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STICH3C: Rationale and Study Protocol

2023· article· en· W4385830339 on OpenAlexafffundabout
Stephen E. Fremes, Guillaume Marquis‐Gravel, Mario Gaudino, Sylvain Bédard, Ruth Masterson Creber, Marc Ruel, Dominique Vervoort, Harindra C. Wijeysundera, Michael E. Farkouh, Jean‐Lucien Rouleau, Reena Karkhanis, Rakesh C. Arora, Michelle M. Graham, Jeff S. Healey, Jonathan G. Howlett, Alex Kiss, Dennis T. Ko, Doug Lee, Michael McGillion, Louise Y. Sun, Richard H. Swartz, Pierre Voisine, Jeroen J. Bax, Filippo Crea, Torsten Doenst, Sanjit S. Jolly, L Koeber, André Lamy, Alexandra J. Lansky, Peter van der Meer, Milan Milojevic, Elmir Ömerovic, Mark Petrie, Christopher M. Reid, Sigrid Sandner, Miguel Sousa‐Uva, Eric J. Velazquez, Subodh Verma, Gregg W. Stone

Bibliographic record

VenueCirculation Cardiovascular Interventions · 2023
Typearticle
Languageen
FieldMedicine
TopicCoronary Interventions and Diagnostics
Canadian institutionsToronto East General HospitalToronto General HospitalCentre de réadaptation Lethbridge-Layton-MackayUniversity of OttawaMontreal Heart InstituteSunnybrook Health Science Centre
FundersCanadian Institutes of Health Research
KeywordsMedicineConventional PCICardiologyRevascularizationInternal medicinePercutaneous coronary interventionMyocardial infarctionEjection fractionRandomized controlled trialCoronary artery diseaseHeart failureStroke (engine)Clinical endpointIschemic cardiomyopathy

Abstract

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BACKGROUND: Coronary artery bypass grafting (CABG) is the recommended mode of revascularization in patients with ischemic left ventricular dysfunction (iLVSD) and multivessel disease. However, contemporary percutaneous coronary intervention (PCI) outcomes have improved with the integration of novel technologies and refinement of revascularization strategies, and PCI is often used in clinical practice in this population. There is a lack of evidence from randomized trials comparing contemporary state-of-the-art PCI versus CABG for the treatment of iLVSD and multivessel disease. This was the impetus for the STICH3C trial (Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy), described here. METHODS: The STICH3C trial is a prospective, unblinded, international, multicenter trial with an expected sample size of 754 participants from ≈45 centers. Patients with multivessel/left main coronary artery disease and iLVSD with left ventricular ejection fraction ≤40% considered by the local Heart Team appropriate for and amenable to revascularization by both modes of revascularization will be randomized in a 1:1 ratio to state-of-the-art PCI or CABG. RESULTS: The primary end point is the composite of death from any cause, stroke, spontaneous myocardial infarction, urgent repeat revascularization, or heart failure readmission, summarized as a time-to-event outcome. The key hierarchical end point is time to death and frequency of hospitalizations for heart failure. The key safety outcome is a composite of major adverse events. Disease-specific quality-of-life and health economics measures will be compared between groups. Participants will be followed for a median of 5 years, with a minimum follow-up of 4 years. CONCLUSIONS: STICH3C will directly inform patients, clinicians, and international practice guidelines about the efficacy and safety of CABG versus PCI in patients with iLVSD. The results will provide novel and broad evidence, including clinical events, health status, and economic assessments, to guide care for patients with iLVSD and severe coronary artery disease. REGISTRATION: URL: https://clinicaltrials.gov/; Unique identifier: NCT05427370.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.039
metaresearch head score (Gemma)0.065
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Not applicable · Consensus signal: Not applicable
GenreCandidate signal: Protocol · Consensus signal: Protocol
Teacher disagreement score0.112
Threshold uncertainty score0.376

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0390.065
Meta-epidemiology (narrow)0.0020.002
Meta-epidemiology (broad)0.0040.003
Bibliometrics0.0020.003
Science and technology studies0.0030.002
Scholarly communication0.0040.002
Open science0.0030.002
Research integrity0.0050.006
Insufficient payload (model declined to judge)0.1120.029

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.

Opus teacher head0.086
GPT teacher head0.373
Teacher spread0.288 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNot applicable
Domainnot available
GenreProtocol

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".

Quick stats

Citations37
Published2023
Admission routes3
Has abstractyes

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