MGUard versus bAre‐metal stents plus manual thRombectomy in ST‐elevation myocarDial infarction pAtieNts—(GUARDIAN) trial: Study design and rationale
Bibliographic record
Abstract
BACKGROUND: Distal embolization may decrease coronary and myocardial reperfusion after percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI). In this setting, manual thrombectomy (MT) resulted in better perfusion and clinical outcomes when compared with "conventional" PCI (direct stenting or stenting after predilation). MGuard net protective stent (MGS, Inspire-MD, Tel-Aviv, Israel) is a new bare-metal stent (BMS) with a polyethylene theraphthalate mesh coverage anchored to the external surface of the struts aiming to minimize distal embolization during PCI. PURPOSE: We intend to determine whether MGS implantation is comparable with a strategy of MT pretreatment followed by BMS deployment. STUDY DESIGN: The MGUard versus bAre-metal stents plus manual thRombectomy in ST-elevation myocarDial Infarction pAtieNts (GUARDIAN) is a multicentre, prospective, randomized, noninferiority, open-label trial with a planned inclusion of 556 STEMI patients. Patients are assigned to treatment with MGS or MT pretreatment followed by BMS implantation in the infarct-related artery. All patients are treated medically according to current international guidelines. Randomization is performed before coronary angiography. The primary endpoint is complete (≥ 70%) ST-segment resolution at 60 min after PCI. Secondary endpoints are thrombolysis in myocardial infarction (TIMI) coronary flow grade ≥ 2, corrected TIMI frame count <23, myocardial blush grade of the infarct related area ≥ 2, and major adverse cardiac events rate at 30-day, 6-month, and 1-year follow-up. A cardiac magnetic resonance imaging substudy is planned to investigate microvascular obstruction and infarct size area reduction, at prespecified time-points, among 80 consecutive patients enrolled. CONCLUSIONS: If MGS implantation is noninferior to a strategy of MT pretreatment followed by BMS deployment, it will lend support to the use of this treatment as another possible option for STEMI patients undergoing PCI.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".