Experts reveal that the real-world medical results are actually 'reassuring' and could assist methods of other trials and studies in the future.
The findings were presented in two separate research papers. According to the experts of this research, real-world patients that have atrial fibrillation progressed in further approach after taking left atrial appendage occlusion or LAAO operation.
Results from First-Generation Watchman Operations
The operations were carried out through the usage of the first-generation Watchman device along with contributing support from the antithrombotic medications that patients received during postprocedure.
Watchman patients between 2016 and 2018 were observed to have fewer complications and yielded lower risks of any implant failures as well as uncontrollable ischemic stroke. When treated with the device, these patients underwent PREVAIL and PROTECT-AF trials that were approved by the US Food and Drug Administration back in 2015.
One of the recent studies that utilized the same data found that there were frequent deviations that followed the postprocedural pharmacologic therapy administered during the trials. According to this study, there were only one in ten real-world patients that received the full protocol were able to undergo stipulation.
Yale School of Medicine specialist and lead of the study James Freeman explained that the study discovered how the protocols indeed vary due to changes and shifts when they are applied in real-world practices.
Freeman adds that the most common changes from various outcomes during postprocedural protocols were demonstrated in the trials through the discharge antithrombotic strategy, reports TCTMD.
The antithrombotic study allowed Freeman and colleagues to analyze the information collected from the LAAO Registry, which is under the umbrella of the American College of Cardiology's National Cardiovascular Data Registry.
In this dataset, included groups were active patients that have follow-ups related to the Watchman procedures. These individuals sum up to nearly 40,000 patients with an average age of 76 years and with 41 percent being female. Almost all patients, approximately at 98.2, were discharged with the help of drugs under anticoagulants and/or antiplatelets.
Efficacy of Postprocedure Medications
The patients involved in the registry were discharged on aspirin and warfarin (36.9 percent), aspiring and direct oral anticoagulants DOAC (20.8 percent), and warfarin only (13.5 percent), and DOAC only (12.3 percent). Smaller groups, which is about five percent, were discharged with dual antiplatelet therapy or DAPT.
Experts found that the risk of adverse effects inflicting the patients within 45 days after the discharge was lower in the warfarin-only and direct oral anticoagulant-only receivers when the rate was compared with similar drugs that were given during the trials. After six months, the adverse effects of other drugs had higher risks.
Freeman explained that the usage of antiplatelet agents with anticoagulation might not be necessary, and the anticoagulation only with a DOC administration would suffice as the most optimal approach for almost all patients, but further studies are needed in order to confirm the said efficacy.
The two studies, along with the supporting findings from other collaborators, were published in the Journal of the American College of Cardiology (1, 2, 3, 4).
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