Schlaganfallprävention im Praxisalltag mit Rivaroxaban

Hintergrund und Methoden: Patienten mit nicht valvulärem Vorhofflimmern (nv VHF) haben ein erhöhtes Risiko für die Entstehung linksatrialer Thromben und damit für das Auftreten von thromboembolischen Schlaganfällen. XANTUS ist eine internationale, prospektive, nicht interventionelle Phase-IV-Studie mit einjährigem Beobachtungszeitraum, die das Sicherheitsprofil und die Effektivität von Rivaroxaban zur Schlaganfallprävention im Praxisalltag untersucht.

Ergebnisse: Von den 6784 Patienten der XANTUS-Studie wurden in Deutschland (XANTUS-DE) 1445 mit Rivaroxaban behandelt, die im Mittel 72 (24–95) Jahre alt waren und deren mittlerer CHADS₂ bzw. CHA₂DS₂-VASc-Score bei 2,0 bzw. 3,5 lag. Schwere Blutungen, darunter eine tödliche Blutung, traten bei 18 Patienten auf (jährliche Inzidenzrate von 1,4 %). Insgesamt verstarben 23 Patienten (1,8 % pro Jahr). Bei 21 Patienten (1,7 % pro Jahr) traten symptomatische Thromboembolien auf (Schlaganfall, systemische Embolie, transitorische ischämische Attacke oder Myokardinfarkt).

Schlussfolgerung: Die in der deutschen Subanalyse XANTUS-DE ermittelten Raten von Schlaganfällen und schweren Blutungen sind vergleichbar mit den niedrigen Raten der internationalen Gesamtkohorte XANTUS. Dies bestätigt das positive Nutzen-Risiko-Profil von Rivaroxaban in der Schlaganfallprophylaxe bei Patienten mit nv VHF unter Alltags bedingungen in Deutschland.

Background: Patients with non-valvular atrial fibrillation have an increased risk for left atrial thrombi and, consequently, to suffer a thromboembolic stroke.

Objectives: Evaluation of safety and effectiveness of rivaroxaban in stroke prevention in routine clinical practice in Germany.

Material and methods: XANTUS is an international, prospective, non-interventional Phase IV study with a 1-year observation period, enrolling patients having non-valvular atrial fibrillation who were prescribed rivaroxaban for stroke prevention. All adverse events were documented. Major bleeding, death, and symptomatic thromboembolic events were centrally adjudicated. Data of the German XANTUS subgroup (XANTUS-DE) were analyzed.

Results: In Germany 1445 of the total of 6784 XANTUS patients were treated with rivaroxaban. The German XANTUS-DE patients had an average age of 72 (24–95) years with mean CHADS2 and CHA2DS2-VASc-scores of 2.0 and 3.5, respectively. Major bleeding, including one fatal bleeding, was recorded for 18 patients, resulting in an incidence rate of 1.4% per year. All-cause death occurred in 23 patients (1.8% per year). Symptomatic thromboembolic events (stroke, non-central nervous system systemic embolism, transient ischemic attack or myocardial infarction) were recorded for 21 patients (1.7% per year).

Conclusions: Rates of stroke and major bleeding in the German XANTUS-DE subgroup analysis were comparable to the low rates observed in the whole international XANTUS cohort. The positive benefit-risk profile of rivaroxaban in stroke prevention in patients with non-valvular atrial fibrillation was confirmed in daily routine in Germany.

Key words

Atrial fibrillation - NOAC - real world - stroke prophylaxis - thromboembolism

• Literatur

• 1 Camm AJ, Lip Y, De Caterina R et al ESC Committee for Practice guidelines-CPG. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation - developed with the special contribution of the European Heart Rhythm Association. Europace 2012; 14: 1385-1413
• 2 Patel MR, Mahaffey KW, Garg J et al ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: 883-891
• 3 Camm AJ, Amarenco P, Haas S et al XANTUS Investigators. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J 2016; 37: 1145-1153
• 4 Camm AJ, Amarenco P, Haas S et al XANTUS: rationale and design of a noninterventional study of rivaroxaban for the prevention of stroke in patients with atrial fibrillation. Vasc Health Risk Manag 2014; 10: 425-434
• 5 Fuster V, Rydén LE, Cannom DS et al ACC/AHA/ESC guidelines for the management of patients with atrial fibrillation-executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients with Atrial Fibrillation). Eur Heart J 2006; 27: 1979-2030
• 6 Gorin L, Fauchier L, Nonin E et al Antithrombotic treatment and the risk of death and stroke in patients with atrial fibrillation and a CHADS2 score=1. Thromb Haemost 2010; 103: 833-840
• 7 Lamassa M, Di Carlo A, Pracucci G et al Characteristics, outcome, and care of stroke associated with atrial fibrillation in Europe: data from a multicenter multinational hospital-based registry (The European Community Stroke Project). Stroke 2001; 32: 392-398
• 8 Sanna T, iener HC, Passman RS et al CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med 2014; 370: 2478-2486
• 9 Völler H, Alban S, Westermann D. Neue orale Antikoagulanzien - Werden sie die Vitamin-K-Antagonisten verdrängen?. Internist 2010; 51: 1571-1581
• 10 Ziff OJ, Camm AJ. Individualized approaches to thromboprophylaxis in atrial fibrillation. Am Heart J 2016; 173: 143-158
• 11 Haas S. im Namen des Garfield-AF Steering Committee. GARFIELD-AF Wie sieht die Versorgungssituation der Patienten mit Vorhofflimmern in Deutschland aus?. Dtsch Med Wochenschr 2015; 140 (Suppl. 01) S13-S14
• 12 Tamayo S, Frank PeacockW, Patel M et al Characterizing major bleeding in patients with nonvalvular atrial fibrillation: a pharmacovigilance study of 27467 patients taking Rivaroxaban. Clin Cardiol 2015; 38: 63-68
• 13 Beyer-Westendorf J, Förster K, Pannach S et al Rates, management, and outcome of Rivaroxaban bleeding in daily care: results from the Dresden NOAC registry. Blood 2014; 124: 955-962
• 14 Laliberté F, Cloutier M, Nelson WW et al Real-world comparative effectiveness and safety of rivaroxaban and warfarin in nonvalvular atrial fibrillation patients. Curr Med Res Opin 2014; 30: 1317-1325