Table 2.
Characteristics of trials combining anticoagulants and platelet inhibitors after percutaneous coronary interventions
| WOEST [31] | PIONEER-AF [32] | RE-DUAL PCI [33] | AUGUSTUS [34] | ENTRUST-AF [35] | |
|---|---|---|---|---|---|
| Triple antithrombotic treatment | VKA INR 2–3 + clopidogrel + acetylsalicylic acid | VKA INR 2–3 + P2Y12 inhibitor + acetylsalicylic acid | VKA INR 2–3 + P2Y12 inhibitor + acetylsalicylic acid | VKA INR 2–3 + P2Y12 inhibitor |
VKA INR 2–3 +P2Y12 inhibitor +acetylsalicylic acid |
| Dual antithrombotic treatment | VKA INR 2–3 + clopidogrel | Rivaroxaban 15 mg + P2Y12 inhibitor | Dabigatran 150 mg + P2Y12 inhibitor | Apixaban 5 mg + P2Y12 inhibitor | Edoxaban 60 mg + P2Y12 inhibitor |
| Additional arm | – | Rivaroxaban 2*2.5 mg + acetylsalicylic acid + P2Y12 inhibitor | Dabigatran 110 mg* + P2Y12 inhibitor | Second randomisation ± acetylsalicylic acid | – |
| Patients (n) | 563 | 2124 | 2725 | 4614 | 1506 |
| Mean age (years) | 70.3 | 70 | 69/72* | 71 | 70 |
| ≥ 75 years (≥ 80 years#) | 394 (70%) | 717 (34%) | 450 (17%)# | 689 (14%)# | 506 (34%) |
| Definition of primary bleeding endpoint | ↓ | ↓ | ↓ | ↓ | ↓ |
|
TIMI major and non-major [37]: • Any intracranial bleeding • Spontaneous gross haematuria or hematemesis (> 120 ml), even if the haemoglobin or haematocrit drop was less than 3 g/dL or less than 10% • Unobserved loss ≥ 4 g/dl in haemoglobin or ≥ 12% in haematocrit |
ISTH major and clinically-relevant non-major [38, 39]: • Fatal bleeding • Symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome • Bleeding causing a fall in haemoglobin level ≥ 2 g/dL or leading to transfusion ≥ 2 units of whole blood or red cells • Any sign or symptom of haemorrhage (e.g. more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria above but does meet at least one of the following criteria: - Requiring medical intervention by a healthcare professional - Leading to hospitalisation or increased level of care - Prompting a face to face (i.e. not just a telephone or electronic communication) evaluation |
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Strategies, definition of bleeding events, and proportion of patients with age ≥ 75 years in the five trials comparing oral anticoagulants in dual and triple antithrombotic regimens following percutaneous coronary intervention and/or acute coronary syndromes in patients with indication for anticoagulation. VKA, vitamin K antagonist; *in RE-DUAL patients ≥ 80 years outside the USA (≥ 70 years in Japan) were only randomised to either VKA or dabigatran 110 mg; #PIONEER-AF and RE-DUAL PCI trials only report data for patients ≥ 80 years