The current manuscript is the second update of the original Practical Guide, published in 2013 [Heidbuchel et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace 2013;15:625-651; Heidbuchel et al. Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 2015;17:1467-1507]. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists (VKAs) to prevent stroke in patients with atrial fibrillation (AF) and have emerged as the preferred choice, particularly in patients newly started on anticoagulation. Both physicians and patients are becoming more accustomed to the use of these drugs in clinical practice. However, many unresolved questions on how to optimally use these agents in specific clinical situations remain. The European Heart Rhythm Association (EHRA) set out to coordinate a unified way of informing physicians on the use of the different NOACs. A writing group identified 20 topics of concrete clinical scenarios for which practical answers were formulated, based on available evidence. The 20 topics are as follows i.e., (1) Eligibility for NOACs; (2) Practical start-up and follow-up scheme for patients on NOACs; (3) Ensuring adherence to prescribed oral anticoagulant intake; (4) Switching between anticoagulant regimens; (5) Pharmacokinetics and drug-drug interactions of NOACs; (6) NOACs in patients with chronic kidney or advanced liver disease; (7) How to measure the anticoagulant effect of NOACs; (8) NOAC plasma level measurement: rare indications, precautions, and potential pitfalls; (9) How to deal with dosing errors; (10) What to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a potential risk of bleeding; (11) Management of bleeding under NOAC therapy; (12) Patients undergoing a planned invasive procedure, surgery or ablation; (13) Patients requiring an urgent surgical intervention; (14) Patients with AF and coronary artery disease; (15) Avoiding confusion with NOAC dosing across indications; (16) Cardioversion in a NOAC-treated patient; (17) AF patients presenting with acute stroke while on NOACs; (18) NOACs in special situations; (19) Anticoagulation in AF patients with a malignancy; and (20) Optimizing dose adjustments of VKA. Additional information and downloads of the text and anticoagulation cards in different languages can be found on an EHRA website (www.NOACforAF.eu).
NOACs; (8) NOAC plasma level measurement: rare indications, precautions, and potential pitfalls; (9) How to deal with dosing errors; (10) What to do if there is a (suspected) overdose without bleeding, or a clotting test is indicating a potential risk of bleeding; (11) Management of bleeding under NOAC therapy; (12) Patients undergoing a planned invasive procedure, surgery or ablation; (13) Patients requiring an urgent surgical intervention; (14) Patients with AF and coronary artery disease; (15) Avoiding confusion with NOAC dosing across indications; (16) Cardioversion in a NOAC-treated patient; (17) AF patients presenting with acute stroke while on NOACs; (18) NOACs in special situations; (19) Anticoagulation in AF patients with a malignancy; and (20) Optimizing dose adjustments of VKA. Additional information and downloads of the text and anticoagulation cards in different languages can be found on an EHRA website (www.NOACforAF.eu).
SummaryBackgroundTranexamic acid can prevent death due to bleeding after trauma and post-partum haemorrhage. We aimed to assess whether tranexamic acid reduces haematoma expansion and improves outcome in adults with stroke due to intracerebral haemorrhage.MethodsWe did an international, randomised placebo-controlled trial in adults with intracerebral haemorrhage from acute stroke units at 124 hospital sites in 12 countries. Participants were randomly assigned (1:1) to receive 1 g intravenous tranexamic acid bolus followed by an 8 h infusion of 1 g tranexamic acid or a matching placebo, within 8 h of symptom onset. Randomisation was done centrally in real time via a secure website, with stratification by country and minimisation on key prognostic factors. Treatment allocation was concealed from patients, outcome assessors, and all other health-care workers involved in the trial. The primary outcome was functional status at day 90, measured by shift in the modified Rankin Scale, using ordinal logistic regression with adjustment for stratification and minimisation criteria. All analyses were done on an intention-to-treat basis. This trial is registered with the ISRCTN registry, number ISRCTN93732214.FindingsWe recruited 2325 participants between March 1, 2013, and Sept 30, 2017. 1161 patients received tranexamic acid and 1164 received placebo; the treatment groups were well balanced at baseline. The primary outcome was assessed for 2307 (99%) participants. The primary outcome, functional status at day 90, did not differ significantly between the groups (adjusted odds ratio [aOR] 0·88, 95% CI 0·76–1·03, p=0·11). Although there were fewer deaths by day 7 in the tranexamic acid group (101 [9%] deaths in the tranexamic acid group vs 123 [11%] deaths in the placebo group; aOR 0·73, 0·53–0·99, p=0·0406), there was no difference in case fatality at 90 days (250 [22%] vs 249 [21%]; adjusted hazard ratio 0·92, 95% CI 0·77–1·10, p=0·37). Fewer patients had serious adverse events after tranexamic acid than after placebo by days 2 (379 [33%] patients vs 417 [36%] patients), 7 (456 [39%] vs 497 [43%]), and 90 (521 [45%] vs 556 [48%]).InterpretationFunctional status 90 days after intracerebral haemorrhage did not differ significantly between patients who received tranexamic acid and those who received placebo, despite a reduction in early deaths and serious adverse events. Larger randomised trials are needed to confirm or refute a clinically significant treatment effect.FundingNational Institute of Health Research Health Technology Assessment Programme and Swiss Heart Foundation.
Poniższy tekst jest streszczeniem drugiej aktualizacji oryginalnego praktycznego przewodnika opublikowanego w 2013 roku. Leki przeciwkrzepliwe niebędące antagonistami witaminy K (NOAC) stanowią cenną alternatywę dla antagonistów witaminy K (VKA) w zapobieganiu udarom u pacjentów z migotaniem przedsionków (AF) i uznano je za leki preferowane, szczególnie dla osób rozpoczynających leczenie przeciwkrzepliwe. Zarówno lekarze, jak i pacjenci przyzwyczajają się do ich stosowania w praktyce klinicznej, istnieje jednak wiele nierozwiązanych kwestii dotyczących optymalnego stosowania tych leków w określonych sytuacjach klinicznych. Europejskie Stowarzyszenie Zaburzeń Rytmu Serca (EHRA, European Heart Rhythm Association) podjęło się koordynacji opracowania jednolitego sposobu komunikowania się z lekarzami na temat stosowania różnych preparatów NOAC. Grupa określiła 20 tematów zawierających konkretne scenariusze kliniczne, w odniesieniu do których sformułowano praktyczne wskazówki na podstawie dostępnych dowodów. Do problemów klinicznych należą: 1) odpowiednia kwalifikacja pacjentów do leczenia; 2) praktyczne schematy rozpoczynania oraz monitorowania terapii za pomocą NOAC; 3) zagwarantowanie przestrzegania zaleceń przyjmowania doustnych leków przeciwkrzepliwych; 4) zmiana schematów leczenia przeciwkrzepliwego; 5) farmakokinetyka oraz interakcje lekowe; 6) stosowanie NOAC u osób z przewlekłą chorobą nerek i zaawansowaną chorobą wątroby; 7) sposoby pomiaru efektu przeciwkrzepliwego NOAC; 8) pomiar stężenia NOAC w surowicy: rzadkie wskazania, środki ostrożności, potencjalne "pułapki"; 9) postępowanie w przypadku pomyłki w dawkowaniu; 10) postępowanie w przypadku (podejrzenia) przedawkowania bez krwawienia lub badania krzepnięcia wskazujące na potencjalne ryzyko krwawienia; 11) postępowanie w przypadku krwawienia w trakcie terapii za pomocą NOAC; 12) postępowanie u pacjentów poddanych planowym zabiegom chirurgicznym, procedurom inwazyjnym czy ablacji; 13) postępowanie u pacjentów wymagających pilnej interwencji chirurgicznej; 14) pacjenci z AF oraz chorobą wieńcową; 15) unikanie pomyłek w dawkowaniu NOAC w różnych wskazaniach; 16) kardiowersja u pacjenta leczonego NOAC; 17) AF u pacjentów z ostrym udarem mózgu leczonych NOAC; 18) NOAC w sytuacjach szczególnych; 19) leczenie przeciwkrzepliwe w przypadku AF u pacjentów z nowotworami złośliwymi; 20) optymalizacja leczenia za pomocą VKA. Dodatkowe informacje oraz materiały do pobrania, jak również karty leczenia przeciwkrzepliwego w kilku językach można znaleźć na stronie internetowej EHRA (www.NOACforAF.eu).
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