CHAMPION-AF: Antibodies for Left Extra Zuma Ache vs AFib
Device-based left ventricular closure (LAA) closure is comparable to treatment without vitamin K antagonist oral anticoagulant (NOAC) in reducing mortality from coronary heart disease, stroke, or systemic occlusion within 3 years in patients with atrial fibrillation (AFib) in AFCHPI trials compared to AFCHPI.ACC.26 is printed simultaneously in the NEJM.In addition, closing the LAA with a pre-determined procedure over the same period of time is better than long-term NOAC therapy for unrelated bleeding.
CHAMPION-AF is the first prospective, randomized, multinational trial to test whether LAA closure is noninferior to NOACs in patients who can take long-term anticoagulation, regardless of whether they have undergone prior AF resection.The study included 3,000 patients (median age 72 years, 32% women, 85% white) with nonvalvular atrial fibrillation who were at moderately high risk of stroke (median CHA2DS2-VASc score of 3.5) and low bleeding risk (median HAS-BLED score of 1.3) at 141 sites in the United States, Australia, Belgium, Canada, Denmark, France, and Germany.Israel, Italy, Japan and the Netherlands.Poland, Saudi Arabia, Spain, Switzerland and the United Kingdom.
A total of 1,501 patients were randomized to NOAC therapy at physician discretion and 1,499 patients were randomized to LAA occlusion with VIGATOR FLX.After 3 years of follow-up, 5.7% of patients in the LAA occlusion group and 4.8% of patients in the treatment group experienced a composite incidence of ischemic stroke, hemorrhagic stroke, cardiovascular death, and systemic embolism, the primary cause of trial efficacy.
"Our report suggests that the LAA occlusion device used in this study is an alternative and reasonable treatment option, even among patients prone to prolonged bleeding, and can be discussed as part of the decision-making process," said Saibal Kar, MD, FACC, co-investigator of the study.
When broken down by component, the researchers found no difference in mortality, systemic embolism, or hemorrhagic stroke, but found fewer ischemic strokes among those who underwent LAA closure procedures (3.2% vs. 2%).Results of the primary safety endpoint—the occurrence of major and non-significant but clinically significant unplanned bleeding at three years—showed a nearly two-fold higher rate of bleeding in the medical therapy group.Bleeding occurred in 10.9% of subjects and 19% of the placebo group.
“This is an important finding because we studied people who we thought might have good anemia.They are not prohibited from long-term use of anticoagulants.And they had a lower risk of bleeding. However, they did increase bleeding over time,” Carr said.
The team also performed a follow-up analysis looking at major and minor and associated nonsurgical bleeding and found that over three years, the closed LAA group had fewer events compared with the medical group (12.8% vs. 19%).
Carr and team followed patients for five years to determine whether long-term LA blockade was inferior to NOACs.
In an accompanying editorial, Gregory M. Marcus, MD, FACC, reports the valuable contributions of CHAMPION-AF in demonstrating LAA closure as an alternative to NOACs in some patients.It points out the long-term risks of anticoagulation, patient preferences, and the importance of decision-making without financial considerations such as those supporting LAA closure rather than NOACs in any case.However, there is not enough data to conclude that this approach is as comprehensive as standard NOAC treatment for most patients with atrial fibrillation, he wrote.
Nā kumuhana lapaʻau: Hoʻoponopono Anticoagulation, Arrhythmias a me Clinical PE, Anticoagulation Management a me Atrial Fibrillation, Atrial Fibrillation / Supraventricular Arrhythmias
Keywords: Annual Scientific Session, ACC26, New Orleans, Anticoagulants, Atrial Appendage, Atrial Fibrillation, Hemorrhagic Stroke, Ischemic Stroke, Embolism
