Table 1.

Summary of Betrixaban Phase 2 and Phase 3 Trials¹³,¹⁴,¹⁹

Study	Indication	Evaluable Patients	Intervention Arms	Control Arms	Design	Primary Outcome
EXPERT (Phase 2)	VTE prevention in total knee replacement	175	Betrixaban 15 mg twice daily and 40 mg twice daily, both six hours postoperatively	Enoxaparin 30 mg SC twice daily 12–24 hours postoperatively	RCT, open label. Blinded to betrixaban doses	Incidence of VTE (DVT or PE through day 10–14) was 14/70 (20%; 95% CI, 11–31) for betrixaban 15 mg, 10/65 (15%; 95% CI, 8–27) for betrixaban 40 mg, and 4/40 (10%; 95% CI: 3–24) for enoxaparin
EXPLORE-Xa (Phase 2)	Stroke prevention in atrial fibrillation	508	Betrixaban 40 mg, 60 mg, or 80 mg daily	Warfarin adjusted to INR (2.0–3.0)	RCT, open label. Blinded to betrixaban doses	Time to occurrence of major or clinically relevant nonmajor bleeding was lowest with betrixaban 40 mg (HR, compared with warfarin, 0.14; 95% CI, 0.017–1.135; P = 0.04)
APEX (Phase 3)	Extended prophylaxis in high-VTE-risk, acute, medically ill patients	7,441	Betrixaban 160 mg loading dose followed by 80 mg once daily for 35–42 days with placebo enoxaparin for 10 ± 4 days	Enoxaparin 40 mg SC for up to 10 ± 4 days followed by placebo betrixaban	RCT, double blind, double dummy	Efficacy (measured in mITT) was assessed by composite outcome score of asymptomatic proximal DVT or symptomatic DVT, nonfatal PE or VTE-related death: betrixaban reduced the incidence of DVT and PE blood clots compared with those taking enoxaparin plus placebo (4.4% vs. 6.0%; RR, 0.75; 95% CI, 0.61–0.91) with no significant increase in major bleeding (0.67% vs. 0.57%).

CI = confidence interval; DVT = deep vein thrombosis; HR = hazard ratio; INR = international normalized ratio; mITT = modified intent-to-treat; PE = pulmonary embolism; RCT = randomized controlled trial; RR = relative risk; SC = subcutaneously; VTE = venous thromboembolism.