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- Dellborg, Mikael, 1954, et al.
(author)
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Comparison of treatment and outcomes for patients with acute myocardial infarction in Minneapolis/St. Paul, Minnesota, and Göteborg, Sweden.
- 2003
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In: American heart journal. - : Mosby, Inc.. - 1097-6744 .- 0002-8703. ; 146:6, s. 1023-9
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Journal article (peer-reviewed)abstract
- Treatment of acute myocardial infarction (AMI) is changing, and differences in medical practice are observed within and between countries on the basis of local practice patterns and available technology. These differing approaches provide an opportunity to evaluate medical practice and outcomes at the population level. The primary aim of this study was to compare medical care in patients hospitalized with AMI in 2 large cities in Sweden and the United States. A secondary aim was to compare medical outcomes.
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| 7. |
- Engdahl, J, et al.
(author)
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Time trends in long-term mortality after out-of-hospital cardiac arrest in 1980-1998 and predictors for death
- 2003
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In: American Heart Journal. - : Mosby, Inc.. - 0002-8703 .- 1097-6744. ; 145:5, s. 826-833
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Journal article (peer-reviewed)abstract
- Abstract Background We studied time trends in long-term survival after out-of-hospital cardiac arrest (OHCA) for patient characteristics and described predictors for death after discharge. Because long-term prognosis among patients with coronary heart disease has improved in the last decades, we hypothesized that the prognosis after OHCA would improve with time. Methods We analyzed data that were prospectively collected from all patients discharged from the hospital after OHCA in the community of Göteborg, Sweden, from 1980 to 1998 and divided the data into 2 time periods, 1980 to 1991 and 1991 to1998, with an equal number of patients. Results A total of 430 patients were included in the survey. Age, sex proportions, cardiovascular comorbidity, resuscitation factors, and inhospital complications did not change with time. A diagnosis of a precipitating myocardial infarction was more common during period 1 (66% vs 54%). The prescription of aspirin (22% vs 52%), angiotensin-converting enzyme inhibitors (7% vs 29%), anticoagulants (13% vs 27%), and lipid-lowering agents (0% vs 6%) at discharge increased during period 2. Long-term survival did not improve with time; the 5-year mortality rates were 53% in period 1 and 52% in period 2. Independent predictors of an increased risk of death included age (risk ratio [RR] 1.06, 95% CI 1.05–1.08), history of myocardial infarction (RR 2.02, 95% CI 1.51–2.72), history of smoking (RR 1.77, 95% CI 1.29–2.44), and worse cerebral performance at discharge (RR 1.71, 95% CI 1.44–2.02). The prescription of β-blockers at discharge was independently predictive of decreased risk of death (RR 0.63, 95% CI 0.46–0.85). Conclusion The long-term survival rate after OHCA did not change. Baseline characteristics remained generally unchanged, but the drugs prescribed at discharge changed in several aspects. Age, a history of myocardial infarction, a history of smoking, cerebral performance category at discharge, and the prescription of β-blockers were independent predictors of outcome.
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- Gyenes, G, et al.
(author)
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Radiation-induced cardiac disease
- 1996
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In: American heart journal. - 0002-8703. ; 131:6, s. 1236-1237
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Journal article (other academic/artistic)
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- Jánosi, A, et al.
(author)
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Metoprolol CR/XL in post-myocardial infarction patients with chronic heart failure. Experiences from MERIT-HF
- 2003
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In: American Heart Journal. - : Mosby, Inc.. - 0002-8703 .- 1097-6744. ; 146:4, s. 721-728
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Journal article (peer-reviewed)abstract
- Abstract Background The benefit of β-blockers post-myocardial infarction (MI) was established in the late 1970s. Major advances in the treatment of MI have since occurred. However, patients with chronic heart failure (CHF) were excluded from those trials. The purpose of this study was to assess the effect of β-blockers in post-MI patients with CHF receiving contemporary management. Methods This was a prespecified subgroup analysis of a double-blind, randomized trial: the Metoprolol CR/XL Randomized Intervention Trial in Heart Failure (MERIT-HF). Patients with CHF in New York Heart Association class II to IV with an ejection fraction (EF) ≤0.40 and a history of being hospitalized for an acute MI (n = 1926) were randomized to metoprolol succinate controlled release/extended release (CR/XL) versus placebo. Mean EF was 0.28, and the mean follow-up was 1 year. Results Metoprolol CR/XL reduced total mortality by 40% (95% CI 0.20–0.55, P = .0004), and sudden death by 50% (95% CI 0.26–0.66, P = .0004). The combined end point of all-cause mortality/hospitalization for worsening CHF was reduced by 31% (95% CI 0.16–0.44, P < .0001), and cardiac death/nonfatal acute MI by 45% (95% CI 0.26–0.58, P < .0001). A post-hoc analysis showed that the outcome in patients with earlier revascularization (44%) and outcome in those with more severe CHF (20%) was similar to the entire post-MI population. Conclusions In post-MI patients with symptomatic CHF, β-blockade continues to exert a profound reduction in mortality and morbidity in the presence of contemporary management that includes early and late revascularization, angiotensin-converting enzyme inhibitors, aspirin, and statins.
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- Aasa, Mikael, et al.
(author)
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Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial.
- 2010
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In: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 160:2, s. 322-8
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Journal article (peer-reviewed)abstract
- BACKGROUND: In ST-elevation myocardial infarction, primary percutaneous coronary intervention (PCI) has a superior clinical outcome, but it may increase costs in comparison to thrombolysis. The aim of the study was to compare costs, clinical outcome, and quality-adjusted survival between primary PCI and thrombolysis. METHODS: Patients with ST-elevation myocardial infarction were randomized to primary PCI with adjunctive enoxaparin and abciximab (n = 101), or to enoxaparin followed by reteplase (n = 104). Data on the use of health care resources, work loss, and health-related quality of life were collected during a 1-year period. Cost-effectiveness was determined by comparing costs and quality-adjusted survival. The joint distribution of incremental costs and quality-adjusted survival was analyzed using a nonparametric bootstrap approach. RESULTS: Clinical outcome did not differ significantly between the groups. Compared with the group treated with thrombolysis, the cost of interventions was higher in the PCI-treated group ($4,602 vs $3,807; P = .047), as well as the cost of drugs ($1,309 vs $1,202; P = .001), whereas the cost of hospitalization was lower ($7,344 vs $9,278; P = .025). The cost of investigations, outpatient care, and loss of production did not differ significantly between the 2 treatment arms. Total cost and quality-adjusted survival were $25,315 and 0.759 vs $27,819 and 0.728 (both not significant) for the primary PCI and thrombolysis groups, respectively. Based on the 1-year follow-up, bootstrap analysis revealed that in 80%, 88%, and 89% of the replications, the cost per health outcome gained for PCI will be <$0, $50,000, and $100,000 respectively. CONCLUSION: In a 1-year perspective, there was a tendency toward lower costs and better health outcome after primary PCI, resulting in costs for PCI in comparison to thrombolysis that will be below the conventional threshold for cost-effectiveness in 88% of bootstrap replications.
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| 22. |
- Ahmed, Hanna N., et al.
(author)
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Coffee consumption and risk of heart failure in men : An analysis from the Cohort of Swedish Men
- 2009
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In: American Heart Journal. - : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 158:4, s. 667-672
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Journal article (peer-reviewed)abstract
- Background A previous study found that consuming 5 or more cups of coffee per day was associated with increased incidence of heart failure (HF). We sought to evaluate this association in a larger population. Methods We measured coffee consumption using food frequency questionnaires among 37,315 men without history of myocardial infarction, diabetes, or HE They were observed for HF hospitalization or mortality from January 1, 1998, until December 3 1, 2006, using record linkage to the Swedish inpatient and cause of death registries. Cox proportional hazards models adjusted for age, dietary, and demographic factors were used to calculate incidence rate ratios (RR) and 95% confidence intervals (CIs). Results For 9 years of follow-up, 784 men experienced an HF event. Compared to men who drank! l cup of coffee per day (unadjusted rate 29.9 HF events/ 10,000 person-years), RR were 0.87 (95% CI 0.69-1.11, unadjusted rate 29.2/10,000 person-years) for 2 cups/d, 0.89 (95% CI 0.70-1.14, unadjusted rate 25.1/10,000 person-years) for 3 cups/d, 0.89 (95% CI 0.69-1.15, unadjusted rate 25.0/10,000 person-years) for 4 cups/d, and 0.89 (95% CI 0.69-1.15, unadjusted rate 18.1/10,000 person-years) for >= 5 cups/d (P for trend in RR = .61). Conclusions This study did not support the hypothesis that high coffee consumption is associated with increased rates of HF hospitalization or mortality. (Am Heart J 2009;158:667-72.)
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| 23. |
- Al-Faleh, Hussam, et al.
(author)
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Unraveling the spectrum of left bundle branch block in acute myocardial infarction : insights from the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT 2 and 3) trials
- 2006
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 151:1, s. 10-5
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Journal article (peer-reviewed)abstract
- BACKGROUND: Left bundle branch block (LBBB) complicates the diagnosis of acute myocardial infarction (AMI). The Sgarbossa criteria were developed from GUSTO I to surmount this diagnostic challenge but have not been prospectively validated in a large population with presumed AMI. We evaluated their utility in the diagnosis and risk stratification of AMI patients in ASSENT 2 & 3. METHODS: Baseline electrocardiograms (ECG) of LBBB patients were scored using Sgarbossa's criteria (0-10) by 2 readers blinded to the CK/CK-MB data and clinical outcomes; 267 (1.2%) patients had LBBB on their baseline ECG. RESULTS: Among 253 LBBB patients with available peak CK/CK-MB data, 158 (62.5%) had peak CK/CK-MB levels > 2x ULN, thereby qualifying for the diagnosis of AMI. A Sgarbossa score of 3 was shown in 48.7% of LBBB patients with elevated CK/CK-MB versus in 12.6% of those without a CK/CK-MB rise (P < .001). Patients with higher Sgarbossa scores, ie, 3, had a higher mortality compared with those with a score < 3, (23.5% vs 7.7% at 30 days P < .001; and 33.7% vs 20.2% at 1 year, P < .001, respectively). CONCLUSIONS: Our findings validate the utility of Sgarbossa criteria for diagnosing AMI in the setting of LBBB. These criteria provide a simple and practical diagnostic approach to risk stratify this diagnostically challenging high-risk group and optimize risk-benefit of acute therapy.
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| 24. |
- Al-Khalili, F, et al.
(author)
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Clinical importance of risk factors and exercise testing for prediction of significant coronary artery stenosis in women recovering from unstable coronary artery disease : The Stockholm Female Coronary Risk Study
- 2000
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In: American Heart Journal. - Karolinska Hosp & Inst, Dept Cardiol, Stockholm, Sweden. Karolinska Hosp & Inst, Dept Thorac Radiol, Stockholm, Sweden. Karolinska Hosp & Inst, Dept Publ Hlth Sci, Div Prevent Med, Stockholm, Sweden. : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 139:6, s. 971-978
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Journal article (peer-reviewed)abstract
- Background The objectives of this study were to investigate the relation between coronary risk factors, exercise testing parameters, and the presence of angiographically significant coronary artery disease (CAD) (>50% luminal stenosis) in female patients previously hospitalized for an acute CAD event. Methods and Results All women younger than age 66 years in the greater Stockholm area in Sweden who were hospitalized for acute coronary syndromes during a 3-year period were recruited, Besides collection of clinical parameters, coronary angiography and a symptom-limited exercise test were performed in 228 patients 3 to 6 months after the index hospitalization. The mean age was 56 +/- 7 years. Angiographically nonsignificant CAD (stenosis <50%) was verified in 37% of the patients; significant CAD was found in 63%. The clinical parameters that showed the strongest relation with the presence of significant CAD after adjusting for age were history of myocardial infarction (odds ratio [OR] 4.91, 95% confidence interval [CI] 2.35 to 7.49), history of diabetes mellitus (OR 3.83, 95% Cl 1.63 to 14.31), serum high-density lipoprotein cholesterol <1.4 mmol/L (OR 2.11, 95% Cl 1.20 to 3.72), and waist-to-hip ratio >0.85 (OR 1.78, 95% Cl 1.02 to 3.10). A low exercise capacity and associated low change of rate-pressure product from rest to peak exercise were the only exercise testing parameters that were significantly related to angiographically verified significant CAD (<90% of the predicted maximal work capacity adjusted for age and weight, OR 1.91, 95% CI 1.04 to 3.50). Conclusions In female patients recovering from unstable CAD, exercise capacity was the only exercise testing parameter of value in the prediction of significant CAD. The consideration of certain clinical characteristics and coronary risk factors offer better or complementary information when deciding on further coronary assessment.
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| 25. |
- Alexander, John H., et al.
(author)
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Documentation of study medication dispensing in a prospective large randomized clinical trial : Experiences from the ARISTOTLE Trial
- 2013
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 166:3, s. 559-
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Journal article (peer-reviewed)abstract
- Background In ARISTOTLE, apixaban resulted in a 21% reduction in stroke, a 31% reduction in major bleeding, and an 11% reduction in death. However, approval of apixaban was delayed to investigate a statement in the clinical study report that "7.3% of subjects in the apixaban group and 1.2% of subjects in the warfarin group received, at some point during the study, a container of the wrong type." Methods Rates of study medication dispensing error were characterized through reviews of study medication container tear-off labels in 6,520 participants from randomly selected study sites. The potential effect of dispensing errors on study outcomes was statistically simulated in sensitivity analyses in the overall population. Results The rate of medication dispensing error resulting in treatment error was 0.04%. Rates of participants receiving at least 1 incorrect container were 1.04% (34/3,273) in the apixaban group and 0.77% (25/3,247) in the warfarin group. Most of the originally reported errors were data entry errors in which the correct medication container was dispensed but the wrong container number was entered into the case report form. Sensitivity simulations in the overall trial population showed no meaningful effect of medication dispensing error on the main efficacy and safety outcomes. Conclusions Rates of medication dispensing error were low and balanced between treatment groups. The initially reported dispensing error rate was the result of data recording and data management errors and not true medication dispensing errors. These analyses confirm the previously reported results of ARISTOTLE.
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| 26. |
- Alexander, Karen P, et al.
(author)
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Outcomes of apixaban versus warfarin in patients with atrial fibrillation and multi-morbidity : Insights from the ARISTOTLE trial
- 2019
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 208, s. 123-131
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Journal article (peer-reviewed)abstract
- BACKGROUND: Patients with atrial fibrillation (AF) often have multi-morbidity, defined as ≥3 comorbid conditions. Multi-morbidity is associated with polypharmacy, adverse events, and frailty potentially altering response to anticoagulation. We sought to describe the prevalence of multi-morbidity among older patients with AF and determine the association between multi-morbidity, clinical outcomes, and the efficacy and safety of apixaban compared with warfarin.METHODS: In this post-hoc subgroup analysis of the ARISTOTLE trial, we studied enrolled patients age ≥ 55 years (n = 16,800). Patients were categorized by the number of comorbid conditions at baseline: no multi-morbidity (0-2 comorbid conditions), moderate multi-morbidity (3-5 comorbid conditions), and high multi-morbidity (≥6 comorbid conditions). Association between multi-morbidity and clinical outcomes were analyzed by treatment with a median follow-up of 1.8 (1.3-2.3) years.RESULTS: Multi-morbidity was present in 64% (n = 10,713) of patients; 51% (n = 8491) had moderate multi-morbidity, 13% (n = 2222) had high multi-morbidity, and 36% (n = 6087) had no multi-morbidity. Compared with the no multi-morbidity group, the high multi-morbidity group was older (74 vs 69 years), took twice as many medications (10 vs 5), and had higher CHA2DS2-VASc scores (4.9 vs 2.7) (all P < .001). Adjusted rates per 100 patient-years for stroke/systemic embolism, death, and major bleeding increased with multi-morbidity (Reference no multi-morbidity; moderate multi-morbidity 1.42 [1.24-1.64] and high multi-morbidity 1.92 [1.59-2.31]), with no interaction in relation to efficacy or safety of apixaban.CONCLUSIONS: Multi-morbidity is prevalent among the population with AF; efficacy and safety of apixaban is preserved in this subgroup supporting extension of trial results to the most complex AF patients.
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| 27. |
- Alfredsson, Joakim, et al.
(author)
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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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In: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 168:4, s. 522-529
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Journal article (peer-reviewed)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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| 28. |
- Alfredsson, Joakim, 1962-, et al.
(author)
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Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction : Sex-related outcomes from DETO2X-AMI
- 2021
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In: American Heart Journal. - : Mosby Inc.. - 0002-8703 .- 1097-6744. ; 237, s. 13-24
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Journal article (peer-reviewed)abstract
- Background: The purpose of this study is to investigate the impact of oxygen therapy on cardiovascular outcomes in relation to sex in patients with confirmed myocardial infarction (MI).Methods: The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction trial randomized 6,629 patients to oxygen at 6 L/min for 6-12 hours or ambient air. In the present subgroup analysis including 5,010 patients (1,388 women and 3,622 men) with confirmed MI, we report the effect of supplemental oxygen on the composite of all-cause death, rehospitalization with MI, or heart failure at long-term follow-up, stratified according to sex.Results: Event rate for the composite endpoint was 18.1% in women allocated to oxygen, compared to 21.4% in women allocated to ambient air (hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.65-1.05). In men, the incidence was 13.6% in patients allocated to oxygen compared to 13.3% in patients allocated to ambient air (HR 1.03, 95% CI 0.86-1.23). No significant interaction in relation to sex was found (P=.16). Irrespective of allocated treatment, the composite endpoint occurred more often in women compared to men (19.7 vs 13.4%, HR 1.51; 95% CI, 1.30-1.75). After adjustment for age alone, there was no difference between the sexes (HR 1.06, 95% CI 0.91-1.24), which remained consistent after multivariate adjustment.Conclusion: Oxygen therapy in normoxemic MI patients did not significantly affect all-cause mortality or rehospitalization for MI or heart failure in women or men. The observed worse outcome in women was explained by differences in baseline characteristics, especially age
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| 30. |
- Ambrosy, A. P., et al.
(author)
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Clinical profile and prognostic value of low systolic blood pressure in patients hospitalized for heart failure with reduced ejection fraction: insights from the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST) trial
- 2013
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 165:2, s. 216-25
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Journal article (peer-reviewed)abstract
- BACKGROUND: Systolic blood pressure (SBP) is related to the pathophysiologic development and progression of heart failure (HF) and is inversely associated with adverse outcomes during hospitalization for HF (HHF). The prognostic value of SBP after initiating inhospital therapy and the mode of death and etiology of cardiovascular readmissions based on SBP have not been well characterized in HHF. METHODS: A post hoc analysis was performed of the placebo group (n = 2061) of the EVEREST trial, which enrolled patients within 48 hours of admission for worsening HF with an ejection fraction (EF) /=90 mm Hg, for a median follow-up of 9.9 months. Systolic blood pressure was measured at baseline, daily during hospitalization, and at discharge/day 7. Patients were divided into the following quartiles by SBP at baseline: /=131 mm Hg. Outcomes were all-cause mortality (ACM) and the composite of cardiovascular mortality or HHF (CVM + HHF). The associations between baseline, discharge, and inhospital change in SBP and ACM and CVM + HHF were assessed using multivariable Cox proportional hazards regression models adjusted for known covariates. RESULTS: Median (25th, 75th) SBP at baseline was 120 (105, 130) mm Hg and ranged from 82 to 202 mm Hg. Patients with a lower SBP were younger and more likely to be male; had a higher prevalence of prior revascularization and ventricular arrhythmias; had a lower EF, worse renal function, higher natriuretic peptide concentrations, and wider QRS durations; and were more likely to require intravenous inotropes during hospitalization. Lower SBP was associated with increased mortality, driven by HF and sudden cardiac death, and cardiovascular hospitalization, primarily caused by HHF. After adjusting for potential confounders, SBP was inversely associated with risk of the coprimary end points both at baseline (ACM: hazard ratio [HR]/10-mm Hg decrease 1.15, 95% CI1.08-1.22; CVM + HHF: HR 1.09/10-mm Hg decrease, 95% CI 1.04-1.14) and at the time of discharge/day 7 (ACM: HR 1.15/10-mm Hg decrease, 95% CI 1.08-1.22; CVM + HHF: HR 1.07/10-mm Hg decrease, 95% CI 1.02-1.13), but the association with inhospital SBP change was not significant. CONCLUSION: Systolic blood pressure is an independent clinical predictor of morbidity and mortality after initial therapy during HHF with reduced EF.
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| 31. |
- Andersson, Bert, 1952, et al.
(author)
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Spectrum and outcome of congestive heart failure in a hospitalized population.
- 1993
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In: American heart journal. - 0002-8703. ; 126:3 Pt 1, s. 632-40
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Journal article (peer-reviewed)abstract
- There are very few contemporary studies on the frequency and cause of congestive heart failure (CHF) in a general population. In western Sweden, inhabited by 1.64 million people, a retrospective survey was performed. All hospital records of patients with CHF, ages 16 through 65 years, were examined in all hospitals in the region. During the study period 2711 patients fulfilled the criteria for CHF or cardiomyopathy. Patients were monitored for 37 +/- 28 months. The most common cause of heart failure was coronary artery disease (IHD) (40%). Other common causes were hypertension (17%), valvular disease (13%), alcohol (11%), diabetes mellitus (10%), and systemic diseases (10%). There were positive correlations between the male sex and IHD, alcohol, and dilated cardiomyopathy; the female sex was associated with systemic diseases, valvular heart disease, and diabetes. The incidence of CHF requiring hospitalization per 100,000 in the population was 1.2 to 263 men and 1.1 to 129 women, in the youngest (age 16 to 30 years) and oldest (61 to 65 years) age groups, respectively. The 5-year survival rate was 50%. Analysis of causes performed with Cox's proportional hazards model for survival showed that age, IHD, alcohol, and diabetes were independent and powerful predictors of mortality (p < 0.001). The mode of death was progressive heart failure in 54% and sudden death in 26%. We concluded that the prognosis in patients with CHF was still very poor, even among this young population. The most common cause of CHF was IHD, and the second was hypertension.
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| 33. |
- Ariti, C. A., et al.
(author)
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Days alive and out of hospital and the patient journey in patients with heart failure: Insights from the Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) program
- 2011
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In: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 162:5, s. 900-6
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Journal article (peer-reviewed)abstract
- BACKGROUND: Conventional composite outcomes in heart failure (HF) trials, for example, time to cardiovascular death or first HF hospitalization, have recognized limitations. We propose an alternative outcome, days alive and out of hospital (DAOH), which incorporates mortality and all hospitalizations into a single measure. A refinement, the patient journey, also uses functional status (New York Heart Association [NYHA] class) measured during follow-up. The CHARM program is used to illustrate the methodology. METHODS: CHARM randomized 7,599 patients with symptomatic HF to placebo or candesartan, with median follow-up of 38 months. We related DAOH and percent DAOH (ie, percentage of time spent alive and out of hospital) to treatment using linear regression adjusting for follow-up time. RESULTS: Mean increase in DAOH for patients on candesartan versus placebo was 24.1 days (95% CI 9.8-38.3 days, P < .001). The corresponding mean increase in percent DAOH was 2.0% (95% CI 0.8%-3.1%, P < .001). These findings were dominated by reduced mortality (23 days) but enhanced by reduced time in hospital (1 day). Percent time spent in hospital because of HF was reduced by 0.10% (95% CI 0.04%-0.14%, P < .001). The patient journey analysis showed that patients in the candesartan group spent more follow-up time in NYHA classes I and II and less in NYHA class IV. CONCLUSIONS: Days alive and out of hospital, especially percent DAOH, provide a valuable tool for summarizing the overall absolute treatment effect on mortality and morbidity. In future HF trials, percent DAOH can provide a useful alternative perspective on the effects of treatment.
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| 34. |
- Armaganijan, Luciana V., et al.
(author)
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Effect of age on efficacy and safety of vorapaxar in patients with non-ST-segment elevation acute coronary syndrome : Insights from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial
- 2016
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 178, s. 176-184
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Journal article (peer-reviewed)abstract
- Background Antithrombotic therapy plays an important role in the treatment of non-ST-segment elevation acute coronary syndromes (NSTE ACS) but is associated with bleeding risk. Advanced age may modify the relationship between efficacy and safety. Methods Efficacy and safety of vorapaxar (a protease-activated receptor 1 antagonist) was analyzed across ages as a continuous and a categorical variable in the 12,944 patients with NSTE ACS enrolled in the TRACER trial. To evaluate the effect of age, Cox regression models were developed to estimate hazard ratios (HRs) with the adjustment of other baseline characteristics and randomized treatment for the primary efficacy composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization, and the primary safety composite of moderate or severe Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) bleeding. Results The median age of the population was 64 years (25th, 75th percentiles = 58, 71). Also, 1,791 patients (13.8%) were <= 54 years of age, 4,968 (38.4%) were between 55 and 64 years, 3,979 (30.7%) were between 65 and 74 years, and 2,206 (17.1%) were 75 years or older. Older patients had higher rates of hypertension, renal insufficiency, and previous stroke and worse Killip class. The oldest age group (>= 75 years) had substantially higher 2-year rates of the composite ischemic end point and moderate or severe GUSTO bleeding compared with the youngest age group (<= 54 years). The relationships between treatment assignment (vorapaxar vs placebo) and efficacy outcomes did not vary by age. For the primary efficacy end point, the HRs (95% CIs) comparing vorapaxar and placebo in the 4 age groups were as follows: 1.12 (0.88-1.43), 0.88 (0.76-1.02), 0.89 (0.76-1.04), and 0.88 (0.74-1.06), respectively (P value for interaction = .435). Similar to what was observed for efficacy outcomes, we did not observe any interaction between vorapaxar and age on bleeding outcomes. For the composite of moderate or severe bleeding according to the GUSTO classification, the HRs (95% CIs) comparing vorapaxar and placebo in the 4 age groups were 1.73 (0.89-3.34), 1.39 (1.04-1.86), 1.10 (0.85-1.42), and 1.73 (1.29-2.33), respectively (P value for interaction = .574). Conclusion Older patients had a greater risk for ischemic and bleeding events; however, the efficacy and safety of vorapaxar in NSTE ACS were not significantly influenced by age.
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| 37. |
- Aspelin, P., et al.
(author)
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Cost-effectiveness of iodixanol in patients at high risk of contrast-induced nephropathy
- 2005
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 149:2, s. 298-303
-
Research review (peer-reviewed)abstract
- Background: Acute renal failure after contrast-induced nephropathy is a clinically important and costly complication after the use of iodine-based contrast media. We investigated the cost and cost-effectiveness of 2 contrast media in patients at high risk of contrast-induced nephropathy. Methods: The analyses were based on a randomized, prospective, multinational clinical study comparing the nephrotoxic effects of an isosmolar nonionic contrast medium, iodixanol, with those of a low-osmolar nonionic contrast medium, iohexol. Resource utilization data were obtained from the study and from a retrospective review of patients' hospital records. Swedish, German, and French unit prices were applied to resources used. Between-group differences in average costs were analyzed using a nonparametric bootstrap method. Results: Resource utilization data for 125 patients were analyzed. Seven contrast media-related serious adverse reactions, of which 6 were acute renal failures, were noted in 6 patients receiving iohexol. Two patients in the iodixanol group had 1 nonserious reaction each. The mean hospitalization cost per patient was €489, €573, and €393 lower after iodixanol than after iohexol using Swedish, German, and French unit prices, respectively. The mean per-patient costs of treating adverse drug reactions were €371, €399, and €445 lower after iodixanol than after iohexol, using the respective unit prices (P = 0.01). Iodixanol was cost-effective compared with iohexol, with both lower costs and better effects related to fewer adverse drug reactions. Conclusions: The isosmolar contrast medium iodixanol appears to be cost-effective when compared with a low-osmolar contrast medium, iohexol, in diabetic patients with renal impairment undergoing angiography. © 2005, Elsevier Inc. All rights reserved.
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| 38. |
- Aulin, Julia, et al.
(author)
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Biomarkers and heart failure events in patients with atrial fibrillation in the ARISTOTLE trial evaluated by a multi-state model
- 2022
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In: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 251, s. 13-24
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Journal article (peer-reviewed)abstract
- BackgroundAtrial fibrillation (AF) and heart failure (HF) often coexist. We investigated the prognostic impact of biomarkers on the development of HF and death in patients with AF and different left ventricular systolic function considering the influence of competing events.MethodsThe study included 11,818 patients with AF from the ARISTOTLE trial who at entry had information on history of HF, an estimate of left ventricular function and plasma samples for determination of biomarkers representing cardiorenal dysfunction (NT-proBNP, troponin T, cystatin C) and inflammation (GDF-15, IL-6, CRP). Patients were categorized into: (I) HF with reduced ejection fraction (HFrEF, n = 2,048), (II) HF with preserved ejection fraction (HFpEF, n = 2,520), and (III) No HF (n = 7,250). Biomarker associations with HF hospitalization and death were analyzed using a multi-state model accounting also for repeated events.ResultsBaseline levels of NT-proBNP, troponin T, cystatin C, GDF-15, IL-6, and CRP were highest in HFrEF and lowest in No HF. During median 1.9 years follow-up, 546 patients were hospitalized at least once for HF and 819 died. Higher levels of all investigated biomarkers were associated with both outcomes (all P < .0001), with highest event rates in HFrEF and lowest in No HF. The associations remained after adjustments and were more pronounced for first than for recurrent events.ConclusionsIn anticoagulated patients with AF, biomarkers indicating cardiorenal dysfunction and inflammation improve the identification of patients at risk of developing HF or worsening of already existing HF. These biomarkers might be useful for targeting novel HF therapies in patients with AF.
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| 39. |
- Aulin, Julia, et al.
(author)
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Interleukin-6 and C-reactive protein and risk for death and cardiovascular events in patients with atrial fibrillation
- 2015
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 170:6, s. 1151-1160
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Journal article (peer-reviewed)abstract
- Background Inflammation has been associated with cardiovascular disease and the burden of atrial fibrillation (AF). In this study we evaluate inflammatory biomarkers and future cardiovascular events in AF patients in the RE-LY study. Methods Interleukin-6 (IL-6), C-reactive protein (CRP) (n = 6,187), and fibrinogen (n = 4,893) were analyzed at randomization; outcomes were evaluated by Cox models and C-statistics. Results Adjusted for clinical risk factors IL-6 was independently associated with stroke or systemic embolism (P =.0041), major bleedings (P =.0001), vascular death (P<.0001), and a composite thromboembolic outcome (ischemic stroke, systemic embolism, myocardial infarction, pulmonary embolism and vascular death) (P<.0001). CRP was independently related to myocardial infarction (P =.0047), vascular death (P =.0004), and the composite thromboembolic outcome (P =.0001). When further adjusted for cardiac (troponin andN-terminal fragment B-type natriuretic peptide [NT-proBNP]) and renal (cystatin-C) biomarkers on top of clinical risk factors IL-6 remained significantly related to vascular death (P<.0001), major bleeding (P<.0170) and the composite thromboembolic outcome (P<.0001), and CRP to myocardial infarction (.0104). Fibrinogen was not associated with any outcome. C-index for stroke or systemic embolism increased from 0.615 to 0.642 (P =.0017) when adding IL-6 to the clinically used CHA(2)DS(2)-VASc risk score with net reclassification improvement of 28%. Conclusion In patients with AF, IL-6 is related to higher risk of stroke and major bleeding, and both markers are related to higher risk of vascular death and the composite of thromboembolic events independent of clinical risk factors. Adjustment for cardiovascular biomarkers attenuated the prognostic value, although IL-6 remained related to mortality, the composite of thromboembolic events, and major bleeding, and CRP to myocardial infarction.
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| 40. |
- Bagai, Akshay, et al.
(author)
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Duration of ischemia and treatment effects of pre- versus in-hospital ticagrelor in patients with ST-segment elevation myocardial infarction: Insights from the ATLANTIC study
- 2018
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In: American Heart Journal. - : MOSBY-ELSEVIER. - 0002-8703 .- 1097-6744. ; 196, s. 56-64
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Journal article (peer-reviewed)abstract
- Background Among patients with STEMI in the ATLANTIC study, pre-hospital administration of ticagrelor improved post-PCI ST-segment resolution and 30-day stent thrombosis. We investigated whether this clinical benefit with pre-hospital ticagrelor differs by ischemic duration. Methods In a post hoc analysis we compared absence of ST-segment resolution post-PCI and stent thrombosis at 30 days between randomized treatment groups (pre-versus in-hospital ticagrelor) stratified by symptom onset to first medical contact (FMC) duration [amp;lt;= 1 hour (n = 773), amp;gt;1 to amp;lt;= 3 hours (n = 772), and amp;gt;3 hours (n = 311)], examining the interaction between randomized treatment strategy and duration of symptom onset to FMC for each outcome. Results Patients presenting later after symptom onset were older, more likely to be female, and have higher baseline risk. Patients with symptom onset to FMC amp;gt;3 hours had the greatest improvement in post-PCI ST-segment elevation resolution with pre-versus in-hospital ticagrelor (absolute risk difference: amp;lt;= 1 hour, 2.9% vs. amp;gt;1 to amp;lt;= 3 hours, 3.6% vs. amp;gt;3 hours, 12.2%; adjusted p for interaction = 0.13), while patients with shorter duration of ischemia had greater improvement in stent thrombosis at 30 days with pre-versus in-hospital ticagrelor (absolute risk difference: amp;lt;= 1 hour, 1.3% vs. amp;gt;1 hour to amp;lt;= 3hours, 0.7% vs. amp;gt;3 hours, 0.4%; adjusted p for interaction = 0.55). Symptom onset to active ticagrelor administration was independently associated with stent thrombosis at 30 days (adjusted OR 1.89 per 100 minute delay, 95% CI 1.20-2.97, P amp;lt; .01), but not post-PCI ST-segment resolution (P = .41). Conclusions The effect of pre-hospital ticagrelor to reduce stent thrombosis was most evident when given early within 3 hours after symptom onset, with delay in ticagrelor administration after symptom onset associated with higher rate of stent thrombosis. These findings re-emphasize the need for early ticagrelor administration in primary PCI treated STEMI patients.
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| 41. |
- Bang, Casper N., et al.
(author)
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Effect of lipid lowering on new-onset atrial fibrillation in patients with asymptomatic aortic stenosis : The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study
- 2012
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In: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 163:4, s. 690-696
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Journal article (peer-reviewed)abstract
- Background Lipid-lowering drugs, particularly statins, have anti-inflammatory and antioxidant properties that may prevent atrial fibrillation (AF). This effect has not been investigated on new-onset AF in asymptomatic patients with aortic stenosis (AS). Methods Asymptomatic patients with mild-to-moderate AS (n = 1,421) were randomized (1: 1) to double-blind simvastatin 40 mg and ezetimibe 10 mg combination or placebo and followed up for a mean of 4.3 years. The primary end point was the time to new-onset AF adjudicated by 12-lead electrocardiogram at a core laboratory reading center. Secondary outcomes were the correlates of new-onset AF with nonfatal nonhemorrhagic stroke and a combined end point of AS-related events. Results During the course of the study, new-onset AF was detected in 85 (6%) patients (14.2/1,000 person-years of follow-up). At baseline, patients who developed AF were, compared with those remaining in sinus rhythm, older and had a higher left ventricular mass index a smaller aortic valve area index. Treatment with simvastatin and ezetimibe was not associated with less new-onset AF (odds ratio 0.89 [95% CI 0.57-1.97], P = .717). In contrast, age (hazard ratio [HR] 1.07 [95% CI 1.05-1.10], P < .001) and left ventricular mass index (HR 1.01 [95% CI 1.01-1.02], P < .001) were independent predictors of new-onset AF. The occurrence of new-onset AF was independently associated with 2-fold higher risk of AS-related outcomes (HR 1.65 [95% CI 1.02-2.66], P = .04) and 4-fold higher risk of nonfatal nonhemorrhagic stroke (HR 4.04 [95% CI 1.18-13.82], P = .03). Conclusions Simvastatin and ezetimibe were not associated with less new-onset AF. Older age and greater left ventricular mass index were independent predictors of AF development. New-onset AF was associated with a worsening of prognosis. (Am Heart J 2012;163:690-6.)
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| 42. |
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| 43. |
- Bao, Xue, et al.
(author)
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Growth differentiation factor-15 is a biomarker for all-cause mortality but less evident for cardiovascular outcomes : A prospective study
- 2021
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In: American Heart Journal. - : Elsevier BV. - 0002-8703. ; 234, s. 81-89
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Journal article (peer-reviewed)abstract
- Background: Previous studies have proposed growth differentiation factor-15 (GDF-15) as a predictor of adverse cardiovascular outcomes and mortality. The present study aimed to determine if such associations remain after accounting for death as a competing risk, and if GDF-15 provides superior prediction performance than other biomarkers. Methods: Plasma GDF-15 levels and cardiovascular risk factors were measured in individuals without cardiovascular diseases (n = 4,143, aged 57.4 ± 5.96 years, 38.6 % men) from Malmö Diet and Cancer-Cardiovascular Cohort and were followed up for more than 20 years. Incidence of coronary events, ischemic stroke, cardiovascular mortality, and all-cause mortality was studied in relation to GDF-15 using Cox proportional hazards regression, with adjustment for potential confounders. Confounding from death as competing risk was carefully checked using the Fine and Gray subdistribution hazard model. Predictive capabilities were further evaluated using C-statistics, continuous net reclassification improvement, and integrated discrimination improvement. Results: During follow-up, 424 coronary events, 327 ischemic stroke, 368 cardiovascular deaths, and 1,308 all-cause deaths occurred. After controlling for death from other causes as competing events, only all-cause mortality remained significantly related to GDF-15. The addition of GDF-15 significantly improved prediction for all-cause mortality in addition to the traditional risk factors, high-sensitive C-reactive protein and N-terminal prohormone of brain natriuretic peptide. Only N-terminal prohormone of brain natriuretic peptide improved prediction for CVD mortality. Conclusions: GDF-15 is a robust biomarker for all-cause mortality but less reliable for coronary event, ischemic stroke or cardiovascular mortality. Competing risk from death is an important consideration when interpreting the results.
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| 44. |
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| 45. |
- Berger, J. S., et al.
(author)
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Design and rationale for the Effects of Ticagrelor and Clopidogrel in Patients with Peripheral Artery Disease (EUCLID) trial
- 2016
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In: American Heart Journal. - : Elsevier BV. - 0002-8703. ; 175, s. 86-93
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Journal article (peer-reviewed)abstract
- Background Despite overwhelming data demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data in peripheral artery disease (PAD) are less compelling. Aspirin has modest evidence supporting a reduction in cardiovascular events in patients with PAD, whereas clopidogrel monotherapy may be more effective in PAD. Ticagrelor, a potent, reversibly binding P2Y(12) receptor antagonist, is beneficial in patients with acute coronary syndrome and prior myocardial infarction. The EUCLID trial is designed to address the need for effective antiplatelet therapy in PAD to decrease the risk of cardiovascular events. Study design EUCLID is a randomized, double-blind, parallel-group, multinational clinical trial designed to evaluate the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events in subjects with symptomatic PAD. Subjects with established PAD will be randomized in a 1: 1 fashion to ticagrelor 90 mg twice daily or clopidogrel 75 mg daily. The primary end point is a composite of cardiovascular death, myocardial infarction, or ischemic stroke. Other end points address limb events including acute leg ischemia, need for revascularization, disease progression by ankle-brachial index, and quality of life. The primary safety objective is Thrombolysis in Myocardial Infarction-defined major bleeding. Recruitment began in December 2012 and was completed in March 2014; 13,887 patients were randomized. The trial will continue until at least 1,364 adjudicated primary end points occur. Conclusions The EUCLID study is investigating whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD.
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| 46. |
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| 47. |
- Bingisser, Roland, et al.
(author)
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Measurement of natriuretic peptides at the point of care in the emergency and ambulatory setting : Current status and future perspectives
- 2013
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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 166:4, s. 614-
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Journal article (peer-reviewed)abstract
- The measurement of natriuretic peptides (NPs), B-type NP or N-terminal pro-B-type NP, can be an important tool in the diagnosis of acute heart failure in patients presenting to an Emergency Department (ED) with acute dyspnea, according to international guidelines. Studies and subsequent meta-analyses are mixed on the absolute value of routine NP assessment of ED patients. However, levels of NPs are likely to be used also to guide treatment and to assess risk of adverse outcomes in other patients at risk of developing heart failure, including those with pulmonary embolism or diabetes, or receiving chemotherapy. Natriuretic peptide levels, like other biomarkers, can now be measured at the point of care (POC). We have reviewed the current status of NP measurement together with the potential contribution of POC measurement of NPs to clinical care delivery in the emergency and other settings. Several POC systems for measuring NP levels are now available: these produce test results within 15 minutes and appear sufficiently sensitive and robust to be used routinely in diagnostic evaluations. Point-of-care systems could be used to assess NP levels in the ED and community outpatient settings to monitor the risk of acute heart failure. Furthermore, the use of protocol-driven POC testing of NP within the time frame of a patient consultation in the ED may facilitate and accelerate the throughput and disposition of at-risk patients. Appropriately designed clinical trials will be needed to confirm these potential benefits. It is also important that processes of care delivery are redesigned to take full advantage of the faster turnaround times provided by POC technology.
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| 48. |
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| 49. |
- Björklund, Erik, et al.
(author)
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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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In: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 148:4, s. 566-573
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Journal article (peer-reviewed)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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| 50. |
- Bosworth, H. B., et al.
(author)
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Medication adherence: a call for action
- 2011
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In: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 162:3, s. 412-24
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Journal article (peer-reviewed)abstract
- Poor adherence to efficacious cardiovascular-related medications has led to considerable morbidity, mortality, and avoidable health care costs. This article provides results of a recent think-tank meeting in which various stakeholder groups representing key experts from consumers, community health providers, the academic community, decision-making government officials (Food and Drug Administration, National Institutes of Health, etc), and industry scientists met to evaluate the current status of medication adherence and provide recommendations for improving outcomes. Below, we review the magnitude of the problem of medication adherence, prevalence, impact, and cost. We then summarize proven effective approaches and conclude with a discussion of recommendations to address this growing and significant public health issue of medication nonadherence.
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