Study | Patients, N | Treatment duration | Rate of VTE recurrence | Rate of bleeding | ||
---|---|---|---|---|---|---|
Major bleeding | All bleeding | Major/CRNM bleeding | ||||
Schulman 2009 RE-COVER [21] | 2564 | 6 months | Dabigatran 2.4% LMWH + VKA 2.1% Difference 0.4% (95% CI −0.8%, 1.5%); p < 0.001, non-inferior HR 1.10 (95% CI 0.65, 1.84) | aDabigatran 1.6% LMWH + VKA 1.9% HR 0.82 (95% CI 0.45, 1.48) | Dabigatran 16.1%LMWH + VKA 21.9% HR 0.71 (95% CI 0.59, 0.85) | bDabigatran 5.6% LMWH + VKA 8.8% HR 0.63 (95% CI 0.47, 0.84); p = 0.002 |
Schulman 2011 RE-COVER II [22] | 2568 | 6 months | Dabigatran 2.4% LMWH + VKA 2.2% Difference 0.2% (95% CI −1.0%, 1.5%); p < 0.0001, non-inferior HR 1.08 (95% CI 0.64, 1.80) | aDabigatran 1.2% LMWH + VKA 1.7% HR 0.69 (95% CI 0.36, 1.32) | Dabigatran 15.6% LMWH + VKA 22.1% HR 0.67 (95% CI 0.56, 0.81) | |
EINSTEIN Investigators 2010 EINSTEIN-DVT [18] | 3451 | 3, 6 or 12 months | Rivaroxaban 2.1% LMWH + VKA 3.0% p < 0.001, non-inferior HR 0.68 (95% CI 0.44, 1.04) | cRivaroxaban 0.8% LMWH + VKA 1.2% HR 0.65 (95% CI 0.33, 1.30); p = 0.21 | dRivaroxaban 8.1% LMWH + VKA 8.1% HR 0.97 (95% CI 0.76, 1.22); p = 0.77 | |
EINSTEIN-PE Investigators 2012 EINSTEIN-PE [19] | 4832 | 3, 6 or 12 months | Rivaroxaban 2.1% LMWH + VKA 1.8% p = 0.003, non-inferior HR 1.12 (95% CI 0.75, 1.68) | cRivaroxaban 1.1% LMWH + VKA 2.2% HR 0.49 (95% CI 0.31, 0.79); p = 0.003 | dRivaroxaban 10.3% LMWH + VKA 11.4% HR 0.90 (95% CI 0.76, 1.07); p = 0.23 |