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Autologous Bone Marrow Stem Cell Therapy in Patients With ST-Elevation Myocardial Infarction: A Systematic Review and
Maya M Jeyaraman1, Rasheda Rabbani1, Leslie Copstein2
1The George and Fay Yee Center for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada; Department of Community Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada.
Insights
Autologous bone marrow stem cell (BMSC) therapy does not improve outcomes for ST-elevation myocardial infarction (STEMI) patients. This meta-analysis of 42 RCTs found no significant reduction in mortality or other adverse events, concluding a lack of benefit.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- Bone marrow stem cell (BMSC) therapy is being investigated for ST-elevation myocardial infarction (STEMI).
- Previous randomized controlled trials (RCTs) have yielded conflicting results regarding its efficacy and safety.
- Intracoronary administration of autologous BMSC therapy is a common approach in STEMI patients post-primary percutaneous coronary intervention.
Purpose of the Study:
- To critically appraise and meta-analyze the available evidence on the efficacy and safety of intracoronary autologous BMSC therapy in STEMI patients.
- To determine the impact of BMSC therapy on mortality, cardiac events, and functional outcomes.
- To evaluate the strength of evidence supporting BMSC therapy in this patient population.
Main Methods:
- A systematic search of multiple databases (MEDLINE, PubMed, EMBASE, CENTRAL, Global Health, CINAHL) was conducted in February 2017.
- Included 42 RCTs involving 3365 STEMI patients.
- Primary outcome was all-cause mortality; secondary outcomes included cardiac death, heart failure, arrhythmias, repeat myocardial infarction, target vessel revascularizations, quality of life, left ventricular ejection fraction, and infarct size. Random effects models were used for analysis.
Main Results:
- BMSC therapy did not significantly reduce all-cause mortality (RR, 0.71; 95% CI, 0.45-1.11) across 40 trials (3289 participants).
- There was no significant absolute risk reduction in mortality (0.1%; 95% CI, -0.71 to 0.91).
- No significant effect was observed on secondary or adverse outcomes. Trial sequential analysis indicated no clinically important difference in mortality, with low probability of future studies altering this conclusion.
Conclusions:
- Evidence from 42 RCTs over 15 years indicates a lack of beneficial effect for autologous BMSC therapy in STEMI patients.
- The therapy did not improve mortality or other key clinical outcomes.
- Current evidence suggests BMSC therapy is not effective for STEMI patients undergoing primary percutaneous coronary intervention.
Background:
Randomized controlled trials (RCTs) on bone marrow stem cell (BMSC) therapy in ST-elevation myocardial infarction (STEMI) patients have reported conflicting results. Our main objective was to critically appraise and meta-analyze best-available evidence on efficacy and safety of intracoronary administration of autologous BMSC therapy in STEMI patients after primary percutaneous coronary intervention.
Methods:
We conducted a search of MEDLINE, PubMed, EMBASE, CENTRAL, Global Health, CINAHL, and conference proceedings in February 2017. Our primary outcome was all-cause mortality. Secondary and safety outcomes included cardiac death, heart failure, arrhythmias, repeat myocardial infarction, or target vessel revascularizations; or improved health-related quality of life, left ventricular ejection fraction, or infarct size. Summary relative and absolute risks were obtained using random effects models. We also evaluated the strength of evidence.
Results:
A comprehensive database search identified 42 RCTs (3365 STEMI patients). BMSC therapy did not significantly decrease mortality (risk ratio, 0.71; 95% confidence interval, 0.45-1.11; I2, 0%; absolute risk reduction, 0.1%; 95% confidence interval, -0.71 to 0.91; 40 trials; 3289 participants; I2, 0%; low strength of evidence). BMSC therapy had no effect on secondary or adverse outcomes. Trial sequential analysis for all-cause mortality showed no evidence of a clinically important difference, with a very low probability that future studies can change the current conclusion.
Conclusions:
On the basis of evidence from 42 RCTs published in the past 15 years, we provide conclusive evidence for a lack of beneficial effect for autologous BMSC therapy in patients with STEMI.
