Ikuko Ueda

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.

Performance and Validation of the U.S. NCDR Acute Kidney Injury Prediction Model in Japan.

BACKGROUND Stratifying patient risk for acute kidney injury (AKI) prior to percutaneous coronary intervention (PCI) can enable clinicians to tailor their approach to minimize AKI. The National Cardiovascular Data Registry (NCDR) CathPCI Registry recently developed 2 prediction models: for AKI and AKI requiring dialysis (AKI-D). OBJECTIVES This study sought to externally validate the NCDR AKI and AKI-D models in a Japanese population. Determining the generalizability of the U.S. model could support quality improvement efforts in Japan. METHODS The NCDR prediction models were applied to 11,041 consecutive patients in the Japanese multicenter PCI registry. AKI was defined as an absolute increase ≥ 0.3 mg/dl or a relative increase of 50% in serum creatinine, in accordance with the definition of AKI Network criteria; AKI-D was defined as initiation of dialysis after PCI. Discrimination and calibration of the NCDR models were tested in the Japanese cohort. If the model was perfectly calibrated, the slope and intercept would equal 1.0 and 0.0, respectively. RESULTS In the Japanese PCI cohort, AKI and AKI-D occurred in 10.5% and 1.5% of patients, respectively. The NCDR AKI prediction model showed good discrimination (c-statistic = 0.76) and calibration (slope = 0.93 and intercept = -0.10) in both acute and nonacute PCI. The AKI-D prediction model had good discrimination (c-statistic = 0.92), but while the calibration slope was good (1.04), the intercept was significantly underestimated (0.96). However, this was corrected with recalibration (slope = 1.04 and intercept = -0.087). CONCLUSIONS In a Japanese population, the NCDR AKI models validly predict post-procedural AKI and, with recalibration, AKI-D. Prospective use of these models to inform clinical decision making should be tested as a means of reducing AKI after PCI in Japan. (Japan Cardiovascular Database, Percutaneous Coronary Intervention Registry; UMIN R000004736).

Use of Intra-aortic Balloon Pump in a Japanese Multicenter Percutaneous Coronary Intervention Registry

This problem is well illustrated in the study by Mangurian et al1 in this issue of JAMA Internal Medicine. The authors used CaliforniaMedicaiddatatoidentifypatientswhowereprescribed an antipsychotic medication. They then assessed what percentage of the patients had some form of glucose screening, a recommendation by the American Diabetes Association2 for persons taking antipsychotic medications, in a yearlong period. Overall, 30.1% of individuals were screened. It would be fair to point out that the efficacy of screening for diabetes has not been well established. However, that less than one-third had such screening for a known adverse effect of antipsychotic medication use suggests opportunities for improvement in integrated health care. Among those who had at least 1 primary care visit during the year, the proportion screened was significantly higher at 35.6% vs 19.8% for those who had no primary care visit. To improve care for persons with serious mental illness, it will be necessary to break down the silos that separate the mental health and physical health care systems. Integrated care (care provided by a team of physical and mental health clinicians)—or at least colocated care (care provided by physical and mental health clinicians in the same place)—offers the promise of improving the physical health of individuals with mental illness, as well as the mental health of those seeking physical health services.

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. METHODSANDRESULTS 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.

Location of the culprit coronary lesion and its association with delay in door-to-balloon time (from a multicenter registry of primary percutaneous coronary intervention)

Current guidelines recommend shorter door-to-balloon times (DBTs) (<90 minutes) for patients with ST-elevation myocardial infarction (STEMI). Clinical factors, including patient or hospital characteristics, associated with prolonged DBT have been identified, but angiographic variables such as culprit lesion location have not been thoroughly investigated. We aimed to evaluate the effect of culprit artery location on DBT of patients with STEMI who underwent percutaneous coronary intervention (PCI). Data were analyzed from 1,725 patients with STEMI who underwent PCI from August 2008 to March 2014 at 16 Japanese hospitals. Patients were divided into 3 groups according to culprit artery location, right coronary artery (RCA), left anterior descending artery (LAD), and left circumflex artery (LC), and associations with DBT were assessed. The LC group had a trend toward a longer DBT among the 3 groups (97.1 [RCA] vs 98.1 [LAD] vs 105.1 [LC] minutes; p = 0.058). In-hospital mortality was also significantly higher in patients with a left coronary artery lesion (3.5% [RCA] vs 6.3% [LAD] vs 5.4% [LC]; p = 0.041). In-hospital mortality for patients with DBT >90 minutes was significantly higher compared with patients with DBT ≤90 minutes (6.5% vs 3.6%; p = 0.006). Multivariate logistic regression analysis revealed that the LC location was an independent predictor for DBT >90 minutes (odds ratio, 1.45; 95% confidence interval, 1.04 to 2.01; p = 0.028). In conclusion, LC location was an independent predictor of longer DBT. The difficulties in diagnosing LC-related STEMI need further evaluation.

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.

Necessity for primary care immediately after the March 11 tsunami and earthquake in Japan

death. Finally, a comparable cohort of 12 108 patients was analyzed in New Zealand and Australia. Again, the hyperoxia group showed an increased risk of mortality compared with the normoxia group (OR, 1.2; 95% CI, 1.1-1.6). Although the statistical significance of this finding was not maintained after multivariable adjustment, certainly no beneficial effects of hyperoxia were found. In the management of ischemic stroke, a randomized trial suggested that hyperbaric oxygen may adversely affect stroke severity. With regard to normobaric oxygen, 3 randomized trials were performed. One showed no benefit on clinical outcome. Another trial in nonhypoxic patients found lower survival at 1 year (OR, 0.45; 95% CI, 0.23-0.90) in those who received supplemental oxygen during initial treatment. The third randomized trial was terminated in 2009 after enrolling 85 patients because of excess mortality in the hyperoxia group (40% vs 17% [P=.01 by our own calculation]) (Clinical Trial of Normobaric Oxygen Therapy in Acute Ischemic Stroke [not published]; clinicaltrials.gov Identifier: NCT00414726). Although an external monitor judged the excess mortality as “unrelated to oxygen treatment,” these results are important because this was the largest randomized trial investigating oxygen treatment for ischemic stroke, and it is remarkable that these results have not (yet) been published. In the management of COPD, the risks of oxygen supplementation are widely acknowledged. Administration of oxygen in patients with COPD may cause hypercapnia due to ventilation-perfusion mismatching, the Haldane effect, inhibition of hypoxic drive, and atelectasis. Guidelines recommend a maximum FIO2 of 0.28. However, patients with COPD often receive higher doses, especially during ambulance transportation, causing hypercapnia and increased mortality. Recently, a randomized trial compared high concentration oxygen with titrated oxygen in prehospital patients with exacerbation of COPD. Mortality was lower in patients receiving titrated oxygen (RR, 0.42; 95% CI, 0.20-0.89). In those with laterconfirmed COPD, mortality reduction was even stronger (RR, 0.22; 95% CI, 0.05-0.91).

Patterns of statin non-prescription in patients with established coronary artery disease: A report from a contemporary multicenter Japanese PCI registry

Statin therapy is regarded as an effective medication to reduce cardiovascular events in patients at higher risk for future incidence of coronary artery disease. However, very few studies have been conducted to examine its implementation in non-Western real-world practice. In this study, we sought to describe statin prescription patterns in relation to patient characteristics in a Japanese multicenter percutaneous coronary intervention (PCI) registry as a foundation for quality improvement. We studied 15,024 patients that were prospectively enrolled in the Japan Cardiovascular Database-Keio interhospital Cardiovascular Study Registry from January 2009 to August 2014. The overall discharge statin non-prescription rate was 15.2%, without significant interhospital (MOR = 1.01) or annual differences (MOR = 1.13) observed. Hierarchical multivariable logistic regression analysis accounting for regional differences revealed that the presence of chronic kidney disease was associated with higher rates of statin non-prescription (OR 1.87, 95% confidence interval, 1.69–2.08, p value <0.001), and higher age (per 1-year increase) showed a trend for prescription of low-intensity statin (OR 1.00, 95% confidence interval, 1.00–1.01, p value = 0.045) within the subset of PCI patients (N = 4,853) enrolled after the year 2011. Our study indicates that patients with chronic kidney disease and elderlies may be the primary targets for maximizing the beneficial effect of statin therapy in post PCI patients.

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 patients 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