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.

Read More

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…

Read More

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…

Read More

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.

Read More

Assessment of the prognostic performance of TIMI, PAMI, CADILLAC and GRACE scores for short-term major adverse cardiovascular events in patients undergoing emergent percutaneous revascularisation: a prospective observational study

Objectives
Accurately predicting short-term MACE (major adverse cardiac events) following primary percutaneous coronary intervention (PCI) remains a clinical challenge. This study aims to assess the effectiveness of four established risk scores in predicting short-term MACE after primary PCI.

Design
Prospective observational study.

Setting
The National Institute of Cardiovascular Diseases, Karachi, Pakistan.

Participants
We enrolled a cohort of consecutive adult patients diagnosed with ST-elevation myocardial infarction undergoing primary PCI over a 6-month period, from 1 January 2022 to 30 June 2022.

Outcome measures
All the patients were followed at intervals of 3 months up to 12 months, and MACE events were recorded. Thrombolysis in Myocardial Infarction (TIMI), Primary Angioplasty in Myocardial Infarction (PAMI), Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications (CADILLAC) and Global Registry of Acute Coronary Events (GRACE) scores were obtained.

Results
A total of 2839 patients (79.3% male, mean age 55.6±11.2 years) were included. Over a median follow-up of 244 days, the composite MACE rate was 18.4% (521). All-cause mortality was 13.5% (384), reinfarction requiring revascularisation was 4.3% (121), heart failure-related rehospitalisation was 2.7% (76), stent thrombosis occurred in 5.6% (160) and cerebrovascular accident events were documented in 1% (28). The area under the curve for TIMI, PAMI, CADILLAC and GRACE scores was 0.682 (95% CI 0.655 to 0.709), 0.688 (95% CI 0.663 to 0.713), 0.686 (95% CI 0.66 to 0.711) and 0.695 (95% CI 0.669 to 0.72), respectively, for the prediction of MACE. On multivariable Cox regression, high-risk categories based on GRACE score were independent predictors of MACE with adjusted HR of 1.88 (95% CI 1.28 to 2.77; p=0.001).

Conclusions
A significant proportion of patients experienced short-term MACE after primary PCI. While none of the assessed scores demonstrated significant predictive power, the GRACE score exhibited comparatively better predictive ability than the TIMI, PAMI and CADILLAC scores.

Read More