Nonculprit Vulnerable Plaques and Prognosis in Myocardial Infarction With Versus Without ST-Segment Elevation: A PROSPECT II Substudy

Circulation, Volume 151, Issue 25, Page 1767-1779, June 24, 2025. BACKGROUND:Clinical guidelines recommend different revascularization strategies for nonculprit lesions in patients with ST-segment–elevation myocardial infarction (STEMI) versus non-STEMI (NSTEMI). Whether the prevalence of untreated high-risk vulnerable plaques differs in STEMI and NSTEMI and affects their outcomes is unknown.METHODS:In PROSPECT II (Providing Regional Observations to Study Predictors of Events in the Coronary Tree II), a multicenter, prospective natural history study, patients with recent myocardial infarction underwent 3-vessel coronary angiography with coregistered near-infrared spectroscopy and intravascular ultrasound after successful percutaneous coronary intervention of obstructive lesions from 2014 through 2017. Two-feature high-risk plaques were defined as those with both plaque burden ≥70% and maximum lipid core burden index over any 4-mm segment ≥324.7. The primary end point was major adverse cardiovascular events arising from untreated nonculprit lesions during a median 3.7-year follow-up.RESULTS:Of 898 patients, 199 (22.2%) with 849 nonculprit lesions had STEMI and 699 (77.8%) with 2784 nonculprit lesions had NSTEMI. By intravascular ultrasound, the median nonculprit lesion length was 17.4 mm (interquartile range, 16.3–18.5) in STEMI and 17.7 mm (interquartile range, 17.1–18.4) in NSTEMI (P=0.63), and the median minimal lumen area was 5.5 mm2(interquartile range, 5.3–5.7 mm2) in STEMI and 5.5 mm2(interquartile range, 5.3–5.6 mm2) in NSTEMI (P=0.99). At the lesion level, the prevalence of 2-feature high-risk nonobstructive nonculprit plaques was slightly higher in patients with STEMI than in patients with NSTEMI (12.8% versus 10.1%;P=0.03). At the patient level, however, the prevalence of 2-feature high-risk plaques was similar in STEMI versus NSTEMI (38.8% versus 32.7%;P=0.11). The prevalence of patients with 1 or more lesions meeting at least 1 high-risk plaque criterion was also similar (plaque burden ≥70%, 63.3% versus 57.8% [P=0.16]; maximum lipid core burden index over any 4-mm segment ≥324.7, 63.3% versus 57.6% [P=0.15]). The 4-year rates of nonculprit lesion–related major adverse cardiovascular events were similar in STEMI versus NSTEMI (8.6% versus 7.8%; hazard ratio, 1.02 [95% CI, 0.57–1.81];P=0.95), as were the rates of all major adverse cardiovascular events (14.2% versus 13.0%; hazard ratio, 1.06 [95% CI, 0.68–1.64];P=0.80).CONCLUSIONS:In the PROSPECT II study, the per-patient prevalence of high-risk vulnerable plaques was comparable in STEMI versus NSTEMI, as was the overall long-term incidence of nonculprit lesion–related and all major adverse cardiovascular events. These results support a similar revascularization strategy for nonculprit lesions in patients with STEMI or NSTEMI after culprit lesion management.REGISTRATION:URL:https://www.clinicaltrials.gov; Unique identifier: NCT02171065.

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Effects of ondansetron applied before the induction of anaesthesia on postoperative nausea and vomiting in high-risk patients: protocol for a randomised controlled trial

Introduction
Postoperative nausea and vomiting (PONV) is a common complication following various surgical procedures, significantly contributing to patient discomfort and increasing healthcare costs. Despite the widespread use of multiple drug combinations, PONV remains a persistent challenge, particularly in high-risk populations. Existing evidence suggests a potential interaction between 5-HT3 receptors and μ-opioid receptors, indicating that they may function as co-receptors with a competitive relationship. Based on this hypothesis, we designed experiments to investigate this correlation.

Methods and analysis
This randomised, parallel, positive-controlled, double-blind (both intervener and participant) trial will take place at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. Based on relevant literature and our pre-test, the incidence of PONV in the intervention group is estimated to be approximately 30%. With an expected 10% loss-to-follow-up rate and a desired statistical power of 0.9 (1-β), the required sample size for each group is 65 participants, totalling 130 subjects to be enrolled from 30 March 2025 to 30 April 2025. Eligible patients will be randomly allocated to either the intervention or control group. Ondansetron will be administered 15 min before anaesthesia induction in the intervention group (n=65) and at the end of surgery in the control group (n=65). The primary outcome is the incidence of PONV within the 0–24-hour postoperative period. The sample size will be calculated using PASS 15, statistical analysis will be conducted using SPSS 25 and missing data will be addressed using the Last Observation Carried Forward method. Two-tailed tests will be employed, with significance set at α=0.05. Results will be considered significant if p

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Barriers and facilitators to offering palliative care to patients with heart failure: a mixed-methods systematic review using the COM-B model and theoretical domains framework

Objectives
Despite palliative care (PC) potentially improving quality of life, only a tiny proportion of patients with heart failure (HF) are receiving PC. Globally, PC for HF patients faces several challenges; however, a systematic assessment of the barriers and facilitators to PC of patients suffering from HF is lacking. We aimed to identify barriers and facilitators to offering PC to HF patients.

Design
The mixed-methods systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis statement.

Data sources
PubMed, CINAHL, MEDLINE, PsycINFO, Web of Science were searched from onset of literature database to 24 March 2025.

Eligibility criteria
We included both qualitative studies and quantitative studies addressing barriers and facilitators to offering PC to patients with HF reported by healthcare providers, patients, family members and caregivers.

Data extraction and synthesis
Data extraction was done independently by two reviewers, and quality assessment was completed using the mixed-methods appraisal tool. The Capabilities-Opportunities-Motivations-Behaviour (COM-B) model and the Theoretical Domain Framework (TDF) were used to identify potential barriers and facilitators.

Results
48 studies were included out of 4168. 289 items related to barriers and 88 items related to facilitators were categorised into 72 themes. These themes were found to align with at least one of the 14 TDF domains and the COM-B model. ‘Environmental context and resources’ (eg, lack of time, human, facilities and equipment resources; 77.2% of barriers vs 22.8% of facilitators), ‘knowledge’ (eg, insufficient awareness and knowledge of PC and/or needs; 91.8% of barriers vs 8.2% of facilitators) and “‘social influences’ (eg, limited communication and collaboration between healthcare professionals; 58.7% of barriers vs 41.3% of facilitators) were the three TDF domains that encoded the largest amount of data.

Conclusions
This review identified key barriers to PC for HF patients, primarily involving resource limitations, knowledge gaps and poor interdisciplinary collaboration. Findings highlight the need for targeted interventions addressing systemic and knowledge-related challenges.

PROSPERO registration number
CRD42023484807.

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Cuff leak test and airway obstruction in mechanically ventilated ICU patients (COSMIC): a pilot feasibility randomized controlled trial protocol

Introduction
The cuff leak test (CLT) is hypothesised to help optimise extubation by assessing for laryngeal oedema which, if unrecognised and untreated, could lead to post-extubation stridor, post-extubation airway obstruction, and reintubation. However, the diagnostic accuracy of the CLT to detect post-extubation stridor (and hence potentially airway obstruction) remains uncertain. Given the equipoise that exists surrounding the CLT, we are conducting a pilot randomised clinical trial (RCT) examining the CLT as part of the pathway to extubation. Herein, we report the protocol for the Cuff Leak Test and Airway Obstruction in Mechanically Ventilated ICU Patients (COSMIC): a Pilot Feasibility Randomized Clinical trial (RCT).

Methods and analysis
This is a multicentre, international, parallel-group, pragmatic, pilot RCT. We will enrol 100 mechanically ventilated patients in the intensive care unit (ICU) who are deemed ready for extubation and have at least one risk factor for laryngeal oedema. In the intervention arm, respiratory therapists will perform a qualitative CLT before extubation. If a patient passes the CLT (suggesting no laryngeal oedema), extubation will be performed in keeping with standard care. If the patient fails the CLT (suggesting laryngeal oedema), extubation will be delayed allowing for administration of dexamethasone, consideration of diuresis, and the CLT will be repeated in 12–24 hours. In the control arm, patients will be extubated without completing a CLT, without steroid administration, and without delay. Randomization will be by a 1:1 allocation, stratified by centre. The primary feasibility outcomes will include recruitment and protocol adherence. Secondary outcomes will include post-extubation stridor, reintubation within 72 hours, emergency surgical airway within 72 hours, and ICU and hospital mortality within 30 days.

Ethics and dissemination
This trial has been approved by Clinical Trials Ontario, Hamilton Integrated Research Ethics Board, State of Kuwait Ministry of Health, University of Texas Health Committee for the Protection of Human Subjects and Brant Community Health Systems Research Ethics Committee. The trial has received a No Objection Letter from Health Canada. Trial results will be disseminated via publication in peer-reviewed journals.

Trial registration number
NCT05456542.

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Effect of prednisolone on live birth rate in women with unexplained recurrent pregnancy loss: a study protocol for a double-blind, placebo-controlled, multicentre, randomised controlled trial (PREMI-study)

Introduction
Recurrent pregnancy loss (RPL) is defined as the occurrence of two or more spontaneous pregnancy losses from the time of conception until 24 weeks of gestation. Currently, an underlying cause can be identified in only a minority of the losses. Potentially, an impaired maternal immune response targeting the semiallograft pregnancy may lead to miscarriage. While prior studies have explored the use of immune-suppressing corticosteroids to modulate the maternal immune system and hopefully improve pregnancy outcome, the absence of sufficiently powered randomised controlled trials (RCT) underscores the need for further research. The primary aim of this study is to evaluate if prednisolone administration in early pregnancy (20 mg daily for 6 weeks, then tapering doses for 2 weeks) in women with unexplained RPL leads to a higher live birth rate (LBR) in comparison to placebo. Additionally, the study assesses the tolerability, safety and the cost-effectiveness of this intervention. Finally, we will explore the effect of prednisolone in various subgroups (based on maternal age, number of previous pregnancy losses, presence of specific antibodies and pre-pregnancy endometrial immune cell level).

Methods and analysis
This ongoing multicentre, double-blind RCT will randomise 490 women with unexplained RPL and pregnancy

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