Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial

Ezekowitz, Michael D.; Pollack, Charles V.; Sanders, Paul; Halperin, Jonathan L.; Spahr, Judith; Cater, Nilo B.; Petkun, William; Breazna, Andrei; Kirchhof, Paulus; Oldgren, Jonas

doi:10.1016/j.ahj.2016.06.008

Cited by 34 publications

(30 citation statements)

References 24 publications

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“…The efficacy and safety of NOACs prior to cardioversion was further evaluated in three large prospective randomized trials: X‐VeRT (eXplore the efficacy and safety of once‐daily oral riVaroxaban for the prevention of caRdiovascular events in patients with non‐valvular aTrial fibrillation scheduled for cardioversion), ENSURE‐AF (EdoxabaN vs. warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation), and more recently EMANATE (Eliquis evaluated in acute cardioversion coMpared to usuAl treatmeNts for AnTicoagulation in subjEcts with non‐valvular atrial fibrillation). These trials showed a comparable risk of periprocedural events for rivaroxaban, edoxaban, and apixaban, respectively, to warfarin for patients undergoing electrical cardioversion . None of these trials considered the presence of intracardiac thrombi.…”

supporting

confidence: 90%

Assessing intracardiac thrombus prior to cardioversion: A story yet to be told

Anouti

Kowey

2018

Cardiovasc electrophysiol

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Direct current cardioversion was invented by Bernard Lown in 1962,and has been used for over half a century to restore sinus rhythm in patients with atrial fibrillation. Unfortunately, electrical cardioversion without anticoagulation has an inherent risk of thromboembolism that ranges from 5% to 7%, usually within the first week after the procedure. Patients undergoing electric cardioversion are therefore treated with therapeutic doses of anticoagulation for 3 weeks before the procedure and, for those without a reason to take chronic anticoagulation, for at least 4 weeks after. 1 The rationale for 3 weeks of therapeutic anticoagulation (that is maintaining an international normalized ratio [INR] > 2 for 3 consecutive weeks) prior to cardioversion is based on a number of lines of evidence. First of all, in nonrandomized studies, the incidence of thromboembolism in patients who have been properly treated with warfarin is a small fraction of what it is in patients who are not so treated. 2 In addition, Goldman et al. proposed that within 14 days there is sufficient fibroblastic infiltration to cause firm adherence of the thrombus to the atrial endocardium, thus reducing the likelihood of dislodgment. 3 Four weeks of anticoagulation following cardioversion is supported by Doppler echocardiographic studies showing restoration of the transmitral atrial (A) wave. 4The Assessment of Cardioversion Using Transesophageal Echocardiography (ACUTE) study showed that transesophageal echocardiography (TEE)-guided cardioversion with short-term anticoagulation was a safe and an effective alternative to warfarin pretreatment. 5 Since then, TEE has provided a reliable and expedient tool for detection of left atrial appendage thrombus before cardioversion. A major breakthrough in the management of atrial fibrillation and its associated thromboembolic risk was the advent of novel oral anticoagulant (NOAC) drugs, each showing noninferiority, and in some cases superiority, to warfarin in rates of all-cause stroke and systemic embolism. Though none of the NOAC trials had detection of left atrial thrombus as a primary endpoint, subgroup analyses of these trials revealed a low thromboembolic risk that was comparable to warfarin in patients treated with a NOAC for ≥3 weeks prior to cardioversion. In a subgroup analysis of patients in the RELY trial (Randomized Evaluation of Long Term Anticoagulant Therapy), the rate of detection of left atrial thrombus among patients undergoing TEE cardioversion was in the range of 1.2-1.8% and 2.9% for patients on dabigatran and warfarin, respectively. 6 In the ARISTOTLE trial (Apixaban for the Prevention of Stroke in Subjects with Atrial Fibrillation), none of the 86 patients who underwent TEE cardioversion had an LA thrombus. 7 The efficacy and safety of NOACs prior to cardioversion was further evaluated in three large prospective randomized trials: X-VeRT (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in patients with non-valvular aTrial fibri...

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supporting

confidence: 90%

Assessing intracardiac thrombus prior to cardioversion: A story yet to be told

Anouti

Kowey

2018

Cardiovasc electrophysiol

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“…Similar to previous studies, this post-hoc analysis does not have sufficient statistical power to find small differences in outcomes, however available data reporting very few peri-cardioversion adverse events with either apixaban or warfarin treatment are reassuring. Currently, a prospective RCT comparing apixaban with the standard care of warfarin in anticoagulation-naïve patients undergoing cardioversion is ongoing [13] and will provide further useful information.…”

Section: Apixaban In Patients Undergoing Cardioversionmentioning

confidence: 99%

Direct oral anticoagulants in patients undergoing cardioversion: insight from randomized clinical trials

Fusco¹,

Colivicchi²,

Aspromonte³

et al. 2017

Monaldi Arch Chest Dis

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Anticoagulation, reducing the risk of thromboembolic events in patients undergoing cardioversion, is a cornerstone of peri-cardioversion management in patients with atrial fibrillation. We aimed to analyse published data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients undergoing cardioversion.We performed a systematic review of randomized prospective clinical trials (RCTs) comparing DOACs with warfarin and reporting data on post-cardioversion outcomes of interest. Outcomes of interest were stroke, systemic thromboembolic events and major bleeding. We reviewed a total of six RCTs including 3900 cardioversions performed using a DOAC for thromboembolic prophylaxis. These studies reported a low incidence overall of adverse outcomes associated with the use of DOACs (around 1% in all studies, except the ROCKET posthoc study which included ablation procedures). The incidence rate of adverse events during DOAC treatment was found to be very similar to that observed with warfarin anticoagulation.In RCTs DOAC treatment in patients undergoing cardioversion appears to be effective and safe. However, because evidence in this clinical setting is still weak, observational reports could be useful in providing further data about peri-procedural outcomes.

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“…50 Direct oral anticoagulants appear to be a safe and effective alternative to warfarin for anticoagulation in cardioversion; some studies suggest improved outcomes with DOAC use. 51 Guidelines that recommend warfarin over DOACs were published prior to the majority of the former data being published. 25 It is reasonable to use DOACs both peri-and postprocedurally in patients undergoing cardioversion.…”

Section: Anti Coag Ul Ati On In C Ardiover S Ion For Atrial Arrhy Tmentioning

confidence: 99%

Anticoagulation in the cardiac patient: A concise review

Larson

German

Shatzel

et al. 2018

European J of Haematology

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Anticoagulation has multiple roles in the treatment of cardiovascular disease, including in management of acute myocardial infarction, during percutaneous coronary intervention, as stroke prophylaxis in patients with atrial arrhythmias, and in patients with mechanical heart valves. Clinical anticoagulation choices in the aforementioned diseases vary widely, due to conflicting data to support established agents and the rapid evolution of evidence-based practice that parallels more widespread use of novel oral anticoagulants. This review concisely summarizes evidence-based guidelines for anticoagulant use in cardiovascular disease, and highlights new data specific to direct oral anticoagulants.

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Apixaban compared with parenteral heparin and/or vitamin K antagonist in patients with nonvalvular atrial fibrillation undergoing cardioversion: Rationale and design of the EMANATE trial

Abstract: This first prospective cardioversion study of a novel anticoagulant in anticoagulation-naïve patients should influence clinical practice.

Cited by 34 publications

References 24 publications

Assessing intracardiac thrombus prior to cardioversion: A story yet to be told

Assessing intracardiac thrombus prior to cardioversion: A story yet to be told

Direct oral anticoagulants in patients undergoing cardioversion: insight from randomized clinical trials

Anticoagulation in the cardiac patient: A concise review

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