Table 4

RWE study overview for use of NOACs in routine clinical practice (excluding registries and claims databases)

Study	Design	Objective	Key findings
XANTUS26	Prospective, observational, international study of patients treated with rivaroxaban for stroke prevention in patients with AF.	To investigate the safety and effectiveness of rivaroxaban in routine clinical use in the AF setting.	At the 1-year follow-up (n=6784), event rates of stroke and major bleeding in patients treated with rivaroxaban were low (event rates per 100 patient-years were 2.1 for treatment-emergent major bleeding, 1.9 for death and 0.7 for stroke).
XALIA27	Prospective, non-interventional, international study of patients with DVT.	To assess the effectiveness and safety of rivaroxaban compared with standard anticoagulation therapy.	In the propensity score-adjusted population (n=4515), results confirmed that rivaroxaban was a well-tolerated and effective alternative to standard anticoagulation therapy. Rates of major bleeding and recurrent VTE were low in the rivaroxaban group compared with standard anticoagulation therapy (0.8% vs 2.1% (P=0.44) and 1.4% vs 2.3% (P=0.72), respectively).
NOAC-TURK study30	Multicentre cross-sectional study in Turkey.	To evaluate the current patterns in NOAC treatment in Turkey, to include demographics and clinical outcomes.	A total of 2862 patients were included and the most frequent indication for NOACs was AF (83.3%). Bleeding events occurred in 7.6% of patients (1.1% major bleeding) and embolic events were observed in 1.3%. Rivaroxaban and dabigatran were preferred compared with apixaban, and 47.6% were receiving suboptimal doses of NOACs.
Tamayo et al 34	Nested case–control post-marketing safety surveillance study.	To assess major bleeding risk factors using data from an ongoing safety study of patients with AF treated with rivaroxaban.	The study included 542 cases and 2710 controls and the risk factors for major bleeding identified were generally consistent with those published previously. The strongest risk factors identified were increased age, anaemia, prior GI bleeding, heart failure and vascular disease (P<0.0001, all factors).
European Heart Rhythm Association survey65	Multinational self-assessment survey in patients with AF.	To assess patients’ attitudes, level of education and knowledge concerning OACs.	A total of 1147 responses were gathered from across Europe. OAC treatment was used by 77% of patients, with around one-third of these patients receiving NOACs. Compliance was identified as an issue in patients with AF, with 14.5% of patients temporarily discontinuing treatment and 26.5% missing at least one dose (self-reported). Further patient education is required to improve treatment adherence and knowledge of treatment monitoring.
Sauter et al 66	Paper-based pilot survey of Swiss practitioners on their knowledge of NOACs.	To assess the knowledge of Swiss general internal medicine physicians around follow-up, guidelines, dosing adjustments, complications and indications.	Of the 53 physicians who completed the survey, NOACs were seen to be well-accepted as the first-choice treatment in newly diagnosed patients. Two-thirds of the respondents adhered to clinical follow-up guidance and bleeding complication rates were low (1.9 events±2.87 in the previous 2 years), with the majority managed without admission to hospital.

AF, atrial fibrillation; DVT, deep vein thrombosis; GI, gastrointestinal; NOAC, non-vitamin K antagonist oral anticoagulant; OAC, oral anticoagulant; RWE, real-world evidence; VTE, venous thromboembolism; XALIA, XArelto for Long-term and Initial Anticoagulation in venous thromboembolism; XANTUS, Xarelto for Prevention of Stroke in Patients with Atrial Fibrillation.