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Meta-Analysis
. 2017 Nov 6;11(11):CD011373.
doi: 10.1002/14651858.CD011373.pub2.

Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease

Miho Kimachi  1 , Toshi A Furukawa, Kimihiko Kimachi, Yoshihito Goto, Shingo Fukuma, Shunichi Fukuhara
Affiliations
Meta-Analysis

Direct oral anticoagulants versus warfarin for preventing stroke and systemic embolic events among atrial fibrillation patients with chronic kidney disease

Miho Kimachi et al. Cochrane Database Syst Rev. .

Abstract

Background: Chronic kidney disease (CKD) is an independent risk factor for atrial fibrillation (AF), which is more prevalent among CKD patients than the general population. AF causes stroke or systemic embolism, leading to increased mortality. The conventional antithrombotic prophylaxis agent warfarin is often prescribed for the prevention of stroke, but risk of bleeding necessitates regular therapeutic monitoring. Recently developed direct oral anticoagulants (DOAC) are expected to be useful as alternatives to warfarin.

Objectives: To assess the efficacy and safety of DOAC including apixaban, dabigatran, edoxaban, and rivaroxaban versus warfarin among AF patients with CKD.

Search methods: We searched the Cochrane Kidney and Transplant Specialised Register (up to 1 August 2017) through contact with the Information Specialist using search terms relevant to this review. Studies in the Specialised Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal, and ClinicalTrials.gov.

Selection criteria: We included all randomised controlled trials (RCTs) which directly compared the efficacy and safety of direct oral anticoagulants (direct thrombin inhibitors or factor Xa inhibitors) with dose-adjusted warfarin for preventing stroke and systemic embolic events in non-valvular AF patients with CKD, defined as creatinine clearance (CrCl) or eGFR between 15 and 60 mL/min (CKD stage G3 and G4).

Data collection and analysis: Two review authors independently selected studies, assessed quality, and extracted data. We calculated the risk ratio (RR) and 95% confidence intervals (95% CI) for the association between anticoagulant therapy and all strokes and systemic embolic events as the primary efficacy outcome and major bleeding events as the primary safety outcome. Confidence in the evidence was assessing using GRADE.

Main results: Our review included 12,545 AF participants with CKD from five studies. All participants were randomised to either DOAC (apixaban, dabigatran, edoxaban, and rivaroxaban) or dose-adjusted warfarin. Four studies used a central, interactive, automated response system for allocation concealment while the other did not specify concealment methods. Four studies were blinded while the other was partially open-label. However, given that all studies involved blinded evaluation of outcome events, we considered the risk of bias to be low. We were unable to create funnel plots due to the small number of studies, thwarting assessment of publication bias. Study duration ranged from 1.8 to 2.8 years. The large majority of participants included in this study were CKD stage G3 (12,155), and a small number were stage G4 (390). Of 12,545 participants from five studies, a total of 321 cases (2.56%) of the primary efficacy outcome occurred per year. Further, of 12,521 participants from five studies, a total of 617 cases (4.93%) of the primary safety outcome occurred per year. DOAC appeared to probably reduce the incidence of stroke and systemic embolism events (5 studies, 12,545 participants: RR 0.81, 95% CI 0.65 to 1.00; moderate certainty evidence) and to slightly reduce the incidence of major bleeding events (5 studies, 12,521 participants: RR 0.79, 95% CI 0.59 to 1.04; low certainty evidence) in comparison with warfarin.

Authors' conclusions: Our findings indicate that DOAC are as likely as warfarin to prevent all strokes and systemic embolic events without increasing risk of major bleeding events among AF patients with kidney impairment. These findings should encourage physicians to prescribe DOAC in AF patients with CKD without fear of bleeding. The major limitation is that the results of this study chiefly reflect CKD stage G3. Application of the results to CKD stage G4 patients requires additional investigation. Furthermore, we could not assess CKD stage G5 patients. Future reviews should assess participants at more advanced CKD stages. Additionally, we could not conduct detailed analyses of subgroups and sensitivity analyses due to lack of data.

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Conflict of interest statement

  1. Miho Kimachi: none known

  2. Toshiaki Furukawa has received lecture fees from Eli Lilly, Janssen, Meiji, Mitsubishi‐Tanabe, MSD and Pfizer. He has received royalties from Igaku‐Shoin and Nihon Bunka Kagaku‐sha publishers. He has received research support from Mitsubishi‐Tanabe and Mochida. These funds are not related to the production of this review.

  3. Kimihiko Kimachi: none known

  4. Yoshihito Goto: none known

  5. Shingo Fukuma: none known

  6. Shunichi Fukuhara: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 1 All strokes and systemic embolic events.
1.2
1.2. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 2 Ischaemic stroke.
1.3
1.3. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 3 Haemorrhagic stroke.
1.4
1.4. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 4 Major bleeding.
1.5
1.5. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 5 Myocardial infarction.
1.6
1.6. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 6 Minor bleeding.
1.7
1.7. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 7 Gastrointestinal bleeding.
1.8
1.8. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 8 Intracranial haemorrhage.
1.9
1.9. Analysis
Comparison 1 Direct oral anticoagulants versus warfarin, Outcome 9 All‐cause mortality.
2.1
2.1. Analysis
Comparison 2 Direct oral anticoagulants versus warfarin: subgroup analysis for participants with CrCl 30 to 50 mL/min, Outcome 1 All strokes and systemic embolic events.
2.2
2.2. Analysis
Comparison 2 Direct oral anticoagulants versus warfarin: subgroup analysis for participants with CrCl 30 to 50 mL/min, Outcome 2 Major bleeding.
3.1
3.1. Analysis
Comparison 3 Direct oral anticoagulants versus warfarin: subgroup analysis for participants with CrCl 15 to 30 mL/min, Outcome 1 All strokes and systemic embolic events.
3.2
3.2. Analysis
Comparison 3 Direct oral anticoagulants versus warfarin: subgroup analysis for participants with CrCl 15 to 30 mL/min, Outcome 2 Major bleeding.
4.1
4.1. Analysis
Comparison 4 Direct oral anticoagulants versus warfarin: subgroup analysis for different doses of DOAC, Outcome 1 All strokes and systemic embolic events.
4.2
4.2. Analysis
Comparison 4 Direct oral anticoagulants versus warfarin: subgroup analysis for different doses of DOAC, Outcome 2 Major bleeding.
4.3
4.3. Analysis
Comparison 4 Direct oral anticoagulants versus warfarin: subgroup analysis for different doses of DOAC, Outcome 3 All‐cause mortality.
5.1
5.1. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 1 Epistaxis.
5.2
5.2. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 2 Nasopharyngitis.
5.3
5.3. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 3 Diarrhoea.
5.4
5.4. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 4 Upper respiratory tract inflammation.
5.5
5.5. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 5 Back pain.
5.6
5.6. Analysis
Comparison 5 Direct oral anticoagulants versus warfarin: adverse events, Outcome 6 Cardiac failure.
6.1
6.1. Analysis
Comparison 6 Direct oral anticoagulants versus warfarin: fixed‐effect model, Outcome 1 All strokes and systemic embolic events.
6.2
6.2. Analysis
Comparison 6 Direct oral anticoagulants versus warfarin: fixed‐effect model, Outcome 2 Major bleeding.
See this image and copyright information in PMC

Comment in

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MeSH terms