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  • 1. Bang, Casper N.
    et al.
    Greve, Anders M.
    Boman, Kurt
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Medicin.
    Egstrup, Kenneth
    Gohlke-Baerwolf, Christa
    Kober, Lars
    Nienaber, Christoph A.
    Ray, Simon
    Rossebo, Anne B.
    Wachtell, Kristian
    Effect of lipid lowering on new-onset atrial fibrillation in patients with asymptomatic aortic stenosis: The Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study2012Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 163, nr 4, s. 690-696Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    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.)

  • 2. Erlinge, David
    et al.
    Koul, Sasha
    Eriksson, Peter
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Kardiologi.
    Schersten, Fredrik
    Omerovic, Elmir
    Linder, Rikard
    Ostlund, Olof Petter
    Wallentin, Lars
    Frobert, Ole
    James, Stefan
    Bivalirudin versus heparin in non-ST and ST-segment elevation myocardial infarction-a registry-based randomized clinical trial in the SWEDEHEART registry (the VALIDATE-SWEDEHEART trial)2016Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 175, s. 36-46Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background The optimal anticoagulant for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) has not been validated in current practice of radial approach and pretreatment with potent P2Y12 inhibitors. Several studies have indicated increased bleeding rate and, in some instances, even increased mortality by the routine use of heparin and glycoprotein IIb/IIIa inhibitors compared to bivalirudin. Direct comparison of bivalirudin versus heparin alone has yielded contradictory results depending on study designs. Methods/design The VALIDATE-SWEDEHEART trial is a multicenter, prospective, randomized, registry-based, controlled, and open-label clinical trial in patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing PCI pretreated with ticagrelor, prasugrel, or cangrelor. We hypothesize that bivalirudin is superior to heparin alone in reducing death, myocardial infarction, and major bleeding events at 180 days (primary end point). The trial will enroll 3,000 patients with STEMI and 3,000 patients with non-STEMI undergoing PCI. The trial will use a hybrid registry-based randomized clinical trial design where inclusion, randomization, and baseline data collection are performed using The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registry. The primary composite end point (death, myocardial infarction, or major bleeding events at 180 days) will be identified through active screening after 7 and 180 days and adjudicated by a blinded central end point committee. Secondary end points and long-term outcomes will be recorded from national registries. Conclusion The VALIDATE-SWEDEHEART trial is founded on a nationwide clinical registry and uses a hybrid registry-based randomized clinical trial (RRCT) design methodology to evaluate efficacy and safety of bivalirudin as compared to heparin alone for acute coronary syndrome, in a large population receiving contemporary recommended therapies including predominantly radial invasive approach and pretreatment with potent P2Y12 inhibitors.

  • 3. Fröbert, Ole
    et al.
    Götberg, Matthias
    Angerås, Oskar
    Jonasson, Lena
    Erlinge, David
    Engstrøm, Thomas
    Persson, Jonas
    Jensen, Svend E.
    Omerovic, Elmir
    James, Stefan K.
    Lagerqvist, Bo
    Nilsson, Johan
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Kardiologi.
    Kåregren, Amra
    Moer, Rasmus
    Yang, Cao
    Agus, David B.
    Erglis, Andrejs
    Jensen, Lisette O.
    Jakobsen, Lars
    Christiansen, Evald H.
    Pernow, John
    Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial: a registry-based randomized clinical trial2017Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 189, s. 94-102Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background Registry studies and case-control studies have demonstrated that the risk of acute myocardial infarction (AMI) is increased following influenza infection. Small randomized trials, underpowered for clinical end points, indicate that future cardiovascular events can be reduced following influenza vaccination in patients with established cardiovascular disease. Influenza vaccination is recommended by international guidelines for patients with cardiovascular disease, but uptake is varying and vaccination is rarely prioritized during hospitalization for AMI. Methods/design The Influenza vaccination After Myocardial Infarction (IAMI) trial is a double-blind, multicenter, prospective, registry-based, randomized, placebo-controlled, clinical trial. A total of 4,400 patients with ST-segment elevation myocardial infarction (STEMI) or non-STEMI undergoing coronary angiography will randomly be assigned either to in-hospital influenza vaccination or to placebo. Baseline information is collected from national heart disease registries, and follow-up will be performed using both registries and a structured telephone interview. The primary end point is a composite of time to all cause death, a new AMI, or stent thrombosis at 1 year. Implications The IAMI trial is the largest randomized trial to date to evaluate the effect of in-hospital influenza vaccination on death and cardiovascular outcomes in patients with STEMI or non-STEMI. The trial is expected to provide highly relevant clinical data on the efficacy of influenza vaccine as secondary prevention after AMI.

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  • 4.
    Fröbert, Ole
    et al.
    Örebro University, Faculty of Health, Department of Cardiology, Örebro, Örebro, Sweden.
    Götberg, Matthias
    Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Scania, Lund, Sweden.
    Erlinge, David
    Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Scania, Lund, Sweden.
    Akhtar, Zubair
    International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka, Dhaka, Bangladesh; The Kirby Institute, UNSW Medicine, University of New South Wales, NSW, Sydney, Australia.
    Christiansen, Evald H.
    Department of Cardiology, Aarhus University Hospital, Aarhus, Aarhus, Denmark.
    MacIntyre, Chandini R.
    The Kirby Institute, UNSW Medicine, University of New South Wales, NSW, Sydney, Australia.
    Oldroyd, Keith G.
    Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom and West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Scotland, Glasgow, United Kingdom.
    Motovska, Zuzana
    Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic and University Hospital Kralovske Vinohrady, Bohemia, Prague, Czech Republic.
    Erglis, Andrejs
    Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Riga, Latvia.
    Moer, Rasmus
    LHL-sykehuset Gardermoen, Ostiandet, Oslo, Norway.
    Hlinomaz, Ota
    nternational clinical research center, St. Anne University Hospital and Masaryk University, South Moravian, Brno, Czech Republic.
    Jakobsen, Lars
    Department of Cardiology, Aarhus University Hospital, Aarhus, Aarhus, Denmark.
    Engstrøm, Thomas
    Rigshospitalet, University of Copenhagen, Copenhagen, Copenhagen, Denmark.
    Jensen, Lisette O.
    Department of Cardiology, Odense University Hospital, Odense, Odense, Denmark.
    Fallesen, Christian O.
    Department of Cardiology, Odense University Hospital, Odense, Odense, Denmark.
    Jensen, Svend E
    Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark and Department of Clinical Medicine, Aalborg University, Kommune, Aalborg, Denmark.
    Angerås, Oskar
    Sahlgrenska University Hospital, Gothenburg, Sweden and Institute of Medicine, Department of molecular and clinical medicine, Gothenburg University, Västergötland, Gothenburg, Sweden.
    Calais, Fredrik
    Örebro University, Faculty of Health, Department of Cardiology, Örebro, Örebro, Sweden.
    Kåregren, Amra
    Västmanlands sjukhus Västerås, Västmanland, Västerås, Sweden.
    Lauermann, Jörg
    Department of Cardiology, Jönköping, Region Jönköping County, Department of Health, Medicine and Caring, Linköping University, Östergötland, Linköping, Sweden.
    Mokhtari, Arash
    Department of Cardiology, Skane University Hospital, Clinical Sciences, Lund University, Scania, Lund, Sweden.
    Nilsson, Johan
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Kardiologi.
    Persson, Jonas
    Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Södermanland and Uppland, Stockholm, Sweden.
    Stalby, Per
    Department of Cardiology, Karlstad Central Hospital, Värmland, Karlstad, Sweden.
    Islam, Abu K.M.M.
    National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Dhaka, Bangladesh.
    Rahman, Afzalur
    National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Dhaka, Bangladesh.
    Malik, Fazila
    National Heart Foundation Hospital & Research Institute, Dhaka, Dhaka, Bangladesh.
    Choudhury, Sohel
    National Heart Foundation Hospital & Research Institute, Dhaka, Dhaka, Bangladesh.
    Collier, Timothy
    Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, United Kingdom.
    Pocock, Stuart J.
    Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, United Kingdom.
    Pernow, John
    Cardiology Unit, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Stockholm, Sweden.
    Clinical impact of influenza vaccination after ST- and non-ST-segment elevation myocardial infarction - insights from the IAMI trial2023Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 255, s. 82-89Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Influenza vaccination early after myocardial infarction (MI) improves prognosis but vaccine effectiveness may differ dependent on type of MI.

    Methods: A total of 2,571 participants were prospectively enrolled in the Influenza vaccination after myocardial infarction (IAMI) trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in eight countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2,467 participants with ST-segment elevation MI (STEMI, n = 1,348) or non-ST-segment elevation MI (NSTEMI, n = 1,119). The primary endpoint was the composite of all-cause death, MI, or stent thrombosis at 12 months. Cumulative incidence of the primary and key secondary endpoints by randomized treatment and NSTEMI/STEMI was estimated using the Kaplan-Meier method. Treatment effects were evaluated with formal interaction testing to assess for effect modification.

    Results: Baseline risk was higher in participants with NSTEMI. In the NSTEMI group the primary endpoint occurred in 6.5% of participants assigned to influenza vaccine and 10.5% assigned to placebo (hazard ratio [HR], 0.60; 95% CI, 0.39-0.91), compared to 4.1% assigned to influenza vaccine and 4.5% assigned to placebo in the STEMI group (HR, 0.90; 95% CI, 0.54-1.50, P = .237 for interaction). Similar findings were seen for the key secondary endpoints of all-cause death and cardiovascular death. The Kaplan-Meier risk difference in all-cause death at one year was more pronounced in participants with NSTEMI (NSTEMI: HR, 0.47; 95% CI 0.28-0.80, STEMI: HR, 0.86; 95% CI, 0.43-1.70, interaction P = .028).

    Conclusions: The beneficial effect of influenza vaccination on adverse cardiovascular events may be enhanced in patients with NSTEMI compared to those with STEMI.

  • 5.
    Herlitz, Johan
    et al.
    Division of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden.
    Engdahl, Johan
    Division of Cardiology, Sahlgrenska University Hospital, Göteborg, Sweden.
    Svensson, Leif
    Division of Cardiology, South Hospital, Stockholm, Sweden.
    Ängquist, Karl-Axel
    Umeå universitet, Medicinska fakulteten, Institutionen för kirurgisk och perioperativ vetenskap, Kirurgi.
    Young, Marie
    Department of Anesthesiology, Malmö University Hospital, Malmö, Sweden.
    Holmberg, Stig
    Department of Anesthesiology, Malmö University Hospital, Malmö, Sweden.
    Factors associated with an increased chance of survival among patients suffering from an out-of-hospital cardiac arrest in a national perspective in Sweden2005Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 149, nr 1, s. 61-66Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Aim: To describe factors associated with an increased chance of survival among patients suffering from an out-of-hospital cardiac arrest in Sweden.

    Patients and Methods: All patients suffering from an out-of-hospital cardiac arrest, which were not crew witnessed, in Sweden and in whom cardiopulmonary resuscitation (CPR) was attempted and who were registered in the Swedish Cardiac Arrest Registry. This registry covers about 85% of the Swedish population and has been running since 1990.

    Results: In all, 33 453 patients, 71% of whom had a cardiac etiology, were included in the survey. The following were independent predictors for an increased chance of survival in order of magnitude: (1) patients found in ventricular fibrillation (odds ratio [OR] 5.3, 95% confidence limits [CL] 4.2-6.8), (2) the interval between call for and arrival of the ambulance less than or equal to the median (OR 3.6, 95% CL 2.9-4.6), (3) cardiac arrest occurred outside the home (OR 2.2, 95% CL 1.9-2.7), (4) cardiac arrest was witnessed (OR 2.0, 95% CL 1.6-2.7), (5) bystanders performing CPR before the arrival of the ambulance (OR 2.0, 95% CL 1.7-2.4), and (6) age less than or equal to the median (OR 1.6, 95% CL 1.4-2.0). When none of these factors were present, survival to 1 m was 0.4%; when all factors were present, survival was 23.8%.

    Conclusion: Among patients suffering from an out-of-hospital cardiac arrest, which were not crew witnessed, in Sweden and in whom CPR was attempted, 6 factors for an increased chance of survival could be defined. These include (1) initial rhythm, (2) delay to arrival of the rescue team, (3) place of arrest, (4) witnessed status, (5) bystander CPR, and (6) age.

  • 6.
    Krachler, Benno
    et al.
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Yrkes- och miljömedicin. Kuopio Research Institute of Exercise Medicine Kuopio Finland.
    Savonen, Kai
    Lakka, Timo
    Obesity is an important source of bias in the assessment of cardiorespiratory fitness2015Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 170, nr 5, s. E7-E8Artikel i tidskrift (Refereegranskat)
  • 7. Labaf, Ashkan
    et al.
    Grzymala-Lubanski, Bartosz
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Medicin.
    Själander, Anders
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Medicin.
    Svensson, Peter J
    Stagmo, Martin
    Glomerular filtration rate and association to stroke, major bleeding, and death in patients with mechanical heart valve prosthesis2015Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 170, nr 3, s. 559-565Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    AIMS: The impact of estimated glomerular filtration rate (eGFR) on adverse events in patients with mechanical heart valves (MHVs) is unknown. We analyzed the independent association of eGFR and thromboembolism (TE), major bleeding, and mortality in patients with MHV in an observational cohort study.

    METHODS AND RESULTS: All patients (n = 520) with MHV replacement on anticoagulation treatment were followed up prospectively regarding TE, major bleeding, and death at 2 anticoagulation centers during 2008 to 2011. The mean age was 69 years, 72% with aortic valve replacement, and time in therapeutic range 2.0 to 4.0 was 91%. The incidence of the combined end point of major bleeding, TE, and death increased sharply with each decreasing eGFR stratum: 5.5, 8.4, 16, and 32 per 100 patient-years for eGFR >60, 45 to 60, 30 to 45, and <30 mL/min per 1.73 m(2), respectively. After multivariate adjustment for comorbidities, every unit decrease in eGFR increased the risk of major bleeding by 2%, death by 3%, and the combined end point by 1%. There was no association between eGFR and TE. There was an increased proportion of international normalized ratio >3.0 and >4.0 and decreasing time in therapeutic range for each decreasing eGFR stratum (P < .001 for trend). The hazard ratios of the combined end point for eGFR <30, 30 to 45, and 45 to 60 mL/min per 1.73 m(2) were 3.2 (95% CI 1.8-5.6), 1.5 (95% CI 0.9-2.5), and 0.9 (95% CI 0.6-1.5), respectively, compared to eGFR >60 mL/min per 1.73 m(2).

    CONCLUSION: In patients with MHV on anticoagulation, eGFR is an independent predictor of major bleeding and death and not TE.

  • 8. Labaf, Ashkan
    et al.
    Svensson, Peter J
    Renlund, Henrik
    Jeppsson, Anders
    Själander, Anders
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Medicin.
    Incidence and risk factors for thromboembolism and major bleeding in patients with mechanical valve prosthesis: a nationwide population-based study2016Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 181, s. 1-9Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    BACKGROUND: Risk factors of stroke/thromboembolism (TE) and major bleeding, and incidence of these events in specific age categories in warfarin-treated patients with mechanical heart valves (MHV) are uncertain. Our objective was to calculate event rates in specific age categories and identify risk factors for adverse events.

    METHODS AND RESULTS: We identified 4,810 treatment periods with MHV between January 2006 and December 2011 in the Auricula and Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies registries. There were 3,751 treatment periods with aortic valve replacements (AVR) and 866 with mitral valve replacements (MVR). Median follow-up time was 4.5 years (IQR, 1.5-6.0). Time in therapeutic range with warfarin for patients with AVR was 74.2% for international normalized ratio of 2.0 to 3.0, with 72% of the patients having this target range. Rate of stroke/TE for AVR and MVR was 1.3 and 1.6 per 100 patient years, respectively (P=.20). The rate of first major bleeding was 2.6 and 3.9 per 100 patient years with AVR and MVR, respectively (P<.001). By multivariate analysis for AVR, age (hazard ratio [HR], 1.02; 95% confidence interval [CI], 1.01-1.03 per year) and previous stroke (HR, 2.4; 95% CI, 1.7-3.5) emerged as independent risk factors for stroke/TE. Heart failure (HR, 0.9; 95% CI, 0.6-1.4) and atrial fibrillation (HR, 1.0; 95% CI, 0.7-1.4) were not associated to stroke/TE. For major bleeding events, age (HR, 1.02; 95% CI, 1.01-1.03 per year) and previous major bleeding (HR, 2.5; 95% CI, 1.9-3.3) emerged as independent risk factors for AVR.

    CONCLUSIONS: In a nationwide cohort study with MHV and high time in therapeutic range, heart failure and atrial fibrillation did not appear as risk factors of stroke/TE.

  • 9. Lindholm, Daniel
    et al.
    James, Stefan
    Andersson, Jonas
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Avdelningen för medicin.
    Braun, Oscar O.
    Heller, Susanne
    Henriksson, Peter
    Lauermann, Jorg
    Ohagen, Patrik
    Varenhorst, Christoph
    Caffeine and incidence of dyspnea in patients treated with ticagrelor2018Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 200, s. 141-143Artikel i tidskrift (Refereegranskat)
  • 10.
    Olsen, Michael Hecht
    et al.
    Glostrup University Hospital, Copenhagen, Denmark.
    Wachtell, Kristian
    Glostrup University Hospital, Copenhagen, Denmark.
    Beevers, Gareth
    City Hospital, Birmingham, United Kingdom.
    Dahllöf, Björn
    Sahlgrenska University Hospital/Östra, Göteborg, Sweden.
    Devereux, Richard B.
    Weill Medical College of Cornell University, New York, NY.
    Faire, Ulf de
    Karolinska University Hospital, Stockholm, Sweden.
    Fyhrquist, Frej
    Helsinki University Central Hospital, Helsinki, Finland.
    Ibsen, Hans
    Glostrup University Hospital, Copenhagen, Denmark.
    Kjeldsen, Sverre E.
    Ullevaal University Hospital, Oslo, Norway.
    Lederballe-Pedersen, Ole
    Viborg Hospital, Viborg, Denmark.
    Lindholm, Lars H
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Allmänmedicin.
    Narayan, Puneet
    Weill Medical College of Cornell University, New York, NY.
    Nieminen, Markku S.
    Helsinki University Central Hospital, Helsinki, Finland.
    Omvik, Per
    Institute of Medicine, University of Bergen, Bergen, Norway.
    Oparil, Suzanne
    University of Alabama, Birmingham, AL.
    Wedel, Hans
    Nordic School of Public Health, Göteborg, Sweden.
    Prognostic importance of haemoglobin in hypertensive patients with electrocardiographic left ventricular hypertrophy: The losartan intervention for end point reduction in hypertension (LIFE) study2009Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 157, nr 1, s. 177-184Artikel i tidskrift (Refereegranskat)
  • 11.
    Omerovic, Elmir
    et al.
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    James, Stefan
    Department of Cardiology, Uppsala University Hospital, Uppsala, Sweden.
    Erlinge, David
    Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
    Hagström, Henrik
    Department of Cardiology, Umeå University Hospital, Umeå, Sweden.
    Venetsanos, Dimitrios
    Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
    Henareh, Loghman
    Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
    Ekenbäck, Christina
    Division of Cardiovascular Medicine, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
    Alfredsson, Joakim
    Department of Cardiology, Linköping University Hospital, Linköping, Sweden.
    Hambreus, Kristina
    Department of Cardiology, Falun Hospital, Falun, Sweden.
    Redfors, Björn
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome2023Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 257, s. 33-40Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background: Takotsubo syndrome (TS) is a life-threatening acute heart failure syndrome without any evidence-based treatment options. No treatment for TS has been examined in a randomized trial.

    Study design and objectives: BROKEN-SWEDEHEART is a multicenter, randomized, open-label, registry-based 2 × 2 factorial clinical trial in patients with TS designed to test whether treatment with adenosine and dipyridamole accelerates cardiac recovery and improves clinical outcomes compared to standard care (study 1); and apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (study 2). The trial will enroll 1,000 patients. Study 1 (adenosine hypothesis) will evaluate 2 coprimary end points: (1) wall motion score index at 48 to 96 hours (evaluated in the first 200 patients); and (2) the composite of death, cardiac arrest, need for mechanical assist device or heart failure hospitalization within 30 days or left ventricular ejection fraction <50% at 48 to 96 hours (evaluated in 1,000 patients). The primary end point in study 2 (apixaban hypothesis) is the composite of death or thromboembolic events within 30 days or the presence of intraventricular thrombus on echocardiography at 48 to 96 hours.

    Conclusions: BROKEN-SWEDEHEART will be the first prospective randomized multicenter trial in patients with TS. It is designed as 2 parallel studies to evaluate whether adenosine accelerates cardiac recovery and improves cardiac function in the acute phase and the efficacy of anticoagulation therapy for preventing thromboembolic complications in TS. If either of its component studies is successful, the trial will provide the first evidence-based treatment recommendation in TS.

    Clinical trials identifier: The trial has been approved by the Swedish Medicinal Product Agency and the Swedish Ethical Board and is registered at ClinicalTrials.gov (NCT04666454).

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  • 12.
    Rinnström, Daniel
    et al.
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Kardiologi.
    Dellborg, Mikael
    Thilén, Ulf
    Sörensson, Peder
    Nielsen, Niels-Erik
    Christersson, Christina
    Johansson, Bengt
    Umeå universitet, Medicinska fakulteten, Institutionen för folkhälsa och klinisk medicin, Kardiologi.
    Hypertension in adults with repaired coarctation of the aorta2016Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 181, s. 10-15Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Aims: In adults with coarctation of the aorta (CoA), hypertension (HTN) is a common long-term complication. We investigated the prevalence of HTN and analyzed factors associated with HTN.

    Methods and results: In the national register for congenital heart disease, 653 adults with repaired CoA were identified (mean age 36.9 ± 14.4 years); 344 (52.7%) of them had HTN, defined as either an existing diagnosis or blood pressure (BP) ≥140/90 mmHg at the clinical visit. In a multivariable model, age (years) (odds ratio [OR] 1.07, CI 1.05-1.10), sex (male) (OR 3.35, CI 1.98-5.68), and body mass index (kilograms per square meter) (OR 1.09, CI 1.03-1.16) were independently associated with having HTN, and so was systolic arm-leg BP gradient where an association with HTN was found at the ranges of (10, 20] and N20 mmHg, in comparison to the interval ≤10 mmHg (OR 3.58, CI 1.70-7.55, and OR 11.38, CI 4.03-32.11). This model remained valid when all patients who had increased BP (≥140/90 mmHg) without having been diagnosed with HTN were excluded from the analyses.

    Conclusions: Hypertension is common in patients with previously repaired CoA and is associated with increasing age, male sex, and elevated body mass index. There is also an association with arm-leg BP gradient, starting at relatively low levels that are usually not considered for intervention.

  • 13.
    Wallert, John
    et al.
    Department of Women's and Children's Health, Uppsala University, Sweden.
    Held, Claes
    Department of Medical Sciences: Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Centre, Uppsala University, Sweden4Department of Medical Sciences, Cardiology, Uppsala University, Sweden.
    Madison, Guy
    Umeå universitet, Samhällsvetenskapliga fakulteten, Institutionen för psykologi.
    Olsson, Erik
    Department of Women's and Children's Health, Uppsala University, Sweden.
    Temporal changes in myocardial infarction incidence rates are associated with periods of perceived psychosocial stress: a SWEDEHEART national registry study2017Ingår i: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 191, s. 12-20Artikel i tidskrift (Refereegranskat)
    Abstract [en]

    Background Psychosocial stress might trigger myocardial infarction (MI). Increased MI incidence coincides with recurrent time periods during the year perceived as particularly stressful in the population.

    Methods A stress-triggering hypothesis on the risk of MI onset was investigated with Swedish population data on MI hospital admission date and symptom onset date (N = 156,690; 148,176) as registered from 2006 through 2013 in the national quality registry database Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART). Poisson regression was applied to analyze daily MI rates during days belonging to the Christmas and New Year holidays, turns of the month, Mondays, weekends, and summer vacation in July compared with remaining control days.

    Results Adjusted incidence rate ratios (IRRs) for MI rates were higher during Christmas and New Year holidays (IRR = 1.07 [1.04-1.09], P < .001) and on Mondays (IRR = 1.11 [1.09-1.13], P < .001) and lower in July (IRR = 0.92 [0.90-0.94], P < .001) and over weekends (IRR = 0.88 [0.87-0.89], P < .001), yet not during the turns of the month (IRR = 1.01 [1.00–1.02], P = .891). These findings were also predominantly robust with symptom onset as alternative outcome, when adjusting for both established and some suggested-but-untested confounders, and in 8 subgroups.

    Conclusions Fluctuations in daily MI incidence rates are systematically related to time periods of presumed psychosocial stress. Further research might clarify mechanisms that are amenable to clinical alteration.

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