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New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2012.

7.10Subgroup Data Reporting

George Wells, PhD, Doug Coyle, PhD, Chris Cameron, MSc PhD (candidate), Sabine Steiner, MD MSc, Kathryn Coyle, BScPharm MSc, Shannon Kelly, MSc (candidate), Anthony Tang, MD FRCPC, Jeff Healey, MD FRCPC, Shu-Ching Hsieh, PhD, and Judith van Berkom, BA.

Author Information

George Wells, PhD,1 Doug Coyle, PhD,2 Chris Cameron, MSc PhD (candidate),1 Sabine Steiner, MD MSc,3 Kathryn Coyle, BScPharm MSc,4 Shannon Kelly, MSc (candidate),1 Anthony Tang, MD FRCPC,5 Jeff Healey, MD FRCPC,6 Shu-Ching Hsieh, PhD,1 and Judith van Berkom, BA7.

1 University of Ottawa Heart Institute, Ottawa, Ontario
2 University of Ottawa, Ottawa, Ontario
3 Medical University of Vienna, Vienna, Austria
4 Coyle Consultancy, Ottawa, Ontario
5 University of British Columbia, Victoria, British Columbia
6 McMaster University, Hamilton, Ontario
7 Independent contractor: Information Specialist, Ottawa, Ontario

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 VKAA,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. Total mortality
  7. cardiovascular mortality
  8. Major GI Bleeding
  9. Total bleeding
  10. Hemorrhagic stroke

Authorship

George Wells wrote the protocol for this review and acted as the primary lead in the conception, design and implementation of the project, as well as all aspects of the development and writing of the report and responses to internal and external reviewers.

Doug Coyle planned and led the economic section, selected articles, and extracted data for the economic review; performed the primary economic analyses; wrote the economic sections; and contributed to revisions and responses to internal and external reviewers.

Chris Cameron extracted and checked data; performed Bayesian mixed treatment comparisons metaanalyses; wrote sections and prepared tables and figures for the clinical review; and contributed to revisions and responses to internal and external reviewers.

Sabine Steiner extracted and checked data; performed frequentist mixed treatment comparisons metaanalyses, wrote sections of the clinical review, and contributed to revisions and responses to internal and external reviewers.

Kathryn Coyle assisted with the development of the methods for the economic analysis; selected economic studies; extracted, tabulated, and analyzed data; and contributed to writing the economic sections of the report.

Shannon Kelly contributed to writing the protocol; led and participated in article selection, study quality assessment, data extraction and tabulation, subgroup appraisal and preparation of tables for the clinical review; wrote and edited sections of the clinical review; contributed to revisions and responses to internal and external reviewers; and edited the final draft.

Anthony Tang provided clinical guidance and feedback for this review; co-wrote the Introduction and Background section in the protocol and this review; assisted with the writing of the Discussion section; and contributed to revisions and responses to external reviewers.

Jeff Healey provided clinical guidance and feedback for this review; co-wrote the Introduction and Background section in the protocol and this review; assisted with the writing of the Discussion section; and contributed to revisions and responses to external reviewers.

Shu-Ching Hseih participated in article selection, study quality assessment, data extraction and checking, subgroup appraisal and preparation of tables for the clinical review; assisted with referencing of studies in the final draft; and contributed to revisions.

Judith van Berkom developed the literature search strategies and performed all searches, managed report referencing, and composed the search methodology sections.

Copyright © 2012 CADTH.

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/

Cover of New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation
New Oral Anticoagulants for the Prevention of Thromboembolic Events in Patients with Atrial Fibrillation [Internet].

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