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. Author manuscript; available in PMC: 2022 Oct 7.
Published in final edited form as: N Engl J Med. 2021 Nov 15;385(23):2161–2172. doi: 10.1056/NEJMoa2113194

Table 2.

Efficacy Outcomes.*

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 outcomeno.
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.