AMI Patients With Multivessel Disease, Staged PCI, Multi Vessel Coronary Artery Disease, Percutaneous Coronary Intervention, STEMI
Conditions
Keywords
AMI, multivessel disease, PCI, staged complete revascularization
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 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.
Detailed 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.
Interventions
PROCEDUREEarly 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).
PROCEDURELate 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.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Xiamen Cardiovascular Hospital, Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac event (MACE), defined as cardiovascular death, MI, ischemia-driven revasculrization (for both culprit and non-culprit lesions). | 12 months | The difference in MACE will be calculated from randomisation to 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 12 months | It will be calculated from randomisation to 12 months. |
| Myocardial Infarction (MI) | 12 months | 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. |
| Revascularization | 12 months | 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. |
| Heart failure-induced rehospitalization | 12 months | Rate of New hospitalization for heart failure |
| Stroke | 12month | 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. |
| Rate of contrast-induced nephropathy（CIN） | 12 months | 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. |
| Cardiovascular death | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stent thrombosis | 12 months | Stent Thrombosis (Based on Academic Research Consortium criteria) 1. Definite ST: Clinical presentation of acute coronary syndrome with angiographic or pathological confirmation. 2. Probable ST: Unexplained death within 30 days or acute ischemia in the target vessel territory without angiographic confirmation. 3. Possible ST: Unexplained death after 30 days post-PCI. |
Countries
China
Outcome results
None listed