XARENO study revealed Xarelto was associated with net clinical benefit.

The study findings were presented at the American Congress of Cardiology’s 71st Annual Scientific Session (ACC.22).

XARENO is the first prospective observational study to evaluate the effectiveness and safety of Xarelto versus VKAs or no oral anticoagulation (at the discretion of attending physicians) in treating patients with NVAF and advanced CKD. The prevention of worsening renal function is an important additional therapeutic target beyond stroke prevention when it comes to the selection of an oral anticoagulant in patients with atrial fibrillation (AF). The XARENO study was undertaken to investigate the real-world effectiveness and safety of Xarelto compared with VKAs in this vulnerable patient group with AF and advanced CKD.

Patients were treated with either Xarelto or VKA at the discretion of the attending physicians. Pre-specified follow-up was at least 12 months with a planned extended data collection period for one up to two additional years. Primary outcomes, as determined by blinded adjudication, included progression of CKD and net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality). Propensity score matched analysis (PSMA) was used to compare the Xarelto and VKA groups.

After one year follow up, the study found that in PSMA (propensity score matched analysis), baseline eGFR was similar in both groups and numerically higher in the rivaroxaban group after follow-up (difference 1.0 mL/min per 1.73 m2, 95% confidence interval [CI] -0.48 to 2.51, p=0.18). The frequency of net-clinical benefit events was 12.9% (51/397) in the rivaroxaban and 18.3% (75/410) in the VKA group (incidence rate ratio [IRR] 0.68, 95% CI 0.47 to 0.96, p=0.03). The incidence risk ratio (IRR) for progression to CKD stage 5 was 0.40 (CI 0.22 to 0.71) and the IRR for in the initiation of chronic renal replacement therapy was 0.08 (CI 0.01 to 0.63).

The study adds to the evidence obtained in the randomized controlled ROCKET-AF study and supports the use of Xarelto in this patient group including patients with CKD stage 4. In agreement with previous data demonstrating various benefits of rivaroxaban over VKAs on kidney outcomes, XARENO also suggests a potential reduction in kidney failure of Xarelto vs VKA. With XARENO and previous studies like ANTENNA Xarelto provides the broadest evidence on preservation of renal function compared to all other NOACs.

Previous studies have found that patients with both AF and renal impairment are at higher risk for bleeding and stroke. They are also more likely to be undertreated with oral anticoagulation such as warfarin than those with normal renal function.