Abstract 10889: Unplanned Limb Revascularization With Rivaroxaban versus Placebo in Patients With Critical Limb Ischemia After Endovascular and Surgical Treatment: Insights From Voyager Pad
Bibliographic record
Abstract
Introduction: Patients with critical limb ischemia (CLI) have a class I indication for lower extremity revascularization (LER) by either endovascular or surgical approach. A common complication is recurrent arterial occlusion requiring unplanned index limb revascularization (UILR). VOYAGER PAD established the efficacy of rivaroxaban in patients with symptomatic peripheral artery disease (PAD) after successful LER, including a reduction in UILR. Whether this benefit differs by LER approach for CLI is unknown. Hypothesis: Rivaroxaban reduces UILR regardless of LER approach for CLI. Methods: LER indication (CLI or claudication) and approach were captured at baseline. The primary composite endpoint was acute limb ischemia, major vascular amputation, MI, ischemic stroke or CV death. TIMI major bleeding was the primary safety outcome. UILR was a prespecified secondary outcome. A Cox proportional-hazards model was used to calculate hazard rations and 95% confidence intervals. Results: Among 6,564 participants randomized , 1,533 (23%) had CLI, of whom 696 (45%) and 837 (55%) underwent surgical and endovascular LER, respectively. CLI patients on rivaroxaban had fewer events at three years compared to those on placebo (HR 0.85). Efficacy of rivaroxaban for the primary endpoint (p-interaction 0.40) and safety (p-interaction 0.18) in CLI were consistent regardless of approach. On background therapy (aspirin in all, statins ~80%, DAPT ~50%), at a median of 28 months, UILR occurred in 26.2% and 14.3% after endovascular and surgical LER, respectively. Rivaroxaban significantly reduced UILR by 22% in patients with CLI (HR 0.78, p=0.019, Figure), with consistent benefits in those treated with endovascular and surgical LER (p-interaction 0.70). Conclusions: CLI patients have high rates of UILR after LER. Rivaroxaban reduced the rate of UILR in this population, regardless of endovascular or surgical approach.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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".