Comparison of Bleeding in Patients With Nonvalvular Atrial Fibrillation Treated With Ximelagatran or Warfarin

Douketis, James D.; Arneklev, Karin; Goldhaber, Samuel Z.; Spandorfer, John; Halperin, Frank; Horrow, Jay

doi:10.1001/archinte.166.8.853

Cited by 80 publications

(20 citation statements)

References 38 publications

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“…Reasons for non-inclusion of study data from such studies have been reported in Appendix 7. A few studies did not report the number of events 50,56,62,68,70,72 or did not clearly report the number of participants in each therapy group, 57,58,61,64,65 whereas a few other publications reported duplicate data from included primary studies. [44][45][46][47]49,71 A few studies reported non-randomised data that did not add any new information to the data available from other studies, either because of a very small sample size 51 or because they did not specify the name of the APT in the combination anticoagulation plus antiplatelet arm.…”

Section: Methodological Issuesmentioning

confidence: 99%

Section: Methodological Issuesmentioning

confidence: 99%

“…[64][65][66][67][68][69][70][71] The original articles of SPORTIF III 64 and SPORTIF V 65 did not specify the number of events and number of participants in the interventions of interest (anticoagulant plus antiplatelet and anticoagulant alone). Six articles [66][67][68][69][70][71] reported pooled post hoc analyses of these two studies. 64,65 Of these, two pooled analyses, by White et al, 68 and Douketis et al, 70 did not report data on the number of events or the number of participants for either intervention group; however, this information was reported in pooled analyses by Flaker et al 69 and Akins et al 67 Two other publications 66,71 reported data for stroke, or stroke and bleeding outcomes, which were also reported in pooled analyses.…”

Section: Methodological Issuesmentioning

confidence: 99%

“…Of these, 14 studies [50][51][52][53][54][55][56][57][58][59][60][61][62][63] (in 14 articles) reported data from observational designs, both prospective [50][51][52][53][54][55] and retrospective [56][57][58][59][60][61][62][63] in nature. The remaining four studies in 10 articles [64][65][66][67][68][69][70][71][72][73] were originally designed to assess the effectiveness of an anticoagulant without additional APT. However, these were included because they reported data on a subgroup of patients treated with combined anticoagulant plus APT.…”

Section: -73mentioning

confidence: 99%

See 3 more Smart Citations

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Lane

Raichand²,

Moore³

et al. 2013

Health Technol Assess

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Section: Methodological Issuesmentioning

confidence: 99%

Section: Methodological Issuesmentioning

confidence: 99%

Section: Methodological Issuesmentioning

confidence: 99%

Section: -73mentioning

confidence: 99%

See 2 more Smart Citations

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Lane

Raichand²,

Moore³

et al. 2013

Health Technol Assess

View full text Add to dashboard Cite

“…Gullov et al found in the AFASAK 2 trial that fixed-minidose warfarin and aspirin alone or in combination were associated with both minor and major bleeding [7]. In a recent study with 3,566 patients with chronic AF, receiving warfarin therapy targeted to achieve an INR of 2.0-3.0, patients who were receiving concomitant aspirin (100 mg/ day) had a more than 2-fold increased risk for major bleeding [10]. The trial conducted by Edvardsson et al [9] on the effect of low-dose warfarin and aspirin vs. no treatment on stroke in a medium-risk population with AF was inconclusive, but consistent with a small beneficial effect of the combination therapy for reduction of stroke and major vascular events.…”

Section: Atrial Fibrillationmentioning

confidence: 99%

Indications of combined vitamin K antagonists and aspirin therapy

Loualidi

Bredie

Janssen

2008

J Thromb Thrombolysis

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Based on their mode of action, it is reasonable to expect that the combination therapy of aspirin and a vitamin K antagonist (VKA) may be more beneficial in preventing (athero) thrombotic complications in high-risk patients for cardiovascular events. However, there is no consensus about additional aspirin use in the most common indications for VKA or the use of VKAs to be added to the most common aspirin indications. The variation in clinical outcomes and bleeding complications suggests that extrapolating from one indication to another may not be appropriate. So far, decisions about the combined use of aspirin and VKA are individualized in the absence of adequate data. Only in patients with mechanical heart valves the benefits and safety of combining aspirin with VKA therapy seems obvious. In patients with peripheral artery disease no beneficial effect was noted for the combination therapy, perhaps with an exception of those with graft failure. For all other clinical situations, this is unclear and should be avoided.

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Combined Aspirin–Oral Anticoagulant Therapy Compared With Oral Anticoagulant Therapy Alone Among Patients at Risk for Cardiovascular Disease

Dentali

Douketis²,

Lim³

et al. 2007

Arch Intern Med

189

112

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Background: For patients receiving oral anticoagulant (OAC) therapy, deciding whether to add aspirin to their treatment is a common clinical scenario with no clear guidelines to aid practice. We performed a systematic review and meta-analysis of randomized controlled trials comparing these 2 treatment strategies (combined aspirin-OAC therapy vs OAC therapy alone) to assess the therapeutic benefits and risks. Data Sources: Randomized controlled trials published up to June 2005 in MEDLINE, EMBASE, and Cochrane Library databases.Study Selection: Randomized controlled trials with at least 3 months of follow-up that compared aspirin-OAC therapy with OAC therapy alone, in which OAC was administered to achieve the same target international normalized ratio or was given at the same fixed dose in both treatment arms.Data Extraction: Two reviewers independently extracted data on study characteristics and outcomes. Pooled odds ratios (ORs) and associated 95% confidence intervals (CIs) were calculated for study outcomes in patients receiving aspirin-OAC therapy and OAC therapy alone.Data Synthesis: Ten studies were included, totaling 4180 patients. The risk for arterial thromboembolism was lower in patients receiving combined aspirin-OAC therapy compared with OAC therapy alone (OR, 0.66; 95% CI, 0.52-0.84). However, these benefits were limited to patients with a mechanical heart valve (OR, 0.27; 95% CI, 0.15-0.49). There was no difference in the risk for arterial thromboembolism with these treatments in patients with atrial fibrillation (OR, 0.99; 95% CI, 0.47-2.07) or coronary artery disease (OR, 0.69; 95% CI, 0.35-1.36). There was no difference in all-cause mortality with either treatment (OR, 0.98; 95% CI, 0.77-1.25). The risk for major bleeding was higher in patients receiving aspirin-OAC therapy compared with OAC therapy alone (OR, 1.43; 95% CI, 1.00-2.02). Conclusion:Our findings question the current practice of using combined aspirin-OAC therapy except in patients with a mechanical heart valve, given the questionable benefits in reducing thromboembolic events and the increased risk of major bleeding.

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Comparison of Bleeding in Patients With Nonvalvular Atrial Fibrillation Treated With Ximelagatran or Warfarin

Cited by 80 publications

References 38 publications

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Combined anticoagulation and antiplatelet therapy for high-risk patients with atrial fibrillation: a systematic review

Indications of combined vitamin K antagonists and aspirin therapy

Combined Aspirin–Oral Anticoagulant Therapy Compared With Oral Anticoagulant Therapy Alone Among Patients at Risk for Cardiovascular Disease

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