Abstract 13635: Atorvastatin for the Prevention of Major Vascular Events in Patients Undergoing Non-Cardiac Surgery: The LOAD-Pilot Randomized Clinical Trial
Bibliographic record
Abstract
Background: There is not a single established effective and safe intervention to prevent major perioperative vascular complications that commonly occur in the first 30 days after noncardiac surgery. Hypothesis: We evaluated the feasibility of a multicenter randomized controlled trial (RCT) testing the perioperative effects of statins. Methods: This is a double blind, placebo-controlled RCT testing a short course of atorvastatin 80mg before surgery, followed by 40mg 12 hours after surgery and then 40mg/day for 7 days in patients undergoing noncardiac surgery who were at risk of a major perioperative vascular complication. The primary outcome (major vascular events) was a composite of all-cause mortality, nonfatal myocardial infarction, MINS (myocardial injury after noncardiac surgery) without myocardial infarction and nonfatal stroke at 30 days after randomization. All analysis followed the intention-to-treat principle. Results: We enrolled 587 patients from 30 centers in Brazil. Mean age was 66.6 years, 37.1% were males, 22.0% had previous cardiovascular disease, 50.2% had diabetes and 89.7 % had hypertension. The majority of participants underwent general (35.9%), orthopedic (30.0%), gynecologic (8.4%), urologic (7.3%), and vascular (6.6%) surgery. A total of 51 out of 300 patients (17.0%) suffered a major vascular complication in the atorvastatin group compared to 49 out of 287 patients (17.1%) in the control group at 30 days (hazard ratio [HR] 1,02; 95% confidence interval (CI) 0.68 to 1.52; P = 0.93). No significant effect was observed on the 30-day secondary outcomes of death or myocardial infarction (8.0% versus [vs.] 7.7%, respectively; HR 0.94; 95% CI 0.52 to 1.70; P = 0.84), myocardial infarction (3.7% vs. 4.5%, respectively; HR 0.84; 95% CI 0.37 to 1.93; P = 0.68), MINS (14.0% vs.15.0%; HR 0.94; 95% CI 0.53 to 1.67; P = 0.84), and all-cause mortality (4.7% vs. 4.5%; HR 1.22; 95% CI 0.53 to 2.78; P = 0.64). Conclusions: The LOAD Trial confirms that a multicenter perioperative statin trial is feasible and highlights the need for large RCTs to establish effective and safe interventions. The study also suggests that effects of a perioperative statin on major vascular complications are, at best, moderate in size, questioning the robustness of prior data.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.011 | 0.001 |
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".