EXPLORE-Xa trial

patients with nonvalvular atrial fibrillation with at least one risk factor for stroke; at least 18 years of age; no uncontrolled hypertension; aspirin <=162 mg daily; INR <=2.2 at randomization or unable to comply with INR monitoring

Exclusion criteria

need for renal dialysis within one year; AF due to reversible causes, mechanical prosthetic valve; SBP > 160 mmHg on repeated measurements; active infective endocarditis; scheduled major surgery, pulmonary vein ablation; recent ischemic stroke, systemic embolic event or acute coronary syndrome within 30 days

Baseline characteristics

age(mean)	73 y
male(%)	67%
weight(mean)	46% weight>90kg

Method and design

Randomized effectives	381 / 127 (studied vs. control)
Design	Parallel groups
Blinding	double-blind
Follow-up duration	4.9 mo (median) (3-12mo)
Primary endpoint	major and clinically relevant non-major bleeding
Remarks	dose finding study

Results

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

major or clinically relevant non-major bleeding

11 / 381
7 / 127
0,52 [0,21;1,32]

All cause death

1 / 381
1 / 127
classic 0,33 [0,02;5,29]

stroke (fatal and non fatal)

2 / 381
0 / 127
classic 3,00 [0,05;186,00] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
major or clinically relevant non-major bleeding	11 / 381 (2,9%)	7 / 127 (5,5%)	0,52	[0,21;1,32]
All cause death	1 / 381 (0,3%)	1 / 127 (0,8%)	0,33	[0,02;5,29]
stroke (fatal and non fatal)	2 / 381 (0,5%)	0 / 127 (0,4%)	1,33	[0,06;29,38]
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
major or clinically relevant non-major bleeding	2,89%	5,51%	-26,2‰
All cause death	2,62‰	7,87‰	-5,2‰

Meta-analysis of all similar trials:

antithrombotics in atrial fibrillation for primary prevention of thromboembolic events

direct factor Xa inhibitors in atrial fibrillation for all type of patients

new anticoagulants in atrial fibrillation for all type of patients

Reference(s)

Trials register #

NCT00742859

EXPLORE-Xa study, 2010

Treatments

Patients

Method and design

Results

Reference(s)