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Aims Previous analyses on sex differences in case fatality rates at population-level data had limited adjustment for key patient clinical characteristics thought to be associated with coronavirus disease 2019 (COVID-19) outcomes. We aimed to estimate the risk of specific organ dysfunctions and mortality in women and men. Methods and results This retrospective cross-sectional study included 17 hospitals within 5 European countries participating in the International Survey of Acute Coronavirus Syndromes COVID-19 (NCT05188612). Participants were individuals hospitalized with positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from March 2020 to February 2022. Risk-adjusted ratios (RRs) of in-hospital mortality, acute respiratory failure (ARF), acute heart failure (AHF), and acute kidney injury (AKI) were calculated for women vs. men. Estimates were evaluated by inverse probability weighting and logistic regression models. The overall care cohort included 4499 patients with COVID-19-associated hospitalizations. Of these, 1524 (33.9%) were admitted to intensive care unit (ICU), and 1117 (24.8%) died during hospitalization. Compared with men, women were less likely to be admitted to ICU [RR: 0.80; 95% confidence interval (CI): 0.71–0.91]. In general wards (GWs) and ICU cohorts, the adjusted women-to-men RRs for in-hospital mortality were of 1.13 (95% CI: 0.90–1.42) and 0.86 (95% CI: 0.70–1.05; pinteraction = 0.04). Development of AHF, AKI, and ARF was associated with increased mortality risk (odds ratios: 2.27, 95% CI: 1.73–2.98; 3.85, 95% CI: 3.21–4.63; and 3.95, 95% CI: 3.04–5.14, respectively). The adjusted RRs for AKI and ARF were comparable among women and men regardless of intensity of care. In contrast, female sex was associated with higher odds for AHF in GW, but not in ICU (RRs: 1.25; 95% CI: 0.94–1.67 vs. 0.83; 95% CI: 0.59–1.16, pinteraction = 0.04). Conclusions Women in GW were at increased risk of AHF and in-hospital mortality for COVID-19 compared with men. For patients receiving ICU care, fatal complications including AHF and mortality appeared to be independent of sex. Equitable access to COVID-19 ICU care is needed to minimize the unfavourable outcome of women presenting with COVID-19-related complications.

There is uncertainty regarding the impact of statins on the risk of atherosclerotic cardiovascular disease (ASCVD) and its major complication, acute heart failure (AHF).The aim of this study was to investigate whether previous statin therapy translates into lower AHF events and improved survival from AHF among patients presenting with an acute coronary syndrome (ACS) as a first manifestation of ASCVD.Data were drawn from the International Survey of Acute Coronary Syndromes Archives. The study participants consisted of 14,542 Caucasian patients presenting with ACS without previous ASCVD events. Statin users before the index event were compared with nonusers by using inverse probability weighting models. Estimates were compared by test of interaction on the log scale. Main outcome measures were the incidence of AHF according to Killip class and the rate of 30-day all-cause mortality in patients presenting with AHF.Previous statin therapy was associated with a significantly decreased rate of AHF on admission (4.3% absolute risk reduction; risk ratio [RR]: 0.72; 95% CI: 0.62-0.83) regardless of younger (40-75 years) or older age (interaction P = 0.27) and sex (interaction P = 0.22). Moreover, previous statin therapy predicted a lower risk of 30-day mortality in the subset of patients presenting with AHF on admission (5.2 % absolute risk reduction; RR: 0.71; 95% CI: 0.50-0.99).Among adults presenting with ACS as a first manifestation of ASCVD, previous statin therapy is associated with a reduced risk of AHF and improved survival from AHF. (International Survey of Acute Coronary Syndromes [ISACS] Archives; NCT04008173).

Background The debate about statins in primary prevention of cardiovascular (CV) disease is still alive, especially in old and very old adults. Purpose We undertook a propensity match-weighted cohort study to investigate whether statin treatment recommendations translate into improved cardiovascular (CV) outcomes in the current routine clinical care of the elderly. Methods We included in our analysis 5,619 people aged 65 years or older from the ISACS (International Survey of Acute Coronary Syndrome) Archives (NCT04008173) who presented to hospital with a first manifestation of CV disease. Participants were stratified as statin users versus nonusers and as old (65 to 75 years) versus very old (76 years or over) adults. We estimated the effects of statins on the most severe clinical manifestation of CV disease, namely ST segment elevation myocardial infarction (STEMI), using inverse probability of treatment weighting models. Estimates were compared by test of interaction on the log scale. Results The risk of STEMI was much lower in statin users than in nonusers in both patients aged 65 to 75 years (14.7% absolute risk reduction; relative risk [RR] ratio: 0.55, 95% CI 0.45 to 0.66) and those aged 76 years and older (13.3% absolute risk reduction; RR ratio: 0.58, 95% CI 0.46 to 0.72). Estimates were similar in patients with and without history of hypercholesterolemia (interaction test; p value= 0.2408). Proportional reductions in STEMI diminished with female sex in the old (p for interaction=0.002), but not in the very old age (p for interaction=0.26). We also observed a remarkable reduction in the risk of 30- day mortality from STEMI with statin therapy in both age groups (10.2% absolute risk reduction; RR ratio: 0.39; 95% CI 0.23 – 0.68 for patients aged 76 or over and 3.8% absolute risk reduction; RR ratio 0.37; 95% CI 0.17 – 0.82 for patients aged 65 to 75 years old; interaction test, p value=0.4570). Conclusion Preventive statin therapy in the elderly reduces the risk of STEMI with benefits in mortality from STEMI, irrespective of the presence of a history of hypercholesterolemia. This effect persists after the age of 76 years. Benefits are less pronounced in women. Funding Acknowledgement Type of funding sources: None.

Introduction: The use of digitalis has been plagued by controversy since its initial use. Previous observations have shown that digoxin can be safely used in patients with chronic heart failure (HF), but concern remains about the effects of digoxin on mortality in patients with incident HF in the acute setting, especially in those with myocardial infarction. Hypothesis: We aimed to determine the relationship between digoxin use and outcomes in hospitalized patients with acute coronary syndromes (ACS) complicated by HF accounting for sex difference and prior heart diseases. Methods: We analyzed information on 88,774 patients presenting with acute HF (Killip class ≥2) in the International Survey of Acute Coronary Syndromes (ISACS)-Archives (NCT04008173) registry, 4,722 (18.7%) who received digoxin on hospital admission. Patients with pre-existing nonischemic congestive cardiomyopathy and without HF were excluded, leaving a final study population of 25,187 patients. The main outcome measure was all-cause 30-day mortality. Estimates were evaluated by inverse probability of treatment weighting models. Results: Women who received digoxin had a higher rate of death than women who did not receive it (33.8% vs. 29.2 %; relative risk [RR] ratio:1.24;95 % confidence interval [CI]: 1.12-1.37). Similar odds for mortality with digoxin were observed in men (28.5 % vs. 24.9 %; RR ratio 1.20; 95% CI:1.10-1.32). Comparable results were obtained in patients with no prior coronary heart disease (RR ratios:1.26; 95 % CI: 1.10 to 1.45 in women and RR:1.21; 95 % CI: 1.06 to 1.39 in men) and those in sinus rhythm at admission (RR ratios:1.34; 95% CI 1.15 to 1.54 in women and 1.26; 95% CI 1.10 to 1.45 in men). Conclusions: Digoxin therapy is associated with an increased risk of early death among women and men with ACS complicated by HF. This finding highlights the need for re-examination of digoxin use in the clinical setting of ACS

BACKGROUND ST-segment elevation myocardial infarction (STEMI) complicated by symptoms of acute de novo heart failure is associated with excess mortality. Whether development of heart failure and its outcomes differ by sex is unknown. OBJECTIVES This study sought to examine the relationships among sex, acute heart failure, and related outcomes after STEMI in patients with no prior history of heart failure recorded at baseline. METHODS Patients were recruited from a network of hospitals in the ISACS-TC (International Survey of Acute Coronary Syndromes in Transitional Countries) registry (NCT01218776). Main outcome measures were incidence of Killip class >= II at hospital presentation and risk-adjusted 30-day mortality rates were estimated using inverse probability of weighting and logistic regression models. RESULTS This study included 10,443 patients (3,112 women). After covariate adjustment and matching for age, cardiovascular risk factors, comorbidities, disease severity, and delay to hospital presentation, the incidence of de novo heart failure at hospital presentation was significantly higher for women than for men (25.1% vs. 20.0%, odds ratio [OR]: 1.34; 95% confidence interval [CI]: 1.21 to 1.48). Women with de novo heart failure had higher 30-day mortality than did their male counterparts (25.1% vs. 20.6%; OR: 1.29; 95% CI: 1.05 to 1.58). The sex-related difference in mortality rates was still apparent in patients with de novo heart failure undergoing reperfusion therapy after hospital presentation (21.3% vs. 15.7%; OR: 1.45; 95% CI: 1.07 to 1.96). CONCLUSIONS Women are at higher risk to develop de novo heart failure after STEMI and women with de novo heart failure have worse survival than do their male counterparts. Therefore, de novo heart failure is a key feature to explain mortality gap after STEMI among women and men. (C) 2019 by the American College of Cardiology Foundation.

Background and aims: An increasing proportion of women believe that smoking few cigarettes daily substantially reduces their risk of developing cardiovascular (CV) related disorders. The effect of low intensity smoking is still largely understudied. We investigated the relation among sex, age, cigarette smoking and ST segment elevation myocardial infarction (STEMI) as initial manifestation of CV disease. Methods: We analyzed data of 50,713 acute coronary syndrome patients with no prior manifestation of CV disease from the ISACS-Archives (NCT04008173) registry. We compared the rates of STEMI in current smokers (n = 11,530) versus nonsmokers (n = 39,183). Results: In the young middle age group (

Introduction: It is still unknown whether traditional risk factors may have a sex specific impact on coronary artery disease (CAD) burden. Hypothesis: We sought to investigate at individual level whether there are sex differences in the four modifiable traditional cardiovascular risk factors and how these differences may impact the CAD and outcomes in ACS. Methods: We identified 14,793 patients who underwent coronary angiography for acute coronary syndromes in the ISACS-TC registry (NCT01218776) from 2010 to 2019. Main outcome measure was the association between traditional risk factors and severity of CAD and its relationship with 30-day mortality. The relative risk (RR) ratios and 95% CI were calculated from the ratio of the absolute risks of women versus men using inverse probability of weighting. Estimates were compared by test of interaction on the log scale. Severity of CAD was categorized as obstructive (≥50% stenosis) versus nonobstructive CAD. Results: The RR ratios for obstructive CAD in women versus men among nondiabetic people was 0.49 (95%CI 0.41-0.60) and diabetic people was 0.89 (95%CI 0.62-1.29); interaction by diabetes status: p=0.018. Exposure to smoking shifted the RR ratios from 0.50 (95%CI 0.4 -0.61) in nonsmokers to 0.75 (95%CI 0.54-1.03) in current smokers; interaction by smoking status: p=0.018. There were no significant sex-related interactions with hypercholesterolemia and hypertension. Women with obstructive CAD had higher 30-day mortality rates than men (RR 1.75, 95%CI 1.48-2.07). No sex differences in mortality were observed in patients with nonobstructive CAD. Conclusions: Obstructive CAD in women signifies a higher risk for mortality compared with men. Current smoking and diabetes disproportionally increase the risk of obstructive CAD in women. Achieving the goal of improving cardiovascular health in women still require intensive efforts toward further implementation of lifestyle and treatment interventions.

Background It is still unknown whether traditional risk factors may have a sex‐specific impact on coronary artery disease (CAD) burden. Methods and Results We identified 14 793 patients who underwent coronary angiography for acute coronary syndromes in the ISACS‐TC (International Survey of Acute Coronary Syndromes in Transitional Countries; Clini​calTr​ials.gov , NCT01218776) registry from 2010 to 2019. The main outcome measure was the association between traditional risk factors and severity of CAD and its relationship with 30‐day mortality. Relative risk (RR) ratios and 95% CIs were calculated from the ratio of the absolute risks of women versus men using inverse probability of weighting. Estimates were compared by test of interaction on the log scale. Severity of CAD was categorized as obstructive (≥50% stenosis) versus nonobstructive CAD. The RR ratio for obstructive CAD in women versus men among people without diabetes mellitus was 0.49 (95% CI, 0.41–0.60) and among those with diabetes mellitus was 0.89 (95% CI, 0.62–1.29), with an interaction by diabetes mellitus status of P =0.002. Exposure to smoking shifted the RR ratios from 0.50 (95% CI, 0.41–0.61) in nonsmokers to 0.75 (95% CI, 0.54–1.03) in current smokers, with an interaction by smoking status of P =0.018. There were no significant sex‐related interactions with hypercholesterolemia and hypertension. Women with obstructive CAD had higher 30‐day mortality rates than men (RR, 1.75; 95% CI, 1.48–2.07). No sex differences in mortality were observed in patients with nonobstructive CAD. Conclusions Obstructive CAD in women signifies a higher risk for mortality compared with men. Current smoking and diabetes mellitus disproportionally increase the risk of obstructive CAD in women. Achieving the goal of improving cardiovascular health in women still requires intensive efforts toward further implementation of lifestyle and treatment interventions. Registration URL: https://www.clini​caltr​ials.gov ; Unique identifier: NCT01218776.

Background: ST-Segment Elevation Myocardial Infarction (STEMI) complicated by symptoms of acute heart failure (HF) is associated with excess mortality. Yet the relative contribution of sex to the development of acute HF and its related outcomes remains controversial. We aimed to compare the incidence and outcomes of patients with HF during index admission for STEMI according to sex and prior HF status: pre-existing diagnosis of HF, as assessed by past medical history, or no prior HF. Methods: Cohort study using a population-based registry consisting of 8,409 STEMI patients with acute HF status recorded at baseline. Adjusted 30-day mortality and HF rates at index admission were estimated using inverse probability of weighting and logistic regression models. HF was defined as Killip class 2 or higher and classified according to prior medical history as acute “de novo” or decompensated HF. Results: A total of 2,526 women and 5,883 men had HF status recorded at baseline and were included in the analysis. Of these patients, 2,403 (95.1%) women and 5,664 (96.3%) men have never experienced HF before index admission. After adjustment for baseline clinical covariates, the incidence of “de novo” HF was significantly higher for women than for men (29.4% vs 21.9 %, OR 1.23; 95%CI 1.10-1.38). For “de novo” HF presentations women have higher 30-day mortality than men (9.5% vs 6.2%: OR 1.58; 95%CI 1.33-1.88). After adjusting for potential confounders, a history of pre-existing HF was strongly associated with increased risk of acute decompensated HF at index admission (OR 3.89; 95%CI, 3.02-5.01). Nevertheless, when women and men presented with acute decompensated HF their outcomes are equally negative with a 30-day mortality of 11.3% vs 12.9%, respectively (OR 0.86; 95%CI 0.43-1.70). Conclusion: Female sex has differing effects among patients with STEMI according to prior medical history of HF. It worsens outcomes in patients with acute “de novo” HF but has neutral effects in those with acute decompensated HF. “De novo” HF is a key feature to explain mortality difference between sexes.

Background Patients with diabetes and non-ST elevation acute coronary syndrome (NSTE-ACS) have an increased risk of mortality and adverse outcomes following percutaneous coronary intervention (PCI). Purpose We aimed to investigate the impact of early, within 24 hours PCI compared with only routine medical treatment on clinical outcomes in a large international cohort of patients with NSTE-ACS and diabetes. Methods We identified 1,250 patients with diabetes and NSTE-ACS from a registry-based population between October 2010 and April 2016. The primary endpoint was 30-day all-cause mortality. The secondary endpoint was the composite outcome of 30-day all-cause mortality and left ventricular dysfunction (ejection fraction Results Of 1,250 NSTE-ACS first-day survivors with diabetes (median age 67 years; 59%, men), 470 (37.6%) received early PCI and 780 routine medical treatment. The overall 30-day all-cause mortality rates were higher in the routine medical treatment than the early PCI group (6.3% vs. 2.5%). The prediction results of the MC algorithms accounted for only one interaction term that was statistically significant: age ≥65 years. After propensity-matched analysis as well as IPTW, early PCI was associated with reduced 30-day all-cause mortality in the older age (OR: 0.35; 95% CI: 0.14 to 0.92 and 0.43; 95% CI: 0.21 to 0.86, respectively), whereas younger age had no association with the primary endpoint. Similar results were also obtained for the secondary endpoint. Conclusions Among patients with diabetes hospitalized for NSTE-ACS, an early, within 24 hours, PCI strategy is associated with reduced odds of 30-day mortality only for patients aged 65 years or over. MC algorithms provide accurate identification of treatment effect modifiers.

Background: It remains uncertain whether female sex is itself a strong risk factor for worse outcomes in ACS. We hypothesized that sex differences in vulnerability to heart failure after ACS may modify the association between sex and outcomes Methods: Data were drawn from the ISACS-Archives network of registries (NCT04008173). The study population consisted of 87,812 patients with known time from symptom onset to hospital presentation. Participants were stratified by ACS subtypes: STEMI and NSTEACS Data on presenting heart failure symptoms were collected from medical record abstraction. Heart failure was categorized as Killip class >2. Time from symptom onset to hospital presentation was categorized as early (≤120 minutes) or late (>120 minutes). The primary outcome measure was 30-day mortality. Estimates were performed using a parametric balancing strategy by weighting and compared by test of interaction on the log scale Results: Among the study sample, 30922 (35.2%) patients were women. Patient outcomes varied according to subtype of ACS. The mortality rates at 30-days were significantly higher among women vs men in STEMI (RR:1.65; 95%CI: 1.56-1.73) compared with NSTEACS (RR:1.18; 95%CI: 1.09-1.28; P interaction

Background: Controversies persist about the role of statins in primary prevention of atherosclerotic cardiovascular disease (ASCVD). We sought to determine whether initiation of statin therapy for primary prevention of cardiovascular disease may lead to a reduction in cardiovascular outcomes across age, sex, and risk factors. Methods: We investigated 14,542 patients aged ≥40 years presenting to hospitals with ACS as first manifestation of cardiovascular disease from 2010 to 2019 in the ISACS Archives network of registries (NCT04008173). Individual risk of STEMI, acute heart failure (HF) on hospital admission and all-cause 30-day mortality were assessed using inverse probability of treatment weighting models matching for concomitant medications. Acute HF was defined as Killip class≥ 2. Estimates were compared by test of interaction on the log scale. Results: Among the study population 12.5% of patients were on statin therapy. Mean (SD) estimated 10-year risk for ASCVD was 25.8 (17.9) in statin users vs 22.5 (17.1) in non-users. The risk of STEMI was much lower in the statin-users than in the non-users (relative risk [RR] ratio 0.64; 95%CI 0.58-0.71). This effect persisted in both sexes, but was substantially stronger in men (absolute reduction: 11.5%; RR ratio: 0.61, 95%CI: 0.54-0.69) than in women (absolute reduction: 6.3%; RR ratio: 0.76, 95% CI: 0.64-0.90, p interaction=0.02). These benefits translated into reductions in acute HF on hospital admission with statin therapy for both women (RR ratio 0.66, 95%CI: 0.53-0.83) and men (RR ratio 0.74, 95%CI 0.62-0.89; p interaction=0.22). No effect on the rates of STEMI or acute HF was noted in patients with 10-year ASCVD risk lower than 10% for either sex. Acute HF was predictive of mortality at 30 days both in women and in men. Conclusion: Preventive statin therapy reduces the risk of STEMI as initial manifestation of cardiovascular disease and acute HF with potential benefits in mortality. The most gain is attained in male subjects with 10-year CV risk equal or more than 10%.

Data supporting the use of percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI) beyond a 12-hour cut-off are sparse and contradictory. We aimed to investigate whether different delays to hospital presentation and patient clinical characteristics may