Criterion | RE-LY N (%) real-world AF patients meeting criterion | ARISTOTLE N (%) real-world patients meeting criterion | ROCKET-AF N (%) real-world patients meeting criterion | |
---|---|---|---|---|
Inclusion | ||||
AF | 83 898 (100) | 83 898 (100) | 83898 (100) | |
Risk factors | Age ≥75 years | 51 034 (61) | 51 267 (61) | 51034 (61) |
Stroke, TIA, systemic embolism | 11 632 (14) | 10 577 (13) | 11632 (14) | |
Congestive heart failure | 1737 (2) | 16 184 (19) | 16009 (19) | |
Ejection fraction | ||||
Age ≥65 years | 70 047 (83) | – | – | |
Diabetes mellitus | 3945 (5) | 14 940 (18) | 14850 (18) | |
Hypertension | 49 747 (59) | 49 747 (59) | 67833 (81) | |
Coronary artery disease | 28 687 (34) | – | – | |
Overall inclusion criteria | 64 710 (77)* | 67956 (81)† | 52540 (63)‡ | |
Exclusion | ||||
Reversible causes of AF | 1124 (1) | 2938 (4) | 350 (<1) | |
Mitral valve stenosis | – | 1213 (1) | 1213 (1) | |
Heart valve disorders and conditions other than AF that require chronic anticoagulant treatment | Conditions other than AF requiring chronic anticoagulant treatment | 5202 (6) | 5202 (6) | 5202 (6) |
Heart valve disorder | 4792 (6) | – | – | |
Stroke or TIA | Recent stroke | 429 (1) | 62 (<1) | 429 (1) |
Recent TIA | – | – | 71 (<1) | |
Increased risk of bleeding | 1044 (1) | 1044 (1) | 1044 (1) | |
Intracranial neoplasm, arteriovenous malformation, or aneurysm | – | – | 2350 (3) | |
Uncontrolled hypertension | 2014 (2) | 2014 (2) | 2014 (2) | |
Planned cardioversion | – | – | 843 (1) | |
Renal impairment | 2149 (3) | 2149 (3) | 2149 (3) | |
Other concomitant treatments | ASA at specified dose | – | 1629 (2) | 1767 (2) |
ASA + thienopyridine | – | 203 (<1) | 203 (<1) | |
Intravenous antiplatelets | – | – | 0 (0) | |
Fibrinolytics | 0 (0) | – | 0 (0) | |
NSAID | – | – | 2729 (3) | |
P450 3A4 inhibitor | – | – | 4 (<1) | |
P450 3A4 inducer | – | – | 1125 (1) | |
Investigational drug | 0 (0) | 0 (0) | 0 (0) | |
Other concomitant conditions | Liver disease | 1547 (2) | – | 1547 (2) |
Hepatitis A, B or C | 698 (<1) | – | ||
HIV | – | – | 14 (<1) | |
Active infective endocarditis | 8 (<1) | 8 (<1) | 8 (<1) | |
Anemia | 794 (1) | 794 (1) | 794 (1) | |
Substance abuse and psychosocial | 28 (<1) | 28 (<1) | – | |
INR monitoring | – | 3513 (4) | – | |
Overall inclusion and exclusion criteria | 53 640 (64%) | 51 415 (61%) | 39892 (48%) |
*Inclusion criteria for RE-LY specify AF plus at least one of age ≥75 years; history of previous stroke, TIA or systemic embolism; ejection fraction <40%; or symptomatic heart failure OR AF plus age ≥65 years plus one of diabetes mellitus; documented coronary artery disease or hypertension requiring medical treatment.7
†Inclusion criteria for ARISTOTLE specify AF plus at least one of age ≥75 years; prior stroke; symptomatic congestive heart failure or ejection fraction ≤40%; diabetes; or hypertension requiring pharmacological treatment.23
‡Inclusion criteria for ROCKET-AF specify AF plus history of stroke, TIA, or systemic embolism OR AF plus at least two of age ≥75 years; congestive heart failure or ejection fraction ≤35%; or diabetes or hypertension.22
Note that the planned cardioversion exclusion criterion within the ROCKET-AF trial was conceptualised within the study by excluding patients having cardioversion within 12 months of the index date.
AF, Atrial Fibrillation; ASA, acetylsalicylic acid; GPRD, General Practice Research Database; INR, International Normalised Ratio; NSAID, Non-steroidal anti-inflammatory drug; TIA, transient ischaemic attack.