Abstract
BackgroundAlthough percutaneous coronary intervention (PCI) is becoming the standard therapy in ST-segment elevation myocardial infarction (STEMI), to date most patients, even in developed countries, are reperfused with intravenous thrombolysis or do not receive a reperfusion therapy at all. In the post-lysis period these patients are at high risk for recurrent ischemic events. Early identification of these patients is mandatory as this subgroup could possibly benefit from an angioplasty of the infarct-related artery.Since viability seems to be related to ischemic adverse events, we initiated a clinical trial to investigate the benefits of PCI with stenting of the infarct-related artery in patients with viability detected early after acute myocardial infarction.MethodsThe VIAMI-study is designed as a prospective, multicenter, randomized, controlled clinical trial. Patients who are hospitalized with an acute myocardial infarction and who did not have primary or rescue PCI, undergo viability testing by low-dose dobutamine echocardiography (LDDE) within 3 days of admission. Consequently, patients with demonstrated viability are randomized to an invasive or conservative strategy. In the invasive strategy patients undergo coronary angiography with the intention to perform PCI with stenting of the infarct-related coronary artery and concomitant use of abciximab. In the conservative group an ischemia-guided approach is adopted (standard optimal care).The primary end point is the composite of death from any cause, reinfarction and unstable angina during a follow-up period of three years.ConclusionThe primary objective of the VIAMI-trial is to demonstrate that angioplasty of the infarct-related coronary artery with stenting and concomitant use of abciximab results in a clinically important risk reduction of future cardiac events in patients with viability in the infarct-area, detected early after myocardial infarction.
Highlights
Percutaneous coronary intervention (PCI) is becoming the standard therapy in ST-segment elevation myocardial infarction (STEMI), to date most patients, even in developed countries, are reperfused with intravenous thrombolysis or do not receive a reperfusion therapy at all
Because of the low availability of such treatment, even in developed countries, most patients with STEMI are reperfused with intravenous thrombolysis
Early risk assessment is of great importance, especially in patients treated with thrombolysis and patients who did not receive reperfusion therapy
Summary
Patient Selection Patients admitted to any of the participating centers with an acute or recent myocardial infarction, who are not treated by direct or rescue angioplasty, and who are stable during the first 48 hours after the acute event, are screened for the study. Reinfarction during hospitalization for index infarct and not related to revascularization procedures - Either ischemic type of chest discomfort or new electrocardiographic changes indicative for transmural ischemia or necrosis with an increase in the total creatine kinase and MB isoenzyme activity. 2. Reinfarction discharge for index infarct and not related to revascularization procedures - Either a history of ischemic chest discomfort, usually lasting > 20 minutes, or classic electrocardiographic changes indicative for transmural ischemia with an increase in the total creatine kinase and MB isoenzyme activity of at least 2 times the upper limit of normal. 3. Periprocedural reinfarction during revascularization after index infarct PCI - Classic electrocardiographic changes indicative for transmural ischemia with an increase in the total creatine kinase and MB isoenzyme activity of at least 2 times the upper limit of normal.
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