Femoral Vascular Closure Devices and Bleeding, Hemostasis, and Ambulation Following Percutaneous Coronary Intervention
Bibliographic record
Abstract
Background The effectiveness of vascular closure devices (VCDs) to reduce bleeding after transfemoral percutaneous coronary intervention remains unsettled. Methods and Results Participants in the REGULATE‐PCI (Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention) trial who underwent transfemoral percutaneous coronary intervention with VCD implantation were compared with those who underwent manual compression. The primary effectiveness end point was type 2, 3, or 5 Bleeding Academic Research Consortium access site bleeding at day 3. Univariate and multivariate analyses were adjusted by the inverse probability weighting method using propensity score. Time to hemostasis and time to ambulation were compared between groups. Of the 1580 patients who underwent transfemoral percutaneous coronary intervention, 1004 (63.5%) underwent VCD implantation and 576 (36.5%) had manual compression. The primary effectiveness end point occurred in 64 (6.4%) participants in the VCD group and in 38 (6.6%) participants in the manual compression group (inverse probability weighting–adjusted odds ratio, 1.02 [95% CI, 0.77–1.36]; P =0.89). There were statistically significant 2‐way interactions between VCD use and female sex, chronic kidney disease, and use of high‐potency P2Y12 inhibition (ticagrelor or prasugrel) ( P <0.05 for all) with less bleeding with VCD use in these high‐risk subgroups. Median time to hemostasis and time to ambulation were shorter in the VCD versus the manual compression group ( P <0.01 for both). Conclusions Following transfemoral percutaneous coronary intervention, VCD use is associated with a shorter time to hemostasis and time to ambulation but not less bleeding. Further study of patients with high‐bleeding risk is required, including women, patients with chronic kidney disease, and those using high‐potency P2Y12 inhibitors. Registration URL: https://clinicaltrials.gov/ct2/show/NCT01848106 ; Unique identifier: NCT01848106.
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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 | 0.006 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| 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) | 0.002 | 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".