Percutaneous coronary intervention during the COVID-19 pandemic in Japan: Insights from the nationwide registration data.

[Background] Coronavirus disease 2019 (COVID-19) has negatively affected access to healthcare systems and treatment timelines. This study was designed to explore the impact of the COVID-19 pandemic on patients who underwent percutaneous coronary intervention (PCI). [Methods] From January 2019 to December 2020, 489, 001 patients from 1068 institutions were registered in the Japanese nationwide PCI (J-PCI) registry. We constructed generalized linear models to assess the difference in the daily number of patients and in-hospital outcomes between 2019 and 2020. [Findings] In total, 207 institutions (19·3%) had closed or restricted access during the first COVID-19 outbreak in May 2020; the number of closed or restricted institutions had plateaued at a median of 121 institutions (11·3%). The daily case volume of PCI significantly decreased in 2020 (by 6·7% compared with that in 2019; 95% confidence interval [CI], 6·2–7·2%; p < 0·001). Marked differences in the presentation of PCI patients were observed; more patients presented with ST-segment elevation myocardial infarction (18·3% vs. 17·5%; p < 0·001), acute heart failure (4·49% vs. 4·30%; p = 0·001), cardiogenic shock (3·79% vs. 3·45%; p < 0·001), and cardiopulmonary arrest (2·12% vs. 2·00%; p = 0·002) in 2020. The excess adjusted in-hospital mortality rate in patients treated in 2020 relative to those treated in 2019 was significant (adjusted odds ratio, 1·054; 95% CI, 1·004–1·107; p = 0·03). [Interpretation] While the number of patients who underwent PCI substantially decreased during the COVID-19 pandemic, more patients presented with high-risk characteristics and were associated with significantly higher adjusted in-hospital mortality. [Funding] The J-PCI registry is a registry led and supported by the Japanese Association of Cardiovascular Intervention and Therapeutics. The present study was supported by the Grant-in-Aid from the Ministry of Health and Labour (No. 20IA2002 and 21FA1015), the Grants-in-Aid for Scientific Research from the Japan Society for the Promotion of Science (KAKENHI; No. 21K08064), and the Japan Agency for Medical Research and Development (No. 17ek0210097h000)

Outcome of hospitalised heart failure in Japan and the United Kingdom stratified by plasma N-terminal pro-B-type natriuretic peptide

© 2018, Springer-Verlag GmbH Germany, part of Springer Nature. Background: Mortality subsequent to a hospitalisation for heart failure is reported to be much lower in Japan than in the United Kingdom (UK). This could reflect differences in disease severity or in management. Accordingly, we directly compared patient backgrounds and outcomes between Japan and UK. Methods: Consecutive patients admitted to academic hospitals in the UK and Japan with heart failure had a common set of variables, including plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP), collected during admission. Mortality during hospitalisations, at 90 and 180 days was recorded and stratified by quintile of NT-proBNP. Results: Overall, 935 patients were enrolled; 197 from UK and 738 from Japan. Median (interquartile range) age [UK: 78 (71–88) vs. Japan: 78 (70–84) years; p = 0.947], glomerular filtration rate [UK: 49 (34–68) vs. Japan: 49 (33–65) ml/min/1.73 m2; p = 0.209] and plasma NT-proBNP [UK: 4957 (2278–10,977) vs. Japan: 4155 (1972–9623) ng/l; p = 0.186] were similar, but systolic blood pressure was lower in the UK [118 (105–131) vs. 137 (118–159) mmHg; p < 0.001]. Patients with a higher plasma NT-proBNP had a worse prognosis in both countries; in-hospital and post-discharge mortality rates were higher in the UK even after adjusting for prognostic variables including NT-proBNP. Conclusions: This analysis suggests that either unobserved differences in patient characteristics or differences in care (formal or informal) rather than greater heart failure severity may account for the worse outcome of heart failure in the UK compared to Japan

Validation of U.S. mortality prediction models for hospitalized heart failure in the United Kingdom and Japan: Validation of risk models in decompensated heart failure

Aims: Prognostic models for hospitalised heart failure (HHF) were developed predominantly for patients of European origin in the United States of America; it is unclear whether they perform similarly in other health-care systems or for different ethnicities. We sought to validate published prediction models for HHF in the United Kingdom (UK) & Japan.Methods and Results: Patients in the UK (894) and Japan (3,158) were prospectively enrolled and similar in terms of sex (~60% men) and median age (~77 years). Models predicted that British patients would have a higher mortality than Japanese, which was indeed true both for in-hospital [4.8% vs 2.5%] and 180-day [20.7% vs 9.5%] mortality. The model c-statistics for the published/derivation [range 0.70-0.76] and Japanese [range 0.75-0.77] cohorts were similar and higher than for the UK [0.62-0.75] but models consistently over-estimated mortality in Japan. For in-hospital mortality, OPTIMIZE-HF performed best, providing similar discrimination in published/derivation, UK and Japanese cohorts [c-indices: 0.75 (0.74-0.77); 0.75 (0.68 - 0.81) and 0.77 (0.70 - 0.83)], and least over-estimated mortality in Japan. For 180-day mortality, the cstatistics for ASCEND-HF were similar in published/derivation [0.70] and UK [0.69 (0.64 - 0.74)] cohorts but higher in Japan [0.75 (0.71 - 0.79)]; calibration was good in the UK but again over-estimated mortality in Japan.Conclusion: Calibration of published prediction models appear moderately accurate and unbiased when applied to British patients but consistently overestimate mortality in Japan. Identifying the reason why patients in Japan have a better than predicted prognosis is of great interest

Effectiveness and Safety of Apixaban in over 3.9 Million People with Atrial Fibrillation: A Systematic Review and Meta-Analysis

Background: There is a plethora of real-world data on the safety and effectiveness of direct-acting oral anticoagulants (DOACs); however, study heterogeneity has contributed to inconsistent findings. We compared the effectiveness and safety of apixaban with those of other direct-acting oral anticoagulants (DOACs) and vitamin K antagonists (VKA e.g., warfarin). Methods: A systematic review and meta-analysis was conducted retrieving data from PubMed, SCOPUS and Web of Science from January 2009 to December 2021. Studies that evaluated apixaban (intervention) prescribed for adults (aged 18 years or older) with AF for stroke prevention compared to other DOACs or VKAs were identified. Primary outcomes included stroke/systemic embolism (SE), all-cause mortality, and major bleeding. Secondary outcomes were intracranial haemorrhage (ICH) and ischaemic stroke. Randomised controlled trials and non-randomised trials were considered for inclusion. Results: In total, 67 studies were included, and 38 studies were meta-analysed. Participants taking apixaban had significantly lower stroke/SE compared to patients taking VKAs (relative risk (RR) 0.77, 95% confidence interval (CI) 0.64–0.93, I2 = 94%) and dabigatran (RR 0.84, 95% CI 0.74–0.95, I2 = 66%), but not to patients administered rivaroxaban. There was no statistical difference in mortality between apixaban and VKAs or apixaban and dabigatran. Compared to patients administered rivaroxaban, participants taking apixaban had lower mortality rates (RR 0.83, 95% CI 0.71–0.96, I2 = 96%). Apixaban was associated with a significantly lower risk of major bleeding compared to VKAs (RR 0.58, 95% CI 0.52–0.65, I2 = 90%), dabigatran (RR 0.79, 95% CI 0.70–0.88, I2 = 78%) and rivaroxaban (RR 0.61, 95% CI 0.53–0.70, I2 = 87%). Conclusions: Apixaban was associated with a better overall safety and effectiveness profile compared to VKAs and other DOACs.</jats:p

Mortality after admission for heart failure in the UK compared with Japan

Objective Mortality amongst patients hospitalised for heart failure (HHF) in Western and Asian countries may differ, but this has not been investigated using individual patient-level data (IPLD). We sought to remedy this through rigorous statistical analysis of HHF registries and variable selection from a systematic literature review.Methods and results IPLD from registries of HHF in Japan (n=3781) and the UK (n=894) were obtained. A systematic literature review identified 23 models for predicting outcome of HHF. Five variables appearing in 10 or more reports were strongly related to prognosis (systolic blood pressure, serum sodium concentration, age, blood urea nitrogen and creatinine). To compare mortality in the UK and Japan, variables were imputed in a propensity model using inverse probability of treatment weighting (IPTW) and IPTW with logistic regression (doubly robust IPTW). Overall, patients in the UK were sicker and in-patient and post-discharge mortalities were greater, suggesting that the threshold for hospital admission was higher. Covariate-adjusted in-hospital mortality was similar in the UK and Japan (IPTW OR: 1.14, 95% CI 0.70 to 1.86), but 180-day postdischarge mortality was substantially higher in the UK (doubly robust IPTW OR: 2.33, 95% CI 1.58 to 3.43).Conclusions Despite robust methods to adjust for differences in patient characteristics and disease severity, HHF patients in the UK have roughly twice the mortality at 180 days compared with those in Japan. Similar analyses should be done using other data sets and in other countries to determine the consistency of these findings and identify factors that might inform healthcare policy and improve outcomes

Risk of cardiovascular events and death associated with initiation of SGLT2 inhibitors compared with DPP-4 inhibitors:an analysis from the CVD-REAL 2 multinational cohort study

Background Cardiovascular outcome trials have shown cardiovascular benefit with sodium-glucose co-transporter-2 (SGLT2) inhibitors in patients with type 2 diabetes, whereas dipeptidyl peptidase-4 (DPP-4) inhibitors have not shown an effect. We aimed to address knowledge gaps regarding the comparative effectiveness of SGLT2 inhibitor use in clinical practice (with DPP-4 inhibitor use as an active comparator) across a range of cardiovascular risks and in diverse geographical settings. Methods In this comparative cohort study, we used data from clinical practice from 13 countries in the Asia-Pacific, Middle East, European, and North American regions to assess the risk of cardiovascular events and death in adult patients with type 2 diabetes newly initiated on SGLT2 inhibitors compared with those newly initiated on DPP-4 inhibitors. De-identified health records were used to select patients who were initiated on these drug classes between Dec 1, 2012, and May 1, 2016, with follow-up until Dec 31, 2014, to Nov 30, 2017 (full range; dates varied by country). Non-parsimonious propensity scores for SGLT2 inhibitor initiation were developed for each country and patients who were initiated on an SGLT2 inhibitor were matched with those who were initiated on a DPP-4 inhibitor in a 1:1 ratio. Outcomes assessed were hospitalisation for heart failure, all-cause death, myocardial infarction, and stroke. Hazard ratios (HRs) were estimated by country and then pooled in a weighted meta-analysis. Findings Following propensity score matching, 193 124 new users of SGLT2 inhibitors and 193 124 new users of DPP-4 inhibitors were included in the study population. Participants had a mean age of 58 years (SD 12.2), 170 335 (44.1%) of 386 248 were women, and 111933 (30.1%) of 372 262 had established cardiovascular disease. Initiation of an SGLT2 inhibitor versus a DPP-4 inhibitor was associated with substantially lower risks of hospitalisation for heart failure (HR 0.69, 95% CI 0. 61-0. 77; p Interpretation In this large, international, observational study, initiation of SGLT2 inhibitors versus DPP-4 inhibitors was associated with lower risks of heart failure, death, myocardial infarction, and stroke, providing further support for the cardiovascular benefits associated with use of SGLT2 inhibitors in patients with type 2 diabetes. Copyright (C) 2020 Elsevier Ltd. All rights reserved