Emulation of ARISTOTLE and ROCKET AF trials in real-world atrial fibrillation patients results in similar efficacy and safety as original landmark trials: insights from the GARFIELD-AF registry

Figure 1. Flow chart for the selection of study population. AF, atrial fibrillation; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events; GARFIELD, Global Anticoagulant Registry in the FIELD; ROCKET, Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial; VKA, vitamin K antagonist.

Figure 2. Comparison of key clinical characteristics of trial-eligible patients in GARFIELD-AF and participants in the original trials. Since no relevant differences in characteristics were seen between study arms in either ARISTOTLE or ROCKET AF trial, data from treatment groups in the original trials are presented as the mean. Definitions of some characteristics differed slightly between the trials as explained in the footnotes. CHADS2 scores were applied as in the respective original ARISTOTLE and ROCKET AF trials. 1Granger et al., 2011. 2Patel et al., 2011. 3Defined in ARISTOTLE as a history of heart failure or left ventricular ejection fraction ≤40% and in ROCKET AF as a history of heart failure or left ventricular ejection fraction ≤35%. 4Defined in ARISTOTLE as hypertension requiring pharmacological treatment and in ROCKET AF as a history of hypertension or hypertension treatment. 5Defined in ARISTOTLE as a history of diabetes mellitus, and in ROCKET AF as a history of diabetes mellitus or use of antidiabetic medication. 6Using the CHADS2 element definitions as applied in the respective original ARISTOTLE and ROCKET AF trials. AF, atrial fibrillation; ARISTOTLE, Apixaban for…

Figure 3. Adjusted HRs comparing NOAC versus VKA. Shown are selected outcomes at 2 years of follow-up in apixaban users eligible for ARISTOTLE (top) and rivaroxaban users eligible for ROCKET AF (bottom), using the VKA users in each group as reference. HRs were obtained using an overlap-weighted Cox model. Variables included in the weighting scheme were country and cohort enrolment, sex, age, ethnicity, type of AF, care setting specialty and location, congestive heart failure, acute coronary syndromes, vascular disease, carotid occlusive disease, prior stroke/transient ischaemic attack/SE, prior bleeding, VTE, hypertension, hypercholesterolaemia, diabetes, moderate to severe chronic kidney disease, hyperthyroidism, hypothyroidism, current smoking, heavy alcohol consumption, body mass index, heart rate, systolic and diastolic blood pressure at diagnosis, and baseline antiplatelet use. AF, atrial fibrillation; ARISTOTLE, Apixaban for Reduction in Stroke and Other Thromboembolic Events; GARFIELD, Global Anticoagulant Registry in the FIELD; NOAC, non-vitamin K antagonist; ROCKET, Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke…