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Intramyocardial Cell Delivery: Observations in Murine Hearts
Published on: January 24, 2014
Meta-Analysis of Cell-based CaRdiac stUdiEs (ACCRUE) in patients with acute myocardial infarction based on individual
Insights
Intracoronary cell therapy after acute myocardial infarction (AMI) showed no significant benefit in reducing major adverse cardiac events or improving left ventricular function in this large meta-analysis. These findings question the efficacy of current cell-based treatments for ischemic heart disease.
Area of Science:
- Cardiology
- Regenerative Medicine
- Clinical Trials
Background:
- The meta-Analysis of Cell-based CaRdiac study is the first multinational database of patients with ischemic heart disease receiving cell therapy.
- It compiles individual patient data from 12 randomized trials.
Purpose of the Study:
- To analyze the safety and efficacy of intracoronary cell therapy post-acute myocardial infarction (AMI).
- To evaluate the impact of cell therapy on major adverse cardiac and cerebrovascular events and left ventricular function.
Main Methods:
- Individual patient data from 12 randomized trials (n=1252) were analyzed.
- Random-effects meta-analyses and Cox regressions were used to assess clinical endpoints.
- ANCOVA was employed to analyze changes in left ventricular parameters.
Main Results:
- No significant difference was observed in major adverse cardiac and cerebrovascular events (14.0% vs 16.3%) between cell therapy and control groups.
- No improvements were noted in hard clinical endpoints like death (1.4% vs 2.1%) or stroke.
- There were no significant changes in ejection fraction, end-diastolic volume, or end-systolic volume.
Conclusions:
- Intracoronary cell therapy offers no discernible benefit for clinical events or left ventricular function in patients with recent AMI.
- These findings are consistent across subgroups, including those with anterior AMI or reduced baseline ejection fraction.
Rationale:
The meta-Analysis of Cell-based CaRdiac study is the first prospectively declared collaborative multinational database, including individual data of patients with ischemic heart disease treated with cell therapy.
Objective:
We analyzed the safety and efficacy of intracoronary cell therapy after acute myocardial infarction (AMI), including individual patient data from 12 randomized trials (ASTAMI, Aalst, BOOST, BONAMI, CADUCEUS, FINCELL, REGENT, REPAIR-AMI, SCAMI, SWISS-AMI, TIME, LATE-TIME; n=1252).
Methods And Results:
The primary end point was freedom from combined major adverse cardiac and cerebrovascular events (including all-cause death, AMI recurrance, stroke, and target vessel revascularization). The secondary end point was freedom from hard clinical end points (death, AMI recurrence, or stroke), assessed with random-effects meta-analyses and Cox regressions for interactions. Secondary efficacy end points included changes in end-diastolic volume, end-systolic volume, and ejection fraction, analyzed with random-effects meta-analyses and ANCOVA. We reported weighted mean differences between cell therapy and control groups. No effect of cell therapy on major adverse cardiac and cerebrovascular events (14.0% versus 16.3%; hazard ratio, 0.86; 95% confidence interval, 0.63-1.18) or death (1.4% versus 2.1%) or death/AMI recurrence/stroke (2.9% versus 4.7%) was identified in comparison with controls. No changes in ejection fraction (mean difference: 0.96%; 95% confidence interval, -0.2 to 2.1), end-diastolic volume, or systolic volume were observed compared with controls. These results were not influenced by anterior AMI location, reduced baseline ejection fraction, or the use of MRI for assessing left ventricular parameters.
Conclusions:
This meta-analysis of individual patient data from randomized trials in patients with recent AMI revealed that intracoronary cell therapy provided no benefit, in terms of clinical events or changes in left ventricular function.
Clinical Trial Registration:
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01098591.
