Meta-analysis: Oral anticoagulants superior to warfarin, closure device for stroke prevention

SAN DIEGO — A systematic review and meta-analysis of randomized controlled trials indicated treatment with novel oral anticoagulants was superior to warfarin and a left atrial appendage closure device for the prevention of stroke in patients with nonvalvular atrial fibrillation.

However, the researchers noted that left atrial appendage closure with a device (Watchman, Boston Scientific) is a “reasonable noninferior alternative to warfarin for stroke prevention when anticoagulation is contraindicated.”

The researchers evaluated data from seven phase 3 randomized controlled trials covering 73,978 patients with comparison groups based on treatment with novel oral anticoagulants and left atrial appendage closure vs. warfarin. Evaluated efficacy outcomes included stroke, systemic embolism and all-cause mortality, and safety outcomes included major bleeding and procedure-related complications. The data were presented at the American College of Cardiology Scientific Sessions.

David F. Briceno

The results favored novel oral anticoagulants for stroke or systemic embolism (OR = 0.84; 95% CI, 0.72-0.97), all-cause mortality (OR = 0.89; 95% CI, 0.84-0.94) and bleeding or procedure-related complications (OR = 0.79; 95% CI, 0.65-0.97) compared with left atrial appendage closure. All-cause mortality and stroke or systemic embolism occurred at a similar rate between patients treated with warfarin and those who underwent left atrial appendage closure; however, risk for complications was significantly higher among patients who received the device (OR = 1.85; 95% CI, 1.14-3.01).

The researchers noted no indication of significant publication bias in the analysis.

“Today, [novel oral anticoagulants] are probably the best strategy for stroke prevention in nonvalvular AF,” David F. Briceno, MD, cardiology fellow at Montefiore Einstein Center for Heart and Vascular Care, told Cardiology Today. However, he noted that this was not a high-risk population for bleeding, where the left atrial appendage closure device would be indicated for use. “In that population, it is definitely an option to consider. In an average-risk population, it seems that the novel oral anticoagulants are still the way to go.”

Luigi Di Biase

Luigi Di Biase, MD, from the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, and Albert Einstein College of Medicine and Montefiore Medical Center in New York City, told Cardiology Today that with the recent FDA approval of the Watchman left atrial appendage closure device there is a need for a randomized trial comparing the device vs. novel oral anticoagulants.

“The Watchman study [compared the device] with warfarin, and we all know [there are] complication and compliance issues with the use of warfarin,” he said. “It is sometimes hard to keep anticoagulating [with warfarin], but with the novel oral anticoagulants this limitation is reduced. I think future steps would include a trial comparing the novel oral anticoagulants vs. the Watchman device.” – by Adam Taliercio

Reference:

Briceno DF, et al. Abstract 1115-239. Presented at: American College of Cardiology Scientific Sessions; March 14-16, 2015; San Diego.

Disclosure: Briceno reports no relevant financial disclosures. Di Biase reports receiving consultant fees/honoraria from Biosense Webster, Hansen Medical and St. Jude Medical, and serving on the speakers’ bureau for AtriCure, Biotronik and EpiEP. Another researcher reports receiving consultant fees/honoraria from Biotronik, Biosense Webster Inc., Boston Scientific, Janssen Pharmaceuticals, Medtronic and St. Jude Medical.