Abstract 16398: Impact of Low-Dose Rivaroxaban Plus Aspirin on Total Vascular Events in Fragile Patients With Peripheral Artery Disease: Insights From VOYAGER PAD
Bibliographic record
Abstract
Background: Rivaroxaban 2.5 mg BID reduced major adverse limb events (MALE) and total vascular events in patients with symptomatic peripheral artery disease (PAD) after lower extremity revascularization (LER) in VOYAGER PAD. The safety and efficacy of rivaroxaban on MALE and total vascular events in fragile patients with PAD has not been described. Hypothesis and Methods: Patients were categorized as fragile based on prespecified criteria (age > 75 years or weight ≤ 50 kg or baseline eGFR < 50 mL/min). MALE was defined as composite of acute limb ischemia (ALI) and major amputation. Total vascular events include cardiovascular, MALE, peripheral revascularizations and venous thromboembolism events. Same-day vascular events are consolidated into a single event. The main safety outcome was TIMI major bleeding. Results: A total of 1,669 (25%) subjects of 6,564 randomized were categorized as fragile at baseline. Rivaroxaban reduced the risk of MALE particularly in fragile (HR 0.56; 95% CI 0.38 - 0.81) vs non-fragile patients (HR 0.82; 95% CI 0.67 - 1.00, p-interaction 0.07, figure upper panel) with the benefits in fragile patients driven by reduced ALI (HR 0.47; 95% CI 0.30 - 0.75). Rivaroxaban reduced the occurrence of total vascular events at 3 years in fragile patients with absolute rates of 82.1 events/100 patients on rivaroxaban vs 99.3 events/100 patients on placebo (HR 0.81; 95% CI 0.68 - 0.98). Similar benefit was seen in non-fragile patients 70.4 events/100 patients on rivaroxaban vs 81.6 events/100 patients on placebo, HR 0.90; 95% CI 0.81-1.00 (figure, lower panel). Rivaroxaban increased TIMI major bleeding similarly in fragile (HR 1.66; 95% CI 0.87 - 3.19) and non-fragile (HR 1.37; 95% CI 0.83 - 2.24, p-interaction 0.65). Conclusions: In a high-risk PAD population rivaroxaban reduces MALE and total vascular events and increases bleeding regardless of fragile status. These data may assist in personalization of antithrombotic therapy in this high-risk population.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".