Table 3.
Summary of major bleeding outcomes across major SRs and RCTs comparing anticoagulants and aspirin
| Study reference | Indication | Comparators | No. of major bleeding events | RR/HR |
|---|---|---|---|---|
| AVERROES51 | Stroke prophylaxis in atrial fibrillation | Apixaban 5 mg BID vs aspirin 81 to 324 mg daily | 44 vs 39 | HR, 1.13 (0.74-1.75) |
| RCT, 2011; n = 5599 | ||||
| Warkentin et al, 201252 | Any indication for long-term antithrombotic therapy | Warfarin vs aspirin 75 to 300 mg daily | 69 vs 54 | OR, 1.27 (0.83-1.94) |
| SR, 8 RCTs; n = 2904 | ||||
| COMPASS53 | Secondary cardiovascular prevention | Rivaroxaban 5 mg BID vs aspirin 100 mg daily | 288 vs 170 | HR, 1.51 (1.25-1.84) |
| RCT, 2017; n = 27 395 | ||||
| EINSTEIN-CHOICE28 | Extended treatment of VTE | Rivaroxaban 10 mg daily vs aspirin 81 mg daily Rivaroxaban 20 mg daily vs aspirin 81 mg daily |
5 vs 3 6 vs 3 |
HR, 1.64 (0.39-6.84) HR, 2.01 (0.50-8.04) |
| RCT, 2017; n = 3365 | ||||
| EPCAT II22 | Post-joint arthroplasty extended VTE prophylaxis | Rivaroxaban 10 mg daily vs aspirin 81 mg | 5 vs 8 | RR, 0.62 (0.20-1.90) |
| RCT, 2018; n = 3424 | ||||
| NAVIGATE ESUS54 | Secondary stroke prophylaxis | Rivaroxaban 15 mg daily vs aspirin 100 mg daily | 62 vs 13 | HR, 2.72 (1.68-4.39) |
| RCT, 2018; n = 7213 | ||||
| Xie et al, 201955 | Prevention of VTE | Rivaroxaban mostly 10 mg daily vs aspirin mostly 100 mg daily or less | 16 vs 11 | RR, 0.81 (0.42-1.55) |
| SR, 9 RCTs; n = 7656 | ||||
| Ng et al, 202056 | Stroke prophylaxis in atrial fibrillation | Aspirin (subgroup, dose not specified) vs warfarin | Not provided | RR, 0.63 (0.41-0.96)* |
| SR, 37 RCTs; n = 100 142 | ||||
| Matharu et al, 202023 | Post-joint arthroplasty VTE prophylaxis | Low- and high-dose aspirin (subgroup) vs comparator anticoagulants | 11 vs 10 | RR, 1.11 (0.47-2.59)* |
| SR, 13 RCTs; n = 6060 |
Major bleeding as defined by criteria set in each individual randomized control trial or systematic review.
AVERROES, Apixaban Versus Acetylsalicylic Acid to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment; BID, twice daily; COMPASS, Cardiovascular Outcomes for People Using Anticoagulation Strategies; EINSTEIN-CHOICE, Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism; EPCAT II, Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty II; NAVIGATE ESUS, New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial versus ASA to Prevent Embolism in Embolic Stroke of Undetermined Source; OR, odds ratio. See Table 2 for expansion of other abbreviations.
Note relative risk ratio is reported with respect to aspirin in contrast to the format in the rest of the table.