No-Reflow Phenomenon Clinical Trial
Official title:
Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).
The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events
in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct
related arterial (IRA) flow related to better ventricular performance and lower mortality
rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of
re-canalization of the IRA.
In recent years, many mechanical or pharmacological treatment strategies including
adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in
patients with STEMI. Although current guidelines recommend that small molecule GPI should be
administered as an upstream bolus followed by a continuous infusion in patients with STEMI,
changes in clinical practice may obviate the need for GPI dosage or routes in current
practice. Previous studies have shown that intravenous and intracoronary administration of
GPI improve the prognosis and significantly reduce mortality in patients with STEMI.
Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial
found that the use of tirofiban started during the pre-hospital phase as upstream therapy
for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours
infusion after the procedure showed an improvement in the markers of reperfusion.
Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction
in urgent target vessel revascularization and thrombotic bailout. However, in the current
literature there are insufficient data regarding the role of intracoronary administration of
GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of
this study was to evaluate the acute effect of intracoronary administration of tirofiban on
no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon
undergoing primary PCI.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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