STaged Interventional Strategies for Acute ST-seGment Elevation Myocardial Infarction Patient With Multi-vessel Disease（STAGED）
Study Details
Study Description
Brief Summary
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 all-cause mortality after in-hospital staged PCI versus out-hospital staged PCI for ST-segment elevated myocardial infarction （STEMI）patients with multi-vessel Disease（MVD） Background: In primary percutaneous coronary intervention for STEMI with MVD, complete revascularization has proved to reduce the risk of cardiovascular death and myocardial infarction. However, a strategy of nonculprit-vessel PCI with the goal of complete revascularization still not to be confirmed. Compare with in-hospital staged PCI, out-hospital PCI as a strategy of nonculprit-vessel PCI for STEMI patients with MVD might have be beneficial results.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
A total of 1700 subjects with STEMI who met inclusion criteria and do not have any exclusion criterion will be randomized to in-hospital staged PCI group and out-hospital staged PCI group. After successful percutaneous coronary intervention for culprit lesion, 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 complete revascularization.
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Patients randomized to in-hospital staged PCI will have treated during the index procedure (7±3 days), after revascularization of the culprit lesion, all significant non-culprit coronary lesions.
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Patients randomized to out-hospital staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized in 30±15 days for complete revascularization of all significant non-culprit coronary lesions.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: In-hospital staged PCI Patients randomized to in-hospital staged PCI will have treated during the index procedure (7±3 days), after revascularization of the culprit lesion, all significant non-culprit coronary lesions. |
Procedure: In-hospital staged PCI
After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).
Other Names:
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| Experimental: Out-hospital staged PCI Patients randomized to out-hospital staged complete revascularization will have treated during the index procedure only the culprit lesion, and they will be hospitalized in 30±15 days for complete revascularization of all significant non-culprit coronary lesions. |
Procedure: Out-hospital staged PCI
During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.
Other Names:
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Outcome Measures
Primary Outcome Measures
- all-cause mortality [12 months]
The difference in all-cause mortality will be calculated from 0 month to 12 months.
Secondary Outcome Measures
- Major adverse cardiovascular and cerebrovascular events (MACE) [12 months]
The difference in MACCE will be calculated from 1 month to 12 months.
- Stroke [12 months]
- contrast-induced nephropathy（CIN） [12 months]
- Dosimetry calculation [Immediately after PCI]
The amount of X-ray exposure shown by the DSA
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provision of informed consent prior to any study specific procedures;
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Established indication to PPCI according to the guidelines of American Heart Association and American College of Cardiology;
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Spontaneous acute STEMI (patients presenting within 24 hours of symptom onset) with MVD after successful revascularization of the culprit artery;
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De novo coronary lesion,
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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.
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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:
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Age <18 yr and >80 yr;
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Cardiac shock, multiple organ failure, cerebral hemorrhage, severe aortic stenosis and myocardial infarction complications(cardiac rupture, ventricular septal rupture and papillary muscle rupture);
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Killip classification >3, cardiognic shock, shore-infarction of culprit artery after emergency PCI in 24 hours;
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Previous documented allergic reaction to drug and device of this study;
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Planned major surgery within 6 weeks in which impact DAPT;
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Participation in another clinical study, interfering with this protocol Uncertain;
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Life expectancy < 1 year;
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Any condition likely to interfere with study processes including follow-up visits or increase of risk accessed by researcher.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xiamen Cardiovascular Hospital Xiamen University | Xiamen | Fujian | China | 361000 |
Sponsors and Collaborators
- Xiamen Cardiovascular Hospital, Xiamen University
Investigators
- Principal Investigator: Yan Wang, Dr, Clinical Trial Center of Xiamen Cardiovascular Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020YLK14