Abstract 2449: Clinical Outcomes in Women with Stable Coronary Artery Disease Randomized to Optimal Medical Therapy With or Without PCI: Pre-Specified Subset Analysis of the COURAGE Trial
Bibliographic record
Abstract
Background: The main results of the COURAGE Trial showed no significant differences in the primary outcome of all-cause mortality or non-fatal MI, or in major secondary outcomes (the composites of death, MI or stroke, and hospitalization for ACS) in the 2,287 patients with stable coronary artery disease randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). In a pre-specified subset analysis, women who received an initial strategy of PCI during a median 4.6 year follow-up appeared to benefit for death or MI, but the interaction P value for this comparison (0.03) exceeded the nominal pre-specified value for all trial subgroup interactions (P<0.01) . Methods: We explored various pre-specified clinical endpoints in the 338 women (15%) of the COURAGE cohort who were randomized to PCI + OMT vs. OMT alone. Chi-Square analyses were conducted for the following outcomes between groups (time to first event): death or MI; death; MI; the composite of death, MI or stroke; death, MI or hospitalization (Hosp) for ACS; and Hosp for CHF. Results: There were no significant differences between treatment arms for major pre-specified cardiovascular events in men, but there was apparent benefit for many clinical outcomes in women randomized to PCI + OMT vs. OMT alone, although in all but one comparison (i.e., CHF), the P values exceeded the pre-specified value for interaction (P < 0.01) during long-term follow-up (Table ): Conclusions: Although the primary endpoint and death alone were not significantly different between groups, women randomized to PCI appeared to fare better than those randomized to OMT alone for selected clinical outcomes. However, because women comprised only 15% of the COURAGE population, it is unclear whether these findings indicative true clinical benefit for PCI in women, or alternatively may represent a statistical play of chance or type II error. These important findings may warrant additional investigation and analysis.
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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 | 0.005 | 0.008 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".