EBQ:RE-LY - Revision history

Danbot: Added Major Points and Criticisms content

2026-03-21T22:43:57Z

Added Major Points and Criticisms content

← Older revision		Revision as of 22:43, 21 March 2026
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	==Major Points==		==Major Points==
			*RE-LY was the first large RCT to demonstrate a novel oral anticoagulant (dabigatran) as an alternative to warfarin for stroke prevention in atrial fibrillation
			*Dabigatran 150mg BID was superior to warfarin for stroke prevention with similar major bleeding rates
			*Dabigatran 110mg BID was non-inferior to warfarin for stroke prevention with lower major bleeding rates
			*Both dabigatran doses had lower rates of intracranial hemorrhage compared to warfarin
			*Dabigatran 150mg BID was associated with higher rates of GI bleeding compared to warfarin

	==Design==		==Design==
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	==Criticisms==		==Criticisms==
			*Open-label design with respect to warfarin (blinded for dabigatran doses but not vs warfarin)
			*Industry-sponsored trial (Boehringer Ingelheim) raises potential for bias
			*Patients in the warfarin arm had time in therapeutic range (TTR) of only 64%, which is suboptimal
			*The study excluded patients with severe renal impairment (CrCl <30 mL/min), limiting applicability
			*No reversal agent was available at the time of the study (idarucizumab was later developed)

	==Funding==		==Funding==

Ostermayer: Text replacement - "EKG" to "ECG"

2016-05-19T17:18:33Z

Text replacement - "EKG" to "ECG"

← Older revision		Revision as of 17:18, 19 May 2016
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	==Inclusion Criteria==		==Inclusion Criteria==
	*A-Fib on screening ~~EKG~~ or within the past 6 months AND one of the following:		*A-Fib on screening ECG or within the past 6 months AND one of the following:
	**Previous stroke or TIA		**Previous stroke or TIA
	**LVEF<40%		**LVEF<40%

Ostermayer at 14:55, 29 November 2015

2015-11-29T14:55:05Z

← Older revision		Revision as of 14:55, 29 November 2015
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	\| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJMoa0905561		\| fulltexturl=http://www.nejm.org/doi/full/10.1056/NEJMoa0905561
	\| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJMoa0905561		\| pdfurl=http://www.nejm.org/doi/pdf/10.1056/NEJMoa0905561
			\| status=Under Review
	}}		}}
	==Clinical Question==		==Clinical Question==

Neil.m.young at 05:41, 29 November 2015

2015-11-29T05:41:13Z

← Older revision		Revision as of 05:41, 29 November 2015
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	Funded by Boehringer Ingelheim and coordinated by the Population Health Research Institute (Hamilton, ON, Canada)		Funded by Boehringer Ingelheim and coordinated by the Population Health Research Institute (Hamilton, ON, Canada)

	==~~Sources~~==		==See Also==
			*[[Atrial fibrillation]]
			*[[Dabigatran]]

			==References==
	<references/>		<references/>

	[[Category:EBQ]]		[[Category:EBQ]]

Cchoff: RE-LY

2014-10-31T22:57:05Z

RE-LY

← Older revision		Revision as of 22:57, 31 October 2014
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	==Funding==		==Funding==
			Funded by Boehringer Ingelheim and coordinated by the Population Health Research Institute (Hamilton, ON, Canada)

	==Sources==		==Sources==

Cchoff: RE-LY

2014-10-31T22:54:07Z

RE-LY

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 *TIA
 *Hospitalization
 ===Subgroup analysis===

Cchoff: RE-LY

2014-10-31T22:30:46Z

RE-LY

← Older revision		Revision as of 22:30, 31 October 2014
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	**stroke: sudden onset of focal neuro deficit, location consistent with major vessel		**stroke: sudden onset of focal neuro deficit, location consistent with major vessel
	**systemic embolism: acute vascular occlusion of extremity or organ, by imaging, surgical confirmation, or autopsy		**systemic embolism: acute vascular occlusion of extremity or organ, by imaging, surgical confirmation, or autopsy
			**Warfarin: 1.69%/year
			**Dabigatran 110mg: 1.53%/yr RR of 0.91 (CI 0.74-1.11)
			**Dabigatran 150mg: 1.11%/yr RR of 0.66 (CI 0.53-0.82)
			**Both Dabigatran doses non-inferior to Warfarin with 150 mg dose being superior to Warfarin

	*Primary safety outcome: Major Bleeding (all other bleeding considered minor)		*Primary safety outcome: Major Bleeding (all other bleeding considered minor)
	**Defined as: Hg drop of 20 g/L, transfusion of 2 units PRBC, or symptomatic bleed in critical area or organ		**Defined as: Hg drop of 20 g/L, transfusion of 2 units PRBC, or symptomatic bleed in critical area or organ
	**Life-threatening bleed (subcategory)		**Life-threatening bleed (subcategory)
	***fatal bleed, symptomatic ICH, decrease in Hgb of at least 50 g/L, transfusion of 4 units PRBC, inotropic agents or surgery required		***fatal bleed, symptomatic ICH, decrease in Hgb of at least 50 g/L, transfusion of 4 units PRBC, inotropic agents or surgery required
			**Warfarin: 3.36%/yr
			**Dabigatran 110mg: 2.71%/yr RR of 0.80 (CI 0.69–0.93)
			**Dabigatran 150mg: 3.11%/yr RR of 0.93 (CI 0.81–1.07)
			**Intracranial bleeding higher in Warfarin group than either Dabigatran group (stat significant)
			**Dabigatran 150 mg higher rate of GI bleed than Warfarin

	===Secondary Outcomes===		===Secondary Outcomes===

Cchoff: RE-LY

2014-10-31T22:06:55Z

RE-LY

← Older revision		Revision as of 22:06, 31 October 2014
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	===Primary Outcomes===		===Primary Outcomes===
			*Stroke or Systemic Embolism
			**stroke: sudden onset of focal neuro deficit, location consistent with major vessel
			**systemic embolism: acute vascular occlusion of extremity or organ, by imaging, surgical confirmation, or autopsy
			*Primary safety outcome: Major Bleeding (all other bleeding considered minor)
			**Defined as: Hg drop of 20 g/L, transfusion of 2 units PRBC, or symptomatic bleed in critical area or organ
			**Life-threatening bleed (subcategory)
			***fatal bleed, symptomatic ICH, decrease in Hgb of at least 50 g/L, transfusion of 4 units PRBC, inotropic agents or surgery required

	===Secondary Outcomes===		===Secondary Outcomes===
			*Hemorrhagic stroke
			*Death
			*MI
			*PE
			*TIA
			*Hospitalization



	===Subgroup analysis===		===Subgroup analysis===



	==Criticisms==		==Criticisms==

Cchoff: RE-LY

2014-10-31T21:50:46Z

RE-LY

← Older revision		Revision as of 21:50, 31 October 2014
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	*Recent surgery		*Recent surgery

	==Interventions==		==Interventions==
			Three groups, of which Dabigatran participants were blinded and Warfarin participants were not
			*Warfarin, adjusted dose, goal INR 2.0-3.0
			*Dabigatran 110 mg BID
			*Dabigatran 150 mg BID

	==Outcome==		==Outcome==

Cchoff: RE-LY

2014-10-31T21:46:53Z

RE-LY

← Older revision		Revision as of 21:46, 31 October 2014
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	==Exclusion Criteria==		==Exclusion Criteria==
			*Severe heart-valve disorder
			*Stroke within 14 days or severe stroke within 6 months
			*Condition increasing risk of hemorrhage
			*CRCL <30mL/min
			*Active liver disease
			*Pregnancy
			*Recent surgery

	==Interventions==		==Interventions==