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Stenting vs. Thrombolysis in Acute Myocardial Infarction Trial (STAT) - STAT
Description:
Stenting vs. Thrombolysis in Acute Myocardial Infarction Trial (STAT).
Hypothesis:
The superiority of PTCA over thrombolysis in acute myocardial infarction (MI) has been documented by several clinical trials. However, little data are available on coronary stenting in comparison to thrombolytic therapy in patients with ST segment elevation MI (STEMI).
Study Design
Study Design:
Patients Enrolled: 123
Drug/Procedures Used:
123 patients with STEMI were randomized to primary stenting (n=62) or accelerated TPA (n=61). Patients with cardiogenic shock, active bleeding, history of stroke, major surgery, severe hypertension, prolonged CPR, inadequate vascular access, or PTCA within 6 months prior stenting of the infarct-related artery and with a history of prior CABG were excluded. The primary end point was a 6-month composite of death, reinfarction, stroke or repeat target vessel revascularization. (TVR).
Principal Findings:
In the stent group, primary stenting was successfully performed in 50 patients (81%), two patients underwent PTCA, primary CABG not due to failed PTCA was required in four patients and five patients were treated with medical therapy. TIMI 3 flow was achieved in 90% of patients undergoing stent implantation. The in-hospital mortality rate was 4.8% in the stent group and 3.3% in the TPA group (p=1.0), while reinfarction occurred in 4.8% and 8.2% of patients (p=0.49), respectively. There was one stroke in each group. Repeat TVR for ischemia was required in 11.3% of stent patients and 42.6% of TPA patients (p=0.001). At 6-month follow-up, the primary end point had occurred in 24.2% of stent patients and 55.7% of TPA patients (p&<0.001). The difference in the incidence of the primary end point was due to a significant reduction in TVR in the stent group when compared with the TPA group (14.5% vs. 49.2% p<0.001). Recurrent unstable ischemia was less frequent in the stent group (9.7% vs. 26.2% p=0.019). There were no additional deaths during follow-up. The median length of initial hospital stay was 4 days in the stent group and 7 days in the TPA group (p<0.001).
Compared with accelerated TPA, primary stenting results in a reduction of a combined end point of death, reinfarction, stroke or repeat TVR and in a shorter hospital stay, predominantly due to a reduction in TVR.
Interpretation:
The major limitation of this study is the very small sample size. Thus, no comments can be made on the non-significant excess mortality in the stent group or on differences in reinfarction rates. In addition, the use of the combined end point is somewhat misleading, given that the difference between the two treatment groups was driven primarily by a difference in TVR rates. Nonetheless, this study confirms the validity of primary percutaneous revascularization as an alternative to thrombolytic therapy in patients with ST segment elevation MI. In addition, it shows that even after exclusion of high-risk patients such as those with cardiogenic shock, overall in-hospital mortality for STEMI continues to remain high.
References:
1. Le May MR, Labinaz M, Davies R, et al. J Am Coll Cardiol 2001;37:985-91.
Clinical Topics: Arrhythmias and Clinical EP, Dyslipidemia, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Prevention, SCD/Ventricular Arrhythmias, Lipid Metabolism, Acute Heart Failure, Hypertension
Keywords: Shock, Cardiogenic, Thrombolytic Therapy, Stroke, Follow-Up Studies, Hospital Mortality, Cardiopulmonary Resuscitation, Fibrinolytic Agents, Tissue Plasminogen Activator, Hypertension, Stents, Length of Stay
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