optimal reperfusion strategy for stemi patients with anticipated ppci delay

Conditions: ST Elevation Myocardial Infarction

Summary: 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.

Eligibility criteria:
inclusion criteria: * aged 18 or over and less than 75 years old; * patents with stemi with symptom onset persisted more than 30mim and within 6 h before randomization; * ecg \>=2 mm st-segment elevation in 2 contiguous precordial leads or \>=1 mm st- segment elevation in 2 contiguous extremity leads, or new left bundle branch block; * patents with an expected time from fmc to pci \>=120 min. * signed informed consent form prior to trial participation. exclusion criteria: * fibrinolysis contradictions: definite hemorrhagic stroke history;ischemic stroke or cerebrovascular accident in nearly 6 months; * any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. \< 3 months); * active bleeding or known bleeding disorder/diathesis; recent administration of any i.v. or s.c. anticoagulation within 12 hours including unfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation (warfarin or coumadin); * arterial aneurysm, arterial/venous malformation and aorta dissection; uncontrolled hypertension, defined as a single blood pressure measurement \>=180/110 mm hg (systolic bp \>=180 mm hg and/or diastolic bp \>=110 mm hg) prior to randomisation; * major surgery, biopsy of a parenchymal organ, noncompressible vascular puncture, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); * prolonged or traumatic cardiopulmonary resuscitation (\> 10 minutes) within the past 2 weeks; major surgery pending in the following 30 days. 2. complex heart condition evidence of cardiac rupture; pre-existing heart failure and previous new york heart function classification iii-ivcardiogenic shock (sbp \<90mmhg after fluid infusion or sbp\<100mmhg after vasoactive drugs); * pci within previous 1 month or previous bypass surgery; * myocardial infarction in the past year or previously known coronary artery disease not suitable for revascularization; * known acute pericarditis and/or subacute bacterial endocarditis; * hospitalization for cardiac reason within past 48 hours; * severe comorbidity: other diseases with life expectancy \<=12 months; * any history of severe renal or hepatic dysfunction (hepatic failure, cirrhosis, portal hypertension or active hepatitis); * neutropenia, thrombocytopenia; * severe copd with hypoxemia; * not suitable for clinical trial: inclusion in another clinical trial; previous enrollment in this study or treatment with an investigational drug or device under another study protocol in the past 7 days; * pregnant or lactating; * body weight \<40kg; * known hypersensitivity to any drug that may be used in the study; * inability to follow the protocol and comply with follow-up requirements or any other reason the investigator feels would place the patient at increased risk.

Keywords: st-elevation myocardial infarction primary percutaneous coronary pharmacoinvasive strategy reduced-dose fibrinolysis