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BRIDGE Trial Summary: Douketis JD et al. randomized 1,884 patients on warfarin (INR 2-3 for ≥3m) with AF or A-flutter and CHADS2 Score ≥1 to LMWH: dalteparin (100 IU/kg BID) or placebo. The objective was to assess if bridging anticoagulation reduce rates of arterial thromboembolism compared to no bridging in patients with atrial fibrillation undergoing an invasive procedure. The results showed noninferiority (P=0.01) of the primary outcome (TIA or stroke or arterial embolism) in patients with no bridging as compared with bridging. The authors of the BRIDGE trial concluded that among patients with low- and intermediate-risk atrial fibrillation receiving anticoagulation and undergoing an invasive procedure, periprocedural bridging anticoagulation with LMWH did not reduce the incidence of arterial thromboembolism when compared to no bridging, but did increase the risk of major bleeding.
2006, Clopidogrel and aspirin versus aspirin alone for prevention of atherothrombosis, NEJM
2014, 30 Days AF monitoring in patients with Cryptogenic Stroke, NEJM
CRYSTAL AF Trial Summary
The Cryptogenic Stroke and Underlying Atrial Fibrillation (CRYSTAL AF) trial randomized 441 patients ,who were 40 years or older and with a diagnosis of cryptogenic stroke or transient ischemic attack within 90 days, in a 1:1 ratio to Insertable Cardiac Monitor (ICM) implantation or routine monitoring at the investigator’s discretion. Prior to randomization, all patients underwent at least 24 hours of ECG monitoring and had no evidence of atrial fibrillation at baseline. Patients were enrolled in 55 centers in Canada, Europe, and the United States. The primary endpoint was the time to first detection of atrial fibrillation, lasting >30 seconds, within 6 months. Approximately, 8.9% of patients in the ICM group were diagnosed with AF, compared with 1.4% in the control group (HR: 6.4; 95%CI: 1.9 to 21.7; p<0.001). Results were consistent through 12 months and 36 months. Atrial fibrillation diagnosed in the ICM group was more frequently asymptomatic than in the control group. Prescription of oral anticoagulants was more than doubled in the ICM group, as compared with the control group, at both 6 and 12 months.
We currently lack significant data or clear cut guidelines for closing left atrial appendage in patients with LAA for prevention of stroke. The current ACC/AHA/HRS guidelines recommends anticoagulation in patients with atrial fibrillation and CHA2DS2-VASc >2 (Grade Ia) irrespective of presence or absence of LAA.
The PROTECT AF trial was a randomized non-inferior trial that studied the usefulness of WATCHMAN device in closing LAA and prevention of stroke. The trial did show non-inferiority of the device closure vs warfarin anticoagulation but it was associated with higher side effects which were mostly periprocedural.
Based on this trial, the 2012 Focus European Society of Cardiology Guidelines called for “LAA closure/occlusion/excision” using percutaneous device in patients who are at high stroke risk and have contraindications for long-term oral anticoagulation (Class IIb; Level of Evidence B). The current AHA/ACC/HRS, however, does not include recommendations of LAA closure devices due to lack of enough robust evidence. However, both ESC and AHA/ACC guidelines suggest that surgical excision of the LAA may be considered in patients undergoing cardiac surgery or thoracoscopic atrial fibrillation surgery (Grade IIB)
Sources: Lancet, 2015 ACC/HRS/SCAI LAA Occlusion Device Societal Overview
Source: JAMA Neurology