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Bivalirudin versus Heparin Monotherapy in Myocardial Infarction

Erlinge, D. (author)
Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups,Lund University, Sweden
Omerovic, Elmir (author)
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
Fröbert, Ole, 1964- (author)
Örebro University,Örebro universitet,Institutionen för medicinska vetenskaper,Department of Cardiology, Faculty of Health, Örebro University, Örebro, Sweden,Rebro Univ, Fac Hlth, Dept Cardiol, Orebro, Sweden.
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Linder, Rikard (author)
Karolinska Institutet,Danderyd Hospital, Sweden
Danielewicz, Mikael (author)
PCI-Unit at Karlstad Hospital, Karlstad, Sweden,Karlstad Hosp, PCI Unit, Karlstad, Sweden.
Hamid, Mehmet (author)
Department of Cardiology, Mälarsjukhuset, Eskilstuna, Sweden,Malarsjukhuset, Dept Cardiol, Eskilstuna, Sweden.
Swahn, Eva (author)
Linköpings universitet,Avdelningen för kardiovaskulär medicin,Medicinska fakulteten,Region Östergötland, Kardiologiska kliniken US
Henareh, Loghman (author)
Karolinska Institutet,Karolinska University Hospital, Sweden
Wagner, H. (author)
Department of Cardiology, Helsingborg Lasarett, Helsingborg, Sweden,Helsingborg Lasarett, Dept Cardiol, Helsingborg, Sweden.,Helsingborg Hospital
Hårdhammar, Peter (author)
Department of Cardiology, Halmstad Hospital, Halmstad, Sweden,Halmstad Cty Hosp, Dept Cardiol, Halmstad, Sweden.,Halmstad County Hospital, Sweden
Sjögren, Iwar (author)
Department of Cardiology, Falun Hospital, Falun, Sweden,Falun Cent Hosp, Dept Cardiol, Falun, Sweden.,Falun Central Hospital, Sweden
Stewart, Jason (author)
Department of Cardiology, Skaraborgs Hospital, Skövde, Sweden,Skaraborgs Hosp, Dept Cardiol, Skovde, Sweden.
Grimfjärd, Per (author)
Department of Internal Medicine, Västmanlands Sjukhus, Västerås, Sweden,Vastmanlands Sjukhus, Dept Internal Med, Vasteras, Sweden.,Västmanland Hospital
Jensen, Jens (author)
Umeå University,Karolinska Institute,Karolinska Institutet,Karolinska Institute, Sweden,Sunderby Sjukhus, Sweden,Umeå University, Sweden
Aasa, Mikael (author)
Department of Cardiology, Södersjukhuset AB, Stockholm, Sweden,Sodersjukhuset AB, Dept Cardiol, Stockholm, Sweden.,Stockholm South General Hospital
Robertsson, Lotta (author)
Department of Internal Medicine, Västmanlands Sjukhus, Västerås, Sweden,Sodra Alvsborgs Sjukhus, Dept Cardiol, Boras, Sweden.,South Elfsborg Hospital
Lindroos, Pontus (author)
Department of Cardiology, Capio St. Görans Hospital, Karolinska Institutet, Stockholm, Sweden,Karolinska Inst, Capio St Gorans Hosp, Dept Cardiol, Stockholm, Sweden.,Capio St. Görans Sjukhus
Haupt, Jan (author)
Department of Cardiology, Sunderby Sjukhus, Luleå, Sweden,Sunderby Hospital
Wikström, Helena (author)
Department of Cardiology, Kristianstad Hospital, Kristianstad, Sweden,Kristianstad Hosp, Dept Cardiol, Kristianstad, Sweden.,Central Hospital Kristianstad
Ulvenstam, Anders (author)
Umeå universitet,Avdelningen för medicin,Ostersund Hosp, Dept Cardiol, Ostersund, Sweden.,Östersund Hospital, Sweden
Bhiladvala, P. (author)
Lund University,Lunds universitet,Kardiologiska klinikens forskargrupp,Forskargrupper vid Lunds universitet,Cardiology Research Group,Lund University Research Groups,Lund University, Sweden
Lindvall, Bo (author)
Department of Cardiology, Sundsvall Hospital, Sundsvall, Sweden,Sundsvall Hosp, Dept Cardiol, Sundsvall, Sweden.
Lundin, Anders (author)
Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden,Lund Univ, Dept Cardiol Clin Sci, Lund, Sweden.
Tödt, T. (author)
Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University, Sweden,Sahlgrens University Hospital, Sweden,Örebro University, Sweden
Ioanes, Dan (author)
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
Råmunddal, Truls (author)
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
Kellerth, Thomas (author)
Örebro University
Zagozdzon, Leszek (author)
Örebro University,Örebro University, Sweden
Götberg, M. (author)
Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University, Sweden
Andersson, Jonas (author)
Umeå universitet,Kardiologi
Angerås, Oskar (author)
Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden,Sahlgrens Univ Hosp, Dept Cardiol, Gothenburg, Sweden.
Östlund, Ollie (author)
Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Uppsala University, Sweden
Lagerqvist, Bo, 1952- (author)
Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR),Uppsala University Hospital,Uppsala University, Sweden
Held, Claes, 1956- (author)
Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Kardiologi,Uppsala University Hospital,Uppsala University, Sweden
Wallentin, Lars, 1943- (author)
Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR),Uppsala University Hospital,Uppsala University, Sweden
Scherstén, F. (author)
Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Lund University, Sweden
Eriksson, Peter (author)
Umeå University,Umeå universitet,Kardiologi,Umea Univ, Dept Cardiol, Umea, Sweden.,Umeå University, Sweden
Koul, S. (author)
Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups,Lund University, Sweden
James, Stefan, 1964- (author)
Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR),Uppsala University Hospital,Uppsala University, Sweden
Linder, Robert, 1981- (author)
Umeå universitet,Lungmedicin
Abdel-Hamid, Mohamed (author)
Mälar Hospital
Östlund, Olof (author)
Uppsala University Hospital
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 (creator_code:org_t)
Massachusetts Medical Society, 2017
2017
English.
In: New England Journal of Medicine. - : Massachusetts Medical Society. - 0028-4793 .- 1533-4406. ; 377:12, s. 1132-1142
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • 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 .).

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Kardiologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)

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