Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry

Beyer‐Westendorf, Jan; Gelbricht, Vera; Förster, Kati; Ebertz, Franziska; Köhler, Christof; Werth, Sebastian; Kuhlisch, Eberhard; Stange, Thoralf; Thieme, Christoph; Daschkow, Katharina; Weiss, Norbert

doi:10.1093/eurheartj/eht557

Cited by 337 publications

(319 citation statements)

References 16 publications

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“…This assumption is based on recent published data from the Dresden NOAC registry investigating the periprocedural management of NOACs in daily care 5. In this registry, 2179 patients were enrolled.…”

Section: Methodsmentioning

confidence: 99%

“…The short half‐lives of NOAC of 5 to 15 hours and their rapid onset of action with maximum plasma concentrations achieved in 1 to 4 hours after administration may allow for brief periods of treatment interruption without the need for heparin bridging 5, 6, 7. Current evidence suggests that if the bleeding risk is low to intermediate, interruption of anticoagulation therapy may not be necessary 8.…”

Section: Introductionmentioning

confidence: 99%

“…However, these secondary analyses are limited by the paucity of detailed information on management of patients who undergo invasive diagnostic/therapeutic procedures, and are retrospective and do not allow for any causality to be established between drug management and endpoint 8, 9, 10. On the other hand, the advantages of prospective studies specifically addressing this question are typically hampered by smaller patient numbers 5, 7…”

Section: Introductionmentioning

confidence: 99%

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

Colonna¹,

Heymann

Santamaría

et al. 2018

Clinical Cardiology

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Non‐vitamin K dependent oral anticoagulants (NOAC) are now widely used in patients with nonvalvular atrial fibrillation (NVAF) for stroke prevention and in patients with venous thromboembolism (VTE) for the treatment and secondary prevention of the disease. Among NOAC, edoxaban demonstrated noninferiority to warfarin for stroke prevention in NVAF and for VTE treatment, with superior safety. EMIT‐AF/VTE (Edoxaban Management in Diagnostic and Therapeutic Procedures) (NCT02950168) is a multicenter, prospective, and noninterventional registry study designed to collect detailed information on the periprocedural management of patients with NVAF and VTE receiving edoxaban. The primary objective of EMIT‐AF/VTE is to document the periprocedural management of patients receiving edoxaban and to collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding. Other assessments include the evaluation of efficacy outcomes, periprocedural dosing, and timing of edoxaban. The observation period will start 5 days prior to the procedure and end 30 days post‐procedure. EMIT‐AF/VTE will aim to prospectively enroll up to approximately 1400 procedures from Europe. Enrollment commenced in December 2016 and will be completed in July 2018. As of July 2018, before database lock and with several procedure forms still temporarily inserted, a preliminary number of 1204 patients have been enrolled, who underwent a total of 1453 procedures. The prospective EMIT‐AF/VTE registry program will expand the knowledge of periprocedural management of patients with NVAF and VTE receiving edoxaban in clinical practice.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Colonna¹,

Heymann

Santamaría

et al. 2018

Clinical Cardiology

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“…Approximately 30 % of DOACs-treated patients received heparin bridging, while the remaining underwent temporary short interruptions (48.6 %) or simply continued the DOACs (21.7 %). Major bleeding complications are higher in procedures with heparin bridging compared to procedures without heparin bridging (2.7 vs 0.5 %, p = 0.010), while no difference is found in major cardiovascular events (1.6 vs 0.8 %, p = 0.265) [20], thus supporting the lack of need for bridging therapy. However, due to the fact that peri-procedural management was left to the discretion of the attending physicians, a selection bias arising from the individual patients characteristics, as well as the type of procedures could have influenced the outcomes.…”

mentioning

confidence: 88%

“…A sub-analysis from the RE-LY trial reports similar rates of peri-procedural major bleeding between dabigatran and warfarin (3.8 % for dabigatran 110 mg BID, 5.1 % for dabigatran 150 mg BID and 4.6 % for warfarin), but 17 % of dabigatran-treated patients received heparin bridging anyway [19]. In the Dresden registry, the overall rates of peri-interventional major cardiovascular events and major bleeding with the DOACs are low (1.0 and 1.2 %, respectively) [20]. Approximately 30 % of DOACs-treated patients received heparin bridging, while the remaining underwent temporary short interruptions (48.6 %) or simply continued the DOACs (21.7 %).…”

mentioning

confidence: 99%

Direct oral anticoagulants in atrial fibrillation: can data from randomized clinical trials be safely transferred to the general population? Yes

Riva

Ageno²

2015

Intern Emerg Med

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Atrial fibrillation is the most common arrhythmia and is associated with significant morbidity and mortality. The current therapeutic options for patients at high thromboembolic risk include the vitamin K antagonists and the direct oral anticoagulants. These novel agents have been evaluated in more than 40,000 patients enrolled in four large randomized controlled trials for stroke prevention in non-valvular atrial fibrillation. When these results were pooled together, a greater efficacy profile, as well as a consistent reduction in life-threatening bleeding was shown in comparison to vitamin K antagonists. Randomized controlled trials offer the highest level of evidence on the efficacy and safety of an intervention; however, their results may not be directly applicable to the general population. The results of a number of post-marketing observational studies from the United States and Europe have been published. The results of these studies substantially confirm the findings of the randomized trials and show a favorable safety profile with the use of the direct oral anticoagulants even in unselected populations. Keywords Atrial fibrillation Á Factor Xa inhibitors Á Thrombin inhibitorsAtrial fibrillation (AF) is the most common dysrhythmia and is associated with significant morbidity and mortality [1]. The presence of AF increases a risk of ischemic stroke approximately five times the non dysrhythmic person, and cardio-embolic strokes carry the highest fatality rates [2]. The risk of stroke in patients with AF is proportional to the number of risk factors which are summarized by the CHA 2 DS 2 -VASc score: congestive heart failure; hypertension; age C75 years (doubled); diabetes mellitus; previous stroke or systemic embolism (doubled); vascular disease; age 65-74 years; and female gender [3]. The current therapeutic options for patients at high thromboembolic risk include the vitamin K antagonists (VKAs) and the novel direct oral anticoagulants (DOACs). VKAs have been the only available oral anticoagulants for about 70 years, but they have several drawbacks, which led to their underuse in real-life AF patients [4]. The DOACs, instead, besides the target-specific action on thrombin (dabigatran) or on factor Xa (apixaban, edoxaban and rivaroxaban) and also have a predictable dose-response, which allows fixed dose regimens without the need for routine laboratory monitoring.The DOACs have been evaluated in more than 40,000 patients enrolled in four large randomized controlled trials (RCTs) for stroke prevention in AF [5]. When these results are pooled together, a greater efficacy profile (19 % reduction in stroke or systemic embolism and 10 % reduction in all-cause mortality), as well as a consistent reduction in lifethreatening bleeding (52 % lower risk of intracranial hemorrhages) is shown in comparison to VKAs [5].RCTs offer the highest level of evidence of the efficacy and safety of an intervention; however, their results may not be directly applicable to the general population. In fact, RCTs have rigoro...

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Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

et al. 2019

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IMPORTANCE Patients with atrial fibrillation (AF) who use a direct oral anticoagulant (DOAC) and request elective surgery or procedure present a common clinical situation yet perioperative management is uncertain. OBJECTIVE To investigate the safety of a standardized perioperative DOAC management strategy. DESIGN, SETTING, AND PARTICIPANTS The Perioperative Anticoagulation Use for Surgery Evaluation (PAUSE) cohort study conducted at 23 clinical centers in Canada, the United States, and Europe enrolled and screened patients from August 1, 2014, through July 31, 2018. Participants (n = 3007) had AF; were 18 years of age or older; were long-term users of apixaban, dabigatran etexilate, or rivaroxaban; were scheduled for an elective surgery or procedure; and could adhere to the DOAC therapy interruption protocol. INTERVENTIONS A simple standardized perioperative DOAC therapy interruption and resumption strategy based on DOAC pharmacokinetic properties, procedure-associated bleeding risk, and creatinine clearance levels. The DOAC regimens were omitted for 1 day before a low-bleeding-risk procedure and 2 days before a high-bleeding-risk procedure. The DOAC regimens were resumed 1 day after a low-bleeding-risk procedure and 2 to 3 days after a high-bleeding-risk procedure. Follow-up of patients occurred for 30 days after the operation. MAIN OUTCOMES AND MEASURES Major bleeding and arterial thromboembolism (ischemic stroke, systemic embolism, and transient ischemic attack) and the proportion of patients with an undetectable or minimal residual anticoagulant level (<50 ng/mL) at the time of the procedure. RESULTS The 3007 patients with AF (mean [SD] age of 72.5 [9.39] years; 1988 men [66.1%]) comprised 1257 (41.8%) in the apixaban cohort, 668 (22.2%) in the dabigatran cohort, and 1082 (36.0%) in the rivaroxaban cohort; 1007 patients (33.5%) had a high-bleeding-risk procedure. The 30-day postoperative rate of major bleeding was 1.35% (95% CI, 0%-2.00%) in the apixaban cohort, 0.90% (95% CI, 0%-1.73%) in the dabigatran cohort, and 1.85% (95% CI, 0%-2.65%) in the rivaroxaban cohort. The rate of arterial thromboembolism was 0.16% (95% CI, 0%-0.48%) in the apixaban cohort, 0.60% (95% CI, 0%-1.33%) in the dabigatran cohort, and 0.37% (95% CI, 0%-0.82%) in the rivaroxaban cohort. In patients with a high-bleeding-risk procedure, the rates of major bleeding were 2.96% (95% CI, 0%-4.68%) in the apixaban cohort and 2.95% (95% CI, 0%-4.76%) in the rivaroxaban cohort. CONCLUSIONS AND RELEVANCE In this study, patients with AF who had DOAC therapy interruption for elective surgery or procedure, a perioperative management strategy without heparin bridging or coagulation function testing was associated with low rates of major bleeding and arterial thromboembolism.

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Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry

Abstract: Continuation or short-term interruption of NOAC is safe strategies for most invasive procedures. Patients at cardiovascular risk undergoing major procedures may benefit from heparin bridging, but bleeding risks need to be considered.

Cited by 337 publications

References 16 publications

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

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

Direct oral anticoagulants in atrial fibrillation: can data from randomized clinical trials be safely transferred to the general population? Yes

Perioperative Management of Patients With Atrial Fibrillation Receiving a Direct Oral Anticoagulant

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