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  • 1.
    Bill-Axelson, Anna
    et al.
    Dept Surg Sci, Univ Uppsala Hosp, Uppsala, Sweden.
    Holmberg, Lars
    Reg Canc Ctr Uppsala Orebro, Univ Uppsala Hosp, Uppsala, Sweden; Sch Med, Div Canc Studies, Kings Coll London, London, England.
    Garmo, Hans
    Reg Canc Ctr Uppsala Orebro, Univ Uppsala Hosp, Uppsala, Sweden; Sch Med, Div Canc Studies, Kings Coll London, London , England.
    Rider, Jennifer R.
    Dept Med, Channing Lab, Brigham & Womens Hosp, Boston MA, USA; Sch Med, Harvard Univ, Boston MA, USA; Sch Publ Hlth, Dept Epidemiol, Harvard Univ, Boston MA, USA.
    Taari, Kimmo
    Cent Hosp, Dept Urol, Univ Helsinki, Helsinki, Finland.
    Busch, Christer
    Dept Immunol Genet & Pathol, Univ Uppsala Hosp, Uppsala, Sweden.
    Nordling, Stig
    Dept Pathol, Univ Helsinki, Helsinki, Finland.
    Häggman, Michael
    Dept Surg Sci, Univ Uppsala Hosp, Uppsala, Sweden.
    Andersson, Swen-Olof
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Dept Urol, Örebro University Hospital, Örebro, Sweden.
    Spångberg, Anders
    Dept Urol, Linköping, Linköping Univ Hosp, Linköping, Sweden.
    Andrén, Ove
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Dept Urol, Örebro University Hospital, Örebro, Sweden.
    Palmgren, Juni
    Dept Med Epidemiol & Biostat, Karolinska Inst, Stockholm, Sweden.
    Steineck, Gunnar
    Dept Pathol & Oncol, Div Clin Canc Epidemiol, Karolinska Inst, Stockholm, Sweden; Div Clin Canc Epidemiol, Sahlgrenska Academy, Gothenburg, Sweden.
    Adami, Hans-Olov
    Dept Med Epidemiol & Biostat, Karolinska Inst, Stockholm, Sweden; Sch Publ Hlth, Dept Epidemiol, Harvard Univ, Boston MA, USA.
    Johansson, Jan-Erik
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Örebro University Hospital. Dept Urol, Örebro University Hospital, Örebro, Sweden.
    Radical Prostatectomy or Watchful Waiting in Early Prostate Cancer2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 370, no 10, p. 932-942Article in journal (Refereed)
    Abstract [en]

    Background: Radical prostatectomy reduces mortality among men with localized prostate cancer; however, important questions regarding long-term benefit remain.

    Methods: Between 1989 and 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy and followed them through the end of 2012. The primary end points in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) were death from any cause, death from prostate cancer, and the risk of metastases. Secondary end points included the initiation of androgen-deprivation therapy.

    Results: During 23.2 years of follow-up, 200 of 347 men in the surgery group and 247 of the 348 men in the watchful-waiting group died. Of the deaths, 63 in the surgery group and 99 in the watchful-waiting group were due to prostate cancer; the relative risk was 0.56 (95% confidence interval [CI], 0.41 to 0.77; P=0.001), and the absolute difference was 11.0 percentage points (95% CI, 4.5 to 17.5). The number needed to treat to prevent one death was 8. One man died after surgery in the radical-prostatectomy group. Androgen-deprivation therapy was used in fewer patients who underwent prostatectomy (a difference of 25.0 percentage points; 95% CI, 17.7 to 32.3). The benefit of surgery with respect to death from prostate cancer was largest in men younger than 65 years of age (relative risk, 0.45) and in those with intermediate-risk prostate cancer (relative risk, 0.38). However, radical prostatectomy was associated with a reduced risk of metastases among older men (relative risk, 0.68; P=0.04).

    Conclusions: Extended follow-up confirmed a substantial reduction in mortality after radical prostatectomy; the number needed to treat to prevent one death continued to decrease when the treatment was modified according to age at diagnosis and tumor risk. A large proportion of long-term survivors in the watchful-waiting group have not required any palliative treatment. (Funded by the Swedish Cancer Society and others.)

    The randomized Swedish trial of prostatectomy versus watchful waiting in disease detected mainly clinically (not by PSA screening) continues to show a benefit for early prostatectomy. The number of men younger than 65 needed to treat to prevent one death is now four. The Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), a randomized trial of radical prostatectomy versus watchful waiting in men with localized prostate cancer diagnosed before the era of prostate-specific antigen (PSA) testing, showed a survival benefit of radical prostatectomy as compared with observation at 15 years of follow-up.(1) By contrast, the Prostate Cancer Intervention versus Observation Trial (PIVOT), initiated in the early era of PSA testing, showed that radical prostatectomy did not significantly reduce prostate cancer-specific or overall mortality after 12 years.(2) PSA screening profoundly changes the clinical domain of study. Among other considerations, the substantial additional lead time ...

  • 2.
    Bill-Axelson, Anna
    et al.
    Dept. Urology, Uppsala University Hospital, Uppsala, Sweden; Dept, Pathology & Oncology, Div. Clinical Cancer Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Holmberg, Lars
    Regional Oncology Center, Uppsala University Hospital, Uppsala, Sweden; School of Medicine, Division of Cancer Studies, Kings College London, London, England.
    Ruutu, Mirja
    Cent Hosp, Dept Urol, Univ Helsinki, Helsinki, Finland.
    Garmo, Hans
    Reg Oncol Ctr, Univ Uppsala Hospital, Uppsala, Sweden; Sch Med, Div Canc Studies, Kings College London, London, UK.
    Stark, Jennifer R
    Deptartment of Urology, Örebro University Hospital, Örebro, Sweden; Dept Med, Channing Lab, Brigham & Womens Hospital, Boston MA, USA; Sch Med, Harvard University, Boston MA, USA.
    Busch, Christer
    Dept Pathol, Uppsala University Hospital, Uppsala, Sweden.
    Nordling, Stig
    Cent Hosp, Dept Pathol, Univ Helsinki, Helsinki, Finland.
    Häggman, Michael
    Dept Urology, Uppsala University Hospital, Uppsala, Sweden.
    Andersson, Swen-Olof
    Örebro University, School of Health and Medical Sciences. Department of Urology, Örebro University Hospital, Örebro, Sweden.
    Bratell, Stefan
    Dept Urology, Borås Hospital, Borås, Sweden.
    Spångberg, Anders
    Dept Urology, Linköping University Hospital, Linköping, Sweden.
    Palmgren, Juni
    Dept Med Epidemiol & Biostat, Karolinska Institute, Stockholm, Sweden.
    Steineck, Gunnar
    Dept, Pathology & Oncology, Div. Clinical Cancer Epidemiology, Karolinska Institute, Stockholm, Sweden; Div Clin Canc Epidemiol, Sahlgrenska Academy, Gothenburg, Sweden.
    Adami, Hans-Olov
    Dept Med Epidemiol & Biostat, Karolinska Institute, Stockholm, Sweden; School of Publ Health, Dept Epidemiology, Harvard Univ, Boston MA, USA.
    Johansson, J-E
    Örebro University, School of Health and Medical Sciences. Dept Urol, Örebro University Hospital, Örebro, Sweden; Center of Assessment Med Technology, Örebro University Hospital, Örebro, Sweden.
    Radical prostatectomy versus watchful waiting in early prostate cancer2011In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 364, no 18, p. 1708-1717Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: In 2008, we reported that radical prostatectomy, as compared with watchful waiting, reduces the rate of death from prostate cancer. After an additional 3 years of follow-up, we now report estimated 15-year results.

    METHODS: From October 1989 through February 1999, we randomly assigned 695 men with early prostate cancer to watchful waiting or radical prostatectomy. Follow-up was complete through December 2009, with histopathological review of biopsy and radical-prostatectomy specimens and blinded evaluation of causes of death. Relative risks, with 95% confidence intervals, were estimated with the use of a Cox proportional-hazards model.

    RESULTS: During a median of 12.8 years, 166 of the 347 men in the radical-prostatectomy group and 201 of the 348 in the watchful-waiting group died (P=0.007). In the case of 55 men assigned to surgery and 81 men assigned to watchful waiting, death was due to prostate cancer. This yielded a cumulative incidence of death from prostate cancer at 15 years of 14.6% and 20.7%, respectively (a difference of 6.1 percentage points; 95% confidence interval [CI], 0.2 to 12.0), and a relative risk with surgery of 0.62 (95% CI, 0.44 to 0.87; P=0.01). The survival benefit was similar before and after 9 years of follow-up, was observed also among men with low-risk prostate cancer, and was confined to men younger than 65 years of age. The number needed to treat to avert one death was 15 overall and 7 for men younger than 65 years of age. Among men who underwent radical prostatectomy, those with extracapsular tumor growth had a risk of death from prostate cancer that was 7 times that of men without extracapsular tumor growth (relative risk, 6.9; 95% CI, 2.6 to 18.4).

    CONCLUSIONS: Radical prostatectomy was associated with a reduction in the rate of death from prostate cancer. Men with extracapsular tumor growth may benefit from adjuvant local or systemic treatment.

  • 3.
    Carlsson, Lena M. S.
    et al.
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Peltonen, Markku
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland.
    Ahlin, Sofie
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Anveden, Åsa
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Bouchard, Claude
    Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge LA, United States.
    Carlsson, Björn
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Jacobson, Peter
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Lönroth, Hans
    Institute of Surgery, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Maglio, Cristina
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Näslund, Ingmar
    Department of Surgery, Örebro University Hospital, Region Örebro län, Örebro, Sweden.
    Pirazzi, Carlo
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Romeo, Stefano
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Sjöholm, Kajsa
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Sjöström, Elisabeth
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Wedel, Hans
    Nordic School of Public Health, Gothenburg, Sweden.
    Svensson, Per-Arne
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Sjöström, Lars
    Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Bariatric Surgery and Prevention of Type 2 Diabetes in Swedish Obese Subjects2012In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 367, no 8, p. 695-704Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Weight loss protects against type 2 diabetes but is hard to maintain with behavioral modification alone. In an analysis of data from a nonrandomized, prospective, controlled study, we examined the effects of bariatric surgery on the prevention of type 2 diabetes.

    METHODS: In this analysis, we included 1658 patients who underwent bariatric surgery and 1771 obese matched controls (with matching performed on a group, rather than individual, level). None of the participants had diabetes at baseline. Patients in the bariatric-surgery cohort underwent banding (19%), vertical banded gastroplasty (69%), or gastric bypass (12%); nonrandomized, matched, prospective controls received usual care. Participants were 37 to 60 years of age, and the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) was 34 or more in men and 38 or more in women. This analysis focused on the rate of incident type 2 diabetes, which was a prespecified secondary end point in the main study. At the time of this analysis (January 1, 2012), participants had been followed for up to 15 years. Despite matching, some baseline characteristics differed significantly between the groups; the baseline body weight was higher and risk factors were more pronounced in the bariatric-surgery group than in the control group. At 15 years, 36.2% of the original participants had dropped out of the study, and 30.9% had not yet reached the time for their 15-year follow-up examination.

    RESULTS: During the follow-up period, type 2 diabetes developed in 392 participants in the control group and in 110 in the bariatric-surgery group, corresponding to incidence rates of 28.4 cases per 1000 person-years and 6.8 cases per 1000 person-years, respectively (adjusted hazard ratio with bariatric surgery, 0.17; 95% confidence interval, 0.13 to 0.21; P< 0.001). The effect of bariatric surgery was influenced by the presence or absence of impaired fasting glucose (P = 0.002 for the interaction) but not by BMI (P = 0.54). Sensitivity analyses, including end-point imputations, did not change the overall conclusions. The postoperative mortality was 0.2%, and 2.8% of patients who underwent bariatric surgery required reoperation within 90 days owing to complications.

    CONCLUSIONS: Bariatric surgery appears to be markedly more efficient than usual care in the prevention of type 2 diabetes in obese persons. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01479452.)

  • 4.
    De Bruyne, Bernard
    et al.
    Cardiovasc Ctr Aalst, Onze Lieve Vrouw Hosp, Aalst, Belgium.
    Fearon, William F.
    Med Ctr, Stanford Univ, Stanford CA, USA.; Palo Alto Vet Affairs Hlth Care Syst, Stanford CA, USA.
    Pijls, Nico H. J.
    Dept Cardiol, Catharina Hosp, Eindhoven, Netherlands; Dept Biomed Engn, Eindhoven Univ Technol, Eindhoven, Netherlands.
    Barbato, Emanuele
    Cardiovasc Ctr Aalst, Onze Lieve Vrouw Hosp, Aalst, Belgium.
    Tonino, Pim
    Dept Cardiol, Catharina Hosp, Eindhoven, Netherlands; Dept Biomed Engn, Eindhoven Univ Technol, Eindhoven, Netherlands.
    Piroth, Zsolt
    Hungarian Inst Cardiol, Budapest, Hungary.
    Jagic, Nikola
    Clin Ctr Kragujevac, Kragujeva, Serbia.
    Mobius-Winckler, Sven
    Heart Ctr Leipzig, Leipzig, Germany.
    Rioufol, Gilles
    Cardiovasc Hosp, Lyon, France.
    Witt, Nils
    Södersjukhuset, Karolinska Inst, Stockholm, Sweden.
    Kala, Petr
    Univ Hosp, Brno, Czech Republic.
    MacCarthy, Philip
    Kings Coll Hosp, London, England.
    Engstroem, Thomas
    Rigshosp, Univ Copenhagen Hosp,Copenhagen, Denmark.
    Oldroyd, Keith
    Golden Jubilee Natl Hosp, Glasgow, UK.
    Mavromatis, Kreton
    Atlanta Vet Affairs Med Ctr, Decatur GA, USA.
    Manoharan, Ganesh
    Royal Victoria Hosp, Belfast, North Ireland.
    Verlee, Peter
    Eastern Maine Med Ctr, Bangor, UK.
    Fröbert, Ole
    Örebro University Hospital.
    Curzen, Nick
    Southampton Univ Hosp NHS Trust, Southampton, England.
    Johnson, Jane B.
    St Jude Med, St Paul MN, USA.
    Limacher, Andreas
    Inst Social & Prevent Med, Univ Bern, Bern, Switzerland; Dept Clin Res, Clin Trials Unit, Univ Bern, Bern, Switzerland.
    Nueesch, Eveline
    Inst Social & Prevent Med, Univ Bern, Bern, Switzerland; Dept Clin Res, Clin Trials Unit, Univ Bern, Bern, Switzerland.
    Jueni, Peter
    Inst Social & Prevent Med, Univ Bern, Bern, Switzerland; Dept Clin Res, Clin Trials Unit, Univ Bern, Bern, Switzerland.
    Fractional Flow Reserve-Guided PCI for Stable Coronary Artery Disease2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 371, no 13, p. 1208-1217Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: We hypothesized that in patients with stable coronary artery disease and stenosis, percutaneous coronary intervention (PCI) performed on the basis of the fractional flow reserve (FFR) would be superior to medical therapy.

    METHODS: In 1220 patients with stable coronary artery disease, we assessed the FFR in all stenoses that were visible on angiography. Patients who had at least one stenosis with an FFR of 0.80 or less were randomly assigned to undergo FFR-guided PCI plus medical therapy or to receive medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy alone and were included in a registry. The primary end point was a composite of death from any cause, nonfatal myocardial infarction, or urgent revascularization within 2 years.

    RESULTS: The rate of the primary end point was significantly lower in the PCI group than in the medical-therapy group (8.1% vs. 19.5%; hazard ratio, 0.39; 95% confidence interval [CI], 0.26 to 0.57; P<0.001). This reduction was driven by a lower rate of urgent revascularization in the PCI group (4.0% vs. 16.3%; hazard ratio, 0.23; 95% CI, 0.14 to 0.38; P<0.001), with no significant between-group differences in the rates of death and myocardial infarction. Urgent revascularizations that were triggered by myocardial infarction or ischemic changes on electrocardiography were less frequent in the PCI group (3.4% vs. 7.0%, P = 0.01). In a landmark analysis, the rate of death or myocardial infarction from 8 days to 2 years was lower in the PCI group than in the medical-therapy group (4.6% vs. 8.0%, P = 0.04). Among registry patients, the rate of the primary end point was 9.0% at 2 years.

    CONCLUSIONS: In patients with stable coronary artery disease, FFR-guided PCI, as compared with medical therapy alone, improved the outcome. Patients without ischemia had a favorable outcome with medical therapy alone.

  • 5.
    De Bruyne, Bernard
    et al.
    Onze-Lieve-Vrouw Clinic, Cardiovascular Center Aalst, Aalst, Belgium .
    Fröbert, Ole
    Örebro University Hospital, Region Örebro län, Örebro, Sweden.
    Fearon, William F.
    Stanford University Medical Center, Stanford CA, USA.
    Fractional Flow Reserve-Guided PCI versus Medical Therapy in Stable Coronary Disease2012In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 367, no 11, p. 991-1001Article in journal (Refereed)
    Abstract [en]

    Background: The preferred initial treatment for patients with stable coronary artery disease is the best available medical therapy. We hypothesized that in patients with functionally significant stenoses, as determined by measurement of fractional flow reserve (FFR), percutaneous coronary intervention (PCI) plus the best available medical therapy would be superior to the best available medical therapy alone.

    Methods: In patients with stable coronary artery disease for whom PCI was being considered, we assessed all stenoses by measuring FFR. Patients in whom at least one stenosis was functionally significant (FFR, ≤0.80) were randomly assigned to FFR-guided PCI plus the best available medical therapy (PCI group) or the best available medical therapy alone (medical-therapy group). Patients in whom all stenoses had an FFR of more than 0.80 were entered into a registry and received the best available medical therapy. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

    Results: Recruitment was halted prematurely after enrollment of 1220 patients (888 who underwent randomization and 332 enrolled in the registry) because of a significant between-group difference in the percentage of patients who had a primary endpoint event: 4.3% in the PCI group and 12.7% in the medical-therapy group (hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The difference was driven by a lower rate of urgent revascularization in the PCI group than in the medical-therapy group (1.6% vs. 11.1%; hazard ratio, 0.13; 95% CI, 0.06 to 0.30; P<0.001); in particular, in the PCI group, fewer urgent revascularizations were triggered by a myocardial infarction or evidence of ischemia on electrocardiography (hazard ratio, 0.13; 95% CI, 0.04 to 0.43; P<0.001). Among patients in the registry, 3.0% had a primary end-point event.

    Conclusions: In patients with stable coronary artery disease and functionally significant stenoses, FFR-guided PCI plus the best available medical therapy, as compared with the best available medical therapy alone, decreased the need for urgent revascularization. In patients without ischemia, the outcome appeared to be favorable with the best available medical therapy alone. (Funded by St. Jude Medical; ClinicalTrials.gov number, NCT01132495.)

  • 6.
    Erlinge, David
    et al.
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Omerovic, Elmir
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences. Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
    Linder, Rikard
    Department of Cardiology, Danderyd Hospital, Stockholm, Sweden.
    Danielewicz, Mikael
    PCI-Unit at Karlstad Hospital, Karlstad, Sweden.
    Hamid, Mehmet
    Department of Cardiology, Mälarsjukhuset, Eskilstuna, Sweden.
    Swahn, Eva
    Department of Cardiology, Linköping University Hospital, Linköping, Sweden.
    Henareh, Loghman
    Department of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
    Wagner, Henrik
    Department of Cardiology, Helsingborg Lasarett, Helsingborg, Sweden.
    Hårdhammar, Peter
    Department of Cardiology, Halmstad Hospital, Halmstad, Sweden.
    Sjögren, Iwar
    Department of Cardiology, Falun Hospital, Falun, Sweden.
    Stewart, Jason
    Department of Cardiology, Skaraborgs Hospital, Skövde, Sweden.
    Grimfjärd, Per
    Department of Internal Medicine, Västmanlands Sjukhus, Västerås, Sweden.
    Jensen, Jens
    Department of Cardiology, Capio St. Görans Hospital, Karolinska Institutet, Stockholm, Sweden.
    Aasa, Mikael
    Department of Cardiology, Södersjukhuset AB, Stockholm, Sweden.
    Robertsson, Lotta
    Department of Internal Medicine, Västmanlands Sjukhus, Västerås, Sweden.
    Lindroos, Pontus
    Department of Cardiology, Capio St. Görans Hospital, Karolinska Institutet, Stockholm, Sweden.
    Haupt, Jan
    Department of Cardiology, Sunderby Sjukhus, Luleå, Sweden.
    Wikström, Helena
    Department of Cardiology, Kristianstad Hospital, Kristianstad, Sweden.
    Ulvenstam, Anders
    Department of Cardiology, Östersund Hospital, Östersund, Sweden.
    Bhiladvala, Pallonji
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Lindvall, Bo
    Department of Cardiology, Sundsvall Hospital, Sundsvall, Sweden.
    Lundin, Anders
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Tödt, Tim
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Ioanes, Dan
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Råmunddal, Truls
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Kellerth, Thomas
    Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
    Zagozdzon, Leszek
    Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden.
    Götberg, Matthias
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Andersson, Jonas
    Department of Cardiology, Umeå University, Umeå, Sweden.
    Angerås, Oskar
    Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Östlund, Ollie
    Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Lagerqvist, Bo
    Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Held, Claes
    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.
    Scherstén, Fredrik
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    Eriksson, Peter
    Department of Cardiology, Umeå University, Umeå, Sweden.
    Koul, Sasha
    Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
    James, Stefan
    Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
    Bivalirudin versus Heparin Monotherapy in Myocardial Infarction2017In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 377, no 12, p. 1132-1142Article in journal (Refereed)
    Abstract [en]

    Background The comparative efficacy of various anticoagulation strategies has not been clearly established in patients with acute myocardial infarction who are undergoing percutaneous coronary intervention (PCI) according to current practice, which includes the use of radial-artery access for PCI and administration of potent P2Y12 inhibitors without the planned use of glycoprotein IIb/IIIa inhibitors. Methods In this multicenter, randomized, registry-based, open-label clinical trial, we enrolled patients with either ST-segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) who were undergoing PCI and receiving treatment with a potent P2Y12 inhibitor (ticagrelor, prasugrel, or cangrelor) without the planned use of glycoprotein IIb/IIIa inhibitors. The patients were randomly assigned to receive bivalirudin or heparin during PCI, which was performed predominantly with the use of radial-artery access. The primary end point was a composite of death from any cause, myocardial infarction, or major bleeding during 180 days of follow-up. Results A total of 6006 patients (3005 with STEMI and 3001 with NSTEMI) were enrolled in the trial. At 180 days, a primary end-point event had occurred in 12.3% of the patients (369 of 3004) in the bivalirudin group and in 12.8% (383 of 3002) in the heparin group (hazard ratio, 0.96; 95% confidence interval [CI], 0.83 to 1.10; P=0.54). The results were consistent between patients with STEMI and those with NSTEMI and across other major subgroups. Myocardial infarction occurred in 2.0% of the patients in the bivalirudin group and in 2.4% in the heparin group (hazard ratio, 0.84; 95% CI, 0.60 to 1.19; P=0.33), major bleeding in 8.6% and 8.6%, respectively (hazard ratio, 1.00; 95% CI, 0.84 to 1.19; P=0.98), definite stent thrombosis in 0.4% and 0.7%, respectively (hazard ratio, 0.54; 95% CI, 0.27 to 1.10; P=0.09), and death in 2.9% and 2.8%, respectively (hazard ratio, 1.05; 95% CI, 0.78 to 1.41; P=0.76). Conclusions Among patients undergoing PCI for myocardial infarction, the rate of the composite of death from any cause, myocardial infarction, or major bleeding was not lower among those who received bivalirudin than among those who received heparin monotherapy. (Funded by the Swedish Heart-Lung Foundation and others; VALIDATE-SWEDEHEART ClinicalTrialsRegister.eu number, 2012-005260-10 ; ClinicalTrials.gov number, NCT02311231 .).

  • 7.
    Fang, Fang
    et al.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Fall, Katja
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden. Clinical Epidemiology and Biostatistics Unit, Örebro University Hospital, Örebro, Sweden; Department of Epidemiology, Harvard School of Public Health, Boston, USA; Center of Public Health Sciences, University of Iceland, Reykjavík, Iceland.
    Mittleman, M.A.
    Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA; Department of Epidemiology, Harvard School of Public Health, Boston, USA.
    Sparen, P.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Ye, W.M.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Adami, H. O.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Epidemiology, Harvard School of Public Health, Boston, USA.
    Valdimarsdottir, Unnur
    Department of Epidemiology, Harvard School of Public Health, Boston, USA; Center of Public Health Sciences, University of Iceland, Reykjavík, Iceland .
    Suicide and cardiovascular death after a cancer diagnosis2012In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 366, no 14, p. 1310-1318Article in journal (Refereed)
    Abstract [en]

    Background: Receiving a diagnosis of cancer is a traumatic experience that may trigger immediate adverse health consequences beyond the effects of the disease or treatment.

    Methods: Using Poisson and negative binomial regression models, we conducted a historical cohort study involving 6,073,240 Swedes to examine the associations between a cancer diagnosis and the immediate risk of suicide or death from cardiovascular causes from 1991 through 2006. To adjust for unmeasured confounders, we also performed a nested, self-matched case-crossover analysis among all patients with cancer who died from suicide or cardiovascular diseases in the cohort.

    Results: As compared with cancer-free persons, the relative risk of suicide among patients receiving a cancer diagnosis was 12.6 (95% confidence interval [CI], 8.6 to 17.8) during the first week (29 patients; incidence rate, 2.50 per 1000 person-years) and 3.1 (95% CI, 2.7 to 3.5) during the first year (260 patients; incidence rate, 0.60 per 1000 person-years). The relative risk of cardiovascular death after diagnosis was 5.6 (95% CI, 5.2 to 5.9) during the first week (1318 patients; incidence rate, 116.80 per 1000 person-years) and 3.3 (95% CI, 3.1 to 3.4) during the first 4 weeks (2641 patients; incidence rate, 65.81 per 1000 person-years). The risk elevations decreased rapidly during the first year after diagnosis. Increased risk was particularly prominent for cancers with a poor prognosis. The case-crossover analysis largely confirmed results from the main analysis.

    Conclusions: In this large cohort study, patients who had recently received a cancer diagnosis had increased risks of both suicide and death from cardiovascular causes, as compared with cancer-free persons. (Funded by the Swedish Council for Working Life and Social Research and others.).

  • 8.
    Fang, Fang
    et al.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Fall, Katja
    Örebro University, School of Health and Medical Sciences, Örebro University, Sweden.
    Valdimarsdottir, Unnur
    Center of Public Health Sciences, University of Iceland, Reykjavík, Iceland.
    Suicide and Cardiovascular Death after a Cancer Diagnosis REPLY2012In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 367, no 3, p. 277-277Article in journal (Refereed)
  • 9.
    Fifer, Helen
    et al.
    Public Health England, London, United Kingdom.
    Natarajan, Usha
    Virgin Care, London, United Kingdom.
    Jones, Lucy
    Virgin Care, London, United Kingdom.
    Alexander, Sarah
    Public Health England, London, United Kingdom.
    Hughes, Gwenda
    Public Health England, London, United Kingdom.
    Golparian, Daniel
    Örebro University, School of Medical Sciences.
    Unemo, Magnus
    Örebro University, School of Health Sciences.
    Failure of Dual Antimicrobial Therapy in Treatment of Gonorrhea2016In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 374, no 25, p. 2504-2506Article in journal (Refereed)
  • 10.
    Fored, C. M.
    et al.
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden; Department of Renal Medicine, Huddinge University Hospital, Huddinge, Sweden.
    Ejerblad, E.
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Lindblad, Per
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Fryzek, J. P.
    International Epidemiology Institute, Rockville, MD, United States; Department of Medicine, Vanderbilt University Medical Center, Nashville, United States.
    Dickman, P. W.
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Signorello, L. B.
    International Epidemiology Institute, Rockville, MD, United States; Department of Medicine, Vanderbilt University Medical Center, Nashville, United States.
    Lipworth, L.
    International Epidemiology Institute, Rockville, MD, United States; Department of Medicine, Vanderbilt University Medical Center, Nashville, United States.
    Elinder, C. G.
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden; Department of Renal Medicine, Huddinge University Hospital, Huddinge, Sweden.
    Blot, W. J.
    International Epidemiology Institute, Rockville, MD, United States.
    McLaughlin, J. K.
    International Epidemiology Institute, Rockville, MD, United States; Department of Medicine, Vanderbilt University Medical Center, Nashville, United States.
    Zack, M. M.
    National Center for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention, Atlanta, United States .
    Nyren, O.
    Department of Medical Epidemiology, Karolinska Institute, Stockholm, Sweden.
    Acetaminophen, aspirin, and chronic renal failure2001In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 345, no 25, p. 1801-1808Article in journal (Refereed)
    Abstract [en]

    Background: Several epidemiologic studies have demonstrated an association between heavy consumption of nonnarcotic analgesics and the occurrence of chronic renal failure, but it is unclear which is the cause and which is the effect.

    Methods: In a nationwide, population-based, case-control study of early-stage chronic renal failure in Sweden, face-to-face interviews were conducted with 926 patients with newly diagnosed renal failure and 998 control subjects, of whom 918 and 980, respectively, had complete data. We used logistic-regression models to estimate the relative risks of disease-specific types of chronic renal failure associated with the use of various analgesics.

    Results: Aspirin and acetaminophen were used regularly by 37 percent and 25 percent, respectively, of the patients with renal failure and by 19 percent and 12 percent, respectively, of the controls. Regular use of either drug in the absence of the other was associated with an increase by a factor of 2.5 in the risk of chronic renal failure from any cause. The relative risks rose with increasing cumulative lifetime doses, rose more consistently with acetaminophen use than with aspirin use, and were increased for most disease-specific types of chronic renal failure. When we disregarded the recent use of analgesics, which could have occurred in response to antecedents of renal disease, the associations were only slightly attenuated.

    Conclusions: Our results are consistent with the existence of exacerbating effects of acetaminophen and aspirin on chronic renal failure. However, we cannot rule out the possibility of bias due to the triggering of analgesic consumption by predisposing conditions.

  • 11.
    Fröbert, Ole
    et al.
    Örebro University Hospital.
    James, Stefan K.
    Uppsala Univ, Uppsala, Sweden.
    Thrombus Aspiration during Myocardial Infarction REPLY2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 370, no 7, p. 675-676Article in journal (Refereed)
  • 12.
    Fröbert, Ole
    et al.
    Örebro University Hospital. Dept Cardiol.
    Lagerqvist, Bo
    Dept Med Sci, Uppsala University, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala University, Uppsala, Sweden.
    Olivecrona, Goran K.
    Dept Cardiol, Lund University Hosp, Lund, Sweden.
    Omerovic, Elmir
    Dept Cardiol, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Gudnason, Thorarinn
    Dept Cardiol, Landspitali University Hospital Iceland, Reykjavik, Iceland; Cardiovasc Res Ctr, Landspitali Univ Hosp Iceland, Reykjavik, Iceland.
    Maeng, Michael
    Dept Cardiol, Aarhus University Hospital, Aarhus, Denmark.
    Aasa, Mikael
    Dept Cardiol, Södersjukhuset, Karolinska Institute, Stockholm, Sweden.
    Angeras, Oskar
    Dept Cardiol, Sahlgrenska University Hospital, Gothenburg, Sweden.
    Calais, Fredrik
    Dept Cardiol, Örebro University Hospital, Örebro, Sweden.
    Danielewicz, Mikael
    Dept Cardiol, Karlstad Hospital, Karlstad, Sweden.
    Erlinge, David
    Dept Cardiol, Lund University Hospital, Lund, Sweden.
    Hellsten, Lars
    Dept Cardiol, Gävle Central Hospital, Gävle, Sweden.
    Jensen, Ulf
    Dept Med, Cardiol Unit, Karolinska University Hospital, Stockholm, Sweden.
    Johansson, Agneta C.
    PCI Unit, Sunderby Hospital, Sunderby, Sweden.
    Karegren, Amra
    Dept Cardiol, Västerås Hospital, Västerås, Sweden.
    Nilsson, Johan
    Dept Cardiol, Ctr Heart, Umeå University, Umeå, Sweden.
    Robertson, Lotta
    Dept Cardiol, Borås Hospital, Borås, Sweden.
    Sandhall, Lennart
    Dept Radiol, Helsingborg Hospital, Helsingborg, Sweden.
    Sjogren, Iwar
    Dept Cardiol, Falun Central Hospital, Falun, Sweden.
    Ostlund, Ollie
    Dept Med Sci, Uppsala University, Uppsala, Sweden; Clin Res Ctr, Uppsala University, Uppsala, Sweden.
    Harnek, Jan
    Dept Cardiol, Lund University Hospital, Lund, Sweden.
    James, Stefan K.
    Dept Med Sci, Uppsala University, Uppsala, Sweden; Clin Res Ctr, Uppsala University, Uppsala, Sweden.
    Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction2013In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 369, no 17, p. 1587-1597Article in journal (Refereed)
    Abstract [en]

    Background:The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. Methods: We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. ResultsNo patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. ConclusionsRoutine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.)

  • 13.
    Götberg, Matthias
    et al.
    Department of Cardiology, Clinical Sciences, Skåne University Hospital, Lund, Sweden.
    Christiansen, Evald H.
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Gudmundsdottir, Ingibjörg J.
    Department of Cardiology, Reykjavik University Hospital, Reykjavik, Iceland.
    Sandhall, Lennart
    Departments of Cardiology and Radiology, Helsingborg Hospital, Helsingborg, Sweden.
    Danielewicz, Mikael
    Department of Cardiology, Karlstad Hospital, Karlstad, Sweden.
    Jakobsen, Lars
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Olsson, Sven-Erik
    Departments of Cardiology and Radiology, Helsingborg Hospital, Helsingborg, Sweden.
    Öhagen, Patrik
    Uppsala Clinical Research Center, Uppsala, Sweden.
    Olsson, Hans
    Department of Cardiology, Karlstad Hospital, Karlstad, Sweden.
    Omerovic, Elmir
    Department of Cardiology, Sahlgrenska University, Gothenburg, Sweden.
    Calais, Fredrik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Cardiology, Örebro University Hospital, Örebro, Sweden.
    Lindroos, Pontus
    Department of Cardiology, St. Göran Hospital, Stockholm, Sweden.
    Maeng, Michael
    Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
    Tödt, Tim
    Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden.
    Venetsanos, Dimitrios
    Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
    James, Stefan K.
    Department of Medical Sciences, Uppsala University, Uppsala, Sweden.
    Kåregren, Amra
    Department of Internal Medicine, Västmanland Hospital, Västerås, Sweden.
    Nilsson, Margareta
    Department of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
    Carlsson, Jörg
    Department of Cardiology, Kalmar County Hospital, Kalmar, Sweden; Faculty of Health and Life Sciences, Linnaeus University, Kalmar, Sweden.
    Hauer, Dario
    Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
    Jensen, Jens
    Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet,Stockholm, Sweden; Unit of Cardiology, Capio St. Görans Sjukhus, Stockholm, Sweden; Department of Medicine, Sundsvall Hospital, Sundsvall, Sweden.
    Karlsson, Ann-Charlotte
    Department of Cardiology, Halmstad Hospital, Halmstad, Sweden.
    Panayi, Georgios
    Departments of Cardiology and of Medical and Health Sciences, Linköping University, Linköping, Sweden.
    Erlinge, David
    Department of Cardiology, Clinical Sciences, Skåne University Hospital, Lund University, Lund, Sweden.
    Fröbert, Ole
    Örebro University Hospital. Örebro University, School of Medical Sciences. Department of Cardiology, Örebro University Hospital, Örebro, Sweden .
    iFR-SWEDEHEART Investigators, Group author
    Instantaneous Wave-free Ratio versus Fractional Flow Reserve to Guide PCI2017In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 376, no 19, p. 1813-1823Article in journal (Refereed)
    Abstract [en]

    Background: The instantaneous wave-free ratio (iFR) is an index used to assess the severity of coronary-artery stenosis. The index has been tested against fractional flow reserve (FFR) in small trials, and the two measures have been found to have similar diagnostic accuracy. However, studies of clinical outcomes associated with the use of iFR are lacking. We aimed to evaluate whether iFR is noninferior to FFR with respect to the rate of subsequent major adverse cardiac events.

    Methods: We conducted a multicenter, randomized, controlled, open-label clinical trial using the Swedish Coronary Angiography and Angioplasty Registry for enrollment. A total of 2037 participants with stable angina or an acute coronary syndrome who had an indication for physiologically guided assessment of coronary-artery stenosis were randomly assigned to undergo revascularization guided by either iFR or FFR. The primary end point was the rate of a composite of death from any cause, nonfatal myocardial infarction, or unplanned revascularization within 12 months after the procedure.

    Results: A primary end-point event occurred in 68 of 1012 patients (6.7%) in the iFR group and in 61 of 1007 (6.1%) in the FFR group (difference in event rates, 0.7 percentage points; 95% confidence interval [CI], -1.5 to 2.8%; P=0.007 for noninferiority; hazard ratio, 1.12; 95% CI, 0.79 to 1.58; P=0.53); the upper limit of the 95% confidence interval for the difference in event rates fell within the prespecified noninferiority margin of 3.2 percentage points. The results were similar among major subgroups. The rates of myocardial infarction, target-lesion revascularization, restenosis, and stent thrombosis did not differ significantly between the two groups. A significantly higher proportion of patients in the FFR group than in the iFR group reported chest discomfort during the procedure.

    Conclusions: Among patients with stable angina or an acute coronary syndrome, an iFR-guided revascularization strategy was noninferior to an FFR-guided revascularization strategy with respect to the rate of major adverse cardiac events at 12 months.

  • 14.
    Götberg, Matthias
    et al.
    Lund University, Lund, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences.
    Instantaneous Wave-free Ratio versus Fractional Flow Reserve: Reply2017In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 377, no 16, p. 1596-1597Article in journal (Refereed)
  • 15. Haïssaguerre, Michel
    et al.
    Derval, Nicolas
    Sacher, Frederic
    Jesel, Laurence
    Deisenhofer, Isabel
    de Roy, Luc
    Pasquié, Jean-Luc
    Nogami, Akihiko
    Babuty, Dominique
    Yli-Mayry, Sinikka
    De Chillou, Christian
    Scanu, Patrice
    Mabo, Philippe
    Matsuo, Seiichiro
    Probst, Vincent
    Le Scouarnec, Solena
    Defaye, Pascal
    Schlaepfer, Juerg
    Rostock, Thomas
    Lacroix, Dominique
    Lamaison, Dominique
    Lavergne, Thomas
    Aizawa, Yoshifusa
    Englund, Anders
    Örebro University, School of Health and Medical Sciences.
    Anselme, Frederic
    O'Neill, Mark
    Hocini, Meleze
    Lim, Kang Teng
    Knecht, Sebastien
    Veenhuyzen, George D.
    Bordachar, Pierre
    Chauvin, Michel
    Jais, Pierre
    Coureau, Gaelle
    Chene, Genevieve
    Klein, George J.
    Clémenty, Jacques
    Sudden cardiac arrest associated with early repolarization2008In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 358, no 19, p. 2016-2023Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Early repolarization is a common electrocardiographic finding that is generally considered to be benign. Its potential to cause cardiac arrhythmias has been hypothesized from experimental studies, but it is not known whether there is a clinical association with sudden cardiac arrest.

    METHODS: We reviewed data from 206 case subjects at 22 centers who were resuscitated after cardiac arrest due to idiopathic ventricular fibrillation and assessed the prevalence of electrocardiographic early repolarization. The latter was defined as an elevation of the QRS-ST junction of at least 0.1 mV from baseline in the inferior or lateral lead, manifested as QRS slurring or notching. The control group comprised 412 subjects without heart disease who were matched for age, sex, race, and level of physical activity. Follow-up data that included the results of monitoring with an implantable defibrillator were obtained for all case subjects.

    RESULTS: Early repolarization was more frequent in case subjects with idiopathic ventricular fibrillation than in control subjects (31% vs. 5%, P<0.001). Among case subjects, those with early repolarization were more likely to be male and to have a history of syncope or sudden cardiac arrest during sleep than those without early repolarization. In eight subjects, the origin of ectopy that initiated ventricular arrhythmias was mapped to sites concordant with the localization of repolarization abnormalities. During a mean (+/-SD) follow-up of 61+/-50 months, defibrillator monitoring showed a higher incidence of recurrent ventricular fibrillation in case subjects with a repolarization abnormality than in those without such an abnormality (hazard ratio, 2.1; 95% confidence interval, 1.2 to 3.5; P=0.008).

    CONCLUSIONS: Among patients with a history of idiopathic ventricular fibrillation, there is an increased prevalence of early repolarization.

  • 16.
    Johansson, Kari
    et al.
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Cnattingius, Sven
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Näslund, Ingmar
    Karolinska Institutet, Stockholm, Sweden; Faculty of Medicine and Health, Department of Surgery, Örebro University, Örebro, Sweden .
    Roos, Nathalie
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Lagerros, Ylva Trolle
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Granath, Fredrik
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Stephansson, Olof
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden; Division of Obstetrics and Gynecology, Department of Women's and Children's Health, ,Sweden .
    Neovius, Martin
    Clinical Epidemiology Unit (T2), Department of Medicine (Solna), Karolinska Institutet, Stockholm, Sweden .
    Outcomes of pregnancy after bariatric surgery2015In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 372, no 9, p. 814-824Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Maternal obesity is associated with increased risks of gestational diabetes, large-for-gestational-age infants, preterm birth, congenital malformations, and stillbirth. The risks of these outcomes among women who have undergone bariatric surgery are unclear.

    METHODS: We identified 627,693 singleton pregnancies in the Swedish Medical Birth Register from 2006 through 2011, of which 670 occurred in women who had previously undergone bariatric surgery and for whom presurgery weight was documented. For each pregnancy after bariatric surgery, up to five control pregnancies were matched for the mother's presurgery body-mass index (BMI; we used early-pregnancy BMI in the controls), age, parity, smoking history, educational level, and delivery year. We assessed the risks of gestational diabetes, large-for-gestational-age and small-for-gestational-age infants, preterm birth, stillbirth, neonatal death, and major congenital malformations.

    RESULTS: Pregnancies after bariatric surgery, as compared with matched control pregnancies, were associated with lower risks of gestational diabetes (1.9% vs. 6.8%; odds ratio, 0.25; 95% confidence interval [CI], 0.13 to 0.47; P< 0.001) and large-for-gestational-age infants (8.6% vs. 22.4%; odds ratio, 0.33; 95% CI, 0.24 to 0.44; P< 0.001). In contrast, they were associated with a higher risk of small-for-gestational-age infants (15.6% vs. 7.6%; odds ratio, 2.20; 95% CI, 1.64 to 2.95; P< 0.001) and shorter gestation (273.0 vs. 277.5 days; mean difference -4.5 days; 95% CI, -2.9 to -6.0; P< 0.001), although the risk of preterm birth was not significantly different (10.0% vs. 7.5%; odds ratio, 1.28; 95% CI, 0.92 to 1.78; P = 0.15). The risk of stillbirth or neonatal death was 1.7% versus 0.7% (odds ratio, 2.39; 95% CI, 0.98 to 5.85; P = 0.06). There was no significant between-group difference in the frequency of congenital malformations.

    CONCLUSIONS: Bariatric surgery was associated with reduced risks of gestational diabetes and excessive fetal growth, shorter gestation, an increased risk of small-for-gestational-age infants, and possibly increased mortality.

  • 17.
    Lagerqvist, Bo
    et al.
    Dept Med Sci, Cardiol Sect, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden.
    Fröbert, Ole
    Örebro University Hospital. Department of Cardiology.
    Olivecrona, Goran K.
    Department of Coronary Heart Disease, Skåne University Hospital, Lund, Sweden; Clinical Sciences Section, Lund University, Lund, Sweden.
    Gudnason, Thorarinn
    Dept Cardiol, Reykjavik, Landspitali Univ Hosp, Reykjavik, Iceland; Cardiovasc Res Ctr, Landspitali Univ Hosp, Reykjavik, Iceland.
    Maeng, Michael
    Dept Cardiol, Aarhus Univ Hosp, Aarhus, Denmark.
    Alstrom, Patrik
    Dept Cardiol, Södersjukhuset, Karolinska Inst, Stockholm, Sweden.
    Andersson, Jonas
    Dept Cardiol, Umeå Univ Hosp, Umeå, Sweden.
    Calais, Fredrik
    Dept Cardiol, Örebro University Hospital, Örebro, Sweden.
    Carlsson, Jorg
    Cardiol Sect, Kalmar Cty Hosp, Kalmar, Sweden; Linnaeus Univ, Kalmar, Sweden.
    Collste, Olov
    Dept Cardiol, Södersjukhuset, Karolinska Inst, Stockholm, Sweden.
    Gotberg, Matthias
    Department of Coronary Heart Disease, Skåne University Hospital, Lund, Sweden; Clinical Sciences Section, Lund University, Lund, Sweden.
    Hardhammar, Peter
    Dept Cardiol, Halmstad Cty Hosp, Halmstad, Sweden.
    Ioanes, Dan
    Dept Cardiol, Sahlgrenska Univ Hosp, Gothenburg, Sweden.
    Kallryd, Anders
    Department of Coronary Heart Disease, Skåne University Hospital, Lund, Sweden; Clinical Sciences Section, Lund University, Lund, Sweden.
    Linder, Rickard
    Dept Cardiol, Karolinska Inst, Stockholm, Sweden.
    Lundin, Anders
    Odenstedt, Jacob
    Dept Cardiol, Sahlgrens Univ Hosp, Gothenburg, Sweden.
    Omerovic, Elmir
    Dept Cardiol, Sahlgrens Univ Hosp, Gothenburg, Sweden.
    Puskar, Verner
    Dept Radiol, Ryhov Hosp, Jönköping, Sweden.
    Todt, Tim
    Dept Cardiol, Linköping Univ Hosp, Linköping, Sweden.
    Zelleroth, Eva
    Dept Radiol, Malarsjukhuset, Eskilstuna, Sweden.
    Ostlund, Ollie
    Dept Med Sci, Cardiol Sect, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden.
    James, Stefan K.
    Dept Med Sci, Cardiol Sect, Uppsala Univ, Uppsala, Sweden; Uppsala Clin Res Ctr, Uppsala Univ, Uppsala, Sweden.
    Outcomes 1 Year after Thrombus Aspiration for Myocardial Infarction2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 371, no 12, p. 1111-1120Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration.

    METHODS: We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial.

    RESULTS: No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P = 0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P = 0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P = 0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P = 0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI.

    CONCLUSIONS: Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year.

  • 18.
    Lichtenstein, Paul
    et al.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Halldner, Linda
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Zetterqvist, Johan
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Sjölander, Arvid
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Serlachius, Eva
    Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
    Fazel, Seena
    Department of Psychiatry, University of Oxford, Oxford, United Kingdom.
    Långström, Niklas
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Larsson, Henrik
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Medication for attention deficit-hyperactivity disorder and criminality2012In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 367, no 21, p. 2006-2014Article in journal (Refereed)
    Abstract [en]

    Background: Attention deficit-hyperactivity disorder (ADHD) is a common disorder that has been associated with criminal behavior in some studies. Pharmacologic treatment is available for ADHD and may reduce the risk of criminality.

    Methods: Using Swedish national registers, we gathered information on 25,656 patients with a diagnosis of ADHD, their pharmacologic treatment, and subsequent criminal convictions in Sweden from 2006 through 2009. We used stratified Cox regression analyses to compare the rate of criminality while the patients were receiving ADHD medication, as compared with the rate for the same patients while not receiving medication.

    Results: As compared with nonmedication periods, among patients receiving ADHD medication, there was a significant reduction of 32% in the criminality rate for men (adjusted hazard ratio, 0.68; 95% confidence interval [CI], 0.63 to 0.73) and 41% for women (hazard ratio, 0.59; 95% CI, 0.50 to 0.70). The rate reduction remained between 17% and 46% in sensitivity analyses among men, with factors that included different types of drugs (e.g., stimulant vs. nonstimulant) and outcomes (e.g., type of crime).

    Conclusions: Among patients with ADHD, rates of criminality were lower during periods when they were receiving ADHD medication. These findings raise the possibility that the use of medication reduces the risk of criminality among patients with ADHD. (Funded by the Swedish Research Council and others.).

  • 19.
    Lichtenstein, Paul
    et al.
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Larsson, Henrik
    Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Medication for attention deficit-hyperactivity disorder and criminality2013In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 368, no 8, p. 775-776Article in journal (Refereed)
  • 20. Ludvigsson, Johnny
    et al.
    Faresjö, Maria
    Hjorth, Maria
    Axelsson, Stina
    Chéramy, Mikael
    Pihl, Mikael
    Vaarala, Outi
    Forsander, Gun
    Ivarsson, Sten
    Johansson, Calle
    Lindh, Agne
    Nilsson, Nils-Östen
    Åman, Jan
    Örebro University, School of Health and Medical Sciences.
    Örtqvist, Eva
    Zerhouni, Peter
    Casas, Rosaura
    GAD treatment and insulin secretion in recent-onset type 1 diabetes2008In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 359, no 18, p. 1909-1920Article in journal (Refereed)
    Abstract [en]

    Background The 65-kD isoform of glutamic acid decarboxylase (GAD) is a major autoantigen in patients with type 1 diabetes mellitus. This trial assessed the ability of alum-formulated GAD (GAD-alum) to reverse recent-onset type 1 diabetes in patients 10 to 18 years of age. Methods We randomly assigned 70 patients with type 1 diabetes who had fasting C-peptide levels above 0.1 nmol per liter (0.3 ng per milliliter) and GAD autoantibodies, recruited within 18 months after receiving the diagnosis of diabetes, to receive subcutaneous injections of 20 μg of GAD-alum (35 patients) or placebo (alum alone, 35 patients) on study days 1 and 30. At day 1 and months 3, 9, 15, 21, and 30, patients underwent a mixed-meal tolerance test to stimulate residual insulin secretion (measured as the C-peptide level). The effect of GAD-alum on the immune system was also studied. Results Insulin secretion gradually decreased in both study groups. The study treatment had no significant effect on change in fasting C-peptide level after 15 months (the primary end point). Fasting C-peptide levels declined from baseline levels significantly less over 30 months in the GAD-alum group than in the placebo group (−0.21 vs. −0.27 nmol per liter [−0.62 vs. −0.81 ng per milliliter], P = 0.045), as did stimulated secretion measured as the area under the curve (−0.72 vs. −1.02 nmol per liter per 2 hours [−2.20 vs. −3.08 ng per milliliter per 2 hours], P = 0.04). No protective effect was seen in patients treated 6 months or more after receiving the diagnosis. Adverse events appeared to be mild and similar in frequency between the two groups. The GAD-alum treatment induced a GAD-specific immune response. Conclusions GAD-alum may contribute to the preservation of residual insulin secretion in patients with recent-onset type 1 diabetes, although it did not change the insulin requirement. (ClinicalTrials.gov number, NCT00435981.)

  • 21.
    Ludvigsson, Jonas F.
    et al.
    Örebro University Hospital. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden; Department of Pediatrics, Örebro University Hospital, Örebro University, Örebro, Sweden.
    Green, Peter H. R.
    Celiac Disease Center, Department of Medicine, Columbia University College of Physicians and Surge., New York, United States.
    The missing environmental factor in celiac disease2014In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 371, no 14, p. 1341-1343Article in journal (Other academic)
  • 22.
    Xaplanteris, P.
    et al.
    Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
    Fournier, S.
    Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
    Pijls, N. H. J.
    Department of Cardiology, Eindhoven University of Technology, Catharina Hospital, Eindhoven, Netherlands.
    Fearon, W. F.
    Stanford University Medical Center and Palo Alto Veterans Affairs (VA) Health Care Systems, Stanford CA, United States.
    Barbato, E.
    Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
    Tonino, P. A. L.
    Department of Cardiology, Eindhoven University of Technology, Catharina Hospital, Eindhoven, Netherlands.
    Engström, T.
    Rigshospitalet University Hospital, D-Copenhagen, Germany.
    Kääb, S.
    Klinikum Der Universitat Munchen-Campus-Innenstadt, Munich, Germany.
    Dambrink, J-H
    Isala Klinieken, Zwolle, Netherlands.
    Rioufol, G.
    Cardiovascular Hospital, Lyon, France.
    Toth, G. G.
    Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium; Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary.
    Piroth, Z.
    Gottsegen Hungarian Institute of Cardiology, Budapest, Hungary.
    Witt, N.
    Karolinska Institutet at Sodersjukhuset, Stockholm, Sweden.
    Fröbert, Ole
    Örebro University, School of Medical Sciences.
    Kala, P.
    Masaryk University and University Hospital, Brno, Czech Republic.
    Linke, A.
    Heart Center Leipzig, Leipzig, Germany; Heart Center Dresden, Dresden, Germany.
    Jagic, N.
    Clinical Center Kragujevac, Kragujevac, Serbia.
    Mates, M.
    Na Homolce Hospital, Prague, Czech Republic.
    Mavromatis, K.
    Atlanta VA Medical Center, Decatur, United States.
    Samady, H.
    Emory University School of Medicine, Atlanta GA, USA.
    Irimpen, A.
    Vascular Institute, Tulane University Heart, New Orleans, United States.
    Oldroyd, K.
    Golden Jubilee National Hospital, Glasgow, United Kingdom.
    Campo, G.
    Gruppo Villa Maria Care and Research, Cardiology Unit, Maria Cecilia Hospital, Ravenna, Italy; Azienda Ospedalieria Universitaria di Ferrara, Ferrara, Italy.
    Rothenbuhler, M.
    Clinical Trials Unit Bern, University of Bern, Bern, Switzerland.
    Jüni, P.
    Applied Health Research Centre, Department of Medicine and Institute of Health Policy, Management, and Evaluation, University of Toronto, Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Canada.
    De Bruyne, B.
    Cardiovascular Center Aalst, Onze-Lieve-Vrouw Clinic, Aalst, Belgium.
    Five-Year Outcomes with PCI Guided by Fractional Flow Reserve2018In: New England Journal of Medicine, ISSN 0028-4793, E-ISSN 1533-4406, Vol. 379, no 3, p. 250-259Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: We hypothesized that fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) would be superior to medical therapy as initial treatment in patients with stable coronary artery disease.

    METHODS: Among 1220 patients with angiographically significant stenoses, those in whom at least one stenosis was hemodynamically significant (FFR, <= 0.80) were randomly assigned to FFR-guided PCI plus medical therapy or to medical therapy alone. Patients in whom all stenoses had an FFR of more than 0.80 received medical therapy and were entered into a registry. The primary end point was a composite of death, myocardial infarction, or urgent revascularization.

    RESULTS: A total of 888 patients underwent randomization (447 patients in the PCI group and 441 in the medical-therapy group). At 5 years, the rate of the primary end point was lower in the PCI group than in the medical-therapy group (13.9% vs. 27.0%; hazard ratio, 0.46; 95% confidence interval (CIS, 0.34 to 0.63; P<0.001). The difference was driven by urgent revascularizations, which occurred in 6.3% of the patients in the PCI group as compared with 21.1% of those in the medical-therapy group (hazard ratio, 0.27; 95% CI, 0.18 to 0.41). There were no significant differences between the PCI group and the medical-therapy group in the rates of death (5.1% and 5.2%, respectively; hazard ratio, 0.98; 95% CI, 0.55 to 1.75) or myocardial infarction (8.1% and 12.0%; hazard ratio, 0.66; 95% CI, 0.43 to 1.00). There was no significant difference in the rate of the primary end point between the PCI group and the registry cohort (13.9% and 15.7%, respectively; hazard ratio, 0.88; 95% CI, 0.55 to 1.39). Relief from angina was more pronounced after PCI than after medical therapy.

    CONCLUSIONS: In patients with stable coronary artery disease, an initial FFR-guided PCI strategy was associated with a significantly lower rate of the primary composite end point of death, myocardial infarction, or urgent revascularization at 5 years than medical therapy alone. Patients without hemodynamically significant stenoses had a favorable long-term outcome with medical therapy alone.

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