The Optimal Anti-Coagulation for Enhanced-Risk Patients Post–Catheter Ablation for Atrial Fibrillation (OCEAN) trial

Verma, Atul; Ha, Andrew C.T.; Kirchhof, Paulus; Hindricks, Gerhard; Healey, Jeff S.; Hill, Michael D.; Sharma, Mukul; Wyse, D. George; Champagne, Jean; Essebag, Vidal; Wells, George A.; Gupta, Dhiraj; Heidbüchel, Hein; Sanders, Prashanthan; Birnie, David H.

doi:10.1016/j.ahj.2017.12.007

Cited by 63 publications

(28 citation statements)

References 58 publications

(60 reference statements)

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…77 The OCEAN trial is an ongoing multicentre randomized controlled trial evaluating two antithrombotic treatment strategies (rivaroxaban vs. aspirin) for patients with risk factors for stroke after apparently successful AF ablation. 78 With the greater availability of screening tools, asymptomatic individuals will be increasingly diagnosed with paroxysmal AF that would be missed by a routine ECG/Holter recording. 5,6,76 The incremental burden of AF, reflected by the clinical types of AF (from paroxysmal, to persistent and to permanent AF), has been associated with increasing risk of stroke in post hoc analyses of randomized clinical trials, [79][80][81][82][83][84][85][86][87] AF registries, [88][89][90][91] and a meta-analysis of 12 studies.…”

Section: Atrial Fibrillation and Fluttermentioning

confidence: 99%

Management of asymptomatic arrhythmias: a European Heart Rhythm Association (EHRA) consensus document, endorsed by the Heart Failure Association (HFA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin America Heart Rhythm Society (LAHRS)

et al. 2019

Self Cite

View full text Add to dashboard Cite

Asymptomatic arrhythmias are frequently encountered in clinical practice. Although studies specifically dedicated to these asymptomatic arrhythmias are lacking, many arrhythmias still require proper diagnostic and prognostic evaluation and treatment to avoid severe consequences, such as stroke or systemic emboli, heart failure, or sudden cardiac death. The present document reviews the evidence, where available, and attempts to reach a consensus, where evidence is insufficient or conflicting.

show abstract

Section: Atrial Fibrillation and Fluttermentioning

confidence: 99%

Management of asymptomatic arrhythmias: a European Heart Rhythm Association (EHRA) consensus document, endorsed by the Heart Failure Association (HFA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), Cardiac Arrhythmia Society of Southern Africa (CASSA), and Latin America Heart Rhythm Society (LAHRS)

et al. 2019

Self Cite

View full text Add to dashboard Cite

show abstract

“…Both studies take patients who have no AF following successful ablation with risk factors for stroke and randomize to withdraw or continue anticoagulation (OAT pilot study) or to rivaroxaban versus aspirin (OCEAN). 35 While completion of these trials will likely yield important results to help determine appropriate therapy post AF ablation, there should still be concern given that AF recurrence can occur in~30% of patients after apparent successful ablation as noted in our study. 3,4 Indeed, we recommend that lifelong daily pulse assessment for recurrent AF and PRN NOAC use be considered as an important safety net in all patients who undergo AF ablation and have their OAC stopped.…”

Section: Comparison To Other Studiesmentioning

confidence: 81%

“…Results of randomized studies such as the OCEAN (Optimal Anticoagulation for Higher Risk Patients Post‐Catheter Ablation for Atrial Fibrillation) trial (NCT02168829), and the OAT pilot study (Safety of Oral Anticoagulation Therapy Withdrawal After Successful Cardiac Ablation in Patients with Atrial Fibrillation and Associated High Risk Factors for Embolic Events, NCT01959425) may shed light on anticoagulation use post successful ablation. Both studies take patients who have no AF following successful ablation with risk factors for stroke and randomize to withdraw or continue anticoagulation (OAT pilot study) or to rivaroxaban versus aspirin (OCEAN) . While completion of these trials will likely yield important results to help determine appropriate therapy post AF ablation, there should still be concern given that AF recurrence can occur in ~30% of patients after apparent successful ablation as noted in our study .…”

Section: Discussionmentioning

confidence: 99%

“As Needed” nonvitamin K antagonist oral anticoagulants for infrequent atrial fibrillation episodes following atrial fibrillation ablation guided by diligent pulse monitoring: A feasibility study

Zado

Pammer

Parham

et al. 2019

Cardiovasc electrophysiol

View full text Add to dashboard Cite

Introduction After atrial fibrillation (AF) ablation, oral anticoagulation (OAC) is recommended if stroke risk as assessed by CHA2DS 2‐VASc score is high. However, patients without AF are often reluctant to take daily OAC. We describe outcome using as needed nonvitamin K antagonist (NOACs) guided by pulse monitoring to detect AF following successful ablation. Methods and Results We identified 99 patients (84% male, age 64 ± 8 years), CHA2DS 2‐VASc score greater than or equal to 1 in men and greater than or equal to 2 in women (median 2, range 1‐6), capable of pulse assessment twice daily and no AF on extended monitoring after AF ablation. All patients were instructed to start NOAC if AF >1 hour or recurrent shorter episodes. Duration of NOAC use after restart was typically 2 to 4 weeks. After 30 ± 14 months (total 244 patient‐years), 22 patients (22%) transitioned to daily NOAC because of noncompliance with pulse assessment or patient preference (six patients) or because of suspected or documented AF episode(s) in 16 (16%) patients. Of the remaining 77 (78%), 14 (14%) used NOACs but did not transition back to daily use, most (10 patients) with single use (seven patients) or non‐AF rhythm (three patients) documented. There was only one thromboembolic event (0.4%/yr of follow‐up) in patient without AF and one mild bleeding event (epistaxis). Conclusion The use of as needed NOACs when AF is suspected with pulse monitoring is effective and safe to maintain low risk of stroke and bleeding after successful ablation. Transition back to daily NOAC use should be anticipated in about one quarter of patients.

show abstract

“…Therefore, the pooled risk of stroke from long‐term studies provided in Saglietto et al 3 further supports the notion of a potential reduction in stroke risk with AF ablation compared with medical therapy, however, additional long‐term studies and randomized trials are warranted to validate these results. The ongoing Optimal Anticoagulation for enhanced‐risk patients postcatheter ablation for atrial fibrillation (OCEAN) trial is randomizing patients to continued oral anticoagulation versus aspirin only after a successful AF ablation 11 . The trial will assess the risk stroke and systemic thromboembolism at 3 years of follow‐up.…”

mentioning

confidence: 99%

Long‐term outcomes of catheter ablation for atrial fibrillation: It's a matter of time

Samuel

AlTurki

Essebag

2020

Cardiovasc electrophysiol

Self Cite

View full text Add to dashboard Cite

Bristol-Myers Squibb, Pfizer, and Servier. All other others have nothing to disclose.Atrial fibrillation (AF) ablation is a minimally invasive rhythm control strategy aimed to restore sinus rhythm in symptomatic patients who are refractory to at least one antiarrhythmic drug (AAD). 1 To reduce the AF burden, AF ablation targets the arrhythmogenic substrate responsible for triggering and maintaining AF in the left atrium. 1 Several randomized trials have demonstrated that AF ablation reduces AF recurrences and improves quality of life when compared with AADs. 2 The efficacy and effectiveness of AF ablation to decrease the incidence of hard outcomes, such as all-cause mortality, stroke, and heart failure (HF) hospitalizations, however, is less consistent, especially for long-term follow up. 3 As AF ablation is increasingly utilized as a treatment option for patients with AF 4 and indications for its use are being widened to AF patients with additional comorbidities, 1 an understanding of the long-term effectiveness of AF ablation is warranted.In this issue of the Journal of Cardiovascular Electrophysiology, Saglietto et al 3 conducted a meta-analysis of randomized controlled trials and observational studies with greater than 2 years of follow up to specifically evaluate the association between AF ablation and allcause mortality, stroke, and HF hospitalizations. Only one randomized trial, catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation (CABANA) trial, 5 and eight large observational studies were included (N = 241 372 patients) and study follow up ranged from 2.1 to 4 years. 3 After pooling the effect estimates with the random effects model, AF ablation was associated with a reduction in the incidence of all-cause mortality (hazard ratio [HR], 0.62 [95% confidence interval [CI], 0.54-0.72]), stroke (HR, 0.63 [95% CI, 0.56-0.70]), and HF hospitalization (HR, 0.64 [95% CI, 0.51-0.80]);which translates to a greater than 35% decrease for each individual event when treated with AF ablation compared with medical therapy. 3 Pooled effect estimates were primarily driven by the observational studies (weight of CABANA estimates between 0.7% and 10.7%). The degree of heterogeneity between pooled studies was low for stroke (I 2 = 23%) and HF hospitalizations (I 2 = 28%), however, there was substantial heterogeneity among estimates for all-cause mortality (I 2 = 54%). 3 The magnitude of heterogeneity (I 2 = 29%) and hazards for all-cause mortality (HR, 0.60 [95% CI, 0.53-0.67]) with AF ablation decreased when the treatment-received (HR, 0.60 [95% CI, 0.42-0.86]) rather than intent-to-treat (HR, 0.85 [95% CI, 0.60-1.21]) estimates for CABANA 5 were included in the random effects model reflecting that the treatment-received analysis more closely mimics the real-world observational estimates. In a meta-regression analysis, only advanced age was a predictor for reduced long-term effectiveness of AF ablation though important variables, such as left atrial size could not be assessed. 3 Overall, the meta-ana...

show abstract

The Optimal Anti-Coagulation for Enhanced-Risk Patients Post–Catheter Ablation for Atrial Fibrillation (OCEAN) trial

Cited by 63 publications

References 58 publications

“As Needed” nonvitamin K antagonist oral anticoagulants for infrequent atrial fibrillation episodes following atrial fibrillation ablation guided by diligent pulse monitoring: A feasibility study

Long‐term outcomes of catheter ablation for atrial fibrillation: It's a matter of time

Contact Info

Product

Resources

About