Preventive Effects of Prasugrel on Cerebrovascular Events Following Percutaneous Coronary Intervention

Stroke, Ahead of Print. BACKGROUND:Dual antiplatelet drug administration is recommended after percutaneous coronary intervention (PCI) stent placement. Although prasugrel, a newer P2Y12 inhibitor, reportedly suppresses cardiovascular events more effectively than the traditional agent clopidogrel, its preventive effects on cerebrovascular disorders remain a topic of ongoing debate. This study aimed to examine the cerebrovascular efficacy and safety of post-PCI prasugrel and clopidogrel using extensive real-world data in Japan.METHODS:Using the CLIDAS (Clinical Deep Data Accumulation System) database, 7412 post-PCI patients who received dual antiplatelet therapy between April 2013 and March 2019 were identified. The primary end point was defined as the incidence of any stroke, while secondary end points included individual ischemic and hemorrhagic cerebrovascular events. The incidence of cerebrovascular events was compared between the prasugrel (2.5–3.75 mg daily; n=2219) and clopidogrel (75 mg daily; n=5193) groups using propensity-score inverse probability of treatment weighting and Fine and Gray models to account for competing risks.RESULTS:Within 1 year after PCI, the prasugrel group had a significantly lower incidence of cerebrovascular events (subdistribution hazard ratio, 0.46 [95% CI, 0.24–0.91];P=0.027) than the clopidogrel group. The subgroup analyses did not show significant differences in the incidence of ischemic (subdistribution hazard ratio, 0.54 [95% CI, 0.25–1.14];P=0.11) and hemorrhagic cerebrovascular events (subdistribution hazard ratio, 0.30 [95% CI, 0.084–1.10];P=0.070) between the use of prasugrel and clopidogrel. One-year health care costs between patients treated with prasugrel and those treated with clopidogrel showed no significant differences.CONCLUSIONS:Our data suggest that post-PCI prasugrel use was associated with lower cerebrovascular events compared with the use of clopidogrel in combination with aspirin. Further research is necessary to substantiate the potential of prasugrel in lowering cerebrovascular risks after post-PCI while upholding a satisfactory safety profile.

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Exploring the causes of elevated kinesiophobia in post-coronary stenting patients: a qualitative analysis in a cardiac rehabilitation setting

Objectives
The primary aim of this study is to investigate the factors contributing to the development of kinesiophobia in patients following coronary artery stent implantation, integrating perspectives from both patients and healthcare professionals. The main hypothesis is that understanding and methods for effectively overcoming the fear of exercise and improving the effectiveness of cardiac rehabilitation require further exploration from both patient and professional viewpoints.

Design
This qualitative study used a semi-structured interview approach to gather data from participants.

Setting
The study was conducted at a hospital in Gansu province, China, focusing on the level of care provided to cardiac rehabilitation patients.

Participants
A total of 11 cardiac rehabilitation patients identified as having kinesiophobia (Tampa Scale for kinesiophobia Heart, TSK-SV Heart >37) through screening and nine healthcare professionals participated in the study. The selection criteria included patients undergoing cardiac rehabilitation and professionals involved in their care.

Results
The study identified a core theme, ‘Navigating Fear and Uncertainty’, encompassing five themes that elucidate how various factors contribute to the prevalent phenomenon of kinesiophobia among patients. These were further delineated into 11 subthemes: (1) physiological factors (fatigue, negative illness experiences), (2) psychological factors (hypervigilance, psychogenic anxiety and depression), (3) capacity factors (reduced physical abilities, lack of rehabilitation knowledge and skills), (4) motivational factors (low exercise self-efficacy, rehabilitation cognitive errors) and (5) support systems (primary caregivers, healthcare professionals and medical support). The results provide a qualitative understanding rather than quantitative measures, hence no CIs or statistical significance levels are provided.

Conclusions
The kinesiophobia observed in patients following coronary artery stent implantation stems from the combined influence of multiple factors, warranting early assessment and intervention by healthcare professionals. The study suggests that healthcare institutions should address the practical concerns faced by cardiac rehabilitation patients and enhance familial, medical and societal support systems to increase patient engagement and compliance with exercise rehabilitation. Further research is needed to develop and validate interventions based on these findings.

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Tirofiban efficacy and safety for percutaneous coronary intervention in patients with acute coronary syndrome: protocol for a systematic review and meta-analysis

Introduction
Percutaneous coronary interventions (PCI) have become a cornerstone in the management of acute coronary syndromes (ACS), yet they carry risks of complications like stent thrombosis and reinfarction. Glycoprotein IIb/IIIa inhibitors, particularly tirofiban, have been employed as adjunctive therapies to reduce these risks. Despite its potential benefits, the use of tirofiban remains a subject of debate, with varying recommendations across major clinical guidelines.

Methods and analysis
We systematically searched five databases from 1 January 1992 to 1 April 2025, including Medline, Embase, Lilacs, Clinicaltrials.org and Cochrane Central Register of Controlled Trials (CENTRAL), in addition to three grey literature databases. Randomised controlled trials and cluster randomised trials investigating the use of intravenous or intracoronary tirofiban in patients with ACS, unstable angina or myocardial infarction were considered for inclusion. Only published studies in English, Portuguese, Spanish and French were included. Data selection and extraction will be performed independently by two researchers, with any inconsistencies resolved with consensus or by consulting a third senior researcher. The risk of bias will be assessed through the risk of bias measurement tool (Rob-2) for interventions and/or cluster trials by two researchers independently, and the overall certainty of evidence will be assessed by using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tool. A meta-analysis will be carried out if there is sufficient homogeneity between studies, with subgroup analysis being performed if significant heterogeneity is detected. Additionally, a metaregression model will be conducted if sufficient data are available.

Ethics and dissemination
As this study involves secondary analysis of published data, ethics approval is not required. The results will be disseminated through peer-reviewed publication, conference presentations and will be shared with relevant clinical guideline committees.

PROSPERO registration number
CRD42024585252.

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SPHINX, a Guardian of Wisdom

We thank Ramchandani et al for their letter on the SPHINX trial and appreciate the opportunity to address their points.1 2 Sample size The SPHINX trial aimed to assess whether endoscopic sphincterotomy (ES) could reduce post-ERCP pancreatitis (PEP). However, quantifying this effect proved difficult due to conflicting results from previous, heterogeneous randomised controlled trials (RCTs), which differed in sample size, patient populations and stent types.3–5 The trial by Zhou et al (2012) reported a 69% relative risk reduction in PEP after ES, which served as reference for our sample size calculation.3 However, since the other trials did not show this benefit, we considered this effect overestimated.4 5 The SPHINX trial was designed to detect a 50% relative risk reduction in PEP in patients with suspected distal malignant biliary obstruction (MBO). Based on…

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Sphincterotomy with FCSEMS (SPHINX): a monumental answer or the beginning of new mysteries?

We read with interest the recently published randomised controlled trial (RCT) ‘SPHINX’,1 addressing the role of endoscopic sphincterotomy (ES) with fully covered s metal stent (FCSEMS) placement in preventing post-ERCP pancreatitis (PEP). Although this is the largest RCT on the topic, several concerns warrant discussion. Published data report variable rates of PEP after SEMS ranging from 0% to 26.8%,2–4 with lot of heterogeneity regarding the PEP preventive measures. Nevertheless severe pancreatitis remains rare. To assess the impact of ES a larger sample size will be required. The SPHINX trial sample estimation was based on two studies by Tol et al,5 which reported 18% PEP with FCSEMS placement in the preoperative biliary drainage setting, and Zhou et al,6 31.7% PEP in the non-ES group, which is way higher than the presumed 16% in the SPHINX trial. Furthermore, it…

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Rapid cycle, randomised testing of precision feedback to improve engagement with a process measure dashboard amongst urologists: study protocol for a hybrid trial

Introduction
Rapid-cycle randomised testing holds high potential to enhance quality improvement practice but remains under-utilised because it requires significant resource commitment. However, infrastructure for learning networks, such as collaborative quality initiatives and large-scale quality improvement consortia, holds potential to support rapid-cycle testing at low cost and with minimal effort. For example, rapid-cycle randomised testing could be used to optimise ‘precision feedback’, which prioritises highly motivating tailored content to improve engagement with audit and feedback. We combined these concepts (rapid cycle, randomised testing and precision feedback) with a low-resource emphasis in conceiving this trial.

Methods and analysis
A stepped wedge randomised controlled trial will deliver an intervention consisting of precision feedback and modifications to audit and feedback communication to 100 urologists performing ureteroscopy within the Michigan Urological Surgery Improvement Collaborative (MUSIC) and will be compared with a control consisting of standard ‘one-size-fits-all’ audit and feedback. The study’s primary endpoint is online dashboard engagement, measured as the clickthrough rate through the tracking of embedded links in emails. The stent rate following pre-stented ureteroscopy will also be measured. The primary hypothesis is that precision feedback will increase engagement with an audit and feedback dashboard and decrease rates of stenting following pre-stented ureteroscopy. Endpoints will be analysed by linear modelling accounting for repeated measures within individuals, exploring the primary hypothesis through a main effect by the study arm.

Ethics and dissemination
Ethics and regulatory approval have been obtained from the Institutional Review Board of the University of Michigan (HUM#00248876). The findings will be disseminated in peer-reviewed journals and conferences.

Trial registration number
ClinicalTrials.gov registration number: NCT06465667. Registered 6/20/2024.

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