Transcript Document

prognosis of patients with
Acute Myocardial Infarction remains dismal
Stem Cell Therapy
The impact on:
• LEFT VENTRICULAR FUNCTION
• INFARCT SIZE
• LV DIMENSIONS
….remains unclear.
OUTCOME OF INTRACORONARY STEM CELL
THERAPY IN ACUTE MYOCARDIAL INFARCTION:
META-ANALYSIS OF RANDOMIZED
CONTROLLED TRIALS
Arvisminda Luz G. Fernandez, MD.
Chong Hua Hospital – Heart Institute
May 24, 2012
General Objectives:
To perform a meta-analysis on the
impact of intracoronary bone marrow stem
cell therapy in acute myocardial infarction
to assess if there is significant difference in the LV
ejection fraction in patients with acute myocardial
infarction who received bone marrow therapy versus
control.
to assess if there is significant difference in the LV end
systolic volume in patients with acute myocardial
infarction who received bone marrow therapy versus
control.
REVIEW QUESTION AND STUDY PROTOCOL
“What is the outcome of bone marrow stem
cell transplantation in patients with acute
myocardial
infarction
following
percutaneous coronary intervention?
This is a protocol-driven systematic review according to
Quality of Reporting of Metaanalysis (QUOROM)
INCLUSION CRITERIA
CRITERIA
EXCLUSION
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Use
of cytokines
for mobilization
of BMCs stem cell
RCTs
with comparison
of intracoronary
Irretrievable
or unclear
transplantation
versusdata
control in patients with acute
Treatment
old myocardial infarction (>14 days)
myocardialofinfarction
Lack of control group
Intention- to- treat analysis
Duplicate reports
Follow-up
3 months from
therapy
Ongoing
or≥unpublished
studies
 PubMed databases (2005-2010)
 Cochrane Central Registry of Controlled
Trials (2005-2010)
 Clinicaltrials.gov Registry (2005-2010)
 keywords:
“stem cells, acute myocardial
infarction, randomized controlled trials”
 Study
features extracted: outcome definitions.
imaging modalities, patient baseline characteristics,
and procedural data
Primary endpoint:
- change in left ventricular ejection fraction
(LVEF) from baseline to follow-up
Secondary endpoint:
- change in left ventricular end systolic volumes
The criteria by Jüni et al
 Dichotomous variables as proportion and percentages.
 Continuous variables as mean ± standard deviation or
median.
 Meta-regression and sensitivity analyses to explore
heterogeneity.
 Statistical significance for hypothesis testing set at the
0.05, 2-tailed level.
REVIEW PROCESS
47
Citations Retrieved
31
Titles/Abstracts non-relevant
16
Complete Articles Assessed
Based on Criteria
4
12
Studies finally included in
the systematic review
- 1 used cytokines for BMC
mobilization
-2 had MI treatment > 14 days
- 1 irretrievable data
Characteristics of Studies Included in the Meta-analysis
N = 934
Characteristics of Studies Included in the Meta-analysis
Range of patients:
20-204
Follow-up Duration Range:
3-18 months
Average Timing of Cell
Transplantation after PCI :
1-18 days
# of Stem cell Use:
24.6±9.4x106 cells
Quality of Assessment Scale for Randomized
Controlled Trials Included in the Meta-Analysis
Forrest plot of unadjusted difference in mean (with 95% confidence intervals
[CIs]) improvement in left ventricular ejection fraction (LVEF) in patients treated
with bone marrow–derived cells (BMCs) compared with controls
Increase in LVEF of
.72%
p value < 0.0001
Forrest plot of unadjusted difference in mean (with 95% confidence intervals
[CIs]) improvement in left ventricular end systolic volume (LVESV) in patients
treated with bone marrow–derived cells (BMCs) compared with controls
Decrease in LVESV
of 0.425 mL
p value < 0.0118
Standard Mean Difference
Intracoronary bone marrow stem cell resulted in:
 modest yet significant increase in LV ejection fraction
 significant decrease in LV end systolic volume
….in patients with acute myocardial infarction