| 1. |
- Aasa, Mikael, et al.
(författare)
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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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Ingår i: American heart journal. - : Elsevier BV. - 1097-6744 .- 0002-8703. ; 160:2, s. 322-8
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Tidskriftsartikel (refereegranskat)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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| 2. |
- Aasa, Mikael, et al.
(författare)
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Risk Reduction for Cardiac Events After Primary Coronary Intervention Compared With Thrombolysis for Acute ST-Elevation Myocardial Infarction (Five-Year Results of the Swedish Early Decision Reperfusion Strategy [SWEDES] Trial).
- 2010
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Ingår i: The American journal of cardiology. - : Elsevier BV. - 1879-1913 .- 0002-9149. ; 106:12, s. 1685-91
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Tidskriftsartikel (refereegranskat)abstract
- Primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction compares favorably to thrombolysis. In previous studies the benefit has been restricted to the early postinfarction period with no additional risk decrease beyond this period. Long-term outcome after use of third-generation thrombolytics and modern adjunctive pharmaceutics in the 2 treatment arms has not been investigated. This study was conducted to compare 5-year outcome after updated regimens of PPCI or thrombolysis. Patients with ST-elevation myocardial infarction were randomized to enoxaparin and abciximab followed by PPCI (n = 101) or enoxaparin followed by reteplase (n = 104), with prehospital initiation of therapy in 42% of patients. Data on survival and major cardiac events were obtained from Swedish national registries after 5.3 years. PPCI resulted in a better outcome with respect to the composite of death or recurrent myocardial infarction (hazard ratio 0.54, confidence interval 0.31 to 0.95) compared to thrombolysis. This was attributed to a significant decrease in cardiac deaths (hazard ratio 0.16, confidence interval 0.04 to 0.74). The difference evolved continuously over the 5-year follow-up. After adjustment for covariates, a significant benefit remained with respect to cardiac death or recurrent infarction but not for the composite of total survival or recurrent myocardial infarction (p = 0.07). The observed differences were not seen in patients in whom therapy was initiated in the prehospital phase. In conclusion, PPCI in combination with enoxaparin and abciximab compares favorably to thrombolysis in combination with enoxaparin with a risk decrease that stretches beyond the early postinfarction period. Prehospital thrombolysis may, however, match PPCI in long-term outcome.
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| 3. |
- Barasa, Anders, 1973, et al.
(författare)
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Heart failure in young adults: 20-year trends in hospitalization, aetiology, and case fatality in Sweden
- 2014
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Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 35:1, s. 25-32
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Tidskriftsartikel (refereegranskat)abstract
- AIMS: To describe trends in incidence and case fatality among younger (18-54 years) and older (55-84 years) Swedish patients with heart failure (HF). METHODS AND RESULTS: Through linking the Swedish national hospital discharge and the cause-specific death registries, we identified patients aged 18-84 years that were discharged 1987-2006 with a diagnosis of HF. Age-specific mean incidence rates per 100 000 person-years were calculated in four 5-year periods. Kaplan-Meier survival curves were plotted up to 3 years. From 1987 to 2006, there were 443 995 HF hospitalizations among adults 18-84 years. Of these, 4660 (1.0%) and 13 507 (3.0%) occurred in people aged 18-44 and 45-54 years (31.6% women), respectively. From the first to the last 5-year period, HF incidence increased by 50 and 43%, among people aged 18-34 and 35-44 years, respectively. Among people >/=45 years, incidence peaked in the mid-1990s and then decreased. Heart failure in the presence of cardiomyopathy increased more than two-fold among all age groups. Case fatality decreased for all age groups until 2001, after which no further significant decrease <55 years was observed. CONCLUSION: Increasing HF hospitalization in young adults in Sweden opposes the general trend seen in older patients, a finding which may reflect true epidemiological changes. Cardiomyopathy accounted for a substantial part of this increase. High case fatality and lack of further case fatality reduction after 2001 are causes for concern.
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| 4. |
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| 5. |
- Dellborg, Helena, et al.
(författare)
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Why do patients participate in long-term cardiovascular trials? - a questionnaire-based study
- 2016
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Ingår i: Scandinavian Cardiovascular Journal. - : Informa UK Limited. - 1401-7431 .- 1651-2006. ; 50:2, s. 83-87
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Participation in clinical trials by patients with cardiovascular disease is paramount to the development of new treatments. Capturing and keeping patients in the trials until the end is very important and trials are often of long duration and include patients in a clinically stable condition, with few symptoms and a low risk of recurrent disease. We investigated what motivates patients to participate in long-term cardiovascular trials. Increased knowledge may enhance inclusion and retention and minimize lost to follow-up or withdrawal of consent. Materials and methods A questionnaire with 11 statements to elucidate the reasons for participation and retention in long-term clinical trials was used and replies from 135 participants in trials, 78% men, mean age was 68 years. Results The two most important reasons for participation were: "I am able to see the same doctor and nurse at the visits", indicated by 89 patients (66%), followed by "I want to promote science", which was indicated by 74 patients (55%). The least important reason was "The visits are free of cost". Conclusion Patients who participate in cardiovascular clinical trials do so because it may provide access to more continuous care but equally important are altruistic motives including a wish to promote science.
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| 6. |
- Fedchenko, Maria, 1988, et al.
(författare)
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Cardiovascular risk factors in adults with coarctation of the aorta.
- 2019
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Ingår i: Congenital heart disease. - : Computers, Materials and Continua (Tech Science Press). - 1747-0803 .- 1747-079X. ; 14:4, s. 549-558
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Tidskriftsartikel (refereegranskat)abstract
- The aging patient with adult congenital heart disease (ACHD) faces the risk of developing atherosclerotic disease. Patients with coarctation of the aorta (CoA) are especially vulnerable because of an inherent high risk of developing hypertension. However, data on the prevalence of other cardiovascular risk factors are scarce. Therefore, this study aimed to describe the prevalence of traditional cardiovascular risk factors (diabetes, hypertension, hyperlipidemia, smoking, obesity, and sedentary lifestyle) in adult patients with CoA.Patients with CoA who were registered at the ACHD clinic in Gothenburg were asked to participate in a comprehensive cardiovascular risk assessment. This assessment included a glucose tolerance test, cholesterol profile, ambulatory blood pressure measurements, and a lifestyle questionnaire.A total of 72 patients participated. The median age was 43.5years and 58.3% were men. Sixty-six (91.7%) patients had ≥one cardiovascular risk factor and 40.3% had ≥three risk factors. Three (4.2%) patients were newly diagnosed with diabetes or impaired glucose tolerance. More than half of the patients had hyperlipidemia (n=42, 58.3%) and 35 patients (48.6%) were overweight or obese. Only three (4.2%) patients smoked regularly. Of the 60 patients who underwent 24-hour ambulatory blood pressure measurement, 33 (55.0%) were hypertensive. Of the 30 patients with known hypertension only 9 (30.0%) had well-controlled blood pressure on ambulatory blood pressure measurement.Cardiovascular risk factors among patients with CoA are prevalent. This may indicate a need for more aggressive screening strategies of traditional risk factors to minimize the risk of these patients also developing atherosclerotic disease.
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| 7. |
- Fedchenko, Maria, 1988, et al.
(författare)
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Validation of myocardial infarction diagnosis in patients with congenital heart disease in Sweden.
- 2020
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Ingår i: BMC cardiovascular disorders. - : Springer Science and Business Media LLC. - 1471-2261. ; 20:1
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Tidskriftsartikel (refereegranskat)abstract
- The population of adults with congenital heart disease (CHD) is growing, and increasingly more patients with CHD reach older ages. Patients with CHD are at an increased risk of myocardial infarction (MI) with increased age. Diagnosing MI in patients with CHD can be challenging in clinical practice owing to a high prevalence of aberrant electrocardiograms, ventricular hypertrophy, and heart failure, among other factors. The National Swedish Patient Register (NPR) is widely used in epidemiological studies; however, MI diagnoses specifically in patients with CHD have never been validated in the NPR.We contacted hospitals and medical archive services to request medical records for 249 patients, born during 1970-2012, with both CHD and MI diagnoses and who were randomly selected from the NPR by the Swedish National Board of Health and Welfare. Follow-up was until 2015. We performed a medical chart review to validate the MI diagnoses; we also validated CHD diagnoses to ensure that only patients with confirmed CHD diagnoses were included in the MI validation process.We received medical records for 96.4% (n=238/249) of patients for validation of CHD diagnoses. In total, 74.8% (n=178/238) had a confirmed CHD diagnosis; of these, 70.2% (n=167) had a fully correct CHD diagnosis in the NPR; a further 4.6% (n=11) had a CHD diagnosis, but it was misclassified. MI diagnoses were validated in 167 (93.8%) patients with confirmed CHD. Of the patients with confirmed CHD, 88.0% (n=147/167) had correct MI diagnoses. Patients with non-complex CHD diagnoses had more correct MI diagnoses than patients with complex CHD (91.0%, n=131 compared with 69.6%, n=16). The main cause for incorrect MI diagnoses was typographical error, contributing to 50.0% of the incorrect diagnoses.The validity of MI diagnoses in patients with confirmed CHD in the NPR is high, with nearly 9 of 10 MI diagnoses being correct (88.0%). MI in patients with CHD can safely be studied using the NPR.
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| 8. |
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| 9. |
- Johansson, Magnus C, 1954, et al.
(författare)
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Pitfalls in diagnosing PFO: characteristics of false-negative contrast injections during transesophageal echocardiography in patients with patent foramen ovales
- 2010
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Ingår i: Journal of the American Society of Echocardiography. - 0894-7317. ; 23:11, s. 1136-1142
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Contrast injections during transesophageal echocardiography for patent foramen ovale (PFO) detection may be false negative. The characteristics of false-negative injections were studied retrospectively. METHODS: Contrast transesophageal echocardiography was analyzed for the presence or absence of two characteristics: leftward bulging of the interatrial septum and dense contrast filling of the region of the right atrium adjacent to the interatrial septum. RESULTS: Two hundred forty-seven injections were administered to 14 patients with PFOs, and 130 (53%) were false negative. The absence of either characteristic during a single injection resulted in low sensitivity for PFO detection of 7%. When the two characteristics were present at the same time, the sensitivity for PFO detection after a single injection was as high as 95%. CONCLUSIONS: The simultaneous presence of both leftward bulging of the interatrial septum and dense contrast filling of the region in the right atrium, adjacent to the interatrial septum, is a prerequisite for PFO detection, and if either characteristic is missing, the injection is inconclusive.
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| 10. |
- Johansson, Magnus C, 1954, et al.
(författare)
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The significance of patent foramen ovale: a current review of associated conditions and treatment
- 2009
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Ingår i: International Journal of Cardiology. - 1874-1754. ; 134:1, s. 17-24
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Tidskriftsartikel (refereegranskat)abstract
- Patent foramen ovale (PFO) is a remnant of the foetal circulation, found in about a quarter of the population. PFO is an asymptomatic condition and the high prevalence infers that it is in most cases of no or only limited clinical significance. However, recent research has found an increased prevalence of PFO in cryptogenic stroke, decompression illness and migraine. The presence of a PFO has also been associated with oxygen desaturation in conditions such as obstructive pulmonary disease and obstructive sleep apnoea. The rapid evolution and widespread availability of catheter-based closing techniques have further stimulated interest. The seemingly growing significance of PFO will be discussed in this review.
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| 11. |
- Karagianni, A., et al.
(författare)
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Recurrent cerebrovascular events in patients after percutaneous closure of patent foramen ovale
- 2020
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Ingår i: Journal of Stroke & Cerebrovascular Diseases. - : Elsevier BV. - 1052-3057. ; 29:8
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Tidskriftsartikel (refereegranskat)abstract
- Background: Recent published trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) for preventing recurrent cryptogenic cerebrovascular events. However, the risk of recurrent cerebrovascular events (rCVEs) is up to 5.7%, and the etiology is unclear. Objective: This study aimed to investigate the risk factors for rCVEs after closure of PFO during long-term follow-up. Methods: In our center, 282 consecutive patients underwent PFO closure because of a cryptogenic cerebrovascular event between 2006 and 2014. Their Risk of Paradoxical Embolism (RoPE) score was calculated retrospectively. We followed up with the patients by telephone, using hospital records to identify those who suffered from rCVEs. Patients with rCVEs were matched with two control patients of the same sex and RoPE score without rCVEs who underwent PFO closure at approximately the same time. The patients with rCVEs and controls participated in a clinical examination, including contrast transthoracic echocardiography (TTE) and Holter electrocardiography, to investigate the possible cause of rCVEs compared with controls. Results: Fourteen (5%) out of the 282 consecutive patients who underwent PFO closure suffered from rCVEs during a mean follow-up of 8.4 years (1.7 rCVEs per 100 patient-years). The median RoPE score of the patients was 7. Recurrent CVE occurred in 3.2 patients per 100 patient-years in patients with residual shunting compared with 0.8 patients per 100 patient-years in those without residual shunt. These patients were on anti-platelet treatment or without any effective anticoagulant treatment at the time rCVE occurred. The risk ratio of rCVEs in patients with residual shunting was 2.9-times higher than in patients without residual shunting (95% CI: 1.4-6.1) at follow-up visit. Four patients who had the BioSTAR device implanted suffered from an rCVE despite lack of residual shunting. Conclusions: This study indicates that residual shunting and choice of the device may be the major reasons for rCVEs.
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| 12. |
- Mirzada, Naqibullah, 1977, et al.
(författare)
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Seven-year follow-up of percutaneous closure of patent foramen ovale
- 2013
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Ingår i: IJC Heart and Vessels. - : Elsevier BV. - 2214-7632. ; 1, s. 32-36
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Tidskriftsartikel (refereegranskat)abstract
- Background: Observational studies favor percutaneous closure of patent foramen ovale (PFO) over medical treatment to reduce recurrent stroke while randomized trials fail to demonstrate significant superiority of percutaneous PFO closure. Few long-term studies are available post PFO closure. This study reports long-term clinical outcomes after percutaneous PFO closure. Methods: Between 1997 and 2006, 86 consecutive eligible patients with cerebrovascular events, presumably related to PFO, underwent percutaneous PFO closure. All 86 patients were invited to a long-term follow-up, which was carried out during 2011 and 2012. Results: Percutaneous PFO closure was successfully performed in 85 of 86 patients. The follow-up rate was 100%. No cardiovascular or cerebrovascular deaths occurred. Two patients (both women) died from lung cancer during follow-up. Follow-up visits were conducted for 64 patients and the remaining 20 patients were followed up by phone. The mean follow-up time was 7.3. years (5 to 12.4. years). Mean age at PFO closure was 49. years. One patient had a minor stroke one month after PFO closure and a transient ischemic attack (TIA) two years afterwards. One other patient suffered from a TIA six years after closure. No long-term device-related complications were observed. Conclusions: Percutaneous PFO closure was associated with very low risk of recurrent stroke and is suitable in most patients. We observed no mortality and no long-term device-related complications related to PFO closure, indicating that percutaneous PFO closure is a safe and efficient treatment even in the long term. © 2013 Elsevier B.V.
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| 13. |
- Aasa, M., et al.
(författare)
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Temporal changes in TIMI myocardial perfusion grade in relation to epicardial flow, ST-resolution and left ventricular function after primary percutaneous coronary intervention
- 2007
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Ingår i: Coron Artery Dis. - 0954-6928. ; 18:7, s. 513-518
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Myocardial perfusion at the end of reperfusion therapy assessed angiographically with thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade (TMPG) has been associated with recovery of left ventricular (LV) function and survival. The aim of this analysis was to study the evolution of TMPG within the first week following primary percutaneous coronary intervention (PCI) and its association with ECG-derived ST-segment resolution (STRES) and recovery of LV function. METHODS: A total of 76 patients with acute myocardial infarction were pretreated with enoxaparine and abciximab and subjected to primary PCI within a prospective study and evaluated with TMPG assessed on coronary angiography at the end of the procedure and after 5-7 days. STRES was evaluated at 120 min post inclusion and global LV function was assessed by echocardiography after 30 days. RESULTS: Reperfusion (TIMI flow 2-3) was reached in all patients. Forty one percent had 'open myocardium' (i.e. TMPG 2 or 3) after PCI, a number that increased to 61% after 5-7 days (P=0.003). STRES >50% was reached in 73% of the patients and there was a good correlation between TMPG and STRES. Furthermore, those who improved from 'closed' to 'open myocardium' had higher STRES (and similar to those with 'open myocardium' already post-PCI) than those who had 'closed myocardium' at both occasions (80 vs. 52%, P=0.012). CONCLUSION: A significant increase was found in the number of patients with 'open myocardium' within the first week post-primary PCI and STRES seems to predict this improvement.
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| 14. |
- Abell, J. E., et al.
(författare)
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Adjunctive use of anticoagulants at the time of percutaneous coronary intervention in patients with an acute coronary syndrome treated with fondaparinux: a multinational retrospective review
- 2017
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Ingår i: European Heart Journal - Cardiovascular Pharmacotherapy. - : Oxford University Press (OUP). - 2055-6837 .- 2055-6845. ; 3:4, s. 214-220
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Tidskriftsartikel (refereegranskat)abstract
- Aim This retrospective chart review was designed to evaluate physician adherence to the prescribing information for fondaparinux regarding adjunctive anticoagulant use during percutaneous coronary intervention (PCI) in patients with an acute coronary syndrome (ACS). Methods and results Medical record abstractors at each site obtained information regarding the use of fondaparinux and adjunctive anticoagulants during PCI. Physician adherence to fondaparinux prescribing information regarding the administration of an adjunctive anticoagulant during PCI was estimated using generalized estimating equations. This retrospective study, conducted in 2008-2010, included a total of 1056 patient records from 27 sites across 6 countries (Canada, France, Germany, Greece, Poland, and Sweden). Over 98% of patients had been treated with fondaparinux at the recommended 2.5 mg dose. Use of adjunctive anticoagulant during PCI was 97.5%, giving an adjusted adherence rate of 98.8% (95% confidence interval: 0.97-0.99), with 86.3% of patients receiving unfractionated heparin. Although the sub-group of patients with ST-elevation myocardial infarction who underwent primary PCI was too small to make a definitive conclusion, 70.4% of the 159 patients did not receive fondaparinux immediately prior to (<24 h) or during primary PCI, suggesting that their treating physicians may have been adherent to the prescribing information. Conclusion Physician adherence to the prescribing information for adjunctive anticoagulation during PCI in patients with an ACS receiving fondaparinux was high. The results were consistent in each of the six countries and across patient sub-groups.
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| 15. |
- Al-Khaiat, Sara, 1994, et al.
(författare)
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Anticoagulation treatment in adult patients with congenital heart defects and bleeding-related mortality
- 2023
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Ingår i: Progress in Pediatric Cardiology. - : Elsevier BV. - 1058-9813. ; 68
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Tidskriftsartikel (refereegranskat)abstract
- Background: Congenital heart disease (CHD) is the most common type of birth defect. Survival, especially for patients with complex heart defects, has increased dramatically and today 97 % of those born with heart defects reach adulthood. As a late effect of both the congenital malformations and various types of interventions, these patients generally have an increased risk of atrial fibrillation, which is strongly associated with stroke. Additionally, implantation of foreign materials such as mechanical heart valves is also associated with higher risk for embolization. Therefore, adult patient with congenital heart disease (ACHD) are at a substantially increased risk of thromboembolism which necessitates anticoagulant therapy. However, the impact and risk of bleeding and bleeding-related mortality, particularly in young ACHD patients, during long-term anticoagulation treatment is unclear. Methods: In this retrospective cohort study, 117 deceased ACHD patients with anticoagulant treatment were identified by using the Swedish registry of congenital heart disease between 2005 and 2021. Data from medical records were collected and analyzed. Variables obtained were main diagnosis, indication and type of anticoagulation treatment, complications, and cause of death. Results: A total of 17 ACHD patients (14.5 %) experienced bleeding events. Ten ACHD patients (8.5 %) experienced major bleeding, including five patients (4.3 %) who died of a hemorrhagic stroke. Another seven ACHD patients had minor bleeding (6 %). Conclusion: Despite the occurrence of bleeding-related complications, the proportion of serious, fatal bleeding was low among deceased ACHD patients with anticoagulation treatment.
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| 16. |
- Alexander, John H., et al.
(författare)
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Apixaban, an oral, direct, selective factor Xa inhibitor, in combination with antiplatelet therapy after acute coronary syndrome : results of the Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) trial
- 2009
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Ingår i: Circulation. - 0009-7322 .- 1524-4539. ; 119:22, s. 2877-2885
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: After an acute coronary syndrome, patients remain at risk of recurrent events. Apixaban, an oral direct factor Xa inhibitor, is a novel anticoagulant that may reduce these events but also poses a risk of bleeding. METHODS AND RESULTS: Apixaban for Prevention of Acute Ischemic and Safety Events (APPRAISE) was a phase 2, double-blind, placebo-controlled, dose-ranging study. Patients (n=1715) with recent ST-elevation or non-ST-elevation acute coronary syndrome were randomized to 6 months of placebo (n=611) or 1 of 4 doses of apixaban: 2.5 mg twice daily (n=317), 10 mg once daily (n=318), 10 mg twice daily (n=248), or 20 mg once daily (n=221). Nearly all patients received aspirin; 76% received clopidogrel. The primary outcome was International Society of Thrombosis and Hemostasis major or clinically relevant nonmajor bleeding. A secondary outcome was cardiovascular death, myocardial infarction, severe recurrent ischemia, or ischemic stroke. At the recommendation of the Data Monitoring Committee, the 2 higher-dose apixaban arms were discontinued because of excess total bleeding. Compared with placebo, apixaban 2.5 mg twice daily (hazard ratio, 1.78; 95% confidence interval, 0.91 to 3.48; P=0.09) and 10 mg once daily (hazard ratio, 2.45; 95% confidence interval, 1.31 to 4.61; P=0.005) resulted in a dose-dependent increase in major or clinically relevant nonmajor bleeding. Apixaban 2.5 mg twice daily (hazard ratio, 0.73; 95% confidence interval, 0.44 to 1.19; P=0.21) and 10 mg once daily (hazard ratio, 0.61; 95% confidence interval, 0.35 to 1.04; P=0.07) resulted in lower rates of ischemic events compared with placebo. The increase in bleeding was more pronounced and the reduction in ischemic events was less evident in patients taking aspirin plus clopidogrel than in those taking aspirin alone. CONCLUSIONS: We observed a dose-related increase in bleeding and a trend toward a reduction in ischemic events with the addition of apixaban to antiplatelet therapy in patients with recent acute coronary syndrome. The safety and efficacy of apixaban may vary depending on background antiplatelet therapy. Further testing of apixaban in patients at risk of recurrent ischemic events is warranted.
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| 17. |
- Anand, Sonia S, et al.
(författare)
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Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial.
- 2018
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Ingår i: Lancet (London, England). - 1474-547X. ; 391:10117, s. 219-229
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Tidskriftsartikel (refereegranskat)abstract
- Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications.This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants.Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043).Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding.Bayer AG.
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| 18. |
- Andersson, Alva, et al.
(författare)
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Functional muscle power in the lower extremity in adults with congenital heart disease
- 2023
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Ingår i: International Journal of Cardiology Congenital Heart Disease. - : Elsevier BV. - 2666-6685. ; 11
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Tidskriftsartikel (refereegranskat)abstract
- Background: We aimed to investigate functional muscular power in the lower extremity in adults with congenital heart disease (ACHD) and compare results with those of healthy persons. Secondarily, we set out to assess muscle power in relation to age, sex, and complexity of ACHD.Methods: Between 2013 and 2019, 1126 patients attended the ACHD Unit of Sahlgrenska University Hospital/Ostra and performed a test battery to determine physical fitness. Of these patients, 559 who performed the Timed-Stands Test (TST)-which requires 10 stands from a chair at the maximal possible speed-were included in the study.Results: Patients with ACHD performed the TST slower than reference (14.6 s [12.0-18.0] vs. 11.7 s [9.8-14.3], p < 0.001). Men with ACHD performed the TST more rapidly or according to reference in 8% of patients aged 18-39 years, 21% of patients aged 40-65 years, and 55% of patients aged >65 years. Women with ACHD performed the TST more rapidly or according to reference in 21% of patients aged 18-39 years, 56% of patients aged 40-65 years, and 32% of patients aged >65 years. Men with ACHD performed the TST significantly faster than women with ACHD (p < 0.001).Conclusions: Decreased functional muscle power was observed in patients with ACHD and was most pronounced in patients aged 18-39 years. Decreased muscle power is important to detect and requires further assessment because it may contribute to an increased risk of falling and developing lifestyle related diseases.
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| 19. |
- Apers, Silke, et al.
(författare)
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Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study (APPROACH-IS) : Rationale, design, and methods
- 2015
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Ingår i: International Journal of Cardiology. - : Elsevier BV. - 0167-5273 .- 1874-1754. ; 179, s. 334-342
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Tidskriftsartikel (refereegranskat)abstract
- Background: Data on patient-reported outcomes (PROs) in adults with congenital heart disease (CHD) are inconsistent and vary across the world. Better understanding of PROs and their differences across cultural and geographic barriers can best be accomplished via international studies using uniform research methods. The APPROACH-IS consortium (Assessment of Patterns of Patient-Reported Outcomes in Adults with Congenital Heart disease - International Study) was created for this purpose and investigates PROs in adults with CHD worldwide. This paper outlines the project rationale, design, and methods. Methods/design: APPROACH-IS is a cross-sectional study. The goal is to recruit 3500-4000 adults with CHD from 15 countries in five major regions of the world (Asia, Australia, Europe, North and South America). Self-report questionnaires are administered to capture information on PRO domains: (i) perceived health status (12-item Short-form Health Survey & EuroQOL-5D); (ii) psychological functioning (Hospital Anxiety and Depression Scale); (iii) health behaviors (Health-Behavior Scale-Congenital Heart Disease); and (iv) quality of life (Linear Analog Scale & Satisfaction With Life Scale). Additionally, potential explanatory variables are assessed: (i) socio-demographic variables; (ii) medical history (chart review); (iii) sense of coherence (Orientation to Life Questionnaire); and (iv) illness perceptions (Brief Illness Perception Questionnaire). Descriptive analyses and multilevel models will examine differences in PROs and investigate potential explanatory variables. Discussion: APPROACH-IS represents a global effort to increase research understanding and capacity in the field of CHD, and will have major implications for patient care. Results will generate valuable information for developing interventions to optimize patients' health and well-being.
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- Ashman Kröönström, Linda, 1982, et al.
(författare)
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Exercise capacity, physical activity, and health-related quality of life in adults with CHD
- 2020
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Ingår i: Cardiology in the Young. - 1047-9511 .- 1467-1107. ; 30:5, s. 668-673
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to assess exercise capacity, physical activity, and health-related quality of life within a broad and unselected group of adults with CHD.Design: From April 2009 to February 2014, 1310 patients were assessed for suitability to participate in this single-centre cross-sectional study. Seven hundred and forty-seven (57%) patients were included, performed a submaximal bicycle test, and answered questionnaires regarding physical activity and health-related quality of life. Exercise capacity, physical activity, and health-related quality of life were compared with reference values and correlations were studied.Results: The exercise capacities of men and women with CHD were 58.7 and 66.3%, respectively, of reference values. Approximately, 20-25% of the patients did not achieve the recommended amount of physical activity. In addition, men scored significantly less points on 7 out of 10 scales of health-related quality of life and women in 6 out of 10 scales, compared with reference values. The strongest correlation was between exercise capacity and the Short Form-36 (physical function).Conclusions: Exercise capacity was impaired in all adults with CHD, including those with less complicated CHD. One-quarter of the patients did not achieve the recommended levels of physical activity. Exercise tests followed by individualised exercise prescriptions may be offered to all patients with CHD aiming to increase exercise capacity, levels of physical activity, improve health-related quality of life, and reduce the risk of acquired life-style diseases.
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- Ashman Kröönström, Linda, 1982, et al.
(författare)
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Muscle function in adults with congenital heart disease
- 2014
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Ingår i: International Journal of Cardiology. - : Elsevier BV. - 0167-5273. ; 170:3, s. 358-363
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The aim was to assess muscle function in a sample of Swedish adult men and women with congenital heart disease (ACHD) and to compare the results with published reference values in healthy adults. METHODS AND RESULTS: From April 2009 to December 2010, 762 adult outpatients were assessed for their suitability and individual need for tests of physical fitness. The patients performed five muscle function tests, two isotonic tests and three isometric tests. Of the 762 patients, 315 (41.3%) patients performed the tests. Patients with ACHD had lower isotonic muscle function compared to healthy reference values. In the heel lift test, men with ACHD performed at 63% and women at 58% of the healthy reference values and in the shoulder flexion test the corresponding performance level was 60% for men with ACHD and 85% for the women. Multiple regression analyses showed that NYHA class II-IV was a significant predictor for a lower isotonic muscle function i.e. heel lift in women (p<0.001) and men (p=0.05) and in shoulder flexion (p<0.001) in women, as well as in isometric knee extension (p=0.04) and isometric shoulder abduction (p<0.001) in women. CONCLUSION: This is the first report of muscle function in a broad and unselected group of patients with ACHD. Our data shows that patients with ACHD have lower isotonic muscle function. The impacts of low muscle function in activities of daily living and the question of whether muscle function could be improved with exercise training need further investigation.
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