Abstract
Background: Slow-flow and no-reflow phenomenon which occurred frequently during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) caused unfavorable prognostic outcomes. Currently, no effectively therapeutic strategy to prevent this phenomenon. Objectives/Design: To evaluate the efficacy and safety of intra-Coronary Administration of Tacrolimus prior to firstballoon inflation, a pilot study was performed. Methods/Results of Pilot Study: Twenty-nine STEMI patients (group 1) were first prospectively administered tacrolimus (2.5 mg intra-coronary slow injection using thrombuster) prior to first-balloon inflation. A historical-control group (group 2) was chosen from fifty-two consecutive patients undergoing primary PCI just prior to the pilot study. Age, gender, CAD-risk factors, peak CK-BM, and baseline left-ventricular performance were not different between groups 1 and 2 (all p>0.1). Chest pain onset-to-door and door-to-balloon times, mean Killip score upon presentation, number of multi-vessel disease, pre-PCI TIMI flow, and 30-day death were similar between these two groups (all p>0.1). The incidences of advanced CHF (≥ NYHA 3) and pulmonary edema were higher in group 2 than in group 1, whereas the incidence of anterior-wall infarction, final TIMI-3 flow and 90 minute ST-segment-resolution rate showed an opposite pattern of advanced CHF between these two groups. The incidence of myocardial blushing grade was significantly higher in group 2 than in group 1 (p=0.034). Conclusion: Tacrolimus therapy shows promise as a safe and effective therapeutic agent for STEMI. The positive preliminary outcomes from this pilot study suggests randomized-controlled trials are now required to evaluate the effectiveness and safety of Tacrolimus for STEMI patients. (clinical trials no: ISRCTN38455499).
Highlights
The development of pump failure depends on the severity of myocardial ischemia and extent of necrosis after Acute Myocardial Infarction (AMI) [1,2,3,4,5,6,7,8,9]
Reperfusion through Percutaneous Coronary Intervention (PCI) [11,12,13], thrombolysis [14,15], together with pharmacomodulation [10,11] have become the current standards for the treatment of ST-segment elevation myocardial infarction (STEMI)
We propose to conduct the intraCOronary Administration of Tacrolimus (COAT-STEMI) trial prior to first-balloon inflation to investigate the impact of intra-coronary administration of tacrolimus on reperfusion rate, LV function, and clinical outcome in patients with STEMI undergoing primary percutaneous coronary intervention
Summary
The development of pump failure depends on the severity of myocardial ischemia and extent of necrosis after Acute Myocardial Infarction (AMI) [1,2,3,4,5,6,7,8,9]. A number of recent studies have attributed myocardial damage after AMI to inflammation [21,22,23,24,25,26] that is promptly elicited by tissue damage and necrosis [17,1926]. In this regard, it is rational to believe that innate immune response [21,22,27] followed by activated adaptive immune signaling [21,27] may play key roles in the regulation of inflammatory reaction after AMI, especially at the early stage of AMI. Beside reperfusion therapy, early inhibition of the propagations of inflammatory reactions and immune signaling may be of utmost importance in suppressing the progression of myocardial damage after AMI
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