Clinical significance of new-onset atrial fibrillation in patients with coronary artery or peripheral artery disease: results from the COMPASS trial

Abstract

Abstract Background The COMPASS trial enrolled patients with coronary artery or peripheral artery disease, but excluded patients requiring oral anticoagulation. Compared to aspirin alone, rivaroxaban in addition to aspirin reduced a composite of cardiovascular death, stroke or myocardial infarction. Purpose This study aimed to explore the clinical significance of a new diagnosis of atrial fibrillation (AF) during follow-up. Methods New AF was identified from unplanned hospitalization, study drug discontinuation and adverse event reports. The associations between new-onset AF, clinical characteristics and outcomes in COMPASS participants were studied using time-updated regression modeling. Event rates were reported as per 100 patient-years (following a new diagnosis of AF vs. from randomization until the end-follow-up or new AF, whichever came first). Results During a mean follow-up of 23 months, 655 of 27,395 participants (2.4%) were newly diagnosed with AF. Advanced age, male sex, white race, higher body mass index, higher systolic blood pressure, heart failure and prior myocardial infarction were independently associated with new-onset AF. The rates of permanent discontinuation of study drug were 83.8% following a new diagnosis of AF, compared to 17.5% in participants without/before new AF. Compared to participants without/before a new diagnosis of AF, participants with new-onset AF were at increased risk of a composite of cardiovascular death, stroke or myocardial infarction (8.9 vs. 2.5 per 100 patient-years, hazard ratio [HR] 4.49, 95% confidence interval [CI] 3.37-6.00) (Figure 1). Risk increases with new-onset AF were also observed for hospitalization for heart failure (9.1 vs. 1.1 per 100 patient-years, HR 6.35, 95% CI 4.59-8.80) (Figure 2) and major bleeding (4.1 vs. 1.3 per 100 patient-years, HR 2.93, 95% CI 1.99-4.33). Conclusion In COMPASS, a new diagnosis of AF during trial follow-up was associated with a marked increase in risk of adverse outcomes.Composite outcome after new-onset AFHeart failure after new-onset AF