Acute Myocardial Infarction
Conditions
Keywords
acute myocardial infarction, thrombolysis, percutaneous coronary interention
Brief summary
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis \<12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.
Detailed description
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis \<12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.
Interventions
DEVICEearly percutaneous coronary intervention
DEVICElate percutaneous coronary intervention
Sponsors
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of MI present for 12 h * ST segment elevation of at least 1 mm in two or more limb leads, * ST segment elevation of at least 2 mm in the precordial leads, * or new bundlebranch block * Patients eligible for thrombolysis * Informed consent for participation
Exclusion criteria
* Secondary or iatrogenic infarction * Chronic renal insufficiency requiring dialysis * Coronary anatomy unsuitable for stent placement * Anticipated indication for surgical coronary revascularization within 6 months * Previous MI in the area of the infarct related vessel * Infarct related lesion not clearly defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular Events | 6 months | The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 6 months | Total mortality as well as cardiac and noncardiac deaths were counted. |
| Reinfarction | 6 months | Reinfarction was defined as two or more of the following criteria: chest pain lasting for more than 30 minutes; a new significant ST-elevation; and a rise in the serum creatine kinase level to more than \>3x upper normal limit. |
| Ischemic Events | 6 months | Ischemic events included unplanned hospitalization and / or unplanned angiography due to postinfarction angina, recurrent angina pectoris lasting for more than 15 minutes despite the administration of nitrates, or being accompanied by electrocardiogram changes, pulmonary edema, or hypotension. |
| Target Vessel Revascularization | 6 months | Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion. |
Countries
Germany
Outcome results
None listed