Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT‐AF/VTE)—Trial design

Colonna, Paolo; Heymann, Christian von; Santamaría, A.; Matsushita, Yasuyuki; Unverdorben, Martin

doi:10.1002/clc.23037

Cited by 9 publications

(8 citation statements)

References 27 publications

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“…The EMIT study was a multicentre, prospective, and noninterventional study integrating data from seven European and four Asian countries. The detailed design has been published [ 13 , 14 ]. The study was conducted in accordance with the Declaration of Helsinki and with local Institutional Review Board approvals and was registered as NCT02950168.…”

Section: Methodsmentioning

confidence: 99%

Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Unverdorben

Heymann

Santamaría

et al. 2020

BMC Cardiovasc Disord

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Background Annually > 10% of patients with atrial fibrillation on oral anticoagulation undergo invasive procedures. Optimal peri-procedural management of anticoagulation, as judged by major bleeding and thromboembolic events, especially in the elderly, is still debated. Methods Procedures from 1442 patients were evaluated. Peri-procedural edoxaban management was guided only by the experience of the attending physician. The primary safety outcome was the rate of major bleeding. Secondary outcomes included the peri-procedural administration of edoxaban, other bleeding events, and the main efficacy outcome, a composite of acute coronary syndrome, non-hemorrhagic stroke, transient ischemic attack, systemic embolic events, deep vein thrombosis, pulmonary embolism, and mortality. Results Of the 1442 patients, 280 (19%) were < 65, 550 (38%) were 65–74, 514 (36%) 75–84, and 98 (7%) were 85 years old or older. With increasing age, comorbidities and risk scores were higher. Any bleeding complications were uncommon across all ages, ranging from 3.9% in patients < 65 to 4.1% in those 85 years or older; major bleeding rates in any age group were ≤ 0.6%. Interruption rates and duration increased with advancing age. Thromboembolic events were more common in the elderly, with all nine events occurring in those > 65, and seven in patients aged > 75 years. Conclusion Despite increased bleeding risk factors in the elderly, bleeding rates were small and similar across all age groups. However, there was a trend toward more thromboembolic complications with advancing age. Further efforts to identify the optimal management to reduce ischemic complications are needed. Trial registration: NCT# 02950168, October 31, 2016

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Section: Methodsmentioning

confidence: 99%

Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Unverdorben

Heymann

Santamaría

et al. 2020

BMC Cardiovasc Disord

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“…This can potentially help optimize the care of patients receiving anticoagulation with edoxaban. In addition, the ongoing Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT)‐AF/VTE registry will provide data on the periprocedural management of edoxaban in routine clinical practice in patients with AF or VTE …”

Section: Discussionmentioning

confidence: 99%

“…In addition, the ongoing Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT)-AF/VTE registry will provide data on the periprocedural management of edoxaban in routine clinical practice in patients with AF or VTE. 22 The Global ETNA program will be the largest source of prospective routine clinical care data on edoxaban with the planned treatment of >31 000 patients. The program will provide important information on the safety of edoxaban and further information on its effectiveness in patients with AF and VTE, enhancing medical knowledge on edoxaban use in routine clinical care.…”

Section: Discussionmentioning

confidence: 99%

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Caterina

Agnelli

Laeis

et al. 2019

Clinical Cardiology

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Background Randomized controlled trials showed the nonvitamin K oral anticoagulant (NOAC) edoxaban was effective and safe for stroke and systemic embolism prevention in nonvalvular atrial fibrillation (AF) and for the prevention and treatment of venous thromboembolism (VTE; including pulmonary embolism and deep vein thrombosis). Additional research is needed to evaluate the effects of edoxaban in routine clinical practice. Therefore, the Edoxaban Treatment in routine cliNical prActice (ETNA) program is being conducted to provide routine clinical care data on characteristics and outcomes in patients with AF or VTE receiving edoxaban. Methods The Global ETNA program integrates prospectively collected data from edoxaban patients in regional ETNA noninterventional studies across Europe, Japan, and East and Southeast Asia into indication‐specific databases for AF and VTE. Targeted enrollment is >31 000 patients (AF >26 000; VTE >4500), with a follow‐up of 2 years for AF and 1 year for VTE. Data integration will be possible using consistent terminology, parameter definitions, and data collection across the regional noninterventional studies. Safety and effectiveness data will be assessed. Crude rates of outcomes including bleeding and thromboembolic events will be reported. Results Globally, enrollment began in early 2015 and is ongoing. Conclusions Global ETNA will generate the largest integrated prospective repository of routine clinical care data for a single NOAC in patients with AF or VTE. It will provide important information on the safety of edoxaban in routine clinical care and gather further information on its effectiveness.

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“…The protocol design 8 and overall results 9 The observation period of the study started 5 days before the procedure and ended 30 days afterwards. To enhance data capture, patients received a memory aid booklet at enrolment into the study, which was reviewed at the end of the study.…”

Section: Methodsmentioning

confidence: 99%

Thromboembolic and bleeding risks in edoxaban patients with pacemaker and cardiac monitoring procedures: Outcomes of the Global EMIT program

Unverdorben

Heymann

Santamaria

et al. 2021

Pacing Clinical Electrophis

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Introduction: Limited data were published on the management of direct oral anticoagulants in the insertion of pacemaker and cardiac monitoring devices. This study describes the management and outcomes of edoxaban, a direct oral factor Xa inhibitor, in patients undergoing pacemaker or monitoring device implantation in routine clinical practice.Methods and Results: EMIT-AF/VTE collected data of patients from Europe, Korea, and Taiwan. Timing and duration of periprocedural interruption of edoxaban were at the treating physician's discretion. Pacemakers or monitoring devices were implanted into 136 patients who were evaluated from 5 days pre-until 30 days post-procedure. The primary outcomes were the incidences of acute thromboembolic events (ATE), ischemic events, and International Society on Thrombosis and Haemostasis-defined Major Bleeding; secondary outcomes included incidence of clinically relevant nonmajor bleeding (CRNMB) and perioperative edoxaban interruption times. Conformance with European Heart Rhythm Association (EHRA) Guidance on interruption of direct oral anticoagulant therapy was variable: of the cardiac monitoring device patients, where no interruption of therapy would be expected, nonetheless, 62.5% had interruption of treatment, whereas in pacemaker procedures, where interruption would be expected, 23.4% had no interruption. No ATE or ischemic events occurred.One case of CRNMB and two of minor bleeding occurred. All bleedings occurred more than 3 days after the procedure. Conclusion/Relevance:The periprocedural complication risk for edoxaban treated patients undergoing pacemaker or invasive cardiac monitoring implantation was low. This population of patients was well managed in routine practice.

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Edoxaban Management in Diagnostic and Therapeutic Procedures (EMIT‐AF/VTE)—Trial design

Cited by 9 publications

References 27 publications

Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

Elderly patients with atrial fibrillation in routine clinical practice—peri-procedural management of edoxaban oral anticoagulation therapy is associated with a low risk of bleeding and thromboembolic complications: a subset analysis of the prospective, observational, multinational EMIT-AF study

The global Edoxaban Treatment in routine cliNical prActice (ETNA) noninterventional study program: rationale and design

Thromboembolic and bleeding risks in edoxaban patients with pacemaker and cardiac monitoring procedures: Outcomes of the Global EMIT program

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