AFIRE: Rivaroxaban monotherapy outperforms dual therapy in AF, stable CAD, prior stenting
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In a new analysis from AFIRE, among patients with atrial fibrillation and stable CAD with prior coronary stenting, rivaroxaban monotherapy was superior to rivaroxaban plus an antiplatelet agent in both efficacy and safety.
The main results of AFIRE, as previously reported by Healio, showed noninferiority for rivaroxaban (Xarelto, Janssen/Bayer) monotherapy compared with rivaroxaban plus an antiplatelet agent in patients with AF and stable CAD. For the present substudy, Tetsuya Matoba, MD, PhD, of Kyushu University in Fukuoka, Japan, and colleagues evaluated rivaroxaban monotherapy benefits and their relation to the time between stenting and enrollment in patients after coronary stenting.
From the 2,215 patients in the modified intention-to-treat population, researchers enrolled 1,444 patients who had received coronary stenting more than 1 year before enrollment (mean age, 74 years; 81% men; 69.9% with angina; 41.9% with prior MI).
The efficacy endpoint was a composite of stroke, systemic embolism, MI, unstable angina requiring revascularization or death of any cause at 36 months. The safety endpoint was major bleeding, as defined by the International Society on Thrombosis and Hemostasis criteria, at 36 months. Researchers also examined ischemic endpoints, net adverse clinical events and time between stenting and enrollment.
According to results, the efficacy (HR = 0.7; 95% CI, 0.5-0.98; P = .036) and safety (HR = 0.55; 95% CI, 0.33-0.92; P = .019) endpoints were superior in the monotherapy arm compared with the combination therapy arm. As time between stenting and enrollment became longer, the HR reduced for both efficacy (P for interaction = .158) and safety (P for interaction = .097).
In other data, no significant difference between groups was reported with ischemic endpoints (HR = 0.82; 95% CI, 0.58-1.15; P = 0.24).
“In a subgroup of patients with AF after coronary stenting, the benefits of rivaroxaban monotherapy in terms of primary efficacy and safety endpoints were consistent with those in the whole population of the AFIRE trial, without any apparent increase in thrombotic events,” Matoba and colleagues wrote. “The efficacy and safety outcomes concerning rivaroxaban monotherapy become apparent as time lengthened between stenting and trial enrollment. Future studies are needed to identify patients at high thrombotic risk as well as those who may potentially need combination therapy with anticoagulation and single-antiplatelet therapy.”
In an accompanying editorial, Cardiology Today Editorial Board Member David P. Faxon, MD, associate chief of cardiovascular medicine at Brigham and Women’s Hospital and senior lecturer on medicine at Harvard Medical School, noted that expert consensus documents have recognized the importance of assessment of ischemic and bleeding risk, suggesting continuation of dual therapy after 1 year in selected patients with high ischemic risk and low bleeding risk.
“Conversely, in patients with a low ischemic or thrombotic risk or a high bleeding risk, discontinuation of dual therapy at 6 months may also be reasonable,” Faxon wrote. “These strategies depend on accurate assessment of ischemic and bleeding risk, and at present we do not have good criteria to estimate either risk. Improved risk assessment would provide needed guidance in tailoring treatment in each patient. Until we do, clinical judgment must be used. We still have much to learn about the optimal antithrombotic regimen for patients with AF undergoing PCI, but in general it is fair to conclude that less is best most of the time.”
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