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Abstract
Aims
This study aims to explore long‐term clinical outcomes of cardiopoiesis‐guided stem cell therapy for ischaemic heart failure assessed in the Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART‐1) trial.
Methods and results
CHART‐1 is a multinational, randomized, and double‐blind trial conducted in 39 centres in heart failure patients (n = 315) on standard‐of‐care therapy. The ‘active’ group received cardiopoietic stem cells delivered intramyocardially using a retention‐enhanced catheter. The ‘control’ group underwent patient‐level sham procedure. Patients were followed up to 104 weeks. In the entire study population, results of the primary hierarchical composite outcome were maintained neutral at Week 52 [Mann–Whitney estimator 0.52, 95% confidence interval (CI) 0.45–0.59, P = 0.51]. Landmark analyses suggested late clinical benefit in patients with significant left ventricular enlargement receiving adequate dosing. Specifically, beyond 100 days of follow‐up, patients with left ventricular end‐diastolic volume of 200–370 mL treated with ≤19 injections of cardiopoietic stem cells showed reduced risk of death or cardiovascular hospitalization (hazard ratio 0.38, 95% CI 0.16–0.91, P = 0.031) and cardiovascular death or heart failure hospitalization (hazard ratio 0.28, 95% CI 0.09–0.94, P = 0.040). Cardiopoietic stem cell therapy was well tolerated long term with no difference in safety readouts compared with sham at 2 years.
Conclusions
Longitudinal follow‐up documents that cardiopoietic stem cell therapy is overall safe, and post hoc analyses suggest benefit in an ischaemic heart failure subpopulation defined by advanced left ventricular enlargement on tolerable stem cell dosing. The long‐term clinical follow‐up thus offers guidance for future targeted trials.
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Details
1 Cardiovascular Center, OLV Hospital, Aalst, Belgium
2 Cardiovascular Center, OLV Hospital, Aalst, Belgium, Department of Cardiovascular Medicine, Mayo Clinic, Center for Regenerative Medicine, Rochester, MN, USA
3 Momentum Research, Inc., Durham, NC, USA
4 Department of Cardiovascular Medicine, Mayo Clinic, Center for Regenerative Medicine, Rochester, MN, USA
5 Cardiology Department, Hospital General Universitario Gregorio Marañón and CIBERCV (Instituto de Salud Carlos III), Madrid, Spain
6 Department of Cardiology and Structural Heart Disease, Medical University of Silesia, Katowice, Poland
7 Consultant, South Egremont, MA, USA
8 Cardiology, Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health, University and Spedali Civili, Brescia, Italy
9 National and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Athens, Greece
10 Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, PA, USA
11 School of Medicine, University of California San Francisco, San Francisco, CA, USA, Section of Cardiology, San Francisco Veterans Affairs Medical Center, San Francisco, CA, USA
12 The Carl Edyth Lindner Center for Research and Education at The Christ Hospital, Cincinnati, OH, USA
13 Phospholamban Foundation, Amsterdam, Netherlands
14 Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA
15 The Lambe Institute for Translational Medicine and Curam, National University of Ireland Galway and Saolta University Healthcare Group, Galway, Ireland