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  • 1.
    Alfredsson, Joakim
    et al.
    Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.
    James, Stefan K.
    Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Erlinge, David
    Department of Clinical Sciences, Cardiology, Lund University, Lund, Sweden.
    Herlitz, Johan
    Department of Health Sciences, University of Borås, Borås, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology.
    Dworeck, Christian
    Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.
    Redfors, Björn
    Department of Molecular and Clinical Medicine and Sahlgrenska University Hospital, Department of Cardiology, University of Gothenburg, Gothenburg, Sweden.
    Arefalk, Gabriel
    Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
    Östlund, Ollie
    Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Jernberg, Tomas
    Department of Clinical Sciences, Cardiology, Karolinska Institutet, Danderyd Hospital, Stockholm, Sweden.
    Mars, Katarina
    Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
    Haaga, Urban
    Department of Cardiology, Karlstad Central Hospital, Karlstad, Sweden.
    Lindahl, Bertil
    Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Swahn, Eva
    Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.
    Lawesson, Sofia Sederholm
    Department of Health, Medicine and Caring Sciences and Department of Cardiology, Linköping University, Linköping, Sweden.
    Hofmann, Robin
    Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
    Randomized comparison of early supplemental oxygen versus ambient air in patients with confirmed myocardial infarction: Sex related outcomes from DETO2X-AMI2021In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 237, p. 13-24Article in journal (Refereed)
    Abstract [en]

    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. (Am Heart J 2021;237:13 & ndash;24.)

  • 2.
    Calais, Fredrik
    et al.
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
    Lagerqvist, Bo
    Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Leppert, Jerzy
    Centre for Clinical Research, Uppsala University, Central Hospital, Västerås, Sweden.
    James, Stefan K.
    Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Fröbert, Ole
    Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
    Thrombus aspiration in patients with large anterior myocardial infarction: A Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia trial substudy2016In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 172, no 2, p. 129-134Article in journal (Refereed)
    Abstract [en]

    Background: The TASTE trial did not demonstrate clinical benefit of thrombus aspiration (TA). High-risk patients might benefit from TA.

    Methods: The TASTE trial was a multicenter, randomized, controlled, open-label trial obtaining end points from national registries. Patients (n = 7,244) with ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI) were randomly assigned 1: 1 to TA and PCI or to PCI alone. We assessed the 1-year clinical effect of TA in a subgroup with potentially large anterior STEMI: mid or proximal left anterior descending coronary artery infarct lesion, thrombolysis in myocardial infarction 0 to 2 flow, and symptom onset to PCI time = 5 hours. In this substudy, patient eligibility criteria corresponded to that of the INFUSE-AMI study.

    Results: In total, 1,826 patients fulfilled inclusion criteria. All-cause mortality at 1 year of patients randomized to TA did not differ from those randomized to PCI only (hazard ratio [HR] 1.05, 95% CI 0.74-1.49, P = .77). Rates of rehospitalization for myocardial infarction, heart failure, and stent thrombosis did not differ between groups (HR 0.87, 95% CI 0.51-1.46, P = .59; HR 1.10 95% CI 0.77-1.58, P = .58; and HR 0.75, 95% CI 0.30-1.86, P = .53, respectively). This was also the case for the combined end point of all-cause mortality and rehospitalization for myocardial infarction, heart failure, or stent thrombosis (HR 1.00, 95% CI 0.79-1.26, P = .99).

    Conclusion: In patients with STEMI and large area of myocardium at risk, TA did not affect outcome within 1 year.

  • 3. Eggers, Kai Marten
    et al.
    Oldgren, Jonas
    Nordenskjöld, Anna
    Lindahl, Bertil
    Diagnostic value of serial measurement of cardiac markers in patients with chest pain: limited value of adding myoglobin to troponin I for exclusion of myocardial infarction2004In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 148, no 4, p. 574-581Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Despite improved laboratory assays for cardiac markers and a revised standard for definition of myocardial infarction (AMI), early detection of coronary ischemia in unselected patients with chest pain remains a difficult challenge.

    METHODS: Rapid measurements of troponin I (TnI), creatine kinase MB (CK-MB), and myoglobin were performed in 197 consecutive patients with chest pain and a nondiagnostic electrocardiogram for AMI. The early diagnostic performances of these markers and different multimarker strategies were evaluated and compared. Diagnosis of AMI was based on European Society of Cardiology/American College of Cardiology criteria.

    RESULTS: At a given specificity of 95%, TnI yielded the highest sensitivity of all markers at all time points. A TnI cutoff corresponding to the 10% coefficient of variation (0.1 microg/L) demonstrated a cumulative sensitivity of 93% with a corresponding specificity of 81% at 2 hours. The sensitivity was considerably higher compared to CK-MB and myoglobin, even considering patients with a short delay until admission. Using the 99th percentile of TnI results as a cutoff (0.07 microg/L) produced a cumulative sensitivity of 98% at 2 hours, but its usefulness was limited due to low specificities. Multimarker strategies including TnI and/or myoglobin did not provide a superior overall diagnostic performance compared to TnI using the 0.1 microg/L cutoff.

    CONCLUSION: A TnI cutoff corresponding to the 10% coefficient of variation was most appropriate for early diagnosis of AMI. A lower TnI cutoff may be useful for very early exclusion of AMI. CK-MB and in particular myoglobin did not offer additional diagnostic value.

  • 4.
    Erlinge, David
    et al.
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Koul, Sasha
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Eriksson, Peter
    Department of Cardiology, Umeå University, Umeå, Sweden.
    Scherstén, Fredrik
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Omerovic, Elmir
    Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
    Linder, Rikard
    Department of Cardiology, Danderyd Karolinska University, Stockholm, Sweden.
    Östlund, Olof Petter
    Department of Medical Sciences, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Wallentin, Lars
    Department of Medical Sciences, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    James, Stefan
    Department of Medical Sciences, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    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)2016In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 175, p. 34-36Article in journal (Refereed)
    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.

  • 5.
    Fröbert, Ole
    et al.
    Örebro University, School of Medical Sciences. Department of Cardiology, Faculty of Health and Medical Sciences, Örebro University, Örebro, Sweden.
    Götberg, Matthias
    Department of Cardiology, University Hospital Lund, Lund, Sweden.
    Angerås, Oskar
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Jonasson, Lena
    Department of Cardiology, University Hospital Linkoping, Linköping, Sweden.
    Erlinge, David
    Department of Cardiology, University Hospital Lund, Lund, Sweden.
    Engström, Thomas
    Department of Cardiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
    Persson, Jonas
    Department of Clinical Sciences, Danderyd University Hospital, Karolinska Institutet, Stockholm, Sweden.
    Jensen, Svend E.
    Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.
    Omerovic, Elmir
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    James, Stefan K.
    Department of Cardiology, University Hospital Uppsala, Uppsala, Sweden.
    Lagerqvist, Bo
    Department of Cardiology, University Hospital Uppsala, Uppsala, Sweden.
    Nilsson, Johan
    Cardiology, Heart Centre, department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Kåregren, Amra
    Department of Cardiology, Västerås County Hospital, Västerås, Sweden.
    Moer, Rasmus
    The Feiring Clinic, Feiring, Norway.
    Cao, Yang
    Örebro University, School of Medical Sciences. Örebro University Hospital. Unit of Biostatistics, Institute of Evironmental Medicine, Karolinska Institutet, Stockholm, Sweden.
    Agus, David B.
    Lawrence J. Ellison Institute for Transformative Medicine, University of Southern California, Los Angeles, United States.
    Erglis, Andrejs
    Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia.
    Jensen, Lisette O.
    Department of Cardiology, Odense University Hospital, Odense, Denmark.
    Jakobsen, Lars
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Christiansen, Evald H.
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Pernow, John
    Cardiology Unit, Department of Medicine, Karolinska University Hospital, Karolinska Institutet, Stockholm, Sweden.
    Design and rationale for the Influenza vaccination After Myocardial Infarction (IAMI) trial: A registry-based randomized clinical trial2017In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 189, p. 94-102Article in journal (Refereed)
    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.

  • 6.
    Fröbert, Ole
    et al.
    Örebro University, School of Medical Sciences. Department of Cardiology.
    Götberg, Matthias
    Department of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.
    Erlinge, David
    Department of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.
    Akhtar, Zubair
    International Centre for Diarrhoeal Disease Research, Bangladesh, (icddr,b) Dhaka, Banglades.
    Christiansen, Evald H.
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    MacIntyre, Chandini R.
    The Kirby Institute, UNSW Medicine, University of New South Wales, Sydney, New South Wales, Australia.
    Oldroyd, Keith G.
    Institute of Cardiovascular and Medical Sciences, University of Glasgow, United Kingdom; West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, Glasgow, United Kingdom, UK.
    Motovska, Zuzana
    Cardiocenter, Third Faculty of Medicine, Charles University, Prague, Czech Republic and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
    Erglis, Andrejs
    Pauls Stradins Clinical University Hospital, University of Latvia, Riga, Latvia.
    Moer, Rasmus
    LHL-sykehuset Gardermoen, Oslo, Norway.
    Hlinomaz, Ota
    International clinical research center, St. Anne University Hospital and Masaryk University, Brno, Czech Republic.
    Jakobsen, Lars
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Engstrøm, Thomas
    Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
    Jensen, Lisette O.
    Department of Cardiology, Odense University Hospital, Odense, Denmark.
    Fallesen, Christian O.
    Department of Cardiology, Odense University Hospital, Odense, Denmark.
    Jensen, Svend E.
    Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark; Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
    Angerås, Oskar
    Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Department of molecular and clinical medicine, Gothenburg University, Gothenburg, Sweden.
    Calais, Fredrik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Cardiology.
    Kåregren, Amra
    Västmanlands sjukhus Västerås, Västerås, Sweden.
    Lauermann, Jörg
    Department of Cardiology, Region Jönköping County, Jönköping, Sweden; Department of Health, Medicine and Caring, Linköping University, Linköping, Sweden.
    Mokhtari, Arash
    Department of Cardiology, Skåne University Hospital, Clinical Sciences, Lund University, Lund, Sweden.
    Nilsson, Johan
    Cardiology, Heart Centre, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden.
    Persson, Jonas
    Division of Cardiovascular Medicine, Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.
    Stalby, Per
    Department of Cardiology, Karlstad Central Hospital, Karlstad, Sweden.
    Islam, Abu K. M. M.
    National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh.
    Rahman, Afzalur
    National Institute of Cardiovascular Diseases, Sher-e-Bangla Nagar, Dhaka, Bangladesh.
    Malik, Fazila
    National Heart Foundation Hospital & Research Institute, Dhaka, Bangladesh.
    Choudhury, Sohel
    National Heart Foundation Hospital & Research Institute, Dhaka, Bangladesh.
    Collier, Timothy
    Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
    Pocock, Stuart J.
    Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
    Pernow, John
    Cardiology Unit, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden; Karolinska University Hospital, Stockholm, Sweden.
    Clinical Impact of Influenza Vaccination after ST- and Non-ST-segment elevation Myocardial Infarction Insights from the IAMI trial2023In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 255, p. 82-89Article in journal (Refereed)
    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 2571 participants were prospectively enrolled in the IAMI trial and randomly assigned to receive in-hospital inactivated influenza vaccine or saline placebo. The trial was conducted at 30 centers in 8 countries from October 1, 2016 to March 1, 2020. Here we report vaccine effectiveness in the 2467 participants with ST-segment elevation MI (STEMI, n=1348) or non-ST-segment elevation MI (NSTEMI, n=1119). 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=0.237 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 1 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=0.028).

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

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  • 7.
    Fröbert, Ole
    et al.
    Örebro University Hospital. Department of Cardiology.
    Scherstén, Fredrik
    Department of Cardiology, Skåne University Hospital, Lund, Sweden.
    James, Stefan K.
    Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Carlsson, Jorg
    Department of Cardiology, Kalmar Hospital, Kalmar, Sweden.
    Lagerqvist, Bo
    Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Long-term safety and efficacy of drug-eluting and bare metal stents in saphenous vein grafts2012In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 164, no 1, p. 87-93Article in journal (Refereed)
    Abstract [en]

    Background: Long-term safety and efficacy data of drug-eluting stents (DESs) in saphenous vein grafts (SVGs) are lacking. This study sought to compare the clinical outcomes of DES versus bare metal stents (BMS) in SVGs.

    Methods: We studied all stent implantations in SVGs in Sweden during 74 months between 2005 and 2011 registered in the Swedish Coronary Angiography and Angioplasty Registry. We evaluated outcome in patients who received DES compared with those who received BMS after adjustments for differences in clinical, vessel, and lesion characteristics.

    Results: Mean follow-up time was 3 years and 4 months. A total of 4,576 stents, implanted at 3,063 procedures, were included in the analysis of which 2,499 stents (54.6 %) were BMS and 2,077 (45.4%) were DES. The outcome analysis was based on 190 stent thromboses, 898 restenoses, and 523 deaths. The incidence of stent thrombosis did not differ between groups. When adjusted for baseline characteristics, including a propensity score for receiving DES, the incidence of restenosis was significantly lower with DES as compared with BMS (risk ratio 0.83, 95% CI 0.70-0.97, P = .019). There was a difference in mortality in the crude analysis between DES and BMS, and after multivariable adjustment, this difference remained statistically significant (risk ratio 0.80, CI 0.65-0.99, P = .038).

    Conclusions: The use of DES compared with BMS in SVGs was associated with a significantly lower adjusted incidence of restenosis and death in this large, national, all-encompassing propensity adjusted observational study. (Am Heart J 2012;164:87-93.)

  • 8.
    Götberg, Matthias
    et al.
    Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
    Christiansen, Evald H.
    Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.
    Gudmundsdottir, Ingibjorg
    Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland.
    Sandhall, Lennart
    Department of Radiology, Helsingborg County Hospital, Helsingborg, Sweden.
    Omerovic, Elmir
    Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
    James, Stefan K.
    Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Erlinge, David
    Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.
    Fröbert, Ole
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Instantaneous Wave-Free Ratio versus Fractional Flow Reserve guided intervention (iFR-SWEDEHEART): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial2015In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 170, no 5, p. 945-950Article in journal (Refereed)
    Abstract [en]

    Background: Instantaneous wave-free ratio (iFR) is a new hemodynamic resting index for assessment of coronary artery stenosis severity. iFR uses high frequency sampling to calculate a gradient across a coronary lesion during a period of diastole. The index has been tested against fractional flow reserve (FFR) and found to have an overall classification agreement of 80% to 85%. Whether the level of disagreement is clinically relevant is unknown. Clinical outcome data on iFR are scarce. This study is a registry-based randomized clinical trial, which is a novel strategy using health quality registries as on-line platforms for randomization, case record forms, and follow-up.

    Design/Methods: iFR-SWEDEHEART is a multicenter, prospective, randomized, controlled, clinical open-label clinical trial. Two thousand patients with stable angina or acute coronary syndrome and an indication for physiology-guided assessment of one or more coronary stenoses will be randomized 1: 1 to either iFR- or FFR-guided intervention. The randomization will be conducted online in the Swedish web-based system for enhancement and development of evidence-based care in heart disease evaluated according to recommended therapies (SWEDEHEART) registry. The trial has a non-inferiority design, with a primary combined end point of all-cause death, non-fatal myocardial infarction, and unplanned revascularization at 12 months. End points will be identified through national registries and undergo central blind adjudication to ensure data quality.

    Discussion: The iFR-SWEDEHEART trial is an registry-based randomized clinical trial evaluating the safety and efficacy of the diagnostic method iFR compared to FFR.

  • 9.
    Nordenskjöld, Anna
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Cardiology.
    Agewall, Stefan
    Department of Cardiology, Oslo University Hospital, Norway, and Institute of Clinical Sciences, University of Oslo, Norway.
    Atar, Dan
    Department of Cardiology, Oslo University Hospital, Norway, and Institute of Clinical Sciences, University of Oslo, Norway.
    Baron, Tomasz
    Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Beltrame, John
    Discipline of Medicine, University of Adelaide, Basil Hetzel Institute, Central Adelaide Local Health Network, Adelaide, Australia.
    Bergström, Olle
    Department of Medicine/Cardiology, County Hospital of Kronoberg, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Gale, Chris P.
    Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
    López-Pais, Javier
    Department of Cardiology, University Hospital Complex of Santiago de Compostela, Spain.
    Jernberg, Tomas
    Department of clinical sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Johansson, Pelle
    The Swedish Heart and Lung Association, Sweden.
    Ravn-Fisher, Annica
    Department of Cardiology, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Sweden.
    Reynolds, Harmony R.
    Sarah Ross Soter Center for Women's Cardiovascular Research, Leon H. Charney Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, USA.
    Somaratne, Jithendra B.
    Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand.
    Tornvall, Per
    Department of Clinical Science and Education Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.
    Lindahl, Bertil
    Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Randomized evaluation of beta blocker and ACE-inhibitor/angiotensin receptor blocker treatment in patients with myocardial infarction with non-obstructive coronary arteries (MINOCA-BAT): Rationale and design2020In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 231, p. 96-104Article in journal (Refereed)
    Abstract [en]

    Myocardial infarction with non-obstructive coronary arteries (MINOCA) is common and occurs in 6-8% of all patients fulfilling the diagnostic criteria for acute myocardial infarction (AMI). This paper describes the rationale behind the trial 'Randomized Evaluation of Beta Blocker and ACE-Inhibitor/Angiotensin Receptor Blocker Treatment (ACEI/ARB) of MINOCA patients' (MINOCA-BAT) and the need to improve the secondary preventive treatment of MINOCA patients. METHODS: MINOCA-BAT is a registry-based, randomized, parallel, open-label, multicenter trial with 2:2 factorial design. The primary aim is to determine whether oral beta blockade compared with no oral beta blockade, and ACEI/ARB compared with no ACEI/ARB, reduce the composite endpoint of death of any cause, readmission because of AMI, ischemic stroke or heart failure in patients discharged after MINOCA without clinical signs of heart failure and with left ventricular ejection fraction ≥40%. A total of 3500 patients will be randomized into four groups; e.g. ACEI/ARB and beta blocker, beta blocker only, ACEI/ARB only and neither ACEI/ARB nor beta blocker, and followed for a mean of 4 years. SUMMARY: While patients with MINOCA have an increased risk of serious cardiovascular events and death, whether conventional secondary preventive therapies are beneficial has not been assessed in randomized trials. There is a limited basis for guideline recommendations in MINOCA. Furthermore, studies of routine clinical practice suggest that use of secondary prevention therapies in MINOCA varies considerably. Thus results from this trial may influence future treatment strategies and guidelines specific to MINOCA patients.

  • 10.
    Omerovic, Elmir
    et al.
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Koul, Sasha
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Fröbert, Ole
    Örebro University Hospital. Örebro University, School of Medical Sciences. Department of Cardiology, Faculty of Health, Örebro University Hospital, Örebro, Sweden; Department of Clinical Medicine, Faculty of Health, Aarhus University, Aarhus, Denmark.
    Andersson, Jonas
    Department of Cardiology, Umeå University Hospital, Umeå, Sweden.
    Ponten, Johan
    Department of Cardiology, Hallands hospital Halmstad, Halmstad, Sweden.
    Björklund, Fredrik
    Department of Cardiology, Östersund Hospital, Östersund, Sweden.
    Kastberg, Robert
    Department of Cardiology, Östersund Hospital, Östersund, Sweden.
    Petzold, Max
    School of Public Health and Community Medicine, Institute of Medicine, University of Gothenburg, Sweden.
    Ljungman, Charlotta
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Bolin, Kristian
    Department of Economics, Centre for Health Economics, University of Gothenburg, Gothenburg, Sweden.
    Redfors, Bjorn
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Rationale and design of switch Swedeheart: A registry-based, stepped-wedge, cluster-randomized, open-label multicenter trial to compare prasugrel and ticagrelor for treatment of patients with acute coronary syndrome2022In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 251, p. 70-77Article in journal (Refereed)
    Abstract [en]

    Background: European treatment guidelines recommend prasugrel over ticagrelor for treating patients with non-ST-elevation acute coronary syndrome (ACS), prompting several Swedish administrative regions to transition from ticagrelor to prasugrel as the preferred treatment for patients with ACS. We aim to systematically evaluate this transition to determine the relative efficacy of prasugrel versus ticagrelor in a real-world cohort of patients with ACS.

    Study design and objectives: The SWITCH SWEDEHEART trial is a prospective, multicenter, open-label, cross-sectional, stepped-wedge cluster-randomized clinical trial, in which administrative regions in Sweden will constitute the clusters. At the start of the study, all clusters will use ticagrelor as the P2Y12 inhibitor drug of choice for ACS. The order in which the clusters will implement the transition from ticagrelor to prasugrel will be randomly assigned. Every 9 months, 1 cluster will switch from ticagrelor to prasugrel as the P2Y12 inhibitor of choice for patients with ACS. The primary endpoint is the composite 1-year rate of the death, stroke, or myocardial infarction.

    Conclusions: The SWITCH SWEDEHEART study will provide an extensive randomized comparison between ticagrelor and prasugrel. Novel therapies are frequently costly and supported by evidence from few or small studies, and systematic evaluation after the introduction is rare. This study will establish an important standard for introducing and evaluating the effects of health care changes within our societies. (Am Heart J 2022;251:70–77.)

  • 11.
    Ragnarsson, Sigurdur
    et al.
    Skane University Hospital and Lund University, Lund, Sweden.
    Janiec, Mikael
    Uppsala University Hospital, Uppsala, Sweden.
    Modrau, Ivy Susanne
    Aarhus University Hospital, Aarhus, Denmark.
    Dreifaldt, Mats
    Örebro University Hospital, Örebro, Sweden.
    Ericsson, Anders
    Blekinge Hospital, Karlskrona, Sweden.
    Holmgren, Anders
    University Hospital of Umeå, Umeå, Sweden.
    Hultkvist, Henrik
    Linköping University Hospital, Linköping, Sweden.
    Jeppsson, Anders
    Sahlgrenska University Hospital, Gothenburg, Sweden.
    Sartipy, Ulrik
    Karolinska University Hospital, Stockholm, Sweden.
    Ternström, Lisa
    Sahlgrenska University Hospital, Gothenburg, Sweden.
    Vikholm, M. D. Per
    Uppsala University Hospital, Uppsala, Sweden.
    de Souza, Domingos Ramos
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    James, Stefan
    Uppsala University Hospital, Uppsala, Sweden.
    Thelin, Stefan
    Uppsala University Hospital, Uppsala, Sweden.
    No-touch saphenous vein grafts in coronary artery surgery (SWEDEGRAFT): Rationale and design of a multicenter, prospective, registry-based randomized clinical trial2020In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 224, p. 17-24Article in journal (Refereed)
    Abstract [en]

    The SWEDEGRAFT study (ClinicalTrials.gov Identifier: NCT03501303) tests the hypothesis that saphenous vein grafts (SVGs) harvested with the "no-touch" technique improves patency of coronary artery bypass grafts compared with the conventional open skeletonized technique. This article describes the rationale and design of the randomized trial and baseline characteristics of the population enrolled during the first 9 months of enrollment.

    The SWEDEGRAFT study is a prospective, binational multicenter, open-label, registry-based trial in patients undergoing first isolated nonemergent coronary artery bypass grafting (CABG), randomized 1:1 to no-touch or conventional open skeletonized vein harvesting technique, with a planned enrollment of 900 patients. The primary end point is the proportion of patients with graft failure defined as SVGs occluded or stenosed >50% on coronary computed tomography angiography at 2 years after CABG, earlier clinically driven coronary angiography demonstrating an occluded or stenosed >50% vein graft, or death within 2 years. High-quality health registries and coronary computed tomography angiography are used to assess the primary end point. The secondary end points include wound healing in the vein graft sites and the composite outcome of major adverse cardiac events during the first 2 years based on registry data. Demographics of the first 200 patients enrolled in the trial and other CABG patients operated in Sweden during the same time period are comparable when the exclusion criteria are taken into consideration.

  • 12.
    Thuresson, Marie
    et al.
    Örebro University, School of Health and Medical Sciences.
    Berglin Jarlöv, Marianne
    Lindahl, Bertil
    Svensson, Leif
    Zedigh, Crister
    Herlitz, Johan
    Factors that influence the use of ambulance in acute coronary syndrome2008In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 156, no 1, p. 170-176Article in journal (Refereed)
    Abstract [en]

    Background

    National guidelines recommend activation of the emergency medical service by patients who have symptoms of acute coronary syndrome (ACS). In spite of this, only 50% to 60% of persons with myocardial infarction initiate care by using the emergency medical service. The aim of this study was to define factors influencing the use of ambulance in ACS.

    Methods

    The method used in this study was a national survey comprising intensive cardiac care units at 11 hospitals in Sweden; 1,939 patients with diagnosed ACS and symptom onset outside the hospital completed a questionnaire a few days after admission.

    Results

    Half of the patients went to the hospital by ambulance. Factors associated with ambulance use were knowledge of the importance of quickly seeking medical care and calling for an ambulance when having chest pain (odds ratio [OR] 3.61, 95% CI 2.43-5.45), abrupt onset of pain reaching maximum intensity within minutes (OR 2.08, 1.62-2.69), nausea or cold sweat (OR 2.02, 1.54-2.65), vertigo or near syncope (OR 1.63, 1.21-2.20), ST-elevation ACS (OR 1.58, 1.21-2.06), increasing age (per year) (OR 1.03, 1.02-1.04), previous history of heart failure (OR 2.48, 1.47-4.26), and distance to the hospital of >5 km (OR 2.0, 1.55-2.59). Those who did not call for an ambulance thought self-transport would be faster or did not believe they were sick enough.

    Conclusions

    Symptoms, patient characteristics, ACS characteristics, and perceptions and knowledge were all associated with ambulance use in ACS. The fact that knowledge increases ambulance use and the need for behavioral change pose a challenge for health-care professionals.

  • 13.
    Thuresson, Marie
    et al.
    Örebro University, Department of Clinical Medicine.
    Berglin Jarlöv, Marianne
    Lindahl, Bertil
    Svensson, Leif
    Zedigh, Crister
    Herlitz, Johan
    Symptoms and type of symptom onset in acute coronary syndrome in relation to ST elevation, sex, age, and a history of diabetes2005In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 150, no 2, p. 234-242Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:

    Various efforts to reduce patient delay in acute coronary syndrome (ACS) have had limited success. One reason might be a misinterpretation of the symptoms of ACS. The aim of this study was therefore to explore the characteristics and severity of symptoms among patients with an ACS in overall terms and in relation to the type of ACS, sex, age, and diabetes.

    METHODS:

    A total of 1939 patients at 11 hospitals in Sweden answered a questionnaire containing questions relating to the localization and intensity of symptoms, the presence of associated symptoms, the characteristics and experience of pain/symptoms, and the type of symptom onset.

    RESULTS:

    Patients with ST elevation differed from those without by more frequently having associated symptoms. They had higher pain/discomfort intensity and more frequently had pain with abrupt onset reaching maximum intensity within minutes. However, this type of symptom onset was only seen in less than half the patients with ST elevation and only 1 in 5 fulfilled all the criteria usually associated with a severe heart attack. Women differed from men in a few respects. They more frequently reported pain/discomfort in the neck or jaw and back, vomiting, and scored their pain/discomfort slightly higher than men. Differences between age groups were minor and there was no difference between patients with and without diabetes.

    CONCLUSIONS:

    The most striking finding was the low proportion of patients with the type of symptoms that are commonly associated with ACS. This is important for the planning of educational campaigns/programs to reduce patient delay.

  • 14.
    Velders, Matthijs A.
    et al.
    Dept Med Sci, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden; Med Ctr, Dept Cardiol, Leiden Univ, Leiden, Netherlands.
    James, Stefan K.
    Dept Med Sci, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden.
    Libungan, Berglind
    Dept Cardiol, Sahlgrenska Univ Hosp, Gothenburg, Sweden.
    Sarno, Giovanna
    Dept Med Sci, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden.
    Fröbert, Ole
    Örebro University Hospital. Dept Cardiol, Örebro University Hospital, Örebro, Sweden.
    Carlsson, Jorg
    Dept Cardiol, Kalmar Hosp, Kalmar, Sweden.
    Schalij, Martin J.
    Med Ctr, Dept Cardiol, Leiden Univ, Leiden, Netherlands.
    Albertsson, Per
    Dept Med Sci, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden; Dept Cardiol, Sahlgrenska Univ Hosp, Gothenburg, Sweden.
    Prognosis of elderly patients with ST-elevation myocardial infarction treated with primary percutaneous coronary intervention in 2001 to 2011: A report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) registry2014In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 167, no 5, article id 666Article in journal (Refereed)
    Abstract [en]

    Background Elderly patients constitute a growing part of the population presenting with ST-elevation myocardial infarction (STEMI). The use of primary percutaneous coronary intervention (PCI) in this high-risk population remains poorly investigated. Methods Using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR), we identified consecutive patients with STEMI 80 years or older undergoing primary PCI during a 10-year period. Temporal trends in care and 1-year prognosis were investigated, and long-term outcome was compared with a reference group of patients with STEMI aged 70 to 79 years. Relative survival was calculated by dividing the observed survival rate with the expected survival rate of the general population. Adjusted end points were calculated using Cox regression. Results In total, 4,876 elderly patients with STEMI were included. During the study period, average age and presence of comorbidity increased, as well as the use of antithrombotic therapy. Procedural success remained constant. One-year mortality was exclusively reduced between the most recent vs the earliest cohort, whereas the risk of reinfarction, heart failure, stroke, and bleeding remained similar. The risk of death was higher for elderly patients early after PCI, after which the prognosis was slightly better compared with the general population. Long-term risk of adverse events increased markedly with age. Conclusions The prognosis of patients older than 80 years treated with primary PCI for STEMI was relatively unchanged during the 10-year inclusion period, despite changes in patient characteristics and treatment. Advanced age increased the risk of adverse events, but survivors of the early phase after PCI had a slightly improved prognosis compared with the general population.

  • 15. Velders, Matthijs A
    et al.
    James, Stefan K
    Libungan, Berglind
    Sarno, Giovanna
    Fröbert, Ole
    Örebro University Hospital.
    Carlsson, Jörg
    Schalij, Martin J
    Albertsson, Per
    Lagerqvist, Bo
    Response to the letter to the editor by Ariza-Solé et al.2014In: American Heart Journal, ISSN 0002-8703, E-ISSN 1097-6744, Vol. 168, no 1, article id e5Article in journal (Refereed)
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