Key result
High-dose AAV1/SERCA2a gene transfer reduced the risk of recurrent cardiovascular events by 82% compared to placebo over 3 years in patients with advanced heart failure (P=0.048).
Why the study?
Does intracoronary infusion of AAV1/SERCA2a reduce recurrent cardiovascular and terminal events in patients with advanced heart failure?
Population
39 patients with advanced heart failure on stable, optimal heart failure therapy
Comparison
Single intracoronary infusion of AAV1/SERCA2a in… vs Placebo
Design
RCT, randomized
Follow-up
3 years
Authors
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Opens a new treatment axis for advanced HF; extends AAV1/SERCA2a gene transfer to randomized long-term event reduction.
RCT (n=39)
Does intracoronary infusion of AAV1/SERCA2a reduce recurrent cardiovascular and terminal events in patients with advanced heart failure?
Effect estimate: 82% risk reduction
p-value: p=0.048
A single intracoronary infusion of high-dose AAV1/SERCA2a gene therapy significantly reduced recurrent cardiovascular events over 3 years in patients with advanced heart failure without safety concerns.
Zsebo et al. (2013) conducted an RCT in advanced heart failure (n=39). AAV1/SERCA2a vs. placebo was evaluated on recurrent cardiovascular and terminal events (myocardial infarction, worsening heart failure, heart failure-related hospitalization, ventricular assist device placement, cardiac transplantation, and death) (82% risk reduction, p=0.048). High-dose AAV1/SERCA2a gene transfer reduced the risk of recurrent cardiovascular events by 82% compared to placebo over 3 years in patients with advanced heart failure (P=0.048).
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