Sterne et al. (2017)[20] review section | Methods and study details | Primary outcomes (number of studies) Main comparator | Main findings |
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Prevention of AF-related stroke | Search: March 2014, updated September 2014 Included: 23 RCTs on AF (41 articles); 94,656 participants Published: 1989 to 2014 Quality tool: Cochrane Risk of Bias | Efficacy: stroke or systemic embolism (15); ischaemic stroke (13); myocardial infarction (15) Safety: major bleeding (18); clinically relevant bleeding (12); intracranial bleeding (6); all-cause mortality (18) Main comparator: warfarin | The analyses suggested that direct OACs were better than warfarin for most efficacy and safety outcomes Apixaban (5 mg twice daily) was likely to be one of the best options for almost all outcomes.* For example, all-cause mortality (OR 0.88, 95% CI 0.79 to 0.98; versus warfarin, INR 2 to 3); and expected incremental net benefit £7533 (95% CI 489.9 to 18,228; at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year) |
VTE primary prevention (mainly in hip and knee surgery) | Search: March 2014, updated September 2014 Included: 43 RCTs on VTE (46 articles); 77,563 participants Published: 1996 to 2012 Quality tool: Cochrane Risk of Bias | Efficacy: symptomatic VTE (29);a symptomatic DVT (25); symptomatic PE (35) Safety: myocardial infarction (9); major bleeding (39); clinically relevant bleeding (27); all-cause mortality (28) Main comparator: low-molecular-weight heparin | There was no strong evidence to support direct OACs; no direct comparisons with warfarin and few events Warfarin (INR 2 to 3) was likely to be best (p > 0.9)* for major bleeding (OR 0.57, 95% CI 0.39 to 0.82), and low-molecular-weight heparin for clinically relevant bleeding (p > 0.6) Rivaroxaban was most likely to be cost-effective, but very uncertain; incremental net monetary benefit (INMB), total replacement of hip £453, 95% CI − 485 to 1312; knee £16, 95% CI − 406 to 329; £20,000 threshold |
Acute treatment of VTE | Search: March 2014, updated September 2014 Included: 9 RCTs on VTE (10 articles); 28,803 participants Published: 2007 to 2014 Quality tool: Cochrane Risk of Bias | Efficacy: symptomatic VTE (8);b symptomatic DVT (9); symptomatic PE (9); myocardial infarction (5) Safety: major bleeding (9); clinically relevant bleeding (8); all-cause mortality (8) Main comparator: warfarin | Analyses suggested that direct OACs were no better than warfarin, but apixaban (5 mg twice daily, e.g., major bleeding OR 0.33, 95% CI 0.18 to 0.56) and rivaroxaban (15 mg twice daily then 20 mg once daily, e.g., major bleeding OR 0.55, 95% CI 0.37 to 0.80) may be better for avoiding bleeding Apixaban (5 mg twice daily) was likely to be one of the best for most outcomes (e.g., p > 0.9 for major bleeding; INMB £710, 95% CI − 1322 to 2185; £20,000 threshold)* |
Secondary prevention of VTE | Search: March 2014, updated September 2014 Included: 10 RCTs on VTE (11 articles); 10,390 participants Published: 1999 to 2013 Quality tool: Cochrane Risk of Bias | Efficacy: symptomatic VTE (10); symptomatic DVT (9); symptomatic PE (9) Safety: myocardial infarction (5); major bleeding (10); clinically relevant bleeding (6); all-cause mortality (9) Main comparator: warfarin | Inconsistent evidence suggested; apixaban (2.5 mg twice daily) was worse than warfarin for symptomatic PE (OR 10.1, 95% CI 1.66 to 102), but better for avoiding bleeding (HR 0.24, 95% CI 0.09 to 0.61); dabigatran (150 mg twice daily) was also better for bleeding (HR 0.54, 95% CI 0.41 to 0.71) There were not enough data for the authors to calculate the likelihood of being the best option None of the treatments was cost-effective, except possibly aspirin (INMB £623, 95% CI − 6404 to 4602; £20,000 threshold) |