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| Name | Class |
|---|---|
| Nanjing First Hospital, Nanjing Medical University | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early staged group | Active Comparator | 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. |
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| Late staged PCI | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early staged PCI | Procedure | After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day). |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions). | The difference in MACE will be calculated from randomisation to 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause death | It will be calculated from randomisation to 12 months. | 12 months |
| Myocardial Infarction (MI) | It will be calculated and compared from randomisation to 12 months Periprocedural MI (PMI): Defined as a CK-MB elevation greater than 10 times the upper reference limit (URL) within 72 hours post-procedure, in the absence of symptoms or ECG changes. If the patient presented with ischemic symptoms, ischemic ECG changes, or intra-procedural slow-flow or side-branch occlusion, PMI is defined as a CK-MB elevation greater than 5 times the URL. Spontaneous MI: Defined as a rise of cardiac biomarkers, preferably cardiac troponin (cTn), with at least one value above the 99th percentile URL, accompanied by at least one of the following: ischemic symptoms, new ischemic ECG changes (including new ST-T changes or new left bundle branch block), development of pathological Q waves, or imaging evidence of new regional wall motion abnormalities or loss of viable myocardium. |
| Measure | Description | Time Frame |
|---|---|---|
| Stent thrombosis | Stent Thrombosis (Based on Academic Research Consortium criteria)
| 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Wang, Dr | Clinical Trial Center of Xiamen Cardiovascular Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Cardiovascular Hospital Xiamen University | Xiamen | Fujian | 361000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41539383 | Derived | Chen X, Li S, Wang B, Chen G, Yao Y, He Y, Wu X, Yang Y, Kang H, Ding L, Cheng Y, Shen Q, Guo H, Wang J, Wen S, Zhu L, Xing Y, Tong Q, Li P, Liu Y, Peng X, Chen SL, Wang Y. Staged interventional strategies for acute ST-segment elevation myocardial infarction patient with multivessel disease: Rationale and design of a multicenter, randomized STAGED trial. Am Heart J. 2026 May;295:107352. doi: 10.1016/j.ahj.2026.107352. Epub 2026 Jan 13. |
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Data sharing could be considered upon the proposal was approved
One year lafter since publication
All can access via reaching to PIs
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| Late staged PCI | Procedure | 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. |
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| 12 months |
| Revascularization | Ischemia-driven Coronary Revascularization Ischemia-driven coronary revascularization was defined in accordance with the Academic Research Consortium-2 (ARC-2) consensus. In this study, ischemia-driven coronary revascularization included any repeat percutaneous coronary intervention or coronary artery bypass grafting performed due to myocardial ischemia, irrespective of whether the lesion was located in a target or non-target vessel. Following the ARC-2 criteria, revascularization was considered ischemia-driven if it was associated with objective evidence of myocardial ischemia, including recurrent ischemic symptoms, ischemic changes on electrocardiogram, positive results from non-invasive stress testing, or fractional flow reserve less than or equal to 0.80. When functional assessment was not available, adjudication by the Clinical Events Committee using independent quantitative coronary angiography of baseline and repeat angiograms was required. | 12 months |
| Cardiovascular death | Cardiovascular death includes sudden cardiac death, death due to acute myocardial infarction, heart failure, cerebrovascular events, other cardiovascular causes, such as pulmonary embolism, aortic disease, or complications arising from cardiovascular interventions or surgeries. | 12 months |
| Heart failure-induced rehospitalization | Rate of New hospitalization for heart failure | 12 months |
| Stroke | According to the 2013 AHA/ASA guidelines, stroke is defined as cerebral infarction, intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH), all characterized by acute, focal dysfunction of the central nervous system (CNS) resulting from vascular causes. | 12month |
| Rate of contrast-induced nephropathy(CIN) | Contrast-Induced Nephropathy (Based on KDIGO criteria)
| 12 months |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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