New data point to LAAO as a safe alternative to long-term drug therapy
One of the most anticipated late-breaking trials presented at ACC.26 in New Orleans was CHAMPION-AF, which showed left atrial appendage occlusion (LAAO) can provide a safe alternative to anticoagulation therapy for patients with atrial fibrillation who are not at a high risk of bleeding.
First author Shephal Doshi, MD, an electrophysiologist at Cedars Sinai Smidt Heart Institute, spoke to Cardiovascular Business about the trial during the conference.
"In terms of efficacy, LAA closure was non-inferior to anticoagulation when you combine those three endpoints of stroke, cardiovascular death and systemic embolism. And the p-value was statistically significant, being less than 0.01. From a safety standpoint, LAA closure was superior to anticoagulant therapy in terms of bleeding," Doshi explained.
The trial enrolled approximately 3,000 patients randomized to receive either LAAO using the Watchman FLX device or standard anticoagulation therapy with non-vitamin K oral anticoagulants (NOACs).
Importantly, LAAO outperformed anticoagulation on safety in bleeding events. This finding is notable because the study population consisted of patients who traditionally face low risk of bleeding complications.
While the results position LAAO as a potential alternative to long-term anticoagulation, the results after five years should be more definitive. The CHAMPION-AF trial is ongoing, with additional follow-up expected to provide more granular data on specific endpoints such as ischemic stroke.
These findings will likely prompt some patients to seek LAAO so that they can avoid taking NOACs daily for the rest of their lives. However, Doshi emphasized that treatment decisions should remain individualized for patients.
"I think this is where it's important to have that shared decision-making with the patient to see what their goals are," he said.
CHAMPION-AF seen as a negative trial by some
While some in the industry have seen the CHAMPION-AF as a positive trial that opens the possibility for fewer patients to be taking anticoagulants, some cardiologists interpret the noninferior finding as a negative trial result because LAAO did not have a big enough impact to change the current standard of care.
"If they truly can't take a DOAC, then I think these devices are terrific, but if a patient can take a DOAC, I would think that's still the way to go," explained Deepak L. Bhatt, MD, MPH, MBA, director of the Mount Sinai Fuster Heart Hospital, in an interview about key ACC.26 trials.
He said the Watchman FLX devices in the trial did have an advantage in terms of nonprocedural bleeding. However, he added that procedural bleeding and possible complications from a device implant also need to be factored in. Bhatt also noted that this study included expert centers; in the real-world, where less experienced clinicians may be performing LAAO, it is possible the outcomes would be different.
"I think it shows LAAO does have a role, but not necessarily in the population where it was being studied in this trial," he said. "On the other hand, there are some patients that are just coming in and saying they're not going to take an anticoagulant even if they could. I think our job is to try to convince them to take it. But ultimately, if patients say they understand what the doctor's saying and they're still going to prefer device-based therapy, I think patients do have a right to voice an opinion."
Boston Scientific, the maker of the Watchman device, said a secondary analysis did include procedural bleeding and continued to demonstrate a significant reduction in bleeding with the FLX device compared to NOACs (12.8% vs. 19.%). The company said this included major and clinically relevant non-major bleeding and represented a 34% relative reduction in procedural and non-procedural bleeding risk.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]