The benefit of rivaroxaban monotherapy for patients with atrial fibrillation (AF) after coronary stenting was dependent on the duration of time from stenting, according to data from a secondary analysis of the AFIRE trial presented at the American Heart Association Scientific Session 2020.
“Although there was a numerical excess of coronary events within 2 years from stenting, the benefit of monotherapy for the safety endpoint and net adverse clinical events support the overall benefit of rivaroxaban monotherapy in patients with AF after 1 year of coronary stenting,” said presented Tetsuya Matoba, MD, PhD, FAHA, of Kyushu University, Japan.
AFIRE assessed antithrombotic therapy in 2,215 patients with AF and stable coronary artery disease. In the primary analysis of the study, rivaroxaban was noninferior to combination therapy with rivaroxaban plus an anti-platelet therapy (APT) for the composite endpoint of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; monotherapy was superior for the safety endpoint of major bleeding.
This analysis was conducted due to concerns about thrombotic events due to cessation of APT in a subgroup of 1,444 patients who had undergone coronary stenting more than 1 year prior. The researchers looked at benefits of rivaroxaban in patients less than 2 years from stenting (n= 419; 29%) and compared them with patients 2 years or more from stenting (n=1,025; 71%). For patients less than 2 years from stenting there was 10 first-generation drug eluting stents (DES) and 381 second generation DES. For patients 2 years or further from stenting it was 213 and 401, respectively.
This analysis examined coronary events – a composite of fatal and non-fatal MI, unstable angina, coronary revascularization, or stent thrombosis – and net adverse clinical events (NACE) – a composite of stroke, MI, death from any cause, or major bleeding.
The cumulative incidence of the primary efficacy endpoint was 5.15% for monotherapy compared with 3.99% for combination therapy (HR=1.29; 95% CI, 0.66-2.50; P=0.453). In patients 2 or more years from stenting the cumulative incidence was 3.71% for monotherapy compared with 6.67% for combination therapy (HR=0.56; 95% CI, 0.37-0.84; P=.004).
Remarkably there was no significant excess of coronary events with monotherapy in patients less than 2 years from stenting, Dr. Matoba said. The cumulative incidence of coronary events for patients within 2 years of stenting was 3.2% for monotherapy compared with 1.33% for combination therapy (HR=2.39; 95% CI, 0.85-6.71; P=.087). In contrast, for patients 2 or more years from stenting the cumulative incidence of coronary events was 2.31% for monotherapy compared with 2.47% for combination therapy (HR=0.94; 95% CI, 0.53-1.65; P=.825).
For the primary safety endpoint, the benefit of monotherapy was consistent. The HR of monotherapy was 0.72 for patients less than 2 years from stenting. For patients 2 or more years from stenting the HR was 0.48 with a P value of 0.019.
Finally, the HRs for the NACE was 0.71 for patients less than 2 years (P=0.284) and 0.54 for patients two or more years from stenting (P=.002).