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: 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,586
After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).
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.
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, Fujian, China
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.
Time frame: 12 months
All-cause death
It will be calculated from randomisation to 12 months.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Heart failure-induced rehospitalization
Rate of New hospitalization for heart failure
Time frame: 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.
Time frame: 12month
Rate of contrast-induced nephropathy（CIN）
Contrast-Induced Nephropathy (Based on KDIGO criteria) 1. An increase in serum creatinine to ≥1.5 times the baseline value within 7 days following exposure to contrast media. 2. An absolute increase in serum creatinine of \>0.3 mg/dL (26.5 μmol/L) within 48 hours after contrast exposure. 3. Urine output \<0.5 mL/kg/h for at least 6 consecutive hours post-procedure.
Time frame: 12 months
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