Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)

Launched by CHONNAM NATIONAL UNIVERSITY HOSPITAL · Jul 9, 2021

Keywords

ClinConnect Summary

The OPTION-NSTEMI trial is studying the best way to treat patients who have had a type of heart attack called non-ST-segment elevation myocardial infarction (NSTEMI) and also have multiple blockages in their heart arteries. The trial is comparing two approaches: one where doctors perform all necessary procedures to open blocked arteries right away during the first visit, and another where they treat the most critical blockage first and wait a few days to treat the others. This study is important because it aims to find out which method leads to better health outcomes for patients with multiple artery blockages.

To participate in this trial, you need to be at least 19 years old, have experienced certain symptoms of NSTEMI, and have been diagnosed with blockages in at least two of your heart's arteries. You should be able to undergo a procedure called percutaneous coronary intervention (PCI) within 72 hours of your symptoms starting. If you join the trial, you can expect to receive careful monitoring and treatment, and you'll be contributing to important research that could help improve care for future patients with similar conditions. However, some people may not be eligible due to specific health issues or other factors, which the trial team will explain to you.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 19 years old
• • 2. Non-ST-segment elevation myocardial infarction
• • Angina pectoris or equivalent ischemic chest discomfort with at least 1 of 3 features and,
• • occurs at rest, usually lasting \> 10 minutes
• • severe and new onset (within the prior 4-6 weeks)
• • crescendo pattern
• • Elevated cardiac biomarkers and,
• • ≥ 99% value of high-sensitivity cardiac troponin
• • No ST-segment elevation ≥ 0.1 mV in ≥ 2 contiguous leads or newly developed left bundle branch block on 12-lead electrocardiogram
• • 3. PCI within 72 hours after symptom development
• • 4. Multivessel disease: Non-IRA with at least 2.5 mm diameter and 50% diameter stenosis by visual estimation
• • 5. Patient's or protector's agreement about study design and the risk of PCI
• Exclusion Criteria:
• • 1. Cardiogenic shock at initial presentation or after treatment of IRA
• • 2. TIMI flow at non-IRA ≤ 2
• • 3. Severe procedural complications (e.g. persistent no-reflow phenomenon, coronary artery perforation) which restricts study enrollment by operators' decision
• • 4. Non-IRA lesion not suitable for PCI treatment by operators' decision
• • 5. Chronic total occlusion at non-IRA
• • 6. History of anaphylaxis to contrast agent
• • 7. Pregnancy and lactation
• • 8. Life expectancy \< 1-year
• • 9. Severe valvular disease
• • 10. History of CABG, or planned CABG
• • 11. Fibrinolysis before admission