Risikoadaptierte Antikoagulation zur Schlaganfallprävention bei Vorhofflimmern in Deutschland, Österreich und der Schweiz

Zusammenfassung

Hintergrund | Das Management von Patienten mit Vorhofflimmern (VHF) hat in den letzten Jahren zahlreiche Verbesserungen erfahren, unter anderem durch die Einführung neuer Scores zur Stratifizierung des Schlaganfallsrisikos, wie auch durch die Verfügbarkeit der nicht-Vitamin-K oralen Antikoagulanzien (NOAK). Ziel der PREFER-in-AF-Studie war es, die Versorgung von Patienten mit VHF unter besonderer Berücksichtigung der Schlaganfallprävention durch Antikoagulation zu untersuchen.

Patienten | In Deutschland, Österreich und der Schweiz wurden zwischen Januar 2012 bis Januar 2013 1771 Patienten in die Studie eingeschlossen (mittleres Alter 71,9 ± 9,2 Jahre; 63 % Männer). Zu Beobachtungsbeginn betrug die mittlere Zeit seit Erstdiagnose von VHF 4,8 ± 5,3 Jahre, wobei 30,7 % der Patienten paroxysmales, 11,0 % persistierendes, 4,7 % langanhaltend persistierendes, und 53,3 % permanentes VHF aufwiesen. Ein Sinusrhythmus lag bei 25,1 % vor. Der mittlere CHA₂DS₂-VASc-Score lag bei 3,7 ± 1,8 Punkten (0 Punkte bei 3,0 %, 1 Punkt bei 7,1 %, ≥ 2 Punkte bei 89,9 %).

Ergebnisse | Zur Prophylaxe thromboembolischer Ereignisse erhielten 68,1 % der Patienten Vitamin-K-Antagonisten (VKA, überwiegend Phenprocoumon), 11,6 % wurden mit einem NOAK behandelt (hauptsächlich Rivaroxaban oder Dabigatran), 7,6 % mit Thrombozytenaggregationshemmern (TAH) und 7,7 % mit VKA und TAH in Kombination. Keinerlei Thromboembolie-Prophylaxe erhielten 5,0 % der Patienten. Ein temporäres Absetzen von VKA bei Interventionen wurde bei 29,7 % in den 12 Monaten vor Einschluss berichtet. Die Rate von adäquat eingestellten Patienten (mindestens 2 von 3 INR-Werten im Bereich 2,0–3,0) lag bei 75,1 % (bezogen auf Patienten mit bekannten INR-Werten und Risikoscore).

Eine Blutungsneigung bzw. Blutungen in der Anamnese wurden bei 5,1 % der Patienten berichtet, Hospitalisierungen aufgrund größerer Blutungen in den letzten 12 Monaten bei 1,9 %. Mögliche Risikofaktoren für eine Antikoagulation bestanden bei 76,7 % der Patienten. Der mittlere HAS-BLED-Score betrug 2,1 ± 1,1 Punkte.

Schlussfolgerung | Die Rate der mit oraler Antikoagulation behandelten VHF-Patienten lag mit knapp 90 % deutlich höher als in älteren Beobachtungsstudien. NOAK wurden bei 12 % der Patienten eingesetzt.

Abstract

Background: The management of patients with atrial fibrillation (AF) has substantially improved in recent years, among others due to the introduction of new risk scores for the stratification of patients, as well as the availability of the non-vitamin K oral antagonists (NOAC). The PREFER-in-AF study aimed to document the management of AF patients with particular focus on stroke prevention on the basis of anticoagulants.

Methods and results: In Germany, Austria and Switzerland a total of 1771 patients were enrolled between January 2012 and January 2013 (mean age 71.9 ± 9.2 years; 63 % males).

At inclusion, the mean time since AF diagnosis was 4.8 ± 5.3 years. Paroxysmal AF was present in 30.7 %, persistent in 11 %, long standing persistent in 4.7 % and permanent AF in 53.3 % of the patients. 25.1 % of the Patients were in sinus rhythm. Mean CHA₂DS₂-VASc Score was 3.7 ± 1.8 points (0 points in 3.0 %, 1 point in 7.1 %, ≥ 2 points in 89.9 %).

For the prevention of thromboembolic events 68.1 % of patients received vitamin K antagonists (VKA, mainly phenprocoumon), 11.6 % received a NOAC (mainly rivaroxaban or dabigatran), 7.6 % an antiplatelet agent, and 7.7 % a combination of VKA plus an antiplatelet agent. 5.0 % of patients did not receive any anticoagulant. During the 12 months prior to inclusion, interruption of VKA therapy due to an interventions was reported in 29.7 %. In the group of patients with known INR values and available CHA₂DS₂-VASc score, 75.1 % were adequately controlled (defined as at least 2 of 3 INR values in the range of 2.0–3.0).

Bleeding propensity or bleedings in patient history were reported for 5.1 % of the patients, hospitalizations due to major bleeding events in the past 12 months for 1.9 %. Possible risk factors associated with anticoagulation were present in 76.7 %. Mean HAS-BLED score was 2.1 ± 1.1 points.

Conclusion: The rates of AF patients who received oral anticoagulation were about 90 % and substantially higher compared to previous observational studies. NAOCs were administered to 11.7 % of patients.

Schlüsselwörter

Register - Querschnittstudie - Antikoagulation - Vitamin K Antagonisten - Neue Orale Antikoagulanzien - Einstellung - INR

Keywords

Registry - Anticoagulation - Vitamin K antagonist - NOAC - INR control

^* geteilte Erstautorenschaft

• Literatur

• 1 Albertsen IE, Rasmussen LH, Overvad TF et al. Risk of stroke or systemic embolism in atrial fibrillation patients treated with warfarin: a systematic review and meta-analysis. Stroke 2013; 44: 1329-1336
• 2 Bonnemeier H, Bosch RF, Kohlhaussen A et al. Presentation of atrial fibrillation and its management by cardiologists in the ambulatory and hospital setting: MOVE cross-sectional study. Curr Med Res Opin 2011; 27: 995-1003
• 3 Camm A, Lip G, Atar D et al. 2012 Focused Update of the ESC Guidelines on the Management of Atrial Fibrillation. Eur Heart J 2012; 33: 2719-2747
• 4 Camm AJ, Kirchhof P, Lip GY et al. Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010; 31: 2369-2429
• 5 Connolly SJ, Ezekowitz MD, Yusuf S et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: 1139-1151
• 6 Delgado-Rodriguez M, Llorca J. Bias. J Epidemiol Community Health 2004; 58: 635-641
• 7 Diener HC, Eikelboom J, Connolly SJ et al. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial. Lancet Neurol 2012; 11: 225-231
• 8 Donze J, Clair C, Hug B et al. Risk of falls and major bleeds in patients on oral anticoagulation therapy. Am J Med 2012; 125: 773-778
• 9 Granger CB, Alexander JH, McMurray JJ et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: 981-992
• 10 Hart RG, Pearce LA. Current status of stroke risk stratification in patients with atrial fibrillation. Stroke 2009; 40: 2607-2610
• 11 Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 2007; 146: 857-867
• 12 Hylek EM, D’Antonio J, Evans-Molina C et al. Translating the results of randomized trials into clinical practice: the challenge of warfarin candidacy among hospitalized elderly patients with atrial fibrillation. Stroke 2006; 37: 1075-1080
• 13 Kakkar AK, Mueller I, Bassand JP et al. Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PloS one 2013; 8: e63479
• 14 Kakkar AK, Mueller I, Bassand JP et al. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J 2012; 163: 13-19
• 15 Kirchhof P, Ammentorp B, Darius H et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events – European Registry in Atrial Fibrillation (PREFER-in-AF). Europace 2014; 16: 6-14
• 16 Le Heuzey J, Breithardt G, Camm J et al. The RecordAF Study: Design, Baseline Data, and Profile of Patients According to Chosen Treatment Strategy for Atrial Fibrillation. Am J Cardiol 2010; 105: 687-693
• 17 Le Heuzey JY, Ammentorp B, Darius H et al. Differences among western European countries in anticoagulation management of atrial fibrillation. Data from the PREFER-IN-AF registry. Thromb Haemost 2014; 111: 833-841
• 18 Mant J, Hobbs FD, Fletcher K et al. Warfarin versus aspirin for stroke prevention in an elderly community population with atrial fibrillation (the Birmingham Atrial Fibrillation Treatment of the Aged Study, BAFTA): a randomised controlled trial. Lancet 2007; 370: 493-503
• 19 Meinertz T, Kirch W, Rosin L et al. Management of atrial fibrillation by primary care physicians in Germany: baseline results of the ATRIUM registry. Clin Res Cardiol 2011; 100: 897-905
• 20 Mozaffarian D, Benjamin EJ, Go AS et al. Heart Disease and Stroke Statistics-2015 Update: A Report From the American Heart Association. Circulation 2015; 131: e29-e322
• 21 Nabauer M, Gerth A, Limbourg T et al. The Registry of the German Competence NETwork on Atrial Fibrillation: patient characteristics and initial management. Europace 2009; 11: 423-434
• 22 Nieuwlaat R, Capucci A, Camm AJ et al. Atrial fibrillation management: a prospective survey in ESC Member Countries: The Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2005; 26: 2422-2434
• 23 Ntaios G, Papavasileiou V, Diener HC et al. Nonvitamin-K-antagonist oral anticoagulants in patients with atrial fibrillation and previous stroke or transient ischemic attack: a systematic review and meta-analysis of randomized controlled trials. Stroke 2012; 43: 3298-3304
• 24 Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation. N Engl J Med 2011; 365: 883-891
• 25 Rosendaal FR, Cannegieter SC, van der Meer FJ, Briet E. A method to determine the optimal intensity of oral anticoagulant therapy. Thromb Haemost 1993; 69: 236-239
• 26 Savelieva I, Camm AJ. ‘Preferred’ management of atrial fibrillation in Europe. Europace 2014; 16: 1-3
• 27 Sellers MB, Newby LK. Atrial fibrillation, anticoagulation, fall risk, and outcomes in elderly patients. Am Heart J 2011; 161: 241-246
• 28 Shireman TI, Mahnken JD, Howard PA et al. Development of a contemporary bleeding risk model for elderly warfarin recipients. Chest 2006; 130: 1390-1396
• 29 Silber S, Jarre F, Pittrow D et al. Kardiovaskuläre Risikoabschätzung in der Hausarztpraxis (DETECT). Med Klin (Munich) 2008; 103: 638-645
• 30 Torn M, Bollen WL, van der Meer FJ et al. Risks of oral anticoagulant therapy with increasing age. Arch Intern Med 2005; 165: 1527-1532
• 31 Wallentin L, Yusuf S, Ezekowitz MD et al. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet 2010; 376: 975-983