{"id":"966093b38adf","type":"article","url":"https://hartvaat.nl/2018/06/09/dabigatran-bij-myocardschade-na-niet-cardiale-chirurgie-lancet-manage-trial/","title":"Dabigatran bij myocardschade na niet-cardiale chirurgie: Lancet MANAGE-trial","title_en":"Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial.","category":"atriumfibrilleren","category_label":"Atriumfibrilleren","professions":["cardioloog","internist"],"tags":["iaso-dcm"],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(18)30832-8","source_url":"https://doi.org/10.1016/S0140-6736(18)30832-8","authors":["P J Devereaux","Emmanuelle Duceppe","Gordon Guyatt","Vikas Tandon","Reitze Rodseth","Bruce M Biccard","Denis Xavier","Wojciech Szczeklik","Christian S Meyhoff","Jessica Vincent","Maria Grazia Franzosi","Sadeesh K Srinathan","Jason Erb","Patrick Magloire","John Neary","Mangala Rao","Prashant V Rahate","Navneet K Chaudhry","Bongani Mayosi","Miriam de Nadal","Pilar Paniagua Iglesias","Otavio Berwanger","Juan Carlos Villar","Fernando Botto","John W Eikelboom","Daniel I Sessler","Clive Kearon","Shirley Pettit","Mukul Sharma","Stuart J Connolly","Shrikant I Bangdiwala","Purnima Rao-Melacini","Andreas Hoeft","Salim Yusuf"],"significance":8,"published":"2018-06-09","source_date":"2018-06-09","image":"","kennis":["https://hartvaat.nl/kennis/antistolling/dubbele-antistolling-indicaties/"],"congress":"","summary_en":"The MANAGE trial showed that low-dose dabigatran reduced the composite of vascular events in patients with myocardial injury after non-cardiac surgery (MINS), providing the first randomized evidence for anticoagulation therapy in this common but undertreated perioperative complication.","created":"2026-07-03T10:27:20Z","updated":"2026-07-03T13:26:35Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Lancet MANAGE gerandomiseerde trial die dabigatran onderzocht bij patiënten met myocardschade na niet-cardiale chirurgie. Eerste trial die perioperatieve anticoagulatie bij troponinestijging onderzocht.","abstract_original":"BACKGROUND: Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. METHODS: In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. FINDINGS: Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55-0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55-1·53; p=0·76). INTERPRETATION: Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication [corrected]. FUNDING: Boehringer Ingelheim and Canadian Institutes of Health Research."}