Safety and Efficacy of Cobalt Chromium Everolimus‐Eluting Stents for Treatment of In‐Stent Restenosis: An ILUMIEN IV Substudy
Bibliographic record
Abstract
Background The optimal management strategy for in‐stent restenosis (ISR) remains unclear. We aimed to determine the safety and efficacy of percutaneous coronary intervention with XIENCE cobalt chromium everolimus‐eluting stents (EES) for treatment of ISR. Methods In the ILUMIEN IV (Optical Coherence Tomography Guided Coronary Stent Implantation Compared to Angiography: A Multicenter Randomized Trial in Percutaneous Coronary Intervention) trial, the 1‐year outcomes of all randomized patients with a single diffuse or multifocal single‐layer ISR lesion treated with EES were compared with a performance goal. The primary end point was target lesion failure, the composite of cardiac death, target vessel‐myocardial infarction, or ischemia‐driven target lesion revascularization. Outcomes in patients with a single EES‐treated ISR and non‐ISR lesion were also compared. Results From May 2018 through December 2020, 247 patients with a single ISR lesion were treated with EES. Target lesion failure at 1 year occurred in 18 patients (7.4% [upper 1‐sided 97.5% CI, 11.5%]), which was lower than the predefined performance goal of 20% ( P <0.001). Compared with non‐ISR lesions treated with EES (n=2021), the postpercutaneous coronary intervention minimal stent area by optical coherence tomography was smaller in treated ISR lesions (5.0±1.8 mm 2 versus 5.6±1.9 mm 2 ; P <0.001), but minimum stent expansion was similar (78.8±18.0% versus 79.0±16.9%; P =0.87), as was 1‐year target lesion failure (7.4% versus 4.7%; hazard ratio, 1.58 [95% CI, 0.95–2.61]; P =0.07). Conclusions XIENCE EES was safe and effective for treatment of single‐layer ISR. Compared with non‐ISR lesions, ISR lesions treated with EES had a smaller postpercutaneous coronary intervention minimal stent area although stent expansion and 1‐year target lesion failure rates were not different. Registration URL: https://clinicaltrials.gov/ ; Unique identifier: NCT03507777.
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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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 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".