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Published on 28.10.2019
Very low-dose anticoagulation in the form of rivaroxaban twice daily is a welcoming addition to the current antithrombotic arsenal in high-risk patients with acute coronary syndrome or stable coronary artery disease. Adequate patient selection in line with the entry criteria of the approval trials appears to be critical to avoid excessive bleeding.
Antithrombotic therapy | NNT for reduction of all-cause death | NNT for reduction of CV event | NNH for additional bleeding event | Ref. |
---|---|---|---|---|
Aspirin given acutely and in the first month after STEMI | 36 | 42 for CV death | 167 for minor bleeding (major bleeding not increased) | [24] |
Aspirin for long-term secondary prevention after MI | 91 | 29 for composite of CV death, MI and stroke | 333 for major extracranial bleeding | [25] |
Clopidogrel added to aspirin for one year after ACS or PCI (DAPT) | NS | 27 for composite of non-fatal MI and stroke | 114 for major bleeding | [26] |
Ticagrelor added instead of clopidogrel to aspirin for one year after ACS (DAPT) | 71 | 53 for composite of CV death, MI and stroke | 143 for major bleeding not related to CABG | [3] |
Prasugrel added instead of clopidogrel to aspirin for one year after ACS (DAPT) | NS | 46 for composite of CV death, non-fatal MI and stroke | 167 for major bleeding not related to CABG | [4] |
Prolongation of DAPT beyond one year in post-MI patients over a mean of 31 months | NS | 91 for composite of CV death, non-fatal MI and stroke | 132 for major bleeding | [27] |
VLD rivaroxaban added to DAPT (aspirin ± clopidogrel or ticlopidine) in ACS patients for a mean of 13 months (ATLAS ACS 2) | 63 | 63 for composite of CV death, non-fatal MI and stroke | 83 for major bleeding not related to CABG | [16] |
VLD rivaroxaban added to SAPT (aspirin) in stable CAD for a mean of 23 months (COMPASS) | 143 | 77 for composite of CV death, non-fatal MI and stroke | 83 for major bleeding | [17] |
VLD rivaroxaban added to patients with CAD and symptomatic HF with reduced ejection fraction (COMMANDER-HF) | NS | NS for composite of all-cause death, MI and stroke, 100 for stroke | 77 for major bleeding | [23] |
Trial acronym and identifier | Target population | Intervention | Estimated enrolment |
---|---|---|---|
APPROACH-ACS-AF (NCT02789917) | ACS with AFib | Apixaban plus clopidogrel vs VKA, clopidogrel and aspirin | 400 |
COACH-AF-PCI (NCT03536611) | CAD after PCI/Stenting with AFib | Dabigatran plus DAPT vs VKA plus DAPT | 1120 |
ENTRUST-AF-PCI (NCT02866175) | CAD after PCI/Stenting with AFib | Edoxaban plus SAPT vs VKA plus SAPT/DAPT | 1500 |
EPIC-CAD (NCT03718559) | Stable CAD with AFib | Edoxaban vs edoxaban plus SAPT | 1000 |
H-REPLACE (NCT03363035) | ACS in the acute phase | Low-dose rivaroxaban vs enoxaparin | 3390 |
RT-AF (NCT02334254) | CAD after PCI and indication for OAC | Low-dose rivaroxaban plus ticagrelor vs VKA plus DAPT | 420 |
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