Comparison among three different antithrombotic strategies after percutaneous LAA occlusion with a Watchman FLX LAAC device.
Data on the optimal antithrombotic therapy (AT) after percutaneous left atrial appendage (LAA) occlusion are still scarce. The classical AT strategy after LAA occlusion includes 6-weeks of warfarin + aspirin followed by dual anti platelet therapy with clopidogrel (75 mg) and aspirin (81-325 mg) until 6 months of follow-up, then aspirin alone is continued indefinitely. Nonetheless, a significant number of patients continues to suffer from device-related thrombosis which carries a high risk of thromboembolic events. Other AT strategies have been tested in order to reduce the risk of thrombus-formation on device. Among them, replacement of clopidogrel with half-dose oral anticoagulation (OAC) in patients with genetic resistance to this drug has been recently reported to reduce the incidence of DRT. Additionally, reduced dose of novel OAC was demonstrated to lead to lower thrombin generation compared to DAPT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
360
OAC (6 weeks) + DAPT (until 6 months) + ASA
Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
Half Dose of novel OAC post-device Implantation
St. David's Medical Center
Austin, Texas, United States
RECRUITINGComposite of Stroke, Systemic Embolism, and Device-related Thrombosis
Time frame: 1 year
Incidence of Major Bleeding Events
Time frame: 1 year
Incidence of Minor Bleeding Events
Time frame: 1 year
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