A large open-label trial from Japan recently assigned 2236 patients with AF and IHD (percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or angiographically confirmed coronary artery disease not requiring revascularization) to receive monotherapy with rivaroxaban or the combination of rivaroxaban + antiplatelet (aspirin or clopidogrel or ticragelor). The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis.
The trial stopped early because the combination-therapy group had increased mortality compared to rivaroxaban alone. Rivaroxaban monotherapy was non-inferior to combination therapy for the primary efficacy end point (event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was safer, with major bleeding at 1.62% compared to 2.76% per patient-year for combination treatment (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01 for superiority).
For those with AF and comorbid CHD, this research supports a approach involving DOAC anticoagulation alone, an important finding giving the prevalence of both issues amongst older people known to be at highest risk. Read more here