Table 3.

Summary of randomised clinical trials for periablation anticoagulation

Randomised studies

Name	Overview	Population/design	Highlighted endpoint	Take-away

COMPARE⁴³	Compare the safety and efficacy of uninterrupted warfarin to interrupted warfarin periablation.	▶ n=1584 patients undergoing ablation for non-valvular atrial fibrillation. ▶ Randomised 1:1 to interrupted versus uninterrupted warfarin before ablation.	▶ Incidence of stroke, transient ischaemic attacks or systemic embolism 48 hours after ablation.	▶ Reduced periprocedural risk for thromboembolic events with uninterrupted warfarin. ▶ Similar risk for major bleeding (tamponade, haematoma and retroperitoneal bleeding). ▶ Reduced risk of minor bleeding (haematoma or other bleeding not requiring intervention) with uninterrupted warfarin.
VENTURE-AF⁴⁵	Compare the safety and efficacy of uninterrupted rivaroxaban to uninterrupted VKA periablation.	▶ n=248 patients undergoing ablation for non-valvular atrial fibrillation. ▶ Randomised 1:1 to uninterrupted VKA or rivaroxaban. ▶ Not powered for superiority or non-inferiority,	▶ Major bleeding (as defined by ISTH, GUSTO or TIMI criteria) within 1 month of ablation. ▶ Incidence of stroke, systemic embolism, myocardial infarction and vascular death), bleeding or procedure-related event.	▶ Similar low thromboembolic and major bleeding events in patients with uninterrupted rivaraxaban or VKA.
RE-CIRCUIT⁴⁶	Compare the safety and efficacy of uninterrupted dabigatran to uninterrupted VKA periablation.	▶ n=704 patients undergoing ablation for non-valvular atrial fibrillation. ▶ Randomised 1:1 to uninterrupted dabigatran or warfarin.	▶ Major bleeding (as defined by ISTH) within 8weeks of ablation. ▶ Stroke, systemic embolism and TIA within 8 weeks of ablation.	▶ Reduced risk of major bleeding events with uninterrupted dabigatran compared with warfarin. ▶ Similar incidence of stroke and systemic embolism.
AXAFA-AFNET 5⁴⁸	Compare the safety and efficacy of uninterrupted apixaban to uninterrupted VKA periablation.	▶ N=767 patients undergoing first time ablation for non-valvular atrial fibrillation. ▶ Randomised 1:1 to continuous apixaban or VKA.	▶ Death, stroke or bleeding (based on BARC) at 90 days. ▶ Acute brain lesion on MRI and cognitive function.	▶ Apixaban was non-inferior to VKA for the stroke, bleeding or death at 90 days. ▶ Similar improvement in cognitive function and similar incidence of brain lesions.
ABRDIGE-J⁴⁹	Compare the safety and efficacy of minimally interrupted dabigatran to uninterrupted warfarin periablation.	▶ N=504 patients undergoing ablation for non-valvular atrial fibrillation. ▶ Randomised 1:1 to minimally interrupted dabigatran or uninterrupted warfarin 4 weeks prior to procedure.	▶ Incidence of embolism and presence of LAA before ablation (on TOE or ICE). ▶ Major bleeding events (as defined by ISTH) up to 3 months postablation. ▶ Major bleeding, thromboembolic events, all-cause death up to 3 months postablation.	▶ Reduced bleeding events in minimally interrupted dabigatran compared with uninterrupted warfarin. ▶ Similar incidence of thromboembolic events.

BARC, Bleeding Academic Research Consortium; GUSTO, Global Use of Strategies to Open Occluded Coronary Arteries; ICE, intracardiac echocardiography; ISTH, International Society on Thrombosis and Haemostasis; LAA, left atrial appendage; TIMI, thrombosis in myocardial infarction; TOE, transoesophageal echocardiography; VKA, vitamin K antagonist.