Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients?

BACKGROUND: The aim of the study was to compare clinical characteristics of real-life atrial fibrillation (AF) patients with populations included in randomized clinical trials (ROCKET AF and RE-LY). METHODS: The analysis included 3528 patients who are participants of the ongoing, multicentre, retrospective CRAFT study. The study is registered in ClinicalTrials.gov: NCT02987062. The study is based on a retrospective analysis of hospital records of AF patients treated with vitamin K antagonists (VKAs) (acenocoumarol, warfarin) and non-vitamin K oral anticoagulants (NOACs) (dabigatran, rivaroxaban). CHADS2 score was used for risk of stroke stratification. RESULTS: VKA was prescribed in 1973 (56.0%), while NOAC in 1549 (44.0%), including dabigatran - 504 (14.3%) and rivaroxaban - 1051 (29.8%), of the 3528 patients. VKA patients in the CRAFT study were at significantly lower risk of stroke (CHADS2 1.9 ± 1.3), compared with the VKA population from the RE-LY (2.1 ± 1.1) and the ROCKET-AF (3.5 ± 1.0). Patients in the CRAFT study treated with NOAC (CHADS2 for patients on dabigatran 150 mg - 1.3 ± 1.2 and on rivaroxaban - 2.2 ± 1.4) had lower risk than patients from the RE-LY (2.2 ± 1.2) and the ROCKET AF (3.5 ± 0.9). CONCLUSIONS: Real-world patients had a lower risk of stroke than patients included in the RE-LY and ROCKET AF trials.

Clinical characteristics and thromboembolic risk of atrial fibrillation patients with and without congestive heart failure. Results from the CRATF study.

Congestive heart failure (CHF) and atrial fibrillation (AF) frequently coexist and are associated with increased risk of cardiovascular events.To compare baseline characteristics, comorbidities and pharmacotherapy in AF patients with concomitant CHF to those without CHF.The study included 3506 real-life AF patients with (37.1%) and without CHF - participants of the multicentre, retrospective MultiCenter expeRience in AFib patients Treated with OAC (CRAFT) trial (NCT02987062).All patients were treated with non-vitamin K antagonist oral anticoagulants (NOAC) or vitamin K antagonists (VKA). The frequency of NOAC among patients with and without CHF was 45.6% and 43.2%, respectively (P = .17). Patients with CHF were older (73.3 vs 64.7 years, P <.001), less likely to be women (37.4% vs 42%, P = .007), had higher CHA2DS2-VASc score (3.8 ±â€Š1.7 vs 2.6 ±â€Š1.8, P <.001), more often had permanent AF (53.0% vs 13.4%, P <.001), chronic obstructive pulmonary disease (16.7% vs 4.9%, P <.001), coronary artery disease (64.3% vs 29.8%, P <.001), peripheral vascular disease (65.3% vs 31.4%, P <.001), chronic kidney disease (43.1% vs 10.0%, P <.001), liver fibrosis (5.7% vs 2.6%, P <.001), neoplasm (9.6% vs 7.3%, P = .05), history of composite of stroke, transient ischemic attack or systemic embolization (16.2% vs 10.7%, P <.001), pacemaker (27.4% vs 22.1%, P = .004), implantable cardioverter-defibrillator (22.7% vs 0.8%, P <.001) or transaortic valve implantation (4.0% vs 0.8%, P <.001), cardiac resynchronization therapy (8.7% vs 0.3%, P <.001), composite of kidney transplantation, hemodialysis or creatinine level > 2.26 mg/dL (3.6% vs 0.8%, P <.001) and had less often hypertension (69.4% vs 72.5%, P = .05).Patients with AF and CHF had a higher thromboembolic risk and had more concomitant diseases.

District versus academic hospitals: differences in the clinical characteristics of patients with atrial fibrillation without valvular heart disease treated with oral anticoagulants

INTRODUCTION Atrial fibrillation (AF) is the most common cardiac arrhythmia with a significant risk of morbidity and mortality. Non-vitamin K antagonist oral anticoagulants are the first­line drugs in stroke prevention in patients with AF. Oral anticoagulant (OAC) therapy may differ between medical centers. OBJECTIVES We compared the clinical characteristics of AF patients treated with OAC in a district and an academic hospital. PATIENTS AND METHODS We analyzed 3528 patients from the multicenter retrospective CRAFT study: 2666 patients from the academic hospital and 862 patients from the district hospital. Their baseline clinical characteristics were compared. RESULTS Patients treated in the district hospital were older (mean [SD] age, 73.9 [10.3] years vs 66.0 [13.4] years; P <0.001) and more likely female (49.1% vs 37.4%; P <0.001). Patients treated in the academic hospital more frequently had paroxysmal AF, while those in the district hospital, permanent AF. The latter group was also more likely to have comorbidities and a higher frequency of previous bleeding episodes or anemia. The groups did not differ regarding kidney function. In both groups, patients were significantly more likely to be on rivaroxaban than on dabigatran. The group treated in the district hospital were at higher risk of thromboembolic events than the other gruop (mean [SD] CHA2DS2VASc score, 4.6 [1.7] vs 3.05 [2.0]; P <0.001), as well as of hemorrhagic events (mean [SD] HASBLED score, 0.6 [0.7] vs 0.4 [0.6]; P <0.001). CONCLUSIONS Patients with AF treated with OACs in the district and academic hospitals have different clinical characteristics. Patients treated in the district hospital were older, had more comorbidities, more frequently had permanent AF, and were at higher risk of thromboembolic and bleeding events than patients treated in the academic hospital.

Comparison of clinical characteristics of real-life atrial fibrillation patients treated with vitamin K antagonists, dabigatran, and rivaroxaban: results from the CRAFT study.

BACKGROUND: The first-line drugs for the treatment of non-valvular atrial fibrillation (AF) are non-vitamin K antagonist oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). There is some evidence that there are dis-crepancies between everyday clinical practice and the guidelines. AIM: The study aimed to compare the characteristics of patients on VKAs, dabigatran, and rivaroxaban in everyday practice (i.e. baseline characteristics, drug doses, risk factors for bleeding and thromboembolic events). Additionally, we assessed the frequency of prescription of different oral anticoagulants (OACs) in recent years. METHODS: This study consisted of data from the multicentre CRAFT (MultiCentre expeRience in AFib patients Treated with OAC) study (NCT02987062). This was a retrospective analysis of hospital records of AF patients (hospitalised in the years 2011-2016) treated with VKAs (acenocoumarol, warfarin) and NOACs (dabigatran, rivaroxaban). A total of 3528 patients with non-valvular AF were enrolled in the CRAFT study. RESULTS: The total cohort consisted of 1973 patients on VKA, 504 patients on dabigatran, and 1051 patients on rivaroxaban. Patients on rivaroxaban were older (70.5 ± 13.1 years) and more often female (47.9%), compared with those on VKAs (67.0 ± 12.8 years, p < 0.001; 35.5%, p < 0.001) and on dabigatran (66.0 ± 13.9 years, p < 0.001; 38.9%, p = 0.001). Among NOACs, patients with persistent and permanent AF were more likely to receive rivaroxaban (54.7% and 73.4%, re-spectively) than dabigatran (45.3%, p < 0.001 and 26.6%, p = 0.002, respectively). Patients on rivaroxaban had higher risk of thromboembolic events (CHA2DS2VASc 3.9 ± 2.0, CHADS2 2.2 ± 1.4) than those on VKAs (3.3 ± 2.0, 1.9 ± 1.3) and on dabigatran (3.1 ± 2.0, 1.8 ± 1.3). Patients on rivaroxaban had also a higher rate of prior major bleeding (11.2%) than those on VKAs (6.7%, p < 0.001) and on dabigatran (7.3%, p = 0.02). Patients on lower doses of dabigatran and rivaroxaban had a significantly higher risk of thromboembolic and bleeding events. Use of VKAs in the year 2011 was reported in over 96% of patients on OACs, but this proportion decreased to 34.6% in 2016. In the last analysed year (2016) AF patients were treated mainly with NOACs - dabigatran (24.2%) and rivaroxaban (41.3%). CONCLUSIONS: The prescription of VKAs declined significantly after the introduction of NOACs. Patients treated with different OACs demonstrated a distinct baseline clinical profile. The highest risk of thromboembolic events and incidence of major bleedings was observed in patients on rivaroxaban, in comparison to patients on VKAs and dabigatran. Among NOACs, patients treated with lower doses of dabigatran and rivaroxaban were older and had a significantly higher risk of thromboembolic and bleeding events.