of 11,570 consecutive patients undergoing PCI between 2008 and 2014 in Japan were analyzed. Associations between IVUS use, PCI-related complications were assessed with logistic regression and propensity score matching analyses. Subgroup analysis was performed in elective PCI patients. IVUS was used in 84.8% of patients (N = 9814; IVUS group); its use was almost universal in elective PCIs (90.8 vs. 81.7% in urgent/emergent PCIs, P < 0.001). The non-IVUS group were older (68.7 ± 11.4 vs. 67.9 ± 10.8 years, P = 0.004), with more comorbid conditions. The non-IVUS group had smaller stent lumens (2.97 ± 0.42 mm vs. 3.09 ± 0.45 mm, P < 0.001) and a higher proportion of plain old balloon angioplasty. After matching, a lower rate of flow-impairing coronary dissections was observed in the IVUS group, although this was limited only to elective PCIs, not among urgent/emergent PCIs (non-IVUS vs. IVUS; 2.7% vs. 1.0%, P = 0.018, 0.7% vs. 1.2%, P = 0.32, respectively). With a multivariate logistic regression analysis, IVUS use remained an independent predictor to reduce risk of flow impairing severe coronary dissection among elective PCIs (odds ratio 0.38, 95% confidence interval 0.22-0.66: P = 0.001). In this Japanese PCI registry, IVUS was used extensively during the study period, particularly in elective cases. Using IVUS was associated with a lower event rate of flow-impairing coronary dissections that was limited to elective PCIs, not among urgent/emergent PCIs, without increasing PCI-related complications.

Predictors of high cost after percutaneous coronary intervention: A review from Japanese multicenter registry overviewing the influence of procedural complications.

BACKGROUND: Percutaneous coronary intervention (PCI) is widely used; however, factors of high-cost care after PCI have not been thoroughly investigated. We sought to evaluate the in-hospital costs related to PCI and identify predictors of high costs. METHODS: We extracted 2,354 consecutive PCI cases (1,243 acute cases, 52.8%) from 3 Japanese cardiovascular centers from 2011 to 2015. In-hospital complications were predefined under consensus definitions (eg, acute kidney injury [AKI]). We extracted the facility cost data for each patient's resource under the universal Japanese insurance system. We classified the patients into total cost quartiles and identified predictors for the highest quartile ("high-cost" group). In addition, incremental costs for procedure-related complications were calculated. RESULTS: During the study period, a total of 401 cases (17.0%) experienced procedure-related complications. The in-hospital acute and elective PCI costs per case were US $14,840 (interquartile range [IQR] 11,370-20,070) and US $11,030 (IQR 8929-14,670), respectively. After adjusting for baseline differences, any of the procedure-related complications remained an independent predictor of high costs (acute: odds ratio 1.66, 95% CIs 1.13-2.43; elective: odds ratio 3.73, 95% CIs 1.96-7.11). Notably, incremental costs were mainly attributed to AKI, which accounted for 37.5% of all incremental costs; it increased by US $9,840 for each AKI event, and the total cost increase reached US $2,588,035. CONCLUSIONS: Procedure-related complications, particularly postprocedural AKI, were associated with higher costs in PCI. Further studies are required to evaluate prospectively whether the preventive strategy with a personalized risk stratification for AKI could save costs.

The Effects of Hydrogen Gas Inhalation on Adverse Left Ventricular Remodeling After Percutaneous Coronary Intervention for ST-Elevated Myocardial Infarction　- First Pilot Study in Humans.

BACKGROUND: Hydrogen gas inhalation (HI) reduced infarct size and mitigated adverse left ventricular (LV) remodeling in a rat model of acute myocardial infarction (AMI). We designed a prospective, open-label, rater-blinded clinical pilot study in patients experiencing ST-elevated MI (STEMI).Methods and Results:The 20 patients with an initial diagnosis of STEMI were assigned to either an HI group (1.3% H2with 26% oxygen) or a control group (26% oxygen). There were no HI-related severe adverse events. In the full analysis set, the cardiac salvage index as evaluated using cardiac magnetic resonance imaging at 7 days after primary percutaneous coronary intervention (PCI), showed no significant between-group difference (HI: 50.0±24.3%; control: 60.1±20.1%; P=0.43). However, the improvement from day 7 in the HI group was numerically greater than that in the control group in some of the surrogate outcomes at 6-month follow-up, including the LV stroke volume index (HI: 9.2±7.1 mL/m2; control: -1.4±7.2 mL/m2; P=0.03) and the LV ejection fraction (HI: 11.0%±9.3%; control: 1.7%±8.3%; P=0.11). CONCLUSIONS: The first clinical study has shown that HI during PCI is feasible and safe and may also promote LV reverse remodeling at 6 months after STEMI. The study was not powered to test efficacy and a further large-scale trial is warranted. (Clinical trials registration: UMIN00006825).

Barriers Associated With Door-to-Balloon Delay in Contemporary Japanese Practice.

BACKGROUND: Door-to-balloon (DTB) time ≤90 min is an important quality indicator in the management of ST-elevation myocardial infarction (STEMI), but a considerable number of patients still do not meet this goal, particularly in countries outside the USA and Europe.Methods and Results:We analyzed 2,428 STEMI patients who underwent primary PCI ≤12 h of symptom onset who were registered in an ongoing prospective multicenter database (JCD-KiCS registry), between 2008 and 2013. We analyzed both the time trend in DTB time within this cohort in the registry, and independent predictors of delayed DTB time >90 min. Median DTB time was 90 min (IQR, 68-115 min) during the study period and there were no significant changes with year. Predictors for delay in DTB time included peripheral artery disease, prior revascularization, off-hour arrival, age >75 years, heart failure at arrival, and use of IABP or VA-ECMO. Notably, high-volume PCI-capable institutions (PCI ≥200/year) were more adept at achieving shorter DTB time compared with low-volume institutions (PCI <200/year). CONCLUSIONS: Half of the present STEMI patients did not achieve DTB time ≤90 min. Targeting the elderly and patients with multiple comorbidities, and PCI performed in off-hours may aid in its improvement.

Effect of Smoking Status on Clinical Outcome and Efficacy of Clopidogrel in Acute Coronary Syndrome.

BACKGROUND: The "smoker's paradox" is an otherwise unexplained phenomenon in which the mortality of smokers after acute myocardial infarction is reduced, contrary to expectations. It has been suggested that an association with antiplatelet agents exists, but the true mechanism remains largely unidentified. METHODS AND RESULTS: The analysis included 6,195 consecutive patients who underwent percutaneous coronary intervention (PCI) for acute coronary syndrome, registered in the Japanese multicenter PCI registry. Smokers were significantly younger and had less comorbidity than non-smokers. Unadjusted in-hospital mortality rate, general complication rate, and bleeding complication rate were lower in smokers than in non-smokers. After adjustment, the trend persisted and smoking was not associated with overall mortality (odds ratio [OR], 0.90; 95% confidence interval [CI]: 0.61-1.34; P=0.62), and was associated with lower overall (P=0.032) and bleeding complication events (P=0.040). Clopidogrel effectively reduced the occurrence of in-hospital complications and major adverse cardiac events in smokers compared with non-smokers (OR, 0.55; 95% CI: 0.53-0.98 vs. OR, 1.20; 95% CI: 0.87-1.67; and OR, 0.37; 95% CI: 0.20-0.70 vs. OR, 1.48; 95% CI: 0.90-2.43, respectively). CONCLUSIONS: The smoker's paradox was largely explained by confounding factors related to the lower risk profile of smokers, and they benefited from a positive modification of the efficacy of clopidogrel. (Circ J 2016; 80: 1590-1599).

Degree of dyspnoea in patients with non-ST-elevation acute coronary syndrome: A report from Japanese multicenter registry.

BACKGROUND: Degree of dyspnoea is almost universally evaluated in the patients presenting with acute coronary syndrome (ACS), but its clinical implications has not been thoroughly investigated. We aimed to describe the relationship between the severity of dyspnoea and in-hospital outcomes in patients with non-ST elevation ACS (NSTE-ACS) complicated with acute heart failure (AHF). METHODS: Between 2009 and 2014, 3287 consecutive patients with NSTE-ACS were enrolled in the Japanese prospective multicenter PCI registry. Patients complicated with AHF were subclassified based on the self-reported dyspnoea severity: no dyspnoeic symptoms, dyspnoea during moderate activity, mild activity or at rest. The recorded outcomes included in-hospital death, major cardiovascular (ie, cardiac death, shock, stroke or major bleeding) and renal events (ie, contrast-induced acute kidney injury [CI-AKI] or AKI requiring dialysis). RESULTS: In total, 441 (13.4%) patients had AHF upon presentation, including 76 (17.2%) with dyspnoea during moderate activity, 160 (36.3%) with dyspnoea during mild activity, and 205 (46.5%) with dyspnoea at rest. In-hospital mortality as well as major cardiovascular and renal events increased as dyspnoea severity worsened. After multivariate adjustment, dyspnoea at rest was strongly associated with in-hospital mortality (odds ratio [OR] 5.79; 95% confidence interval [CI], 2.56-13.11; P<.001) as well as major cardiovascular (OR, 2.55; 95% CI, 1.46-4.48; P<.001) and renal events (OR, 3.32; 95% CI, 2.05-5.38; P<.001), when compared to the patients without dyspnoea. CONCLUSIONS: Among NSTE-ACS patients complicated with AHF, both cardiovascular and renal event rates were associated with presence of dyspnoea, and its incidence increased in parallel with dyspnoea severity.

An international comparison of patients undergoing percutaneous coronary intervention: A collaborative study of the National Cardiovascular Data Registry (NCDR) and Japan Cardiovascular Database-Keio interhospital Cardiovascular Studies (JCD-KiCS).

BACKGROUND: Details on Japanese patients undergoing percutaneous coronary intervention (PCI) and how they compare to US patients remain unclear. Furthermore, the application of US risk models has not been evaluated internationally. METHODS: The JCD-KiCS, a multicenter registry of consecutive PCI patients, was launched in 2008, with variables defined in accordance with the US NCDR. Patient and procedural characteristics from patients enrolled from 2008 to 2010 in the JCD-KiCS database (n = 9,941) and those in the NCDR (n = 732,345) were compared. The primary outcomes of this analysis were the hospital-level all-cause mortality and bleeding complications. The NCDR risk models for these 2 outcomes were evaluated in the Japanese data set; from the expected mortality and bleeding rates, the observed/expected ratios were calculated. RESULTS: The Japanese patients were older, with a higher proportion of men, diabetes, and smoking than the US patients. The Japanese patients also had a higher rate of complex lesions (26.1 vs 12.7% for bifurcation and 6.2% vs 3.2% for chronic total occlusions, all P < .001), longer procedure time (29.7 ± 21.5 vs 14.4 ± 11.5 minutes, P < .001), and higher mortality (1.6% vs 0.9%, P < .001) and bleeding rates (2.9% vs 1.8%, P < .001) compared with US patients. The observed/expected ratios for mortality and bleeding were 0.921 and 0.467, respectively, in Japanese patients, and 1.002 and 0.981, respectively, for US patients. CONCLUSIONS: The characteristics of patients undergoing PCI in clinical practice in Japan and the US differ substantially. The NCDR risk models applied well in Japanese patients for prediction of mortality, but not for bleeding, which tended to underestimate the risk.

Outcomes of Percutaneous Coronary Intervention Performed With or Without Preprocedural Dual Antiplatelet Therapy.

BACKGROUND: Preprocedural dual antiplatelet therapy (DAPT) in percutaneous coronary interventions (PCI) has been shown to improve outcomes; however, the efficacy of the procedure and its complications in Japanese patients remain largely unexplored, so we examined the risks and benefits of DAPT before PCI and its association with in-hospital outcomes. METHODS AND RESULTS: We analyzed data from patients who had undergone PCI at 12 centers within the metropolitan Tokyo area between September 2008 and September 2013.Our study group comprised 6,528 patients, of whom 2,079 (31.8%) were not administered preprocedural DAPT. Non-use of preprocedural DAPT was associated with death, postprocedural shock, or heart failure (odds ratio [OR]: 1.47, 95% confidence interval [CI]: 1.10-1.96, P=0.009), and postprocedural myocardial infarction (OR: 1.41, 95% CI: 1.18-1.69, P<0.001) after adjusting propensity scores for known predictors of in-hospital complications. Non-use of DAPT was not associated with procedure-related bleeding complications (OR: 0.98, 95% CI: 0.71-1.59, P=0.764). CONCLUSIONS: Approximately one-third of the patients who underwent PCI did not receive preprocedural DAPT despite guideline recommendations. Our results indicate that patients undergoing PCI with DAPT have a lower risk of postprocedural cardiac events without any increased bleeding risk. Further studies are needed to implement the use of DAPT in real-world PCI.

Appropriateness of coronary interventions in Japan by the US and Japanese standards.

BACKGROUND: Appropriateness use criteria (AUC) are widely used to assess quality of care. American professional organizations and Japanese experts have both developed original AUC for percutaneous coronary intervention (PCI). However, rating discrepancies have not been investigated. METHODS: Patients registered in the Japanese multicenter PCI registry were analyzed. We assessed the appropriateness of PCI based on both the US and Japanese criteria and compared the ratings. A logistic regression analysis was performed to identify clinical predictors of inappropriate ratings under both standards. RESULTS: From a total of 4,950 nonacute, consecutive PCIs, 1,982 and 2,077 procedures could be successfully rated using the US and Japanese criteria, respectively. The major difference between the 2 criteria was the rating of "asymptomatic, low- or intermediate-risk patients, no lesion in the proximal left anterior descending coronary artery (PLAD)"; this scenario was deemed appropriate in the Japanese but not in the US criteria. As a consequence, the rate of inappropriate PCI using the Japanese criteria (5.2%) was substantially lower when compared with the rating using the US criteria (15%). Common clinical variables associated with "inappropriate" PCI were male, multivessel diseases, and lesions in the non-PLAD. Suboptimal antianginal medication was also a significant predictor of inappropriate PCI under the US but not under the Japanese criteria. CONCLUSIONS: Significant and clinically relevant rating discrepancies were observed between the US and Japanese criteria-based assessments, owing largely to the ratings of asymptomatic, non-PLAD-related, low- or intermediate-risk cases.

Comparative incidence and risk factors for gastrointestinal bleeding following percutaneous coronary intervention for coronary artery disease: Insights from the Keio Cardiovascular Registry in Japan.

BACKGROUND: In patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI), antiplatelet medication usage is crucial for preventing thrombotic events. However, it requires careful monitoring, especially because of the risk of life-threatening bleeding complications. In hemorrhagic complications, assessment of patient background and risk of gastrointestinal bleeding (GIB) remain limited for GIB that develops during long-term observation after hospital discharge. This study aimed to examine the incidence of GIB and patient characteristics in CAD post-PCI. METHODS: All CAD patients undergoing PCI for urgent, emergent, or elective indications were enrolled in the Keio Interhospital Cardiovascular Studies (JCD-KiCS)-PCI registry (January 2009 and December 2017) and followed up to 2 years after PCI discharge. From the JCD-KiCS PCI registry, 8864 patients (median [interquartile range [IQR]] age: non-GIB: 69.0 y [16 y], upper GIB (UGI): 72.0 y [15.5 y], lower GIB (LGI): 73.0 y [IQR: 13 y]) were categorized based on the occurrence of hospitalization-requiring GIB. Patient characteristics and detailed information regarding these GIB events, including the location (upper vs lower GI) and bleeding severity, were analyzed. RESULTS: Overall, 36 patients experienced UGI, while 85 patients experienced LGI. The rates of dual antiplatelet therapy (DAPT) and triple therapy were significantly different among the non-GIB (n = 8734), UGI (n = 36) and LGI (n = 85) groups (DAPT [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)]: 64 [76.2 %] in the LGI group vs 24 [68.6 %] in the UGI group vs 7330 [84.6 %] in the non-GIB group; triple therapy [aspirin + P2Y12 (clopidogrel/prasugrel/ticlopidine)] + oral anticoagulant (OAC) (warfarin/direct oral anticoagulant [DOAC]): 17 [20.2 %] in the LGI group vs 8 [22.9 %] in the UGI group vs 836 [9.6 %] in the non-GIB group; p < 0.001). In the LGI and UGI groups, aspirin and warfarin were used in 2 (2.4 %) and 2 (5.7 %) patients, respectively, but not in combination with DOAC. The 2-year post-PCI hospitalization incidence for GIB was 1.4 % (LGI, 1.0 %; UGI, 0.4 %). The most common causes were colonic diverticular hemorrhage (43.5 %) for LGI and duodenal ulcer (21.9 %) for UGI. No significant differences were found in the cumulative 2-year post-PCI risks between the LGI and UGI groups (log-rank p = 0.97). Most GIB events were Bleeding Academic Research Consortium 2-equivalent (hemoglobin decrease <3 g/dL). Notably, the use of OACs at PCI discharge, bleeding complications within 72 h, and preprocedural anemia were significantly correlated with an increased GIB risk. CONCLUSIONS: The real-world incidence of LGI is two times higher than that of UGI in CAD patients undergoing PCI, and most events are mild. OAC use at PCI discharge is the strongest potential risk factor for GIB development.

Enhancing Coronary Intervention Outcomes Using Intravascular Ultrasound: Analysis of Long-Term Benefits in a Japanese Multicenter Registry.

Background: Although the use of intravascular ultrasound (IVUS) during percutaneous coronary intervention (PCI) has been shown to improve clinical outcomes, its utilization remains inconsistent. We aimed to assess the association between IVUS-guided PCI and long-term outcomes in Japan, where a high proportion of patients undergo IVUS. Methods: We analyzed 8721 consecutive patients in a multicenter PCI registry. The primary outcome was a composite of death, acute coronary syndrome, and heart failure requiring admission and coronary artery bypass grafting at 2 years after discharge. The secondary outcome was each component of the primary outcome. We used inverse probability-weighted analysis for adjustment. Subgroup analysis was conducted on patients with complex coronary anatomy (eg, those with bifurcation, chronic total occlusion, type C lesion, left main and those who underwent rotational atherectomy). Results: Overall, 83.8% of patients underwent IVUS-guided PCI (mean age, 68.3 ± 11.3 years). After adjustments, the IVUS group had significantly lower rates of death and coronary bypass compared to no IVUS group (hazard ratio [HR], 0.73; 95% CI, 0.55-0.96; and HR, 0.62; 95% CI, 0.39-0.98) at 2-year follow-up, although the primary outcome showed only marginal differences (HR, 0.85; 95% CI, 0.71-1.01). In the subgroup analysis of complex coronary anatomy, the use of IVUS was significantly associated with a reduced risk of the primary outcome (HR, 0.72; 95% CI, 0.55-0.93) as well as death, coronary bypass, and heart failure. Conclusions: IVUS was frequently utilized in our registry and demonstrated potential benefit in reducing mortality and need for coronary bypass surgery, particularly in patients with complex coronary anatomy.

Physician Estimates and Patient-Reported Health Status in Atrial Fibrillation.

Importance: A primary objective in managing atrial fibrillation (AF) is to optimize patients' health status, which can be done only if physicians accurately quantify the outcomes associated with AF in patients' lives. Objective: To explore physicians' estimation of the health status of patients with AF and its association with subsequent care and outcomes. Design, Setting, and Participants: A multicenter, prospective cohort study was conducted in 2 outpatient practices in Tokyo, Japan. Participants included patients with newly diagnosed AF or those referred for initial treatment of AF at outpatient practices and treating physicians from November 8, 2018, to April 1, 2020. Data analysis was performed from December 22, 2022, to July 7, 2023. Exposures: Participating patients completed the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire, a 20-item tool covering 4 domains with a 7-point Likert scale; 3 domains (symptoms, daily activities, and treatment concerns) were used in this study. Blinded to patients' responses, treating physicians answered a 3-item questionnaire quantifying each patient's AFEQT domain with a single item. Patients' mean Likert scale responses within each AFEQT domain were subtracted from the physicians' assessments so that higher scores (≥0.5 points) indicate physician underestimation, while lower scores (≤0.5 points) indicate physician overestimation of the health status of patients with AF. Main Outcomes and Measures: The independent association of physician-patient concordance with treatment escalation (alteration or initiation of antiarrhythmic drugs, cardioversion, or catheter ablation) and 1-year adjusted changes in AFEQT scores. Results: Among 330 patients (238 [72.1%] men; mean [SD] age, 67.9 [11.9] years; 163 [49.4%] with paroxysmal AF), physicians correctly estimated health status in 112 patients (33.9%), underestimated it in 42 patients (12.7%), and overestimated it in 176 patients (53.3%). Treatment escalation occurred in 63.6% of patients whose health status was correctly estimated, 47.6% of those whose health status was underestimated, and 66.3% of patients whose health status was overestimated. After multivariable adjustment, underestimation of health status was independently associated with less treatment escalation (adjusted odds ratio, 0.43; 95% CI, 0.20-0.90) and less frequent AFEQT overall summary score improvement at 1 year (underestimated, 2.5 [95% CI, -1.6 to 6.7] vs correctly and overestimated health status, 8.4 [95% CI, 7.0-9.9] points; P = .01). Conclusions and Relevance: In this cohort study, physician underestimation of the health status of patients with AF was common and associated with less aggressive treatment and less health status improvement at 1 year.