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  • 1.
    Erlinge, D.
    et al.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Omerovic, E.
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Fröbert, O.
    Rebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden..
    Linder, R.
    Danderyd Hosp, Dept Cardiol, Danderyd, Sweden..
    Danielewicz, M.
    Karlstad Hosp, PCI Unit, Karlstad, Sweden..
    Hamid, M.
    Malarsjukhuset, Dept Cardiol, Eskilstuna, Sweden..
    Swahn, E.
    Linkoping Univ Hosp, Dept Cardiol, Linkoping, Sweden..
    Henareh, L.
    Karolinska Univ Hosp, Dept Cardiol, Stockholm, Sweden..
    Wagner, H.
    Helsingborg Lasarett, Dept Cardiol, Helsingborg, Sweden..
    Hårdhammar, P.
    Halmstad Cty Hosp, Dept Cardiol, Halmstad, Sweden..
    Sjögren, I.
    Falun Cent Hosp, Dept Cardiol, Falun, Sweden..
    Stewart, J.
    Skaraborgs Hosp, Dept Cardiol, Skovde, Sweden..
    Grimfjärd, P.
    Vastmanlands Sjukhus, Dept Internal Med, Vasteras, Sweden..
    Jensen, J.
    Karolinska Inst, Capio St Gorans Hosp, Dept Cardiol, Stockholm, Sweden..
    Aasa, M.
    Sodersjukhuset AB, Dept Cardiol, Stockholm, Sweden..
    Robertsson, L.
    Sodra Alvsborgs Sjukhus, Dept Cardiol, Boras, Sweden..
    Lindroos, P.
    Karolinska Inst, Capio St Gorans Hosp, Dept Cardiol, Stockholm, Sweden..
    Haupt, J.
    Sunderby Sjukhus, Dept Cardiol, Lulea, Sweden..
    Wikström, H.
    Kristianstad Hosp, Dept Cardiol, Kristianstad, Sweden..
    Ulvenstam, A.
    Ostersund Hosp, Dept Cardiol, Ostersund, Sweden..
    Bhiladvala, P.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Lindvall, B.
    Sundsvall Hosp, Dept Cardiol, Sundsvall, Sweden..
    Lundin, A.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Tödt, T.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Ioanes, D.
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Råmunddal, T.
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Kellerth, T.
    Rebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden..
    Zagozdzon, L.
    Rebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden..
    Götberg, M.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Andersson, J.
    Umea Univ, Dept Cardiol, Umea, Sweden..
    Angerås, O.
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden..
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Schersten, F.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    Eriksson, P.
    Umea Univ, Dept Cardiol, Umea, Sweden..
    Koul, S.
    Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden..
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    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 P2Y 12 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 P2Y(12) 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;

  • 2.
    Erlinge, David
    et al.
    Lund Univ, Dept Cardiol, Clin Sci, Lund, Sweden..
    Koul, Sasha
    Lund Univ, Dept Cardiol, Clin Sci, Lund, Sweden..
    Eriksson, Peter
    Umea Univ, Dept Cardiol, Umea, Sweden..
    Schersten, Fredrik
    Lund Univ, Dept Cardiol, Clin Sci, Lund, Sweden..
    Omerovic, Elmir
    Sahlgrenska Univ, Dept Cardiol, Gothenburg, Sweden..
    Linder, Rikard
    Karolinska Univ, Dept Cardiol, Stockholm, Sweden..
    Ostlund, Olof Petter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Frobert, Ole
    Univ Orebro, Dept Cardiol, Fac Hlth, SE-70182 Orebro, Sweden..
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    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. 36-46Article 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.

  • 3.
    Erlinge, David
    et al.
    Lund Univ, Dept Cardiol, Lund, Sweden.
    Koul, Sasha
    Lund Univ, Dept Cardiol, Lund, Sweden.
    Omerovic, Elmir
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Fröbert, Ole
    Örebro Univ, Dept Cardiol, Örebro, Sweden.
    Linder, Rikard
    Danderyd Hosp, Dept Cardiol, Danderyd, Sweden.
    Danielewicz, Mikael
    Karlstad Hosp, PCI Unit, Karlstad, Sweden.
    Hamid, Mehmet
    Mälarsjukhuset, Dept Cardiol, Eskilstuna, Sweden.
    Venetsanos, Dimitrios
    Karolinska Univ Hosp, Dept Cardiol, Solna, Sweden.
    Henareh, Loghman
    Karolinska Univ Hosp, Dept Cardiol, Solna, Sweden.
    Pettersson, Björn
    Umeå Univ, Dept Cardiol, Umeå, Sweden.
    Wagner, Henrik
    Helsingborg Lasarett, Dept Cardiol, Helsingborg, Sweden.
    Grimfjärd, Per
    Västmanlands Sjukhus, Dept Internal Med, Köping, Sweden.
    Jensen, Jens
    Capio St Görans Hosp AB, Dept Cardiol, Stockholm, Sweden.
    Hofmann, Robin
    Södersjukhuset, Dept Clin Sci & Educ, Stockholm, Sweden.
    Ulvenstam, Anders
    Östersund Hosp, Dept Cardiol, Östersund, Sweden.
    Völz, Sebastian
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Petursson, Petur
    Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Östlund, Olof Petter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Sarno, Giovanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Scherstén, Fredrik
    Lund Univ, Dept Cardiol, Lund, Sweden.
    Eriksson, Peter
    Umeå Univ, Dept Cardiol, Umeå, Sweden.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Bivalirudin versus heparin monotherapy in non-ST-segment elevation myocardial infarction2019In: European heart journal. Acute cardiovascular care., ISSN 2048-8726, Vol. 8, p. 492-501, article id 2048872618805663Article in journal (Refereed)
    Abstract [en]

    Background: The optimal anti-coagulation strategy for patients with non-ST-elevation myocardial infarction treated with percutaneous coronary intervention is unclear in contemporary clinical practice of radial access and potent P2Y12-inhibitors. The aim of this study was to investigate whether bivalirudin was superior to heparin monotherapy in patients with non-ST-elevation myocardial infarction without routine glycoprotein IIb/IIIa inhibitor use.

    Methods: In a large pre-specified subgroup of the multicentre, prospective, randomised, registry-based, open-label clinical VALIDATE-SWEDEHEART trial we randomised patients with non-ST-elevation myocardial infarction undergoing percutaneous coronary intervention, treated with ticagrelor or prasugrel, to bivalirudin or heparin monotherapy with no planned use of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention. The primary endpoint was the rate of a composite of all-cause death, myocardial infarction or major bleeding within 180 days.

    Results: A total of 3001 patients with non-ST-elevation myocardial infarction, were enrolled. The primary endpoint occurred in 12.1% (182 of 1503) and 12.5% (187 of 1498) of patients in the bivalirudin and heparin groups, respectively (hazard ratio of bivalirudin compared to heparin treatment 0.96, 95% confidence interval 0.78–1.18, p=0.69). The results were consistent in all major subgroups. All-cause death occurred in 2.0% versus 1.7% (hazard ratio 1.15, 0.68–1.94, p=0.61), myocardial infarction in 2.3% versus 2.5% (hazard ratio 0.91, 0.58–1.45, p=0.70), major bleeding in 8.9% versus 9.1% (hazard ratio 0.97, 0.77–1.24, p=0.82) and definite stent thrombosis in 0.3% versus 0.2% (hazard ratio 1.33, 0.30–5.93, p=0.82).

    Conclusion: Bivalirudin as compared to heparin during percutaneous coronary intervention for non-ST-elevation myocardial infarction did not reduce the composite of all-cause death, myocardial infarction or major bleeding in non-ST-elevation myocardial infarction patients receiving current recommended treatments with modern P2Y12-inhibitors and predominantly radial access.

  • 4.
    Hijazi, Ziad
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lindbäck, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Östlund, Olof Petter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Siegbahn, Agneta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Coagulation and inflammation science. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Alexander, J. H.
    Duke Univ, Med Ctr, Durham, NC 27706 USA..
    Granger, C. B.
    Duke Univ, Med Ctr, Durham, NC 27706 USA..
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Stewart, R. A. H.
    Univ Auckland, Auckland City Hosp, Green Lane Cardiovasc Serv, Auckland 1, New Zealand..
    White, H. D.
    Univ Auckland, Auckland City Hosp, Green Lane Cardiovasc Serv, Auckland 1, New Zealand..
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    External validation of the biomarker-based ABC-stroke risk score for atrial fibrillation2015In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 36, no Suppl. 1, p. 710-711Article in journal (Other academic)
  • 5.
    Hofmann, Robin
    et al.
    Karolinska Inst, Div Cardiol, Dept Clin Sci & Educ, Soder Sjukhuset, Sjukhusbacken 10, S-11883 Stockholm, Sweden.
    Witt, Nils
    Karolinska Inst, Div Cardiol, Dept Clin Sci & Educ, Soder Sjukhuset, Sjukhusbacken 10, S-11883 Stockholm, Sweden.
    Lagerqvist, Bo
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Jernberg, Tomas
    Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Cardiol, Morbygardsvagen 5, S-18288 Stockholm, Sweden.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Erlinge, David
    Lund Univ, Dept Cardiol, Clin Sci, S-22185 Lund, Sweden.
    Herlitz, Johan
    Univ Boras, Dept Hlth Sci, S-50190 Boras, Sweden;Sahlgrens Univ Hosp, Dept Cardiol, S-41345 Gothenburg, Sweden.
    Alfredsson, Joakim
    Linkoping Univ, Dept Med & Hlth Sci, Sandbacksgatan 7, S-58183 Linkoping, Sweden;Linkoping Univ Hosp, Dept Cardiol, S-58185 Linkoping, Sweden.
    Linder, Rikard
    Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Cardiol, Morbygardsvagen 5, S-18288 Stockholm, Sweden.
    Omerovic, Elmir
    Sahlgrens Univ Hosp, Dept Cardiol, S-41345 Gothenburg, Sweden.
    Angeras, Oskar
    Sahlgrens Univ Hosp, Dept Cardiol, S-41345 Gothenburg, Sweden.
    Venetsanos, Dimitrios
    Linkoping Univ, Dept Med & Hlth Sci, Sandbacksgatan 7, S-58183 Linkoping, Sweden;Linkoping Univ Hosp, Dept Cardiol, S-58185 Linkoping, Sweden.
    Kellerth, Thomas
    Orebro Univ Hosp, Dept Cardiol, S-70185 Orebro, Sweden.
    Sparv, David
    Lund Univ, Dept Cardiol, Clin Sci, S-22185 Lund, Sweden.
    Lauermann, Jorg
    Ryhov Hosp, Dept Internal Med, Div Cardiol, Sjukhusgatan, S-55305 Jonkoping, Sweden.
    Barmano, Neshro
    Ryhov Hosp, Dept Internal Med, Div Cardiol, Sjukhusgatan, S-55305 Jonkoping, Sweden.
    Verouhis, Dinos
    Karolinska Inst, Karolinska Univ Hosp, Dept Med, S-17176 Solna, Sweden;Karolinska Univ Hosp, Dept Cardiol, S-17176 Stockholm, Sweden.
    Östlund, Olof Petter
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Svensson, Leif
    Karolinska Inst, Karolinska Univ Hosp, Dept Med, S-17176 Solna, Sweden;Karolinska Inst, Ctr Resuscitat Sci, Soder Sjukhuset, Jagargatan 20, S-11883 Stockholm, Sweden.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Oxygen therapy in ST-elevation myocardial infarction2018In: European Heart Journal, ISSN 0195-668X, E-ISSN 1522-9645, Vol. 39, no 29, p. 2730-2739Article in journal (Refereed)
    Abstract [en]

    Aims

    To determine whether supplemental oxygen in patients with ST-elevation myocardial infarction (STEMI) impacts on procedure-related and clinical outcomes.

    Methods and results The DETermination of the role of Oxygen in suspected Acute Myocardial Infarction (DETO2X-AMI) trial randomized patients with suspected myocardial infarction (MI) to receive oxygen at 6 L/min for 6-12 h or ambient air. In this pre-specified analysis, we included only STEMI patients who underwent percutaneous coronary intervention (PCI). In total, 2807 patients were included, 1361 assigned to receive oxygen, and 1446 assigned to ambient air. The pre-specified primary composite endpoint of all-cause death, rehospitalization with MI, cardiogenic shock, or stent thrombosis at 1 year occurred in 6.3% (86 of 1361) of patients allocated to oxygen compared to 7.5% (108 of 1446) allocated to ambient air [hazard ratio (HR) 0.85, 95% confidence interval (95% CI) 0.64-1.13; P = 0.27]. There was no difference in the rate of death from any cause (HR 0.86, 95% CI 0.61-1.22; P = 0.41), rate of rehospitalization for MI (HR 0.92, 95% CI 0.57-1.48; P = 0.73), rehospitalization for cardiogenic shock (HR 1.05, 95% CI 0.21-5.22; P = 0.95), or stent thrombosis (HR 1.27, 95% CI 0.46-3.51; P = 0.64). The primary composite endpoint was consistent across all subgroups, as well as at different time points, such as during hospital stay, at 30 days and the total duration of follow-up up to 1356 days.

    Conclusions Routine use of supplemental oxygen in normoxemic patients with STEMI undergoing primary PCI did not significantly affect 1-year all-cause death, rehospitalization with MI, cardiogenic shock, or stent thrombosis.

  • 6.
    Jernberg, Tomas
    et al.
    Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Div Cardiol, Stockholm, Sweden.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Alfredsson, Joakim
    Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden;Linkoping Univ, Dept Cardiol, Linkoping, Sweden.
    Berglund, Ellinor
    Karolinska Inst, Ctr Resuscitat Sci, Dept Med, Stockholm, Sweden.
    Bergstroem, Olle
    Vaxjo Hosp, Dept Med, Vaxjo, Sweden.
    Engstrom, Anders
    Kalmar Reg Hosp, Div Cardiol, Dept Med, Kalmar, Sweden.
    Erlinge, David
    Lund Univ, Dept Clin Sci, Cardiol, Lund, Sweden.
    Herlitz, Johan
    Univ Gothenburg, Dept Mol & Clin Med, Gothenburg, Sweden;Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Cardiol, Gothenburg, Sweden;Univ Boras, Dept Hlth Sci, Boras, Sweden.
    Jumatate, Raluca
    Kristianstad Hosp, Dept Med, Kristianstad, Sweden.
    Kellerth, Thomas
    Orebro Univ Hosp, Dept Cardiol, Orebro, Sweden.
    Lauermann, Jorg
    Ryhov Hosp, Div Cardiol, Dept Internal Med, Jonkoping, Sweden.
    Lindmark, Krister
    Umea Univ, Dept Publ Hlth & Clin Med, Umea, Sweden.
    Lingman, Markus
    Halland Hosp, Dept Med, Halmstad, Sweden;Univ Gothenburg, Sahlgrenska Acad, Inst Med, Dept Mol & Clin Med, Gothenburg, Sweden.
    Ljung, Lina
    Karolinska Inst, Sodersjukhuset, Div Cardiol, Dept Clin Sci & Educ, Sjukhusbacken 10, S-11883 Stockholm, Sweden.
    Nilsson, Carina
    Ljungby Hosp, Dept Med, Ljungby, Sweden.
    Omerovic, Elmir
    Univ Gothenburg, Dept Mol & Clin Med, Gothenburg, Sweden;Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Pernow, John
    Karolinska Inst, Div Cardiol, Dept Med, Solna, Sweden;Karolinska Univ Hosp, Stockholm, Sweden.
    Ravn-Fischer, Annica
    Univ Gothenburg, Dept Mol & Clin Med, Gothenburg, Sweden;Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Sparv, David
    Lund Univ, Dept Clin Sci, Cardiol, Lund, Sweden.
    Yndigegn, Troels
    Lund Univ, Dept Clin Sci, Cardiol, Lund, Sweden.
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Hofmann, Robin
    Karolinska Inst, Sodersjukhuset, Div Cardiol, Dept Clin Sci & Educ, Sjukhusbacken 10, S-11883 Stockholm, Sweden.
    Long-Term Effects of Oxygen Therapy on Death or Hospitalization for Heart Failure in Patients With Suspected Acute Myocardial Infarction2018In: Circulation, ISSN 0009-7322, E-ISSN 1524-4539, Vol. 138, no 24, p. 2754-2762Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: In the DETO2X-AMI trial (Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction), we compared supplemental oxygen with ambient air in normoxemic patients presenting with suspected myocardial infarction and found no significant survival benefit at 1 year. However, important secondary end points were not yet available. We now report the prespecified secondary end points cardiovascular death and the composite of all-cause death and hospitalization for heart failure. METHODS: In this pragmatic, registry-based randomized clinical trial, we used a nationwide quality registry for coronary care for trial procedures and evaluated end points through the Swedish population registry (mortality), the Swedish inpatient registry (heart failure), and cause of death registry (cardiovascular death). Patients with suspected acute myocardial infarction and oxygen saturation of >= 90% were randomly assigned to receive either supplemental oxygen at 6 L/min for 6 to 12 hours delivered by open face mask or ambient air. RESULTS: A total of 6629 patients were enrolled. Acute heart failure treatment, left ventricular systolic function assessed by echocardiography, and infarct size measured by high-sensitive cardiac troponin T were similar in the 2 groups during the hospitalization period. All-cause death or hospitalization for heart failure within 1 year after randomization occurred in 8.0% of patients assigned to oxygen and in 7.9% of patients assigned to ambient air (hazard ratio, 0.99; 95% CI, 0.84-1.18; P=0.92). During long-term follow-up (median [range], 2.1 [1.0-3.7] years), the composite end point occurred in 11.2% of patients assigned to oxygen and in 10.8% of patients assigned to ambient air (hazard ratio, 1.02; 95% CI, 0.88-1.17; P=0.84), and cardiovascular death occurred in 5.2% of patients assigned to oxygen and in 4.8% assigned to ambient air (hazard ratio, 1.07; 95% CI, 0.87-1.33; P=0.52). The results were consistent across all predefined subgroups. CONCLUSIONS: Routine use of supplemental oxygen in normoxemic patients with suspected myocardial infarction was not found to reduce the composite of all-cause mortality and hospitalization for heart failure, or cardiovascular death within 1 year or during long-term follow-up.

  • 7.
    Lindholm, Daniel
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lindbäck, Johan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Armstrong, Paul W.
    Budaj, Andrzej
    Cannon, Christopher P.
    Granger, Christopher B.
    Hagström, Emil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Held, Claes
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Koenig, Wolfgang
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Stewart, Ralph A.H.
    Soffer, Joseph
    White, Harvey D.
    de Winter, Robbert J.
    Steg, Philippe Gabriel
    Siegbahn, Agneta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Chemistry.
    Kleber, Marcus E.
    Dressel, Alexander
    Grammer, Tanja B.
    März, Winfried
    Wallentin, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Biomarker-Based Risk Model to Predict Cardiovascular Mortality in Patients With Stable Coronary Disease2017In: Journal of the American College of Cardiology, ISSN 0735-1097, E-ISSN 1558-3597, Vol. 70, no 7, p. 813-826Article in journal (Refereed)
    Abstract [en]

    Background Currently, there is no generally accepted model to predict outcomes in stable coronary heart disease (CHD).Objectives This study evaluated and compared the prognostic value of biomarkers and clinical variables to develop a biomarker-based prediction model in patients with stable CHD.Methods In a prospective, randomized trial cohort of 13,164 patients with stable CHD, we analyzed several candidate biomarkers and clinical variables and used multivariable Cox regression to develop a clinical prediction model based on the most important markers. The primary outcome was cardiovascular (CV) death, but model performance was also explored for other key outcomes. It was internally bootstrap validated, and externally validated in 1,547 patients in another study.Results During a median follow-up of 3.7 years, there were 591 cases of CV death. The 3 most important biomarkers were N-terminal pro–B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), and low-density lipoprotein cholesterol, where NT-proBNP and hs-cTnT had greater prognostic value than any other biomarker or clinical variable. The final prediction model included age (A), biomarkers (B) (NT-proBNP, hs-cTnT, and low-density lipoprotein cholesterol), and clinical variables (C) (smoking, diabetes mellitus, and peripheral arterial disease). This “ABC-CHD” model had high discriminatory ability for CV death (c-index 0.81 in derivation cohort, 0.78 in validation cohort), with adequate calibration in both cohorts.Conclusions This model provided a robust tool for the prediction of CV death in patients with stable CHD. As it is based on a small number of readily available biomarkers and clinical factors, it can be widely employed to complement clinical assessment and guide management based on CV risk. (The Stabilization of Atherosclerotic Plaque by Initiation of Darapladib Therapy Trial [STABILITY]; NCT00799903)

  • 8.
    Nyström, Thomas
    et al.
    Karolinska Inst, Dept Clin Sci & Educ, Div Endocrinol, Sodersjukhuset, Stockholm, Sweden.
    James, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lindahl, Bertil
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Erlinge, David
    Lund Univ, Dept Clin Sci, Cardiol, Lund, Sweden.
    Herlitz, Johan
    Univ Boras, Dept Hlth Sci, Boras, Sweden.
    Omerovic, Elmir
    Univ Gothenburg, Dept Mol & Clin Med, Gothenburg, Sweden;Univ Gothenburg, Sahlgrenska Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
    Mellbin, Linda
    Karolinska Inst, Div Cardiol, Dept Med, Stockholm, Sweden;Karolinska Univ Hosp, Heart & Vasc Theme, Stockholm, Sweden.
    Alfredsson, Joakim
    Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden.
    Fröbert, Ole
    Orebro Univ, Fac Med & Hlth, Dept Cardiol, Orebro, Sweden.
    Jernberg, Tomas
    Karolinska Inst, Danderyd Hosp, Dept Clin Sci, Cardiol, Stockholm, Sweden.
    Hofmann, Robin
    Karolinska Inst, Dept Clin Sci & Educ, Div Cardiol, Sodersjukhuset, Stockholm, Sweden.
    Oxygen Therapy in Myocardial Infarction Patients With or Without Diabetes: A Predefined Subgroup Analysis From the DETO2X-AMI Trial2019In: Diabetes Care, ISSN 0149-5992, E-ISSN 1935-5548, Vol. 42, no 11, p. 2032-2041Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To determine the effects of oxygen therapy in myocardial infarction (MI) patients with and without diabetes.

    RESEARCH DESIGN AND METHODS: In the Determination of the Role of Oxygen in Suspected Acute Myocardial Infarction (DETO2X-AMI) trial, 6,629 normoxemic patients with suspected MI were randomized to oxygen at 6 L/min for 6-12 h or ambient air. In this prespecified analysis involving 5,010 patients with confirmed MI, 934 had known diabetes. Oxidative stress may be of particular importance in diabetes, and the primary objective was to study the effect of supplemental oxygen on the composite of all-cause death and rehospitalization with MI or heart failure (HF) at 1 year in patients with and without diabetes.

    RESULTS: As expected, event rates were significantly higher in patients with diabetes compared with patients without diabetes (main composite end point: hazard ratio [HR] 1.60 [95% CI 1.32-1.93], P < 0.01). In patients with diabetes, the main composite end point occurred in 16.2% (72 of 445) allocated to oxygen as compared with 16.6% (81 of 489) allocated to ambient air (HR 0.93 [95% CI 0.67-1.27], P = 0.81). There was no statistically significant difference for the individual components of the composite end point or the rate of cardiovascular death up to 1 year. Likewise, corresponding end points in patients without diabetes were similar between the treatment groups.

    CONCLUSIONS: Despite markedly higher event rates in patients with MI and diabetes, oxygen therapy did not significantly affect 1-year all-cause death, cardiovascular death, or rehospitalization with MI or HF, irrespective of underlying diabetes, in line with the results of the entire study.

  • 9.
    Sundström, Johan
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Epidemiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lind, Lars
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Epidemiology.
    Nowrouzi, Shamim
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Lytsy, Per
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Social Medicine.
    Marttala, Kerstin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
    Ekman, Inger
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Öhagen, Patrik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Östlund, Ollie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    The Precision HYpertenSIon Care (PHYSIC) study: a double-blind, randomized, repeated cross-over study2019In: Upsala Journal of Medical Sciences, ISSN 0300-9734, E-ISSN 2000-1967, Vol. 124, no 1, p. 51-58Article in journal (Refereed)
    Abstract [en]

    High blood pressure is the leading risk factor for premature deaths and a major cost to societies worldwide. Effective blood pressure-lowering drugs are available, but patient adherence to them is low, likely partly due to side effects. To identify patient-specific differences in treatment effects, a repeated cross-over design, where the same treatment contrasts are repeated within each patient, is needed. Such designs have been surprisingly rarely used, given the current focus on precision medicine. The Precision HYpertenSIon Care (PHYSIC) study aims to investigate if there is a consistent between-person variation in blood pressure response to the common blood pressure-lowering drug classes of a clinically relevant magnitude, given the within-person variation in blood pressure. The study will also investigate the between-person variation in side effects of the drugs. In a double-blind, randomized, repeated cross-over trial, 300 patients with mild hypertension will be treated with four blood pressure-lowering drugs (candesartan, lisinopril, amlodipine, and hydrochlorothiazide) in monotherapy, with two of the drugs repeated for each patient. If the study indicates that there is a potential for precision hypertension care, the most promising predictors of blood pressure and side effect response to the drugs will be explored, as will the potential for development of a biomarker panel to rank the suitability of blood pressure-lowering drug classes for individual patients in terms of anticipated blood pressure effects and side effects, with the ultimate goal to maximize adherence. The study follows a protocol pre-registered at ClinicalTrials.gov with the identifier NCT02774460.

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