STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED） (SAGED)

Xiamen Cardiovascular Hospital, Xiamen University

Status: Completed

Conditions: Percutaneous Coronary Intervention; Multi Vessel Coronary Artery Disease; AMI Patients With Multivessel Disease, Staged PCI; STEMI

Treatments: Procedure: Early staged PCI; Procedure: Late staged PCI

Study type: Interventional

Funder types: Other

Identifiers

NCT04918030

2020YLK14

Details and patient eligibility

About

An investigator-initiated, randomized, multicenter, two-arm, open-label study of consecutive patients presenting with STEMI and MVD Objectives: The present study aimed to investigate the difference in major adverse cardiac event (MACE) between Early staged PCI versus Late staged PCI groups among patients with ST-segment elevated myocardial infarction （STEMI and multi-vessel Disease（MVD) who underwent primary PCI using DES for culprit lesions.

Background: In patients with STEMI with MVD who underwent primary PCI, complete revascularization for non-culprit lesions has proved to reduce the risk of cardiovascular death and myocardial infarction. However, the ideal timing point for staged PCI for nonculprit lesions remains uncertain.

Full description

A total of 1586 subjects with STEMI who met inclusion criteria and had no any exclusion criterion will be randomized (at a 1:1 ratio) to Early staged PCI group and Late staged PCI group. After successful percutaneous coronary intervention for culprit lesion, staged PCI for all non-culprit vessel with significant lesion defined at least 80% diameter stenosis by visual estimation and accompanied by a QFR measurement of less than or equal to 0.80 will be performed. Patients will be ranmized to the following groups at 1:1 ratio:

1. Patients randomized to the in-hospital staged PCI (Early group) will undergo PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.
2. Patients randomized to out-hospital staged complete revascularization (Late group) will undergo PCI for all significant non-culprit lesions at 30±15 days after primary PCI.

Enrollment: 1,586 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of informed consent prior to any study specific procedures;
• Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
• Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
• De novo coronary lesion,
• TIMI Flow 3 ( Cases with TIMI flow 2 need to perform angiographic again in 24h ensured TIMI flow 3 for enrolling case )after revascularization of the culprit artery, residual stenosis ≤20% and no coronary dissection greater than or equal to type C leading to (threatening) vessel closure.
• At least one non-culprit coronary stenosis ≥ 80% and accompanied by QFR ≤0.8 in a vessel with a lumen diameter ≥2.5;

Exclusion criteria

• Age <18 yr and >80 yr;
• Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
• Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
• Previous documented allergic reaction to drug and device of this study;
• Planned major surgery within 6 weeks in which impact DAPT;
• Participation in another clinical study, interfering with this protocol Uncertain;
• Life expectancy < 1 year;
• Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,586 participants in 2 patient groups

Early staged group

Active Comparator group

Description:

Patients randomized to Early group will undergo staged PCI for all significant non-culprit lesions at 7±3 days after revascularization of the culprit lesion.

Treatment:

Procedure: Early staged PCI

Late staged PCI

Experimental group

Description:

Patients randomized to Late Group will undergo staged PCI for all significant non-culprit lesion at 30±15 days after primary PCI for culprit coronary lesions.

Treatment:

Procedure: Late staged PCI