Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban)

Gibson, CM; Chi, G; Halaby, R; Korjian, S; Daaboul, Y; Jain, P; Arbetter, D; Goldhaber, SZ; Hull, R; Hernandez, AF; Gold, A; Bandman, O; Harrington, RA; Cohen, AT; APEX Investigators

doi:10.1161/circulationaha.116.025427

Pulmonary vascular disease & thromboembolism

Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban)

CirculationPublished 14 Nov 2016Secondary analysis of the APEX randomised trial

Primary result · All-cause strokeResultRelative risk 0.56 95% CI 0.32–0.96

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Authors' conclusion

Among hospitalized medically ill patients, extended-duration betrixaban significantly reduced all-cause stroke and ischemic stroke through 77 days of follow-up

Study context

Population: Hospitalized acutely medically ill patients
Participants: 7,513 patients

Comparison: Extended-duration betrixaban vs standard-dose enoxaparin
Primary endpoint: All-cause stroke
Follow-up: 77 days

Methodological detailsretrospective substudy, double-blind, double-dummy, blinded event adjudication

Retrospective substudy
Double-blind
Double-dummy
Blinded event adjudication

Primary result

As reported in the abstract

77 days

Relative risk

0.56

95% CI 0.32–0.96

P = 0.032

By group

Betrixaban0.54%

Enoxaparin0.97%

Betrixaban vs Enoxaparin

RR 0.56 (95% CI 0.32–0.96); P = 0.032

Further findings

Outcome	Betrixaban	Enoxaparin	← Lower risk with betrixaban ←→ Higher risk with betrixaban →	RR (95% CI)	P value
Ischemic stroke · 77 daysAdjusted RR=0.43%; NNT=233	0.48%	0.91%	0.20.5125	0.53 (0.30–0.94)	P = 0.026
All-cause stroke, high-risk (HF or ischemic stroke index event) (subgroup)Adjusted RR=0.76%; NNT=132	0.72%	1.48%	0.20.5125	0.49 (0.26–0.90)	P = 0.019
Ischemic stroke, high-risk (HF or ischemic stroke index event) (subgroup)Adjusted RR=0.75%; NNT=134	0.63%	1.38%	0.20.5125	0.45 (0.24–0.87)	P = 0.014
			0.20.5125Relative risk (log scale)

Original publication

Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. Published 14 November 2016. doi:10.1161/circulationaha.116.025427

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Summarised from the published abstract; every number is checked against it