Dataset related to the article "G-CSF for Extensive STEMI: Results From the STEM-AMI OUTCOME CMR Substudy"

This record contains raw data related to the article "G-CSF for Extensive STEMI: Results From the STEM-AMI OUTCOME CMR Substudy".

Rationale: In the exploratory Phase II STEM-AMI (Stem Cells Mobilization in Acute Myocardial Infarction) trial,

we reported that early administration of G-CSF (granulocyte colony-stimulating factor), in patients with anterior

ST-segment–elevation myocardial infarction and left ventricular (LV) dysfunction after successful percutaneous

coronary intervention, had the potential to significantly attenuate LV adverse remodeling in the long-term.

Objective: The STEM-AMI OUTCOME CMR (Stem Cells Mobilization in Acute Myocardial Infarction Outcome

Cardiac Magnetic Resonance) Substudy was adequately powered to evaluate, in a population showing LV ejection

fraction ≤45% after percutaneous coronary intervention for extensive ST-segment–elevation myocardial infarction,

the effects of early administration of G-CSF in terms of LV remodeling and function, infarct size assessed by late

gadolinium enhancement, and myocardial strain.

Methods and Results: Within the Italian, multicenter, prospective, randomized, Phase III STEM-AMI OUTCOME trial,

161 ST-segment–elevation myocardial infarction patients were enrolled in the CMR Substudy and assigned to standard

of care (SOC) plus G-CSF or SOC alone. In 119 patients (61 G-CSF and 58 SOC, respectively), CMR was available at

baseline and 6-month follow-up. Paired imaging data were independently analyzed by 2 blinded experts in a core CMR

lab. The 2 groups were similar for clinical characteristics, cardiovascular risk factors, and pharmacological treatment,

except for a trend towards a larger infarct size and longer symptom-to-balloon time in G-CSF patients. ANCOVA showed

that the improvement of LV ejection fraction from baseline to 6 months was 5.1% higher in G-CSF patients versus

SOC (P=0.01); concurrently, there was a significant between-group difference of 6.7 mL/m2 in the change of indexed LV

end-systolic volume in favor of G-CSF group (P=0.02). Indexed late gadolinium enhancement significantly decreased in

G-CSF group only (P=0.04). Moreover, over time improvement of global longitudinal strain was 2.4% higher in G-CSF

patients versus SOC (P=0.04). Global circumferential strain significantly improved in G-CSF group only (P=0.006).

Conclusions: Early administration of G-CSF exerted a beneficial effect on top of SOC in patients with LV

dysfunction after extensive ST-segment–elevation myocardial infarction in terms of global systolic function,

adverse remodeling, scar size, and myocardial strain.