Non-ST-segment elevation myocardial infarction (NSTEMI) with multivessel disease (MVD)
Conditions
Interventions
Complete revascularization group:Complete revascularization with PCI of all angiographically significant nonculprit lesions
Culprit-lesion-only revascularization:Without further revascularization of non-culprit lesions
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females aged >=18 years; 2. Admitted to the hospital with NSTEMI; 3. The patient had a clearly identifiable culprit lesion that had been successfully treated. In NSTEMI patients, identification of the culprit lesion primarily relies on electrocardiography, echocardiography, and conventional coronary angiography. For patients in whom conventional assessment is inconclusive, intravascular imaging (optical coherence tomography or intravascular ultrasound) is recommended to assist in identifying the culprit lesion in centers where conditions permit; 4. Multivessel disease (MVD) was defined as the presence of at least one angiographically significant non-culprit lesion, in addition to the culprit lesion. Significant non-culprit lesions are those that meet both of the following criteria: 1) they are located in a vessel with a diameter of >=2.0 mm that was not stented as part of the index culprit lesion-PCI, and 2) they exhibit a diameter stenosis of >=70% in a single view or >=50% in 2 views on visual estimation; 5. Presence of chronic total occlusion (CTO) is not an exclusion criterion per se, although CTO vessel cannot be the object of randomization. Another eligible non-CTO vessel with a qualifying non-culprit lesion should be present for enrollment; 6. The operator determined that the non-culprit lesion was suitable for PCI; 7. The patient (or legal representative) understood the study requirements and treatment procedures and signed the informed consen;
Exclusion criteria
Exclusion criteria: 1. Hemodynamic instability, cardiogenic shock, or the need for circulatory assistance devices such as extracorporeal membrane oxygenation (ECMO), or left ventricular assist device; 2. Severe renal dysfunction (defined as eGFR =30 ml/min/1.73 m² or serum creatinine =2.0 mg/dL) and not undergoing regular dialysis (patients with chronic renal dysfunction and regular dialysis may be considered for inclusion); 3. Sustained ventricular tachycardia or ventricular fibrillation; 4. Intolerance to antiplatelet therapy (e.g., aspirin, clopidogrel, ticagrelor); 5. Previous PCI or CABG, or planned CABG; 6. Co-morbidity with life expectancy less than 12 months; 7. Pregnancy and breast feeding period; 8. Type 2 myocardial infarction, as defined by the Fourth universal definition of myocardial infarction; 9. Unable to comply with the study protocol or other circumstances deemed by the investigator as unsuitable for participation in the study; 10. There was a pre-randomization intent to revascularize a non-culprit lesion, irrespective of randomized allocation; 11. Left main disease (>=50% visual diameter stenosis on angiography) or severe tortuosity or calcification of the target vessel;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major adverse cardiac events (MACEs) comprised all-cause death, non-fatal MI and ischemia-driven revascularization; | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death;Cardiovascular death;Myocardial infarction;Non-fatal myocardial infarction;Revascularization;Ischemia-driven revascularization;Definite, and probable stent thrombosis;Stroke;Non-fatal stroke;Rehospitalization for unstable angina;Rehospitalization for heart failure;Patient-oriented composite events, include all-cause mortality, stroke, MI and revascularization;Quality of life at 12 months (by EQ-5D questionnaire);Serious bleeding event (BARC type 3 or 5);Contrast-induced acute kidney injury;Coronary procedure-related myocardial infarction; | — |
Countries
China
Contacts
Public ContactJiannan Dai
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed