The VIAMI-trial is a study protocol designed to evaluate whether PCI with stenting reduces cardiac events in patients with viability early after myocardial infarction, and thus reports no clinical results.
RCT (n=400)
Open-label (blinded endpoint adjudication)
Randomized in blocks of 10
Yes
Does an invasive strategy with PCI and abciximab reduce the composite of death, reinfarction, and unstable angina compared to a conservative ischemia-guided approach in patients with acute myocardial infarction and demonstrated viability who did not receive primary or rescue PCI?
The VIAMI-trial is designed to evaluate whether early viability-guided PCI of the infarct-related artery improves long-term clinical outcomes in post-MI patients who did not receive primary reperfusion.
BACKGROUND: Although 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. METHODS: The 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. CONCLUSION: The 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.
Loon et al. (Thu,) conducted a rct in Acute myocardial infarction with viability (n=400). Percutaneous coronary intervention (PCI) with stenting and abciximab vs. Conservative ischemia-guided approach was evaluated on Composite of death from any cause, reinfarction, and unstable angina. The VIAMI-trial is a study protocol designed to evaluate whether PCI with stenting reduces cardiac events in patients with viability early after myocardial infarction, and thus reports no clinical results.