Table 2.
Proportion of GPRD AF patients eligible for trial participation according to each inclusion/exclusion criteria identified for RE-LY, ARISTOTLE and ROCKET-AF
| 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.