This research is Trending!
June 4, 2026JAMA1 citations
View Full PaperLow-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease
Key Result
Low-dose rivaroxaban did not reduce the composite of cardiovascular events compared with placebo in patients with advanced CKD (HR 1.09; 95% CI 0.87-1.36; P=0.46).
Key Points
- To determine the effect of low-dose rivaroxaban on cardiovascular events in patients with advanced chronic kidney disease.
- Randomized, double-blind, placebo-controlled trial at 90 centers across 12 countries
- Participants were adults with stage 4 or 5 CKD or dialysis-dependent kidney failure
- Enrollment occurred between January 2021 and July 2025
- In the rivaroxaban group, 22.6% experienced the primary outcome compared to 20.7% in the placebo group (HR 1.09, 95% CI 0.87-1.36, P=0.46)
- Major bleeding was higher in the rivaroxaban group (8.8%) than placebo (6.0%) with HR 1.51 (95% CI 1.02-2.22, P=0.04)
- The trial was stopped early for lack of efficacy.
Study Design
Type
RCT (n=1,458)
Blinding
Double-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does low-dose rivaroxaban reduce the composite of cardiovascular death, nonfatal myocardial infarction, stroke, or a peripheral artery disease event in adults with advanced CKD at high cardiovascular risk?
P
Population
1,458 adults with advanced CKD (stage 4-5 or dialysis) and high cardiovascular risk, followed for a median of 1.7 years.
I
Intervention
Rivaroxaban 2.5 mg twice daily
C
Comparator
Placebo
O
Outcome
Composite of cardiovascular death, nonfatal myocardial infarction, stroke, or a peripheral artery disease eventcomposite
In patients with advanced CKD at high cardiovascular risk, low-dose rivaroxaban does not reduce cardiovascular events but significantly increases the risk of major bleeding.
Main Result
Hazard Ratio: 1.09 (95% CI 0.87–1.36)
Absolute Event Rate: 22.6% vs 20.7%
p-value: p=0.46
Abstract
Importance: Approximately 10% to 15% of patients with advanced chronic kidney disease (CKD) experience a fatal or nonfatal cardiovascular event annually. The effects of antithrombotic therapies on cardiovascular events in patients with advanced CKD are unknown. 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.
Expert Takes2 quotes
1/2
“TRACK sets the direction for the questions that must be asked next, particularly regarding which patients are most likely to benefit (e.g., those with established cardiovascular disease) and whether alternative oral anticoagulation strategies may prove more effective or safer in selected CKD popu...”
ACC Journal ScanView source
Trending Research#4 this week
The TRACK trial is a significant negative trial showing that low-dose rivaroxaban does not reduce cardiovascular events and increases major bleeding in patients with advanced CKD. This finding clarifies the risk-benefit profile of this anticoagulant strategy in a high-risk population and will discourage its use for this indication.
Social attention
82
Preprint velocity
0
News coverage
85
Conference
0
Expert commentary
0