Key result
Intracoronary bone-marrow progenitor cells reduce death, MI, or revascularization vs placebo at 12 months.
RCT (n=204)
Double-blind
Randomized
Yes
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AIMS: To investigate the clinical outcome after intracoronary administration of autologous progenitor cells in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Using a double-blind, placebo-controlled multicentre trial design, we randomized 204 patients with successfully reperfused AMI to receive intracoronary infusion of bone-marrow-derived progenitor cells (BMCs) or placebo medium into the infarct artery 3-7 days after successful infarct reperfusion therapy. At 12 months, the pre-specified cumulative endpoint of death, myocardial infarction, or necessity for revascularization was significantly reduced in the BMC group compared with placebo (P=0.009). Likewise, the combined endpoint death, recurrence of myocardial infarction, and rehospitalization for heart failure was significantly (P=0.006) reduced in patients receiving intracoronary BMC administration. Intracoronary administration of BMC remained a significant predictor of a favourable clinical outcome by Cox regression analysis, adjusting for classical predictors of poor outcome after AMI. CONCLUSION: Intracoronary administration of BMCs is associated with a significant reduction of the occurrence of major adverse cardiovascular events after AMI. Large-scale studies are warranted to confirm the effects of BMC administration on mortality and morbidity in patients with AMIs.
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Schächinger et al. (2006) conducted an RCT in Acute myocardial infarction (AMI) (n=204). Intracoronary infusion of bone-marrow-derived progenitor cells (BMCs) vs. Placebo medium was evaluated on Cumulative endpoint of death, myocardial infarction, or necessity for revascularization (p=0.009). Intracoronary bone-marrow-derived progenitor cell infusion reduced death, myocardial infarction, or revascularization vs placebo at 12 months.
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