Impact of early death recording on international comparison of acute myocardial infarction mortality - administrative hospital data study using the example of Germany and the United States.

BACKGROUND: In-hospital mortality from acute myocardial infarction (AMI) is widely used in international comparisons as an indicator of health system performance. Because of the high risk of early death after AMI, international comparisons may be biased by differences in the recording of early death cases in hospital inpatient data. This study examined whether differences in the recording of early deaths affect international comparisons of AMI in-hospital mortality by using the example of Germany and the United States, and explored approaches to address this issue. METHODS: The German Diagnosis-Related Groups Statistics (DRG Statistics), the U.S. National Inpatient Sample (NIS) and the U.S. Nationwide Emergency Department Sample (NEDS) were analysed from 2014 to 2019. Cases with treatment for AMI were identified in German and U.S. inpatient data. AMI deaths occurring in the emergency department (ED) without inpatient admission were extracted from NEDS data. 30-day in-hospital mortality figures were calculated according to the OECD indicator definition (unlinked data) and modified by including ED deaths, or excluding all same-day cases. RESULTS: German age-and-sex standardized 30-day in-hospital mortality was substantially higher compared to the U.S. (in 2019, 7.3% vs. 4.6%). The ratio of German vs. U.S. mortality was 1.6. After inclusion of ED deaths in U.S. data this ratio declined to 1.4. Exclusion of same-day cases in German and U.S. data led to a similar ratio. CONCLUSIONS: While short-duration treatments due to early death are generally recorded in German inpatient data, in U.S. inpatient data those cases are partially missing. Excluding cases with short-duration treatment from the calculation of mortality indicators could be a feasible approach to account for differences in the recording of early deaths, that might be existent in other countries as well.

Hospital competition and health outcomes: Evidence from acute myocardial infarction admissions in Germany.

Countries increasingly rely on competition among hospitals to improve health outcomes. However, there is limited empirical evidence on the effect of competition on health outcomes in Germany. We examined the effect of hospital competition on quality of care, which is assessed using health outcomes (risk-adjusted in-hospital and post-hospitalization mortality and cardiac-related readmissions), focusing on acute myocardial infarction (AMI) treatment. We obtained data on all hospital utilizations and mortality of 13.2% of the population from a large statutory health insurer and all AMI admission records from Diagnosis-Related Groups Statistic from 2015-19. We constructed the measures of hospital competition, which mitigates the possibility of endogeneity bias. The relationships between health outcomes and competition measures are estimated using linear probability models. Intense competition was associated with lower quality of care in terms of mortality and cardiac-related readmissions. Patients treated in hospitals facing high competition were 0.9 (1.2) percentage points more likely to die within 90 days (2 years) of admission, and 1.4 (1.6) percentage points more likely to be readmitted within 90 days (2 years) of discharge than patients treated in hospitals facing low competition. Our results indicate that hospital competition does not lead to better health outcomes for AMI patients in Germany. Therefore, additional measures are necessary to achieve quality improvement.

Socioeconomic disparities in the management and outcomes of acute myocardial infarction.

BACKGROUND: Patients from lower socioeconomic status areas have poorer outcomes following acute myocardial infarction (AMI); however, how ethnicity modifies such socioeconomic disparities is unclear. METHODS: Using the UK Myocardial Ischaemia National Audit Project (MINAP) registry, we divided 370 064 patients with AMI into quintiles based on Index of Multiple Deprivation (IMD) score, comprising seven domains including income, health, employment and education. We compared white and 'ethnic-minority' patients, comprising Black, Asian and mixed ethnicity patients (as recorded in MINAP); further analyses compared the constituents of the ethnic-minority group. Logistic regression models examined the role of the IMD, ethnicity and their interaction on the odds of in-hospital mortality. RESULTS: More patients from the most deprived quintile (Q5) were from ethnic-minority backgrounds (Q5; 15% vs Q1; 4%). In-hospital mortality (OR 1.10, 95% CI 1.01 to 1.19, p=0.025) and major adverse cardiovascular event (MACE) (OR 1.07, 95% CI 1.00 to 1.15, p=0.048) were more likely in Q5, and MACE was more likely in ethnic-minority patients (OR 1.40, 95% CI 1.00 to 1.95, p=0.048) versus white (OR 1.05, 95% CI 0.98 to 1.13, p=0.027) in Q5. In subgroup analyses, Black patients had the highest in-hospital mortality within the most affluent quintile (Q1) (Black: 0.079, 95% CI 0.046 to 0.112, p<0.001; White: 0.062, 95% CI 0.059 to 0.066, p<0.001), but not in Q5 (Black: 0.065, 95% CI 0.054 to 0.077, p<0.001; White: 0.065, 95% CI 0.061 to 0.069, p<0.001). CONCLUSION: Patients with a higher deprivation score were more often from an ethnic-minority background, more likely to suffer in-hospital mortality or MACE when compared with the most affluent quintile, and this relationship was stronger in ethnic minorities compared with White patients.

Differences in Treatment Patterns and Outcomes of Acute Myocardial Infarction for Low- and High-Income Patients in 6 Countries.

Importance: Differences in the organization and financing of health systems may produce more or less equitable outcomes for advantaged vs disadvantaged populations. We compared treatments and outcomes of older high- and low-income patients across 6 countries. Objective: To determine whether treatment patterns and outcomes for patients presenting with acute myocardial infarction differ for low- vs high-income individuals across 6 countries. Design, Setting, and Participants: Serial cross-sectional cohort study of all adults aged 66 years or older hospitalized with acute myocardial infarction from 2013 through 2018 in the US, Canada, England, the Netherlands, Taiwan, and Israel using population-representative administrative data. Exposures: Being in the top and bottom quintile of income within and across countries. Main Outcomes and Measures: Thirty-day and 1-year mortality; secondary outcomes included rates of cardiac catheterization and revascularization, length of stay, and readmission rates. Results: We studied 289 376 patients hospitalized with ST-segment elevation myocardial infarction (STEMI) and 843 046 hospitalized with non-STEMI (NSTEMI). Adjusted 30-day mortality generally was 1 to 3 percentage points lower for high-income patients. For instance, 30-day mortality among patients admitted with STEMI in the Netherlands was 10.2% for those with high income vs 13.1% for those with low income (difference, -2.8 percentage points [95% CI, -4.1 to -1.5]). One-year mortality differences for STEMI were even larger than 30-day mortality, with the highest difference in Israel (16.2% vs 25.3%; difference, -9.1 percentage points [95% CI, -16.7 to -1.6]). In all countries, rates of cardiac catheterization and percutaneous coronary intervention were higher among high- vs low-income populations, with absolute differences ranging from 1 to 6 percentage points (eg, 73.6% vs 67.4%; difference, 6.1 percentage points [95% CI, 1.2 to 11.0] for percutaneous intervention in England for STEMI). Rates of coronary artery bypass graft surgery for patients with STEMI in low- vs high-income strata were similar but for NSTEMI were generally 1 to 2 percentage points higher among high-income patients (eg, 12.5% vs 11.0% in the US; difference, 1.5 percentage points [95% CI, 1.3 to 1.8 ]). Thirty-day readmission rates generally also were 1 to 3 percentage points lower and hospital length of stay generally was 0.2 to 0.5 days shorter for high-income patients. Conclusions and Relevance: High-income individuals had substantially better survival and were more likely to receive lifesaving revascularization and had shorter hospital lengths of stay and fewer readmissions across almost all countries. Our results suggest that income-based disparities were present even in countries with universal health insurance and robust social safety net systems.

How real can we get in generating real world evidence? Exploring the opportunities of routinely collected administrative data for evaluation of medical devices.

Real-world data are considered a potentially valuable source of evidence for assessing medical technologies in clinical practice, but their widespread use is hampered by numerous challenges. Using the case of coronary stents in Italy, we investigate the potential of administrative databases for estimating costs and health outcomes associated with the use of medical devices in real world conditions. An administrative dataset was created ad hoc by merging hospital records from patients admitted between 2013 and 2019 for stent implantations with ambulatory records, pharmaceutical use data and vital statistics. Health outcomes were multifold: all-cause and cardiac mortality and myocardial infarction, within 30 days, 1, 2, 5 years. Costs were estimated from the National Health System perspective. We used multivariable Cox models and propensity score (PS) methods (PS matching; stratification on PS; inverse probability of treatment weighting using PS; PS adjustment). 257,907 coronary stents were implanted in 113,912 patients. For all health outcomes and follow-up times, and across all methods, patients receiving drug-eluting stents (DES) presented lower risk. For all-cause mortality, the DES patient advantage over bare-metal stent (BMS) patients declined over time but remained significant even at 5 years. For myocardial infarction, results remained quite stable. The DES group presented lower cumulative total costs (ranging from 3264 to 2363 Euros less depending on methods). Our results confirm the consolidated evidence of the benefits of DES compared to BMS. The consistency of results across methods suggests internal validity of the study, while highlighting strengths and limitations of each depending on research context. Administrative data yield great potential to perform comparative effectiveness and cost-effectiveness analysis of medical devices provided certain conditions are met.

Rural-Urban Disparities in Outcomes of Myocardial Infarction, Heart Failure, and Stroke in the United States.

BACKGROUND: U.S. policy efforts have focused on reducing rural-urban health inequities. However, it is unclear whether gaps in care and outcomes remain among older adults with acute cardiovascular conditions. OBJECTIVES: This study aims to evaluate rural-urban differences in procedural care and mortality for acute myocardial infarction (AMI), heart failure (HF), and ischemic stroke. METHODS: This is a retrospective cross-sectional study of Medicare fee-for-service beneficiaries aged ≥65 years with acute cardiovascular conditions from 2016 to 2018. Cox proportional hazards models with random hospital intercepts were fit to examine the association of presenting to a rural (vs urban) hospital and 30- and 90-day patient-level mortality. RESULTS: There were 2,182,903 Medicare patients hospitalized with AMI, HF, or ischemic stroke from 2016 to 2018. Patients with AMI were less likely to undergo cardiac catherization (49.7% vs 63.6%, P < 0.001), percutaneous coronary intervention (42.1% vs 45.7%, P < 0.001) or coronary artery bypass graft (9.0% vs 10.2%, P < 0.001) within 30 days at rural versus urban hospitals. Thrombolysis rates (3.1% vs 10.1%, P < 0.001) and endovascular therapy (1.8% vs 3.6%, P < 0.001) for ischemic stroke were lower at rural hospitals. After adjustment for demographics and clinical comorbidities, the 30-day mortality HR was significantly higher among patients presenting to rural hospitals for AMI (HR: 1.10, 95% CI: 1.08 to 1.12), HF (HR: 1.15; 95% CI: 1.13 to 1.16), and ischemic stroke (HR: 1.20; 95% CI: 1.18 to 1.22), with similar patterns at 90 days. These differences were most pronounced for the subset of critical access hospitals that serve remote, rural areas. CONCLUSIONS: Clinical, public health, and policy efforts are needed to improve rural-urban gaps in care and outcomes for acute cardiovascular conditions.

Demographic and Regional Trends of Mortality in Patients With Acute Myocardial Infarction in the United States, 1999 to 2019.

Acute myocardial infarction (AMI)-related mortality has been decreasing within the United States because of improvements in management and preventive efforts; however, persistent disparities in demographic subsets such as race may exist. In this study, the nationwide trends in mortality related to AMI in adults in the United States from 1999 to 2019 are described. Trends in mortality related to AMI were assessed through a cross-sectional analysis of the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database. Age-adjusted mortality rates per 100,000 people and associated annual percentage change and average annual percentage changes with 95% confidence intervals (CIs) were determined. Joinpoint regression was used to assess the trends in the overall, demographic (gender, race/ethnicity, age), and regional groups. Between 1999 and 2019, a total of 3,655,274 deaths related to AMI occurred. In the overall population, age-adjusted mortality rates decreased from 134.7 (95% CI 134.2 to 135.3) in 1999 to 48.5 (95% CI 48.3 to 48.8) in 2019 with an average annual percentage change of -5.0 (95% CI -5.5 to -4.6). Higher mortality rates were seen in Black individuals, men, and those living in the South. Patients older than 85 years experienced substantial decreases in mortality. In addition, rural counties had persistently higher mortality rates in comparison with urban counties. In conclusion, despite decreasing mortality rates in all groups, persistent disparities continued to exist throughout the study period.

Quality of Care Before and After Mergers and Acquisitions of Rural Hospitals.

Importance: Rural hospitals are increasingly merging with other hospitals. The associations of hospital mergers with quality of care need further investigation. Objectives: To examine changes in quality of care for patients at rural hospitals that merged compared with those that remained independent. Design, Setting, and Participants: In this case-control study, mergers at community nonrehabilitation hospitals in Federal Office of Rural Health Policy-eligible zip codes during 2009 to 2016 in 32 states were identified from Irving Levin Associates and the American Hospital Association Annual Survey. Outcomes for inpatient stays for select conditions and elective procedures were derived from the Healthcare Cost and Utilization Project State Inpatient Databases. Difference-in-differences linear probability models were used to assess premerger to postmerger changes in outcomes for patients discharged from merged vs comparison hospitals that remained independent. Data were analyzed from February to December 2020. Exposures: Hospital mergers. Main Outcomes and Measures: The main outcome was in-hospital mortality among patients admitted for acute myocardial infarction (AMI), heart failure, stroke, gastrointestinal hemorrhage, hip fracture, or pneumonia, as well as complications during stays for elective surgeries. Results: A total of 172 merged hospitals and 266 comparison hospitals were analyzed. After matching, baseline patient characteristics were similar for 303 747 medical stays and 175 970 surgical stays at merged hospitals and 461 092 medical stays and 278 070 surgical stays at comparison hospitals. In-hospital mortality among AMI stays decreased from premerger to postmerger at merged hospitals (9.4% to 5.0%) and comparison hospitals (7.9% to 6.3%). Adjusting for patient, hospital, and community characteristics, the decrease in in-hospital mortality among AMI stays 1 year postmerger was 1.755 (95% CI, -2.825 to -0.685) percentage points greater at merged hospitals than at comparison hospitals (P < .001). This finding held up to 4 years postmerger (DID, -2.039 [95% CI, -3.388 to -0.691] percentage points; P = .003). Greater premerger to postmerger decreases in mortality at merged vs comparison hospitals were also observed at 5 years postmerger among stays for heart failure (DID, -0.756 [95% CI, -1.448 to -0.064] percentage points; P = .03), stroke (DID, -1.667 [95% CI, -3.050 to -0.283] percentage points; P = .02), and pneumonia (DID, -0.862 [95% CI, -1.681 to -0.042] percentage points; P = .04). Conclusions and Relevance: These findings suggest that rural hospital mergers were associated with better mortality outcomes for AMI and several other conditions. This finding is important to enhancing rural health care and reducing urban-rural disparities in quality of care.

Fifteen-Year Trends in Incidence of Cardiogenic Shock Hospitalization and In-Hospital Mortality in the United States.

Background There is a lack of contemporary data on cardiogenic shock (CS) in-hospital mortality trends. Methods and Results Patients with CS admitted January 1, 2004 to December 31, 2018, were identified from the US National Inpatient Sample. We reported the crude and adjusted trends of in-hospital mortality among the overall population and selected subgroups. Among a total of 563 949 644 hospitalizations during the period from January 1, 2004, to December 30, 2018, 1 254 358 (0.2%) were attributed to CS. There has been a steady increase in hospitalizations attributed to CS from 122 per 100 000 hospitalizations in 2004 to 408 per 100 000 hospitalizations in 2018 (Ptrend<0.001). This was associated with a steady decline in the adjusted trends of in-hospital mortality during the study period in the overall population (from 49% in 2004 to 37% in 2018; Ptrend<0.001), among patients with acute myocardial infarction CS (from 43% in 2004 to 34% in 2018; Ptrend<0.001), and among patients with non-acute myocardial infarction CS (from 52% in 2004 to 37% in 2018; Ptrend<0.001). Consistent trends of reduced mortality were seen among women, men, different racial/ethnic groups, different US regions, and different hospital sizes, regardless of the hospital teaching status. Conclusions Hospitalizations attributed to CS have tripled in the period from January 2004 to December 2018. However, there has been a slow decline in CS in-hospital mortality during the studied period. Further studies are necessary to determine if the recent adoption of treatment algorithms in treating patients with CS will further impact in-hospital mortality.

Incorporating Present-on-Admission Indicators in Medicare Claims to Inform Hospital Quality Measure Risk Adjustment Models.

Importance: Present-on-admission (POA) indicators in administrative claims data allow researchers to distinguish between preexisting conditions and those acquired during a hospital stay. The impact of adding POA information to claims-based measures of hospital quality has not yet been investigated to better understand patient underlying risk factors in the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision setting. Objective: To assess POA indicator use on Medicare claims and to assess the hospital- and patient-level outcomes associated with incorporating POA indicators in identifying risk factors for publicly reported outcome measures used by the Centers for Medicare & Medicaid Services (CMS). Design, Setting, and Participants: This comparative effectiveness study used national CMS claims data between July 1, 2015, and June 30, 2018. Six hospital quality measures assessing readmission and mortality outcomes were modified to include POA indicators in risk adjustment models. The models using POA were then compared with models using the existing complications-of-care algorithm to evaluate changes in risk model performance. Patient claims data were included for all Medicare fee-for-service and Veterans Administration beneficiaries aged 65 years or older with inpatient hospitalizations for acute myocardial infarction, heart failure, or pneumonia within the measurement period. Data were analyzed between September 2019 and March 2020. Main Outcomes and Measures: Changes in patient-level (C statistics) and hospital-level (quintile shifts in risk-standardized outcome rates) model performance after including POA indicators in risk adjustment. Results: Data from a total of 6 027 988 index admissions were included for analysis, ranging from 491 366 admissions (269 209 [54.8%] men; mean [SD] age, 78.2 [8.3] years) for the acute myocardial infarction mortality outcome measure to 1 395 870 admissions (677 158 [48.5%] men; mean [SD] age, 80.3 [8.7] years) for the pneumonia readmission measure. Use of POA indicators was associated with improvements in risk adjustment model performance, particularly for mortality measures (eg, the C statistic increased from 0.728 [95% CI, 0.726-0.730] to 0.774 [95% CI, 0.773-0.776] when incorporating POA indicators into the acute myocardial infarction mortality measure). Conclusions and Relevance: The findings of this quality improvement study suggest that leveraging POA indicators in the risk adjustment methodology for hospital quality outcome measures may help to more fully capture patients' risk factors and improve overall model performance. Incorporating POA indicators does not require extra effort on the part of hospitals and would be easy to implement in publicly reported quality outcome measures.

Temporal Trends, Management and Outcomes of Acute Myocardial Infarction with Concomitant Respiratory Infections.

There are limited contemporary data on the management and outcomes of acute myocardial infarction (AMI) in patients with concomitant acute respiratory infections. Hence, using the National Inpatient Sample from 2000-2017, adult AMI admissions with and without concomitant respiratory infections were identified. We evaluated in-hospital mortality, utilization of cardiac procedures, hospital length of stay, hospitalization costs, and discharge disposition. Among 10,880,856 AMI admissions, respiratory infections were identified in 745,536 (6.9%). Temporal trends revealed a relatively stable tr end with a peak during 2008-2009. Admissions with respiratory infections were on average older (74 vs. 67 years), female (45% vs 39%), with greater comorbidity (mean Charlson comorbidity index 5.9 ± 2.2 vs 4.4 ± 2.3), and had higher rates of non-ST-segment-elevation AMI presentation (71.8% vs. 62.2%) (all p < 0.001). Higher rates of cardiac arrest (8.2% vs 4.8%), cardiogenic shock (10.7% vs 4.4%), and acute organ failure (27.8% vs 8.1%) were seen in AMI admissions with respiratory infections. Coronary angiography (41.4% vs 65.6%, p < 0.001) and percutaneous coronary intervention (20.7% vs 43.5%, p < 0.001) were used less commonly in those with respiratory infections. Admissions with respiratory infections had higher in-hospital mortality (14.5% vs 5.5%; propensity matched analysis: 14.6% vs 12.5%; adjusted odds ratio 1.25 [95% confidence interval 1.24-1.26], p < 0.001), longer hospital stay, higher hospitalization costs, and less frequent discharges to home compared to those without respiratory infections. In conclusion, respiratory infections significantly impact AMI admissions with higher rates of complications, mortality and resource utilization.

Cost-effectiveness of percutaneous coronary intervention versus medical therapy in patients with acute myocardial infarction: real-world and lifetime-horizon data from Taiwan.

Although some studies have assessed the cost-effectiveness of percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI), there has been a lack of nationwide real-world studies estimating life expectancy (LE), loss-of-LE, life-years saved, and lifetime medical costs. We evaluated the cost-effectiveness of PCI versus non-PCI therapy by integrating a survival function and mean-cost function over a lifelong horizon to obtain the estimations for AMI patients without major comorbidities. We constructed a longitudinal AMI cohort based on the claim database of Taiwan's National Health Insurance during 1999-2015. Taiwan's National Mortality Registry Database was linked to derive a survival function to estimate LE, loss-of-LE, life-years saved, and lifetime medical costs in both therapies. This study enrolled a total of 38,441 AMI patients; AMI patients receiving PCI showed a fewer loss-of-LE (3.6 versus 5.2 years), and more lifetime medical costs (US$ 49,112 versus US$ 43,532). The incremental cost-effectiveness ratio (ICER) was US$ 3488 per life-year saved. After stratification by age, the AMI patients aged 50-59 years receiving PCI was shown to be cost-saving. From the perspective of Taiwan's National Health Insurance, PCI is cost-effective in AMI patients without major comorbidities. Notably, for patients aged 50-59 years, PCI is cost-saving.

(Ultra-)long-acting insulin analogues for people with type 1 diabetes mellitus.

BACKGROUND: People with type 1 diabetes mellitus (T1DM) need treatment with insulin for survival. Whether any particular type of (ultra-)long-acting insulin provides benefit especially regarding risk of diabetes complications and hypoglycaemia is unknown. OBJECTIVES: To compare the effects of long-term treatment with (ultra-)long-acting insulin analogues to NPH insulin (neutral protamine Hagedorn) or another (ultra-)long-acting insulin analogue in people with type 1 diabetes mellitus. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We explored the US Food and Drug Administration (FDA) and European Medical Agency (EMA) web pages. We asked pharmaceutical companies, EMA and investigators for additional data and clinical study reports (CSRs). The date of the last search of all databases was 24 August 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with a duration of 24 weeks or more comparing one (ultra-)long-acting insulin to NPH insulin or another (ultra-)long-acting insulin in people with T1DM. DATA COLLECTION AND ANALYSIS: Two review authors assessed risk of bias using the new Cochrane 'Risk of bias' 2 (RoB 2) tool and extracted data. Our main outcomes were all-cause mortality, health-related quality of life (QoL), severe hypoglycaemia, non-fatal myocardial infarction/stroke (NFMI/NFS), severe nocturnal hypoglycaemia, serious adverse events (SAEs) and glycosylated haemoglobin A1c (HbA1c). We used a random-effects model to perform meta-analyses and calculated risk ratios (RRs) and odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) and 95% prediction intervals for effect estimates. We evaluated the certainty of the evidence applying the GRADE instrument. MAIN RESULTS: We included 26 RCTs. Two studies were unpublished. We obtained CSRs, clinical study synopses or both as well as medical reviews from regulatory agencies on 23 studies which contributed to better analysis of risk of bias and improved data extraction. A total of 8784 participants were randomised: 2428 participants were allocated to NPH insulin, 2889 participants to insulin detemir, 2095 participants to insulin glargine and 1372 participants to insulin degludec. Eight studies contributing 21% of all participants comprised children. The duration of the intervention varied from 24 weeks to 104 weeks. Insulin degludec versus NPH insulin: we identified no studies comparing insulin degludec with NPH insulin. Insulin detemir versus NPH insulin (9 RCTs): five deaths reported in two studies including adults occurred in the insulin detemir group (Peto OR 4.97, 95% CI 0.79 to 31.38; 9 studies, 3334 participants; moderate-certainty evidence). Three studies with 870 participants reported QoL showing no true beneficial or harmful effect for either intervention (low-certainty evidence). There was a reduction in severe hypoglycaemia in favour of insulin detemir: 171/2019 participants (8.5%) in the insulin detemir group compared with 138/1200 participants (11.5%) in the NPH insulin group experienced severe hypoglycaemia (RR 0.69, 95% CI 0.52 to 0.92; 8 studies, 3219 participants; moderate-certainty evidence). The 95% prediction interval ranged between 0.34 and 1.39. Only 1/331 participants in the insulin detemir group compared with 0/164 participants in the NPH insulin group experienced a NFMI (1 study, 495 participants; low-certainty evidence). No study reported NFS. A total of 165/2094 participants (7.9%) in the insulin detemir group compared with 102/1238 participants (8.2%) in the NPH insulin group experienced SAEs (RR 0.95, 95% CI 0.75 to 1.21; 9 studies, 3332 participants; moderate-certainty evidence). Severe nocturnal hypoglycaemia was observed in 70/1823 participants (3.8%) in the insulin detemir group compared with 60/1102 participants (5.4%) in the NPH insulin group (RR 0.67, 95% CI 0.39 to 1.17; 7 studies, 2925 participants; moderate-certainty evidence). The MD in HbA1c comparing insulin detemir with NPH insulin was 0.01%, 95% CI -0.1 to 0.1; 8 studies, 3122 participants; moderate-certainty evidence. Insulin glargine versus NPH insulin (9 RCTs): one adult died in the NPH insulin group (Peto OR 0.14, 95% CI 0.00 to 6.98; 8 studies, 2175 participants; moderate-certainty evidence). Four studies with 1013 participants reported QoL showing no true beneficial effect or harmful effect for either intervention (low-certainty evidence). Severe hypoglycaemia was observed in 122/1191 participants (10.2%) in the insulin glargine group compared with 145/1159 participants (12.5%) in the NPH insulin group (RR 0.84, 95% CI 0.67 to 1.04; 9 studies, 2350 participants; moderate-certainty evidence). No participant experienced a NFMI and one participant in the NPH insulin group experienced a NFS in the single study reporting this outcome (585 participants; low-certainty evidence). A total of 109/1131 participants (9.6%) in the insulin glargine group compared with 110/1098 participants (10.0%) in the NPH insulin group experienced SAEs (RR 1.08, 95% CI 0.63 to 1.84; 8 studies, 2229 participants; moderate-certainty evidence). Severe nocturnal hypoglycaemia was observed in 69/938 participants (7.4%) in the insulin glargine group compared with 83/955 participants (8.7%) in the NPH insulin group (RR 0.83, 95% CI 0.62 to 1.12; 6 studies, 1893 participants; moderate-certainty evidence). The MD in HbA1c comparing insulin glargine with NPH insulin was 0.02%, 95% CI -0.1 to 0.1; 9 studies, 2285 participants; moderate-certainty evidence. Insulin detemir versus insulin glargine (2 RCTs),insulin degludec versus insulin detemir (2 RCTs), insulin degludec versus insulin glargine (4 RCTs): there was no evidence of a clinically relevant difference for all main outcomes comparing (ultra-)long-acting insulin analogues with each other. For all outcomes none of the comparisons indicated differences in tests of interaction for children versus adults. AUTHORS' CONCLUSIONS: Comparing insulin detemir with NPH insulin for T1DM showed lower risk of severe hypoglycaemia in favour of insulin detemir (moderate-certainty evidence). However, the 95% prediction interval indicated inconsistency in this finding. Both insulin detemir and insulin glargine compared with NPH insulin did not show benefits or harms for severe nocturnal hypoglycaemia. For all other main outcomes with overall low risk of bias and comparing insulin analogues with each other, there was no true beneficial or harmful effect for any intervention. Data on patient-important outcomes such as QoL, macrovascular and microvascular diabetic complications were sparse or missing. No clinically relevant differences were found between children and adults.

Temporal Trends, Predictors, and Outcomes of Acute Ischemic Stroke in Acute Myocardial Infarction in the United States.

Background There are limited contemporary data prevalence and outcomes of acute ischemic stroke (AIS) complicating acute myocardial infarction (AMI). Methods and Results Adult (>18 years) AMI admissions using the National Inpatient Sample database (2000-2017) were evaluated for in-hospital AIS. Outcomes of interest included in-hospital mortality, hospitalization costs, length of stay, discharge disposition, and use of tracheostomy and percutaneous endoscopic gastrostomy. The discharge destination was used to classify survivors into good and poor outcomes. Of a total 11 622 528 AMI admissions, 183 896 (1.6%) had concomitant AIS. As compared with 2000, in 2017, AIS rates increased slightly among ST-segment-elevation AMI (adjusted odds ratio, 1.10 [95% CI, 1.04-1.15]) and decreased in non-ST-segment-elevation AMI (adjusted odds ratio, 0.47 [95% CI, 0.46-0.49]) admissions (P<0.001). Compared with those without, the AIS cohort was on average older, female, of non-White race, with greater comorbidities, and higher rates of arrhythmias. The AMI-AIS admissions received less frequent coronary angiography (46.9% versus 63.8%) and percutaneous coronary intervention (22.7% versus 41.8%) (P<0.001). The AIS cohort had higher in-hospital mortality (16.4% versus 6.0%; adjusted odds ratio, 1.75 [95% CI, 1.72-1.78]; P<0.001), longer hospital length of stay, higher hospitalization costs, greater use of tracheostomy and percutaneous endoscopic gastrostomy, and less frequent discharges to home (all P<0.001). Among AMI-AIS survivors (N=153 318), 57.3% had a poor functional outcome at discharge with relatively stable temporal trends. Conclusions AIS is associated with significantly higher in-hospital mortality and poor functional outcomes in AMI admissions.

Age-Stratified Sex-Related Differences in the Incidence, Management, and Outcomes of Acute Myocardial Infarction.

OBJECTIVE: To assess the impact of female sex on the incidence, management, and outcomes of myocardial infarction (MI) in different age groups. METHODS: Patients admitted with ST-elevation MI (STEMI) and non-ST-elevation MI (NSTEMI), between January 1, 2003, and December 31, 2015, were identified in the National Inpatient Sample. We compared STEMI and NSTEMI rates, management patterns, and in-hospital morbidity and mortality in men and women stratified into 4 age groups (<45, 45 to 64, 65 to 84, and ≥85 years of age). RESULTS: A total of 6,720,639 weighted hospitalizations for MI (79.8% NSTEMI, and 20.2% STEMI) were included. The incidence rate of hospitalizations for MI was lower in women than men across all age groups. Women were less likely than men to undergo coronary angiography, revascularization, or to use circulatory-support devices. These differences were consistent across all age groups. Adjusted odds of death for women (vs men) varied by age: odds ratio (95% confidence interval) 1.08 (0.97 to 1.20), 1.05 (1.02 to 1.08), 0.92 (0.91 to 0.94), and 0.86 (0.85 to 0.88) for NSTEMI, and 1.15 (1.04 to 1.27), 1.22 (1.18 to 1.26), 1.09 (1.06 to 1.11), and 0.97 (0.94 to 0.99), for STEMI, in age groups (<45, 45 to 64, 65 to 84, and ≥85), respectively. The magnitude of differences in complications between men and women was higher in younger and middle-age patients. CONCLUSION: Compared with men, women have lower incidence of MI and less likelihood of undergoing invasive treatment regardless of age. However, post-MI outcomes are age specific. The negative impact of female sex on most outcomes was most pronounced in young and middle-aged women.

Inflammatory Bowel Disease Does Not Impact Mortality but Increases Length of Hospitalization in Patients with Acute Myocardial Infarction.

BACKGROUND AND AIM: Inflammatory bowel diseases (IBD) have been associated with increased risk of cardiovascular events. We aimed to investigate the outcomes of myocardial infarction (MI) in patients with IBD. METHODS: We performed a cross-sectional study utilizing data from the Nationwide Inpatient Sample from the years 1998 to 2010. ICD-9-CM codes were used to identify patients with Crohn's disease (CD) (555.X), ulcerative colitis (UC) (556.X), and acute MI (410.X). Outcomes in patients with MI with and without IBD were compared. Univariate analysis was performed. Multivariate logistic regression was used to determine the effect of UC and CD on in-hospital MI mortality after adjusting for confounders. RESULTS: A total of 2,629,161 MI, 3,607 UC and 3784 CD patients were analyzed. UC (odds ratio [OR], 1.12; 95% CI 0.98-1.29) and CD (OR 0.99; 95% CI 0.86-1.15) did not affect in-hospital mortality in patients with MI. There was no difference between in-hospital mortality in patients with MI with or without UC (7.75% vs. 7.05%; p = 0.25) or in patients with MI with or without CD (6.50% vs. 6.59%; p = 0.87). The length of stay (LOS) was higher in IBD patients and total charges were statistically higher in patients with UC as compared to non-IBD patients ($65,182 vs. $53,542; p < 0.001). CONCLUSIONS: This study shows that IBD does not impact in-hospital mortality from MI. However, patients with MI with IBD have longer LOS. Patients with UC have higher total hospitalization charges than patients with MI without IBD. Further prospective studies are needed to assess the outcomes of MI in IBD patients.

Efficacy and safety of rivaroxaban plus aspirin in women and men with chronic coronary or peripheral artery disease.

AIMS: The COMPASS trial demonstrated that the combination of rivaroxaban 2.5 mg twice daily and aspirin 100 mg once daily compared with aspirin 100 mg once daily reduced major adverse cardiovascular events (MACE) in patients with chronic coronary artery disease or peripheral artery disease by 24% during a mean follow-up of 23 months. We explored whether this effect varies by sex. METHODS AND RESULTS: The effects were examined in women and men using log-rank tests and Kaplan-Meier curve. Hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) were obtained from stratified Cox proportional hazards models to explore subgroup effects including subgroup of women and men according to baseline modified REACH risk score. Of 27 395 patients randomized, 18 278 were allocated to receive rivaroxaban plus aspirin (n = 9152) or aspirin alone (n = 9126), and of these, 22.1% were women. Women compared with men had similar incidence rates for MACE and major bleeding but borderline lower rates for myocardial infarction (1.7% vs. 2.2%, P = 0.05). The effect of combination therapy compared with aspirin in women and men was consistent for MACE (women: 3.8% vs. 5.2%, HR 0.72, 95% CI 0.54-0.97; men: 4.2% vs. 5.5%, HR 0.76, 95% CI 0.66-0.89; P interaction 0.75) and major bleeding (women: 3.1% vs. 1.4%, HR 2.22, 95% CI 1.42-3.46; men: 3.2% vs. 2.0%, HR 1.60, 95% CI 1.29-1.97; P interaction 0.19). There was no significant interaction between randomized treatment and baseline modified REACH score above or below the median for MACE or major bleeding. CONCLUSION: In patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban (2.5 mg twice daily) and aspirin compared with aspirin alone appears to produce consistent benefits in women and men, independent of baseline cardiovascular risk.