Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial

Cardiopoietic cells, produced through cardiogenic conditioning of patients' mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort

Imagerie du mois: Sténose coronaire démontrée par la tomodensitométrie multibarrette

SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Drug-Eluting Resorbable Magnesium Scaffold Implantation in ST-Segment Elevation Myocardial Infarction: A Pilot Study

OBJECTIVES: To assess feasibility and short-term clinical outcomes associated with resorbable magnesium scaffold (RMS) implantation in the setting of primary percutaneous coronary intervention for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: RMS implantation has demonstrated favorable clinical outcomes in stable coronary artery disease patients. However, to date, data are lacking in the setting of STEMI. METHODS: This is a single-center prospective non-randomized pilot study. Patients admitted for STEMI were enrolled according to prespecified inclusion and exclusion criteria. The primary endpoint was device-oriented composite endpoint (DOCE), including cardiac death, target-vessel myocardial infarction, and target-lesion revascularization (TLR) within 30 days of the index procedure. Secondary endpoints were procedural success, any probable/definite scaffold thrombosis, and DOCE at subsequent follow-up. RESULTS: From December 1, 2016 to October 30, 2017, a total of 18 patients were included. Follow-up data were available for 17 patients (94%). There was no primary endpoint event. Procedural success was 100%. Patients were followed for a median of 153 days (range, 59-326 days). Over that extended follow-up period, 1 case of TLR occurred 102 days after the index procedure. There was no case of definite or probable scaffold thrombosis. CONCLUSIONS: This pilot study is the first to assess feasibility and clinical outcomes associated with RMS implantation in selected STEMI patients. The results seem reassuring, with favorable short-term clinical outcomes and absence of definite/probable scaffold thrombosis, and should prompt further research including randomized controlled trials evaluating RMS implantation in the setting of STEMI.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Cardiopoietic cell therapy for advanced ischemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled chart-1 clinical trial

Aims Cardiopoietic cells, produced through cardiogenic conditioning of patients\u27 mesenchymal stem cells, have shown preliminary efficacy. The Congestive Heart Failure Cardiopoietic Regenerative Therapy (CHART-1) trial aimed to validate cardiopoiesis-based biotherapy in a larger heart failure cohort. Methods and results This multinational, randomized, double-blind, sham-controlled study was conducted in 39 hospitals. Patients with symptomatic ischaemic heart failure on guideline-directed therapy (n= 484) were screened; n = 348 underwent bone marrow harvest and mesenchymal stem cell expansion. Those achieving> 24 million mesenchymal stem cells (n= 315) were randomized to cardiopoietic cells delivered endomyocardially with a retention-enhanced catheter (n= 157) or sham procedure (n= 158). Procedures were performed as randomized in 271 patients (n = 120 cardiopoietic cells, n= 151 sham). The primary efficacy endpoint was a Finkelstein-Schoenfeld hierarchical composite (all-cause mortality, worsening heart failure, Minnesota Living with Heart Failure Questionnaire score, 6-min walk distance, left ventricular end-systolic volume, and ejection fraction) at 39 weeks. The primary outcome was neutral (Mann-Whitney estimator 0.54, 95% confidence interval [CI] 0.47-0.61 [value> 0.5 favours cell treatment], P = 0.27). Exploratory analyses suggested a benefit of cell treatment on the primary composite in patients with baseline left ventricular end-diastolic volume 200-370mL (60% of patients) (Mann-Whitney estimator 0.61, 95% CI 0.52-0.70, P = 0.015). No difference was observed in serious adverse events. One (0.9%) cardiopoietic cell patient and 9 (5.4%) sham patients experienced aborted or sudden cardiac death. Conclusion The primary endpoint was neutral, with safety demonstrated across the cohort. Further evaluation of cardiopoietic cell therapy in patients with elevated end-diastolic volume is warranted