Supplementary Table 4.Summarised inclusion and exclusion criteria and corresponding ICD-10-AM and ATC codes used to determine sample population eligibility for the ROCKET-AF trial4
ROCKET-AF (rivaroxaban)4ROCKET-AF inclusion criteria applied / International Statistical Classification of Diseases and Related Health Problems, 10th revision, Australian Modification (ICD-10-AM) a / Anatomical Therapeutic Chemical (ATC) code a
Arial fibrillation / I48
History of prior ischemic stroke, TIA or non-CNS systemic embolism believed to be cardioembolic in origin / G45, I63, I64, I74
OR has ≥ 2 of the following risk factors:
Heart failure and/or left ventricular ejection fraction ≤35% / I11.0, I13.0, I13.2, I42.0, I50.0, I50.1, I50.9, U82.2b / C03C
Hypertension / I10
U82.3a / Hypertension: patients prescribed at least two of the following medications
1. Non-loop diuretics: C02DA, C02L, C03A, C03B, C03D, C03E, C03X, C07C, C07D, C08G, C09BA, C09DA
2. Beta blockers: C07
3. Calcium channel blockers: C07F, C08, C09BB, C09DB
4. Renin-angiotensin system inhibitors: C09
5. Alpha adrenergic blockers: C02A, C02B, C02C
Age ≥75 years / Age recorded during admission
Diabetes mellitus / E10, E11, E12, E13, E14 / A10
ROCKET-AF exclusion criteria applied / International Statistical Classification of Diseases and Related Health Problems, 10th revision, Australian Modification (ICD-10-AM) a / Anatomical Therapeutic Chemical (ATC) code a
Cardiac-Related Conditions:
1. Haemodynamically significant mitral valve stenosis / I05.0, I05.2
2. Prosthetic heart valve / Z95.2, Z95.4
3. Transient atrial fibrillation caused by a reversible disorder / E05, E06, I30
4. Known presence of atrialmyxoma or left ventricular thrombus / D15.1, I51.3
5. Active endocarditis / I34
Haemorrhage Risk-Related Criteria
History of or condition associated with increased bleeding risk including, but not limited to:
a. Clinically significant gastrointestinal bleeding within 6 months before the randomization visit / K25.0, K25.4, K26.0, K26.4, K27.0, K27.4, K29.0, K92.2
b. History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding / I60, I61, I62, H35.6, H43.1, K66.1, K36.81, M25.0, S06.3, S06.4, S06.5, S06.6
c. Chronic haemorrhagic disorder / D65, D66, D67, D68, D69
d. Known intracranial neoplasm, arteriovenous malformation, or aneurysm / I67.1, Q28.2, C71
Concomitant Conditions and Therapies
Severe, disabling stroke within 3 months or any stroke within 14 days before randomization / I63, I64 (coded as a primary diagnosis)
Transient ischemic attack within 3 days before randomization / G45 (coded as a primary diagnosis)
Indication for anticoagulant therapy for a condition other than atrial fibrillation (e.g., VTE) / Z95.2, Z95.4
Treatment with:
– Aspirin in combination with thienopyridines within 5 days before randomization / Aspirin + clopidogrel: B01AC30
OR
Aspirin (B01AC06, N02BA01) plus one of the following:
Clopidogrel: B01AC04
Prasugrel: B01AC22
Ticagrelor: B01AC24
(Ticlopidine not available in Australia)
Anticipated need for chronic treatment with a non-steroidal anti-inflammatory drug / M01A
Systemic treatment with a strong inhibitor of cytochrome P450 3A4 / Strong inhibitors of CYP450 3A45:
J02AB02, J02AC02, J02AC04, J02AC03, J01FA09, V03AX03, J05AE
Treatment with a strong inducer of cytochrome P450 3A4 / Strong inducers of CYP450 3A45:
J04AB02, J04AB04, N03AF01, N03AB02, L02BB04
Any other contraindication to warfarin / D68.3
Known HIV infection at time of screening / B20, B21, B22, B23, B24, B25
Calculated CLCR <30 mL/min / N18.4, N18.5
Known significant liver disease / B15, B16, B17, B18, B19, K70.4, K72, K76.6, I85
Study Participation and Follow-up-Related Criteria
Drug addiction or alcohol abuse within 3 years before randomisation visit / G31.2, G62.1, G72.1, I42.6, K29.2, K70, K86.0, T51, Z71.4, Z72.1, F00-F05, F10-F19 / N06D
ROCKET-AF exclusion criteria not applied: planned cardioversion (electrical or pharmacological), active internal bleeding, major surgical procedure or trauma within 30 days before the randomization visit, planned invasive procedure with potential for uncontrolled bleeding (including major surgery), platelet count <90,000/μL, sustained uncontrolled hypertension: systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg, aspirin use >100mg daily, use of IV antiplatelets within 5 days or fibrinolytics within 10 days, anaemia (haemoglobin <10 g/dL), pregnancy or breast-feeding, females of child bearing potential not abstinent or using contraception, serious concomitant illness associated with a life expectancy of less than 2 years, received an experimental drug within 30 days, known hypersensitivity or allergy to any component of rivaroxaban
aCodes relating to ROCKET-AF criteria were established by consulting the hospital Health Information unit and adapted from Lip et al (2015)1.
1. Lip GY, Skjoth F, Rasmussen LH, Larsen TB. Oral anticoagulation, aspirin, or no therapy in patients with nonvalvular AF with 0 or 1 stroke risk factor based on the CHA2DS2-VASc score. J Am CollCardiol 2015;65:1385-94.
aChroniccomorbidity code (Australia only, commenced July 2015); TIA = transient ischaemic attack
References
1.Lip GY, Skjoth F, Rasmussen LH, Larsen TB. Oral anticoagulation, aspirin, or no therapy in patients with nonvalvular AF with 0 or 1 stroke risk factor based on the CHA2DS2-VASc score. J Am Coll Cardiol 2015;65:1385-94.
4.Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Eng J Med 2011;365:883-91.
5.Australian Medicines Handbook. Adelaide: Australian Medicines Handbook Pty Ltd; 2016.