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Wells G, Coyle D, Cameron C, et al. Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2012 Apr 9.

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Safety, Effectiveness, and Cost-Effectiveness of New Oral Anticoagulants Compared with Warfarin in Preventing Stroke and Other Cardiovascular Events in Patients with Atrial Fibrillation [Internet].

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7.10Subgroup Data Reporting

Table 46Subgroup Data Reporting — Comparison By Trial

RE-LYARISTOTLEROCKET-AFPETROARISTOTLE-J
Major
SubGroup		Minor
Subgroup
(if applicable)		OutcomeCategoriesOutcomesCategoriesOutcomeCategoriesOutcomeCategoriesOutcomesCategories
WeightBMIABMI < 28
BMI ≥ 28		NRNRA,BBMI ≤2 5
BMI 25 ≤ 35
BMI > 35		NRNRNRNR
KgA< 50 kg
50 to 99 kg
> 100 kg		A,C≤ 60 kg
> 60 kg		A≤ 70 kg
70 ≤ 90 kg
> 90kg		NRNRNRNR
Age2 Categories ReportedA,C,D,E,F< 75
≥ 75		NRNRA< 75
> 75		NRNRK2.5 mg Apix
< 65
≥ 65
5 mg Apix
< 75
≥ 75
Warfarin
< 75
≥ 75
3 Categories ReportedC< 65
65 to 74
≥ 75		A,C< 65
65 to < 75
≥ 75		B< 65
65 to < 75
≥ 75		NRNRNRNR
Renal
Impairment		Creatinine
Clearance		A,C*-Moderate (cClear < 50)
-Mild (cClear 50 to 79)
-Mild (cClear 80+)		A,C†-Severe or moderate
-Mild
-None		A,B*-Moderate (cClear < 50)
-Mild (cClear 50 to 79)
-None (cClear 80+)		NRNRNRNR
CHADS2 ScoreA,C,D,G,H0 to 1
2
3 to 6		A,C1,2, ≥ 3A,BNo 0 or 1
(excluded)
2,3,4,5,6		NRNRNRNR
CHADS2VASC ScoreA, C0-2
3
4
5-9		NRNRNRNRNRNRNRNR
Prior use of VKA‡A,C, D,H, IYES
NO		A,CYES
NO		A,BYES
NO		NRNRNRNR
History of GI BleedNRNRNRNRNRNRNRNRNRNR
Concurrent use of NSAIDNRNRNRNRExcludedExcludedNRNRNRNR
Concurrent use of AntiplateletsNRNRNRNRNRNRNRNRNRNR
TTRA,C,D,G,J,K

< 57.1%
57.1% to 65.5%
65.5% to 72.6%
> 72.6%		A,B,C,LCenter TTR
< 58%
58.0% to 65.7%
65.7% to 72.2%
≥ 72.2		A,BQuartile Centre TTR

0 to 50.6%
50.7% to 58.5%
58.6% to 65.7%
65.7% to 100%		NRNRNRNR

Apix = apixaban; BMI = body mass index; GI = gastrointestinal; NR = not reported; NSAID = nonsteroidal antiinflammatory drug; TTR = time in therapeutic range.

*

Excluded below 30 ml/min.

†

Excluded calculated creatinine clearance of < 25 mL per minute.

‡

Definitions may vary across trials.

Outcome Legend:

  1. Stroke or systemic embolism
  2. Major and non-major clinically relevant bleeding while on treatment
  3. Major bleeding
  4. Intracranial bleeding
  5. Extracranial bleeding
  6. GI Bleeding
  7. Total mortality
  8. cardiovascular mortality
  9. Myocardial infarction
  10. Major GI Bleeding
  11. Total bleeding
  12. Hemorrhagic stroke

Copyright © 2012 Canadian Collaborative for Drug Safety, Effectiveness and Network Meta-Analysis.

Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/

Bookshelf ID: NBK169812
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