Phase 3 N=1,426 Randomized Treatment

Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation (ENVISAGE-TAVI AF)

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT02943785 ↗

Enrolled (actual)

1,426

Serious AEs

55.2%

Results posted

Mar 2022

Primary outcome: Primary: Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA — 170; 157 Participants — p=0.0141

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Edoxaban-based Regimen (Drug); VKA-based Regimen (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Daiichi Sankyo
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA	170; 157	0.0141 sig
PRIMARY Number of Participants Who Experienced Major Bleeding (Adjudicated Data) Based on ISTH Criteria in Participants Taking Edoxaban vs VKA	98; 68	0.9267
SECONDARY Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on TIMI Criteria in Participants Taking Edoxaban vs VKA	154; 141; 72; 42	—
SECONDARY Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on BARC Type 3 or 5 Criteria in Participants Taking Edoxaban vs VKA	164; 151; 89; 57	—
SECONDARY Number of Participants Who Experienced Net Adverse Clinical Events (Adjudicated Data) Based on GUSTO Criteria in Participants Taking Edoxaban vs VKA	160; 146; 82; 51	—
SECONDARY Number of Participants Who Experienced Major Adverse Cardiac Events (MACE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)	61; 53	—
SECONDARY Number of Participants Who Experienced Major Adverse Cardiac and Cerebrovascular Events (MACCE) in Participants Taking Edoxaban vs VKA (Adjudicated Data)	86; 80	—
SECONDARY Number of Participants Who Experienced a Composite of Adverse Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)	151; 123	—
SECONDARY Number of Participants Who Experienced Stroke Events (Ischemic, Hemorrhagic, Undetermined) in Participants Taking Edoxaban vs VKA (Adjudicated Data)	29; 35; 4; 3; 25; 32	—
SECONDARY Number of Participants Who Experienced Systemic Embolic Events in Participants Taking Edoxaban vs VKA (Adjudicated Data)	2; 3	—
SECONDARY Number of Participants Who Experienced Myocardial Infarctions (MI) in Participants Taking Edoxaban vs VKA (Adjudicated Data)	12; 7	—
SECONDARY Number of Participants Who Experienced Valve Thrombosis in Participants Taking Edoxaban vs VKA (Adjudicated Data)	0; 0	—

Summary

When the upper chambers of a person's heart receive or generate irregular electrical signals, it causes abnormal rhythm in the heartbeat. This is called atrial fibrillation. Atrial fibrillation goes along with blood clots that may cause mainly strokes and less often other diseases, such as a heart attack. Some patients with atrial fibrillation have other heart disease, such as heart valves that may need to be replaced using catheters. Often doctors give patients drugs that reduce those blood clots. These are either vitamin K antagonist (VKA) or direct anticoagulants, such as edoxaban. In these patients, it is unclear which of the drugs is better for reducing stroke without increasing severe bleedings.

Eligibility Criteria

Inclusion Criteria

Meets protocol-specified criteria for qualification and contraception
Is willing and able to comply with any restrictions related food, drink and medications
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
the safety or well-being of the participant or study staff
the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
the analysis of results

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02943785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.