| 1. |
- Aktaa, Suleman, et al.
(författare)
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Data standards for heart failure : the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)
- 2022
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Ingår i: European Heart Journal. - : Oxford University Press. - 0195-668X .- 1522-9645. ; 43:23, s. 2185-
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Tidskriftsartikel (refereegranskat)abstract
- Standardized data definitions are essential for assessing the quality of care and patient outcomes in observational studies and randomized controlled trials. The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create contemporary pan-European data standards for cardiovascular diseases, including heart failure (HF). We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group including experts in HF registries, representatives from the Heart Failure Association of the ESC, and the EuroHeart was formed. Using Embase and Medline (2016-21), we conducted a systematic review of the literature on data standards, registries, and trials to identify variables pertinent to HF. A modified Delphi method was used to reach a consensus on the final set of variables. For each variable, the Working Group developed data definitions and agreed on whether it was mandatory (Level 1) or additional (Level 2). In total, 84 Level 1 and 79 Level 2 variables were selected for nine domains of HF care. These variables were reviewed by an international Reference Group with the Level 1 variables providing the dataset for registration of patients with HF on the EuroHeart IT platform. By means of a structured process and interaction with international stakeholders, harmonized data standards for HF have been developed. In the context of the EuroHeart, this will facilitate quality improvement, international observational research, registry-based randomized trials, and post-marketing surveillance of devices and pharmacotherapies across Europe.
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| 2. |
- Alfredsson, Joakim, et al.
(författare)
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Gender differences in management and outcome in non-ST-elevation acute coronary syndrome
- 2007
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Ingår i: Heart. - : BMJ Publishing group Ltd. - 1355-6037 .- 1468-201X. ; 93:11, s. 1357-1362
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To study gender differences in management and outcome in patients with non-ST-elevation acute coronary syndrome. Design, setting and patients: Cohort study of 53 781 consecutive patients (37% women) from the Register of Information and Knowledge about Swedish Heart Intensive care Admissions (RIKS-HIA), with a diagnosis of either unstable angina pectoris or non-ST-elevation myocardial infarction. All patients were admitted to intensive coronary care units in Sweden, between 1998 and 2002, and followed for 1 year. Main outcome measures: Treatment intensity and in-hospital, 30-day and 1 -year mortality. Results: Women were older (73 vs 69 years, p<0.001) and more likely to have a history of hypertension and diabetes, but less likely to have a history of myocardial infarction or revascularisation. After adjustment, there were no major differences in acute pharmacological treatment or prophylactic medication at discharge. Revascularisation was, however, even after adjustment, performed more often in men (OR 1.15, 95% CI, 1.09 to 1.21). After adjustment, there was no significant difference in in-hospital (OR 1.03, 95% CI, 0.94 to 1.13) or 30-days (OR 1.07, 95% CI, 0.99 to 1.15) mortality, but at 1 year being male was associated with higher mortality (OR 1.12, 95% CI, 1.06 to 1.19). Conclusion: Although women are somewhat less intensively treated, especially regarding invasive procedures, after adjustment for differences in background characteristics, they have better long-term outcomes than men.
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| 3. |
- Alfredsson, Joakim, et al.
(författare)
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Impact of an invasive strategy on 5 years outcome in men and women with non-ST-segment elevation acute coronary syndromes
- 2014
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Ingår i: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 168:4, s. 522-529
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Tidskriftsartikel (refereegranskat)abstract
- Background A routine invasive (RI) strategy in non-ST-segment elevation acute coronary syndromes (NSTE ACS) has been associated with better outcome compared with a selective invasive (SI) strategy in men, but results in women have yielded disparate results. The aim of this study was to assess gender differences in long-term outcome with an SI compared with an RI strategy in NSTE ACS. Methods Individual patient data were obtained from the FRISC II trial, ICTUS trial, and RITA 3 trial for a collaborative meta-analysis. Results Men treated with an RI strategy had significantly lower rate of the primary outcome 5-year cardiovascular (CV) death/myocardial infarction (MI) compared with men treated with an SI strategy (15.6% vs 19.8%, P = .001); risk-adjusted hazards ratio (HR) 0.73 (95% CI 0.63-0.86). In contrast, there was little impact of an RI compared with an SI strategy on the primary outcome among women (16.5% vs 15.1%, P = .324); risk-adjusted HR 1.13 (95% CI 0.89-1.43), interaction P = .01. For the individual components of the primary outcome, a similar pattern was seen with lower rate of MI (adjusted HR 0.69, 95% CI 0.57-0.83) and CV death (adjusted HR 0.71, 95% CI 0.56-0.89) in men but without obvious difference in women in MI (adjusted HR 1.13, 95% CI 0.85-1.50) or CV death (adjusted HR 0.97, 95% CI 0.68-1.39). Conclusions In this meta-analysis comparing an SI and RI strategy, benefit from an RI strategy during long-term follow-up was confirmed in men. Conversely, in women, there was no evidence of benefit.
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| 4. |
- Alfredsson, Joakim, et al.
(författare)
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Similar outcome with an invasive strategy in men and women with non-ST-elevation acute coronary syndromes From the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART)
- 2011
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Ingår i: European Heart Journal. - : Oxford University Press (OUP): Policy B. - 0195-668X .- 1522-9645. ; 32:24, s. 3128-3136
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Tidskriftsartikel (refereegranskat)abstract
- Aims To assess gender differences in outcome with an early invasive or non-invasive strategy in patients with non-ST-elevation acute coronary syndromes (NSTE ACS). less thanbrgreater than less thanbrgreater thanMethods and results We included 46 455 patients [14 819 women (32%) and 31 636 men (68%)] from the SWEDEHEART register, with NSTE ACS, between 2000 and 2006, and followed them for 1 year. In the non-invasive strategy arm, the relative risk (RR) of death was (women vs. men) 1.02 [95% confidence interval (CI), 0.94-1.11] and in the invasive strategy arm 1.12 (95% CI, 0.96-1.29). After adjustment for baseline differences between the genders, with propensity score and discharge medication, there was a similar trend towards better outcome among women in both the early non-invasive cohort [RR 0.90 (95% CI, 0.82-0.99)] and the early invasive cohort [RR 0.90 (95% CI, 0.76-1.06)], although it did not reach statistical significance in the early invasive cohort. Results were similar with the combined endpoint death/myocardial infarction. An early invasive treatment was associated with a marked, and similar, mortality reduction in women [RR 0.46 (95% CI, 0.38-0.55)] and men [RR 0.45 (95% CI, 0.40-0.52)], without interaction with gender. less thanbrgreater than less thanbrgreater thanConclusion In this large cohort of patients with NSTE ACS, reflecting real-life management, women and men had similar and better outcome associated with an invasive strategy.
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| 5. |
- Batra, Gorav, et al.
(författare)
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Biomarker-Based Prediction of Recurrent Ischemic Events in Patients With Acute Coronary Syndromes
- 2022
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Ingår i: Journal of the American College of Cardiology. - : Elsevier. - 0735-1097 .- 1558-3597. ; 80:18, s. 1735-1747
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: In patients with acute coronary syndrome (ACS), there is residual and variable risk of recurrent ischemic events.OBJECTIVES: This study aimed to develop biomarker-based prediction models for 1-year risk of cardiovascular (CV) death and myocardial infarction (MI) in patients with ACS undergoing percutaneous coronary intervention.METHODS: We included 10,713 patients from the PLATO (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome) trial in the development cohort and externally validated in 3,508 patients from the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) trial. Variables contributing to risk of CV death/MI were assessed using Cox regression models, and a score was derived using subsets of variables approximating the full model.RESULTS: There were 632 and 190 episodes of CV death/MI in the development and validation cohorts. The most important predictors of CV death/MI were the biomarkers, growth differentiation factor 15, and N-terminal pro-B-type natriuretic peptide, which had greater prognostic value than all candidate variables. The final model included 8 items: age (A), biomarkers (B) (growth differentiation factor 15 and N-terminal pro-B-type natriuretic peptide), and clinical variables (C) (extent of coronary artery disease, previous vascular disease, Killip class, ACS type, P2Y12 inhibitor). The model, named ABC-ACS ischemia, was well calibrated and showed good discriminatory ability for 1-year risk of CV death/MI with C-indices of 0.71 and 0.72 in the development and validation cohorts, respectively. For CV death, the score performed better, with C-indices of 0.80 and 0.84 in the development and validation cohorts, respectively.CONCLUSIONS: An 8-item score for the prediction of CV death/MI was developed and validated for patients with ACS undergoing percutaneous coronary intervention. The ABC-ACS ischemia score showed good calibration and discrimination and might be useful for risk prediction and decision support in patients with ACS. (A Comparison of Ticagrelor [AZD6140] and Clopidogrel in Patients With Acute Coronary Syndrome [PLATO]; NCT00391872; Trial to Assess the Effects of Vorapaxar [SCH 530348; MK-5348] in Preventing Heart Attack and Stroke in Participants With Acute Coronary Syndrome [TRACER]; NCT00527943)
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| 6. |
- Björck, Lena, 1959, et al.
(författare)
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Medication in relation to ST-segment elevation myocardial infarction in patients with a first myocardial infarction: Swedish Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA)
- 2010
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Ingår i: Archives of Internal Medicine. - : American Medical Association (AMA). - 0003-9926 .- 1538-3679. ; 170:15, s. 1375-1381
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The extent and the severity of acute myocardial infarction (MI) is decreasing. Out-of-hospital medical management before the hospital admission could alter clinical presentation in acute MI. We used a large national patient register to investigate the relation between previous medication use (aspirin, beta-blockers, angiotensin-converting enzyme [ACE] inhibitors, and statins) and the risk of presenting with ST-segment elevation MI (STEMI) or non-STEMI. METHODS: We included 103 459 consecutive patients from the Swedish Register of Information and Knowledge About Swedish Heart Intensive Care Admissions (RIKS-HIA) admitted between January 1, 1996, and December 31, 2006, with a first acute MI. RESULTS: The patients with STEMI (43.5% of the total) were younger, had less prior cardiovascular disease, and used fewer medications before hospitalization. Of the STEMI patients, 61.4% had used no medication vs 45.9% of the patients with non-STEMI. After multiple adjustments, use of aspirin, beta-blockers, ACE inhibitors, and statins before hospitalization were all associated with substantially lower odds of presenting with STEMI. Furthermore, the risk decreased with the number of previous medications, and the use of 3 or more medications was associated with a multiply adjusted odds ratio of presenting with STEMI of 0.48 (99% confidence interval, 0.44-0.52) compared with no medications at admission. CONCLUSIONS: Use of aspirin, beta-blockers, ACE inhibitors, or statins before hospital admission in patients with a first acute MI is associated with substantially less risk of presenting with STEMI. The risk decreases with the increasing number of these medications used before acute MI, underlining the benefit of preventive medication in high-risk patients.
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| 7. |
- Björck, Lena, 1959, et al.
(författare)
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Smoking in relation to ST-segment elevation acute myocardial infarction: findings from the Register of Information and Knowledge about Swedish Heart Intensive Care Admissions.
- 2009
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Ingår i: Heart (British Cardiac Society). - : BMJ. - 1468-201X .- 1355-6037. ; 95:12, s. 1006-11
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: In the past few decades, clinical presentation in AMI has been reported to be changing, with milder cases and less ST-elevation myocardial infarction, the most serious form of AMI. The better outcome may be due to improved medical and interventional management, as well as more sensitive methods for detecting AMI. However, changes in risk factors have also been documented, especially lower tobacco-smoking rates. Therefore, the relation between smoking and ST-elevation AMI in a large observational cohort was analysed. METHODS: Data were derived from 93 416 consecutive patients aged 25 to 84 years and admitted to hospital between 1996 and 2004 with a first AMI. RESULTS: Tobacco smoking was more prevalent in younger patients (ie, <65 years). More than 50% of younger patients presenting with STEMI were smokers at the time of hospitalisation. After multiple adjustments, smoking was found to be an independent determinant for presenting with STEMI compared with non-STEMI. The adjusted odds ratio (OR) associated with smoking was 2.01 (99% CI 1.75 to 2.30) in younger women and 1.33 (99% CI 1.22 to 1.43) in younger men, with a significant interaction between smoking and gender. In older women and men (> or =65 years), the corresponding ORs were 1.33 (99% CI 1.20 to 1.48) and 1.14 (99% CI 1.04 to 1.25), respectively. CONCLUSION: Tobacco smoking is a major determinant for presenting with STEMI compared with non-STEMI, particularly among younger patients and among women. These results indicate that smoking is one of the major risk factors for presenting with more severe AMIs.
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| 8. |
- Björklund, Erik, et al.
(författare)
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Outcome of ST-elevation myocardial infarction treated with thrombolysis in the unselected population is vastly different from samples of eligible patients in a large-scale clinical trial
- 2004
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Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 148:4, s. 566-573
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND:Patients in clinical trials of fibrinolytic agents have been shown to be younger, less often female, and to have lower risk characteristics and a better outcome compared with unselected patients with ST-elevation myocardial infarction. However, a direct comparison of patients treated with fibrinolytic agents and not enrolled versus those enrolled in a trial, including a large number of patients, has not been performed.METHODS:Prospective data from the Swedish Register of Cardiac Intensive Care on patients admitted with acute myocardial infarction treated with thrombolytic agents in 60 Swedish hospitals were linked to data on trial participants in the ASsessment of Safety and Efficacy of a New Thrombolytic (ASSENT)-2 trial of fibrinolytic agents. Baseline characteristics, treatments, and long-term outcome were evaluated in 729 trial participants (A2), 2048 nonparticipants at trial hospitals (non-A2), and 964 nonparticipants at other hospitals (non-A2-Hosp).RESULTS:Nontrial patients compared with A2 patients were older and had higher risk characteristics and more early complications, although the treatments were similar. Patients at highest risk of death were the least likely to be enrolled in the trial. The 1-year mortality rate was 8.8% versus 20.3% and 19.0% (P <.001 for both) among A2 compared with non-A2 and non-A2-Hosp patients, respectively. After adjustment for a number of risk factors, the 1-year mortality rate was still twice as high in nontrial compared with A2 patients.CONCLUSIONS:The adjusted 1-year mortality rate was twice as high in patients treated with fibrinolytic agents and not enrolled in a clinical trial compared with those enrolled. One major reason for the difference in outcome appeared to be the selection of less critically ill patients to the trial.
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| 9. |
- Björklund, Erik, et al.
(författare)
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Pre-hospital thrombolysis delivered by paramedics is associated with reduced time delay and mortality in ambulance-transported real-life patients with ST-elevation myocardial infarction
- 2006
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 27:10, s. 1146-1152
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: There are sparse data on the impact of pre-hospital thrombolysis (PHT) in real-life patients. We therefore evaluated treatment delays and outcome in a large cohort of ambulance-transported real-life patients with ST-elevation myocardial infarction (STEMI) according to PHT delivered by paramedics or in-hospital thrombolysis. METHODS AND RESULTS: Prospective cohort study used data from the Swedish Register of Cardiac intensive care on patients admitted to the coronary care units of 75 Swedish hospitals in 2001-2004. Ambulance-transported thrombolytic-treated patients younger than age 80 with a diagnosis of acute myocardial infarction were included. Patients with PHT (n=1690) were younger, had a lower prevalence of co-morbid conditions, fewer complications, and a higher ejection fraction (EF) than in-hospital-treated patients (n=3685). Median time from symptom onset to treatment was 113 min for PHT and 165 min for in-hospital thrombolysis. One-year mortality was 7.2 vs. 11.8% for PHT and in-hospital thrombolysis, respectively. In a multivariable analysis, after adjusting for baseline characteristics and rescue angioplasty, PHT was associated with lower 1-year mortality (odds ratio 0.71, 0.55-0.92, P=0.008). CONCLUSION: When compared with regular in-hospital thrombolysis, pre-hospital diagnosis and thrombolysis with trained paramedics in the ambulances are associated with reduced time to thrombolysis by almost 1 h and reduced adjusted 1-year mortality by 30% in real-life STEMI patients.
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| 10. |
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