Table 2.
Outcome | Milvexian Twice Daily | Milvexian Once Daily | Enoxaparin (N = 252) | |||||
---|---|---|---|---|---|---|---|---|
25 mg (N = 129) | 50 mg (N = 124) | 100 mg (N = 134) | 200 mg (N = 131) | 25 mg (N = 28) | 50 mg (N = 127) | 200 mg (N = 123) | ||
Primary efficacy outcome: venous thromboembolism † | ||||||||
Any event — no. (%) | 27 (21) | 14 (11) | 12 (9) | 10 (8) | 7 (25) | 30 (24) | 8 (7) | 54 (21) |
Relative risk vs. enoxaparin (95% CI) | 0.97 (0.65–1.45) | 0.53 (0.31–0.90) | 0.42 (0.23–0.76) | 0.37 (0.19–0.69) | 1.00 (0.51–1.97) | 1.15 (0.78–1.70) | 0.30 (0.15–0.62) | — |
Components of the primary efficacy outcome — no.‡ | ||||||||
Death from any cause | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Nonfatal pulmonary embolism | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 |
Symptomatic distal deep-vein thrombosis | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 |
Asymptomatic proximal deep-vein thrombosis | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 2 |
Asymptomatic distal deep-vein thrombosis | 26 | 13 | 9 | 10 | 7 | 26 | 8 | 50 |
Extent of deep-vein thrombosis on venography — no. | ||||||||
Confluent distal into proximal | 1 | 0 | 1 | 0 | 0 | 2 | 0 | 1 |
Isolated proximal | ||||||||
Large: ≥10 cm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Small: <10 cm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Isolated distal | ||||||||
Extensive: ≥2 veins | 9 | 5 | 1 | 2 | 5 | 9 | 1 | 20 |
Limited: <2 veins | 17 | 8 | 9 | 8 | 2 | 18 | 7 | 30 |
Efficacy outcomes were assessed in the modified intention-to-treat population, which included all the patients who had received at least one dose of a trial medication and had a venogram within the prespecified time window that could be evaluated, a documented symptomatic venous thromboembolic event, or a fatal event. CI denotes confidence interval.
Venous thromboembolism was a composite of asymptomatic deep-vein thrombosis (detected by mandatory unilateral venography performed 10 to 14 days after surgery), confirmed symptomatic venous thromboembolism (symptomatic deep-vein thrombosis of the leg or nonfatal pulmonary embolism), or death from any cause.
There were no cases of symptomatic proximal deep-vein thrombosis.