Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease: The TRACK Randomized Clinical Trial.
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Badve Sunil V, Perkovic Vlado, Jha Vivekanand, Ramachandran Raja, Mushahar Lily, Menne Jan, De Vriese An S, Rossignol Patrick, Flahault Adrien, Al Ammari Maha, Skhiri Habib, Walsh Michael, Collister David, Liew Adrian, Billot Laurent, Bompoint Severine, Devaux Anthony, Jun Min, Lin Enmoore, Ramos da Cruz Aline, Ha Jeffrey T, Eikelboom John W, Shaman Ahmed, Jardine Meg J, Jesudason Shilpanjali, Wong Muh Geot, Anderson Craig S, Garg Amit X, Heerspink Hiddo J L, Monaghan Helen, Patel Anushka, Mark Patrick B, Wheeler David C, Lv Jicheng, Zuo Li, Pilmore Helen, Gallagher Martin, TRACK Trial Investigators
Аннотация
OBJECTIVE: To determine whether low-dose rivaroxaban reduces rates of adverse cardiovascular events compared with placebo in patients with advanced CKD.
DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial conducted at 90 centers in 12 countries. Eligible participants were adults with CKD stage 4 or 5 and patients with dialysis-dependent kidney failure. Participants had a history of either coronary artery disease; nonhemorrhagic, nonlacunar stroke; peripheral artery disease; diabetes; or were 65 years or older. Enrollment occurred between January 2021 and July 2025. The trial was stopped early on August 7, 2025, for lack of efficacy. Final follow-up occurred on October 30, 2025. Statistical analyses were conducted in February and March 2026.
INTERVENTIONS: Patients were randomized 1:1 to receive rivaroxaban 2.5 mg twice daily or placebo.
MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, stroke, or a peripheral artery disease event. The primary safety outcome was major bleeding.
RESULTS: Of 1458 randomized patients (mean [SD] age, 63.2 [11.6] years, 432 [29.6%] female), 1360 (93.3%) completed follow-up. During a median follow-up of 1.7 years, the primary outcome occurred in 164 patients (22.6%) in the low-dose rivaroxaban group and 151 (20.7%) in the placebo group (13.0 vs 11.8 events per 100 person-years; hazard ratio, 1.09 [95% CI, 0.87-1.36]; P = .46). Major bleeding occurred in 64 patients (8.8%) receiving low-dose rivaroxaban and 44 (6.0%) receiving placebo (5.1 vs 3.4 events per 100 person-years; hazard ratio, 1.51 [95% CI, 1.02-2.22]; P = .04).
CONCLUSIONS AND RELEVANCE: In patients with advanced CKD at high cardiovascular risk, low-dose rivaroxaban did not reduce the risk of a composite cardiovascular outcome. Major bleeding rates were significantly higher in the low-dose rivaroxaban group compared with the placebo group.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03969953.