For long-term prevention of major cardiovascular, neurological, or bleeding events, left atrial appendage (LAA) closure was non-inferior to non-warfarin oral anticoagulants (NOACs). These findings were presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, held on November 4 to 6, 2021, and were published in the Journal of the American College of Cardiology.
The PRAGUE-17 trial (ClinicalTrials.gov Identifier: NCT02426944) was an investigator-initiated, randomized, non-inferiority trial conducted at 10 centers in the Czech Republic between 2015 and 2019. Patients (N=402) with non-valvular atrial fibrillation (AF) with increased risk for bleeding or stroke were randomly assigned to receive LAA closure (n=201) or NOACs (n=201). The primary endpoint was the composite instance of stroke, transient ischemic attack, systemic embolism, clinically significant bleeding, cardiovascular death, or significant device- or peri-procedural-related complication at a median of 3.5 years.
Patients in the LAA closure and NOAC cohorts had a mean age of 73.4±6.7 and 73.2±7.2 years; 66.7% and 64.7% were men; 92.5% and 92.5% had hypertension; 41.3% and 35.8% had permanent AF; and 26.4% and 33.3% had paroxysmal AF, respectively.
A total of 187 ultimately underwent LAA closure, and procedure attempts were successful among 96.8%. Patients received an Amulet (61.3%), Watchman (35.9%), or Watchman-FLX (2.8%) device.
Among the NOAC cohort, most received 5 mg twice daily apixaban (79.1%), followed by 2.5 mg apixaban (16.4%), dabigatran (4.0%), or rivaroxaban (0.5%).
By year 4, the composite endpoint occurred among 24.4% of the LAA closure and 31.3% of the NOAC cohorts, which did not differ between groups (subdistribution hazard ratio [sHR], 0.81; 95% CI, 0.56-1.18; P =.27), indicating LAA closure was non-inferior to NOAC (P =.006).
Stratified by specific event, no group differences were observed for cardiovascular death (sHR, 0.68; 95% CI, 0.39-1.20; P =.19), stroke or transient ischemic attack (sHR, 1.14; 95% CI, 0.56-2.30; P =.72), stroke (sHR, 1.38; 95% CI, 0.63-3.03; P =.42), clinically-relevant bleeding (sHR, 0.75; 95% CI, 0.44-1.27; P =.28), non-cardiovascular death (sHR, 0.99; 95% CI, 0.55-1.77; P =.96), or all-cause death (sHR, 0.81; 95% CI, 0.54-1.22; P =.31).
For non-procedural clinically-relevant bleeding, LAA closure recipients had a decreased rate compared with NOAC recipients (3.41 vs 5.89; sHR, 0.55; 95% CI, 0.31-0.97; P =.039).
In a subgroup analysis, no differential effects were observed for age (P =.59); sex (P =.26); weight (P =.50); history of cardioembolic event (P =.28); history of bleeding (P =.58); center type (P =.47); or congestive heart failure, hypertension, age 75 years and older, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, or sex category (P =.98).
This study was underpowered to detect relative differences among the individual components of the primary endpoint.
“Among non-valvular patients with atrial fibrillation and at high risk for stroke and
bleeding, the non-inferiority of LAAC to NOAC relative to the composite of cardioembolic events, CV death, significant procedure/device-related complications, or clinically-relevant bleeding, was maintained during long-term follow-up,” the study authors said.
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Osmancik P, Herman D, Neuzil P, et al. Left atrial appendage closure versus non-warfarin oral anticoagulation in atrial fibrillation: 4-year outcomes of PRAGUE-17. J Am Coll Cardiol. Published online November 5, 2021. doi:10.1016/j.jacc.2021.10.023