The OPTIMAL-REPERFUSION trial will help determine whether reduced-dose facilitated PCI strategy improves clinical outcomes in patients with STEMI and anticipated PPCI delay
OPTIMAL-REPERFUSION is an investigator-initiated, prospective, multicenter, randomized, open-label, superiority trial with blinded evaluation of outcomes. A total of 632 STEMI patients presenting within 6 hours after symptom onset and with an expected time of medical contact to percutaneous coronary intervention ≥120 min will be randomized to a reduced-dose facilitated PCI strategy (reduced-dose fibrinolysis combined with simultaneous transfer for immediate invasive therapy with a time interval between fibrinolysis to PCI \< 3 hours) or to pharmacoinvasive treatment. The primary endpoint is the composite of death, reinfarction, refractory ischemia, congestive heart failure, or cardiogenic shock at 30-days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
632
Pharmacoinvasive treatment \[full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolysis)
Reduced-dose facilitated PCI\[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(\<3 hours)\]
The rate of major composite endpoint events
Composite of death, reinfarction, refractory ischaemia, congestive heart failure, or cardiogenic shock
Time frame: 30 days
The rate of major ventricular arrhythmia
Ventricular arrhythmias, occurring more than 6 hours after randomization, persisting for at least 30 seconds, and accompanying with unstable hemodynamics that required electrical cardioversion / defibrillation
Time frame: 1 year
The rate of ischemia stroke
Defined as the presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours. It is strongly recommended (but not required) that an imaging procedure such as a computerized tomography (CT) or magnetic resonance imaging (MRI) be performed.
Time frame: 1 year
The rate of death
Death will be classified as cardiovascular or non-cardiovascular.
Time frame: 1 year
The rate of reinfarction
Recurrent symptoms or signs of cardiac ischemia lasting more than 30 minutes with new ST-T segment changes or Q-wave in at least 2 contiguous leads or new onset LBBB and recurrent significant increase in cardiac enzyme levels. The increase in CK-MB level is considered significant when it occurs after at least a ≥25% decrease in CK-MB from a prior peak level and is \>2 times the upper limit of normal (ULN) in the absence of coronary interventions, or \>5 times above the ULN after PCI
Time frame: 1 year
The rate of stent thrombosis
The stent thrombosis are defined in accordance with the Academic Research Consortium (ARC) definitions
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Time frame: 1 year
The rate of target vessel revascularization
The target vessel revascularizationare defined in accordance with the Academic Research Consortium (ARC) definitions
Time frame: 1year
The rate of congestive heart failure
New or worsening congestive heart failure will be considered as patients presenting with at least one of the following conditions and requiring treatment with diuretics: 1) Pulmonary oedema/congestion on chest X-ray without suspicion of a non-cardiac cause; 2) Rales \>1/3 up from the lung base; 3) Pulmonary capillary wedge pressure (PCWP) \>25 mmHg; 4) Dyspnea with PO2 \< 80 mmHg or O2 sat \< 90 % (no supplemental O2) in the absence of known lung disease.
Time frame: 1 year
The rate of Cardiogenic shock
The manifestation of vascular collapse and shock (systolic BP \< 90 mmHg for at least 30 min or systolic BP \> 90 mmHg after inotropic or intra-aortic balloon support with a cardiac index \< 2.2 L/min/m2 or \< 2.5 L/min/m2 after inotropic or intra-aortic balloon support, peripheral signs of hypoperfusion, and chest X-ray with pulmonary edema
Time frame: 1 year
Number of Participants with TIMI flow grade (TFG) 3 for epicardial reperfusion
TIMI flow grade (TFG) 3 for epicardial reperfusion
Time frame: 1 minute after stent was deployed
Number of Participants with TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
TIMI myocardial perfusion grade (TMPG) 3 for myocardial reperfusion
Time frame: 1 minute after stent was deployed
Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
Resolution of the initial sum of ST- segment elevation (STR) ≥ 70% post catheterization
Time frame: 60min after the stent was deployed
Peak CK-MB level
Peak CK-MB level
Time frame: 48 hours after system onset
Adverse events
Intracranial bleeding or major bleeding
Time frame: 1 year