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

CriterionRE-LY
N (%) real-world AF patients meeting criterion
ARISTOTLE
N (%) real-world patients meeting criterion
ROCKET-AF
N (%) real-world patients meeting criterion
Inclusion
AF83 898 (100)83 898 (100)83898 (100)
Risk factorsAge ≥75 years51 034 (61)51 267 (61)51034 (61)
Stroke, TIA, systemic embolism11 632 (14)10 577 (13)11632 (14)
Congestive heart failure1737 (2)16 184 (19)16009 (19)
Ejection fraction
Age ≥65 years70 047 (83)
Diabetes mellitus3945 (5)14 940 (18)14850 (18)
Hypertension49 747 (59)49 747 (59)67833 (81)
Coronary artery disease28 687 (34)
Overall inclusion criteria64 710 (77)*67956 (81)†52540 (63)‡
Exclusion
Reversible causes of AF1124 (1)2938 (4)350 (<1)
Mitral valve stenosis1213 (1)1213 (1)
Heart valve disorders and conditions other than AF that require chronic anticoagulant treatmentConditions other than AF requiring chronic anticoagulant treatment5202 (6)5202 (6)5202 (6)
Heart valve disorder4792 (6)
Stroke or TIARecent stroke429 (1)62 (<1)429 (1)
Recent TIA71 (<1)
Increased risk of bleeding1044 (1)1044 (1)1044 (1)
Intracranial neoplasm, arteriovenous malformation, or aneurysm2350 (3)
Uncontrolled hypertension2014 (2)2014 (2)2014 (2)
Planned cardioversion843 (1)
Renal impairment2149 (3)2149 (3)2149 (3)
Other concomitant treatmentsASA at specified dose1629 (2)1767 (2)
ASA + thienopyridine203 (<1)203 (<1)
Intravenous antiplatelets0 (0)
Fibrinolytics0 (0)0 (0)
NSAID2729 (3)
P450 3A4 inhibitor4 (<1)
P450 3A4 inducer1125 (1)
Investigational drug0 (0)0 (0)0 (0)
Other concomitant conditionsLiver disease1547 (2)1547 (2)
Hepatitis A, B or C698 (<1)
HIV14 (<1)
Active infective endocarditis8 (<1)8 (<1)8 (<1)
Anemia794 (1)794 (1)794 (1)
Substance abuse and psychosocial28 (<1)28 (<1)
INR monitoring3513 (4)
Overall inclusion and exclusion criteria53 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.