Characteristics of the 13 included studies assessing the use of prothrombin complex concentrate in factor Xa inhibitor–associated major bleeding
| Reference . | Study design . | No. . | Treatment . | Major bleeding definition . | Factor Xa inhibitor . | Indication for anticoagulation . | Follow-up (d) . | Intracranial hemorrhage . | Gastrointestinal bleeding . | Other bleeding . |
|---|---|---|---|---|---|---|---|---|---|---|
| Allison7 | Retrospective | 33 | 4F-PCC (35 U/kg) | Other | Apixaban = 6 | AF = 24 | 7.1 | 30 | 1 | 2 |
| Rivaroxaban = 27 | VTE = 6 | |||||||||
| Other = 3 | ||||||||||
| Arachchillage8 | Retrospective | 80 | 4F-PCC | ISTH | Apixaban = 40 | AF = 67 | 30 | 46 | 24 | 10 |
| Rivaroxaban = 40 | VTE = 12 | |||||||||
| Both = 1 | ||||||||||
| Berger9 | Retrospective | 22 | 4F-PCC (25 U/kg) | Other | Apixaban = 5 | AF = 17 | 5.9 | 22 | — | — |
| Rivaroxaban = 15 | VTE = 4 | |||||||||
| Dabigatran = 2 | Other = 3 | |||||||||
| (>1 possible per patient) | ||||||||||
| Dybdahl10 | Retrospective | 35 | 4F-PCC (50 U/kg) | Other | Apixaban = 17 | AF = 30 | 6.4 | 35 | — | — |
| Rivaroxaban = 18 | VTE = 4 | |||||||||
| Both = 1 | ||||||||||
| Grandhi11 | Retrospective | 18 | 4F-PCC | Other | Apixaban = 2 | AF = 15 | 8.4 | 18 | — | — |
| Rivaroxaban = 18 | VTE = 1 | |||||||||
| Both = 1 | ||||||||||
| Other = 1 | ||||||||||
| Harrison12 | Retrospective | 14 | 4F-PCC | Other | N/A | AF = 12 | 7.1 | 14 | — | — |
| VTE = 3 | ||||||||||
| Other = 2 | ||||||||||
| (>1 possible per patient) | ||||||||||
| Majeed3 | Prospective | 84 | 4F-PCC (25 U/kg) | ISTH | Apixaban = 39 | AF = 63 | 30 | 59 | 13 | 12 |
| Rivaroxaban = 45 | VTE = 3 | |||||||||
| Both = 18 | ||||||||||
| Müller13 | Retrospective | 74* | 4F-PCC | N/A | Apixaban = 5 | AF = 48 | 4.9 | 45 | 14 | 14 |
| Rivaroxaban = 67 | VTE = 13 | |||||||||
| Edoxaban = 1 | Other = 13 | |||||||||
| Dabigatran = 1 | ||||||||||
| Schenk4 | Prospective | 13 | 4F-PCC (25 U/kg) | N/A | Rivaroxaban = 13 | N/A | 30 | 10 | 1 | 2 |
| Schulman5 | Prospective | 66 | 4F-PCC (2000 U) | ISTH | Apixaban = 29 | AF = 54 | 30 | 36 | 16 | 14 |
| Rivaroxaban = 37 | VTE = 8 | |||||||||
| Both = 2 | ||||||||||
| Other = 1 | ||||||||||
| Sheikh-Taha14 | Retrospective | 29 | 4F-PCC (50 U/kg) | ISTH | Apixaban = 13 | AF = 23 | 5.9 | 21 | 4 | 4 |
| Rivaroxaban = 16 | VTE = 5 | |||||||||
| Other = 1 | ||||||||||
| Smith15 | Retrospective | 31 | 4F-PCC (25-50 U/kg) | Other | Apixaban = 17 | AF = 28 | 7.2 | 18 | 1 | 12 |
| Rivaroxaban = 14 | VTE = 3 | |||||||||
| Testa6 | Prospective | 22 | PCC | ISTH | Apixaban = 6 | N/A | 3 | 20 | 2 | 0 |
| Rivaroxaban = 16 |
| Reference . | Study design . | No. . | Treatment . | Major bleeding definition . | Factor Xa inhibitor . | Indication for anticoagulation . | Follow-up (d) . | Intracranial hemorrhage . | Gastrointestinal bleeding . | Other bleeding . |
|---|---|---|---|---|---|---|---|---|---|---|
| Allison7 | Retrospective | 33 | 4F-PCC (35 U/kg) | Other | Apixaban = 6 | AF = 24 | 7.1 | 30 | 1 | 2 |
| Rivaroxaban = 27 | VTE = 6 | |||||||||
| Other = 3 | ||||||||||
| Arachchillage8 | Retrospective | 80 | 4F-PCC | ISTH | Apixaban = 40 | AF = 67 | 30 | 46 | 24 | 10 |
| Rivaroxaban = 40 | VTE = 12 | |||||||||
| Both = 1 | ||||||||||
| Berger9 | Retrospective | 22 | 4F-PCC (25 U/kg) | Other | Apixaban = 5 | AF = 17 | 5.9 | 22 | — | — |
| Rivaroxaban = 15 | VTE = 4 | |||||||||
| Dabigatran = 2 | Other = 3 | |||||||||
| (>1 possible per patient) | ||||||||||
| Dybdahl10 | Retrospective | 35 | 4F-PCC (50 U/kg) | Other | Apixaban = 17 | AF = 30 | 6.4 | 35 | — | — |
| Rivaroxaban = 18 | VTE = 4 | |||||||||
| Both = 1 | ||||||||||
| Grandhi11 | Retrospective | 18 | 4F-PCC | Other | Apixaban = 2 | AF = 15 | 8.4 | 18 | — | — |
| Rivaroxaban = 18 | VTE = 1 | |||||||||
| Both = 1 | ||||||||||
| Other = 1 | ||||||||||
| Harrison12 | Retrospective | 14 | 4F-PCC | Other | N/A | AF = 12 | 7.1 | 14 | — | — |
| VTE = 3 | ||||||||||
| Other = 2 | ||||||||||
| (>1 possible per patient) | ||||||||||
| Majeed3 | Prospective | 84 | 4F-PCC (25 U/kg) | ISTH | Apixaban = 39 | AF = 63 | 30 | 59 | 13 | 12 |
| Rivaroxaban = 45 | VTE = 3 | |||||||||
| Both = 18 | ||||||||||
| Müller13 | Retrospective | 74* | 4F-PCC | N/A | Apixaban = 5 | AF = 48 | 4.9 | 45 | 14 | 14 |
| Rivaroxaban = 67 | VTE = 13 | |||||||||
| Edoxaban = 1 | Other = 13 | |||||||||
| Dabigatran = 1 | ||||||||||
| Schenk4 | Prospective | 13 | 4F-PCC (25 U/kg) | N/A | Rivaroxaban = 13 | N/A | 30 | 10 | 1 | 2 |
| Schulman5 | Prospective | 66 | 4F-PCC (2000 U) | ISTH | Apixaban = 29 | AF = 54 | 30 | 36 | 16 | 14 |
| Rivaroxaban = 37 | VTE = 8 | |||||||||
| Both = 2 | ||||||||||
| Other = 1 | ||||||||||
| Sheikh-Taha14 | Retrospective | 29 | 4F-PCC (50 U/kg) | ISTH | Apixaban = 13 | AF = 23 | 5.9 | 21 | 4 | 4 |
| Rivaroxaban = 16 | VTE = 5 | |||||||||
| Other = 1 | ||||||||||
| Smith15 | Retrospective | 31 | 4F-PCC (25-50 U/kg) | Other | Apixaban = 17 | AF = 28 | 7.2 | 18 | 1 | 12 |
| Rivaroxaban = 14 | VTE = 3 | |||||||||
| Testa6 | Prospective | 22 | PCC | ISTH | Apixaban = 6 | N/A | 3 | 20 | 2 | 0 |
| Rivaroxaban = 16 |
4F, four-factor; AF, atrial fibrillation; ISTH, International Society on Thrombosis and Haemostasis; N/A, not available; PCC, prothrombin complex concentrate; VTE, venous thromboembolism .
93% of patients received PCCs for major bleeding.