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PROTECT AF: LAA closure superior to warfarin in preventing outcomes at 3.8 years
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New 3.8-year follow-up data from the PROTECT AF trial have shown that left atrial appendage closure met the criteria for superiority vs. warfarin for the prevention of a composite endpoint of adverse events in patients with nonvalvular atrial fibrillation at elevated risk for stroke.
These results come just more than a month after FDA advisory panel members were split on the revote for the left atrial appendage (LAA) occlusion device (Watchman, Boston Scientific), which was tested in the PROTECT AF and PREVAIL trials.
In this new analysis of the multicenter, randomized, unblinded PROTECT AF trial, published in JAMA, Vivek Y. Reddy, MD, of the Mount Sinai School of Medicine, and colleagues examined long-term outcomes in 707 patients with nonvalvular AF and at least one additional stroke risk factor (CHADS2 score ≥1). Patients were enrolled between February 2005 and June 2008 and followed for 4 years through October 2012. They received either LAA closure (n=463) or warfarin (n=244; target INR, 2-3).
Vivek Y. Reddy
Researchers defined noninferiority as a posterior probability >97.5% and superiority as a probability of ≥95%.
The primary outcome measure was the composite efficacy endpoint of stroke, systemic
embolism and CV/unexplained death, which was analyzed by intention-to-treat.
At follow-up (mean, 3.8 years), Reddy and colleagues reported 39 (8.4%) events in the LAA closure group vs. 34 (13.9%) events in the warfarin group. The primary event rate was 2.3 events per 100 patient-years with the device vs. 3.8 events per 100 patient-years with warfarin (rate ratio=0.6; 95% credible interval, 0.41-1.05). The criteria for both noninferiority (posterior probability, >99.9%) and superiority (posterior probability, 96%) were met.
Furthermore, the device led to lower rates of both CV mortality (1 event per 100 patient-years vs. 2.4 events per 100 patient-years; HR=0.4; P=.005) and all-cause mortality (3.2 events per 100 patient-years vs. 4.8 events per 100 patient-years; HR=0.66; P=.04).
“However, it should be noted that these mortality endpoints are secondary endpoints, and due to multiplicity of data analysis, there is some uncertainty in the confidence of this conclusion,” Reddy and colleagues wrote. “Although the device implantation procedure was associated with early complications, the accumulation of complications related to chronic anticoagulation resulted in similar safety profiles for the two modalities.”
Disclosure: Reddy reports receiving grant support and consultant fees from Boston Scientific. Several other researchers also report financial disclosures with Boston Scientific.
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