(primary endpoint). All patients were followed for one year. The baseline demographic, clinical and scintigraphic charac
Adenosine sestamibi SPECT post-infarction evaluation (INSPIRE) trial: A randomized, prospective multicenter trial evaluating the role of adenosine Tc-99m sestamibi SPECT for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction John J. Mahmarian, MD, Leslee J. Shaw, PhD, Gerald H. Olszewski, Bradley K. Pounds, Maria E. Frias, and Craig M. Pratt, MD, for the INSPIRE Investigators Background. Preliminary studies indicate that adenosine myocardial perfusion single photon tomography (SPECT) can safely and accurately stratify patients into low and high risk groups early after acute myocardial infarction (AMI). Methods and Results. INSPIRE is a prospective, randomized multicenter trial which enrolled 728 clinically stable survivors of AMI. Following baseline adenosine sestamibi gated SPECT, patients were classified as low, intermediate or high risk based on the quantified total and ischemic left ventricular (LV) perfusion defect size (PDS). A subset of high risk patients with a LV ejection fraction >35% were randomized to a strategy of either intensive medical therapy or coronary revascularization. Adenosine SPECT was repeated at 6-8 weeks to determine the relative effects of anti-ischemic therapies on total and ischemic PDS (primary endpoint). All patients were followed for one year. The baseline demographic, clinical and scintigraphic characteristics of the study population are presented. Adenosine SPECT was performed within 1 day of admission in 12% of patients and in 64% by Day 4. Conclusion. The unique study design features of INSPIRE will further clarify the role of adenosine sestamibi SPECT in defining initial patient risk after AMI and in monitoring the benefits of intensive anti-ischemic therapies. (J Nucl Cardiol 2004;11:458-69.) Comment: The widespread acceptance of a routine invasive strategy as the community standard of care (modality of choice in patients with STEMI and in those whom clinical instability develops during acute coronary syndrome) for evaluating and treating patients and improving patients outcome after uncomplicated AMI has developed despite the lack of definitive support from controlled clinical trials. In fact intensive medical therapy has been independently shown to significantly reduce myocardial ischemia in patients after AMI and improve patients outcome. Due to this reason, INSPIRE trial was conceived to answer the following two questions: 1) may adenosine Tc-99m sestamibi gated SPECT define the initial patient risk after uncomplicated AMI and assess subsequent patient outcome after intensive anti-ischemic therapies; 2) may it also compare the relative temporal benefit of intensive medical therapy versus PCI/CABG for suppressing myocardial ischemia in stable but MPS high risk survivors of AMI.
High risk pts with LVEFt35% assigned to strategy 1 (Figure 1) received med therapy titrated to max tolerated doses over a period of 4 to 8 wks: long-acting mononitrate at doses of 60 mg to 120 mg/d. Pts with LVEF50% LM stenosis, 3VD or diabetes and MVD. All pts enrolled in INSPIRE (protocol in Figure 2), based on gated SPECT LVEF
