Acute ST-elevation myocardial infarction
The study is an investigator-initiated, prospective, open-label, randomised, non-inferiority study. The study will be conducted across multiple primary angioplasty (heart attack) centres within the UK. The target population for this study includes adult patients presenting with ST-segment elevation myocardial infarction requiring primary angioplasty treatment. Pre-procedure examinations, including the collection of medical and medication history, assessment of angina index, and current medication, are conducted in accordance with routine practice. Patients who are included as part of the emergency consent process will be randomized (1:1) to one of two groups. One group will receive Drug Coated Balloon (DCB) treatment and the other will receive Drug Eluting Stent (DES) treatment. All participants will receive appropriate medications before, during and after their treatment as per current guidelines and operator/hospital approach, and will be discharged according to hospital policies. No changes to their inpatient care are performed. Post-treatment investigations are as per current practice and guidelines, including blood sampling for troponin at 24 hours and assessment of left ventricular function with transthoracic echo prior to discharge. Written information regarding the study will be provided to the patient post-procedure and consent obtained for further participation prior to discharge from hospital, usually on day 1. Follow-up in-person examinations will be conducted in accordance with the usual practices of the participating hospital. Additional study-specific follow-ups will be conducted at 30 days, 1 year, 3 years, 5 years and 8 years via telephone and with a review of patient notes as required. During the follow-up telephone appointments, medical and medication history will be collected to assess if any endpoints or adverse events have occurred and the angina index will be assessed via a short questionnaire. The primary endpoint will be examined as
This trial presents an all-comers design allowing broad inclusion and few exclusion criteria. Specifically, patients can be included if suffering from STEMI, which requires emergent percutaneous coronary intervention (PCI) via the primary angioplasty service. To meet the criteria of a STEMI, patients need to have: 1. Symptoms of myocardial ischemia lasting for ≥30 min 2. Definite ECG changes indicating STEMI: ST elevation of >0.1 mV in two contiguous limb leads or ≥0.2 mV in two contiguous precordial leads
Current exclusion criteria as of 06/01/2026: 1. Previous CABG Previous exclusion criteria: 1. Prior PCI of the target vessel 2. Previous CABG 3. Recent (<2 months) history of significant bleeding 4. Cardiac arrest requiring intubation before PPCI 5. Known allergy or contraindication for aspirin, clopidogrel, prasugrel, fondaparinux and/or heparin 6. Life expectancy less than 12 months