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Ivabradine in Patients Undergoing Noncardiac Surgery: A Randomized Controlled Trial

2025· article· en· W4413849555 on OpenAlexaff
Wojciech Szczeklik, Jakub Fronczek, Zbigniew Putowski, Anna Włudarczyk, Jacek Górka, Bożena Seczyńska, Dominika Gryszówka, Agnieszka Widawska, Szymon Białka, Piotr Palaczyński, Michał Borys, Paweł Kutnik, Tomasz Czarnik, Anna Szczepańska, Marcin Możański, Marcin Mieszkowski, Katarzyna Kotfis, Janusz Trzebicki, Łukasz Sadowski, Joanna Sołek-Pastuszka, Paweł Grudzień, Wojciech Mudyna, Agnieszka Misiewska-Kaczur, Radosław Owczuk, Bartosz Kudliński, Dorota Studzińska, Jarosław Pawlik, Adam Makowski, Mirosław Ziętkiewicz, Mikołaj Przydacz, Waldemar Goździk, Wojciech Gola, Przemysław Jasiewicz, Zhiguo Zhao, Yu Shyr, P.J. Devereaux

Bibliographic record

VenueCirculation · 2025
Typearticle
Languageen
FieldMedicine
TopicHeart rate and cardiovascular health
Canadian institutionsPopulation Health Research Institute
FundersAgencja Badań Medycznych
KeywordsMedicineIvabradinePlaceboAnesthesiaPerioperativeMyocardial infarctionStroke (engine)RandomizationHeart rateRandomized controlled trialConfidence intervalClinical endpointInterim analysisCardiologyInternal medicineSurgeryBlood pressure

Abstract

fetched live from OpenAlex

BACKGROUND: Perioperative beta blockade lowers heart rate and decreases the risk of myocardial infarction but increases the risk of hypotension, death, and stroke. Ivabradine, a selective heart rate–lowering agent, may prevent prognostically important myocardial injury after noncardiac surgery (MINS) without causing hemodynamic instability. METHODS: In this multicenter, double-blind, placebo-controlled trial, we assigned patients ≥45 years of age with, or at risk of, atherosclerotic disease undergoing noncardiac surgery to receive ivabradine (5 mg orally twice daily for up to 7 days, starting 1 hour before surgery) or placebo. The primary outcome was MINS within 30 days from randomization. RESULTS: All of the 2101 participants who underwent randomization were included in the intention-to-treat population. MINS occurred in 178 of 1050 patients (17.0%) in the ivabradine group and in 159 of 1051 patients (15.1%) in the placebo group (relative risk, 1.12 [95% CI, 0.92 to 1.37]; P =0.25). Enrollment was halted at the prespecified interim analysis because of a conditional power of 6%, below the futility boundary of 20%. The intraoperative mean heart rate was lower in the ivabradine group by 3.2 beats per minute than in the placebo group (95% CI, –4.07 to –2.36), with no difference in intraoperative mean arterial pressure. CONCLUSIONS: Among patients undergoing noncardiac surgery, ivabradine did not reduce the occurrence of MINS. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT05279651.

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)0.003
metaresearch head score (Gemma)0.004
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.007
Threshold uncertainty score0.025

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0030.004
Meta-epidemiology (narrow)0.0010.001
Meta-epidemiology (broad)0.0040.002
Bibliometrics0.0000.001
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.002
Insufficient payload (model declined to judge)0.0070.001

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 head0.012
GPT teacher head0.273
Teacher spread0.261 · 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 designRandomized trial
Domainnot available
GenreEmpirical

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

Citations5
Published2025
Admission routes1
Has abstractyes

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