Cardiopoietic stem cell therapy in ischaemic heart failure: long-term clinical outcomes.
Cardiopoietic stem cell therapy in ischaemic heart failure: long-term clinical outcomes.
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DOI：
10.1002/ehf2.13031
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发表时间：
2020-12
影响因子：
3.8
通讯作者：
CHART Program
中科院分区：
文献类型：
--
作者：
Bartunek J;Terzic A;Davison BA;Behfar A;Sanz-Ruiz R;Wojakowski W;Sherman W;Heyndrickx GR;Metra M;Filippatos GS;Waldman SA;Teerlink JR;Henry TD;Gersh BJ;Hajjar R;Tendera M;Senger S;Cotter G;Povsic TJ;Wijns W;CHART Program
本研究旨在探讨在充血性心力衰竭心脏再生治疗(CHAP-1)试验中评估的心脏生成引导干细胞治疗缺血性心力衰竭的长期临床结果。CHART-1是一项多国、随机、双盲试验，在39个中心进行，心力衰竭患者(n=315)接受标准护理治疗。“主动”组接受了使用固位增强型导管经心肌内输送的心脏干细胞。对照组接受患者水平的假手术。对患者进行了长达104周的随访。在整个研究人群中，主要分级综合结果的结果在52周保持中性[Mann-Whitney估计值0.52，95%可信区间(CI)0.45-0.59，P=0.51]。里程碑式的分析表明，接受足够剂量的左心室显著增大的患者的晚期临床受益。具体而言，在超过100d的随访中，接受≤19心脏造血干细胞注射治疗的左室舒张末期容量为200-370mL者，死亡或心血管住院的风险(风险比0.38，95%可信区间0.16~0.91，P=0.031)和心血管死亡或心力衰竭住院的风险(风险比0.28，95%可信区间0.09~0.94，P=0.040)。两年后，心脏干细胞治疗长期耐受性良好，安全性读数与假手术组相比没有差异。纵向随访文件表明，心脏干细胞治疗总体上是安全的，后组分析表明，通过耐受干细胞剂量的晚期左室扩大定义的缺血性心力衰竭亚群中，心脏干细胞治疗是有益的。长期的临床随访为今后的靶向试验提供了指导。
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. 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. 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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DOI：
10.1161/circinterventions.112.000422
发表时间：
2013-12
期刊：
Circulation. Cardiovascular interventions
影响因子：
--
作者：
Behfar A;Latere JP;Bartunek J;Homsy C;Daro D;Crespo-Diaz RJ;Stalboerger PG;Steenwinckel V;Seron A;Redfield MM;Terzic A
通讯作者：
Terzic A
晚期缺血性心力衰竭的心脏生成细胞疗法：前瞻性、随机、双盲、假对照 CHART-1 临床试验 39 周的结果。
影响因子：
39.3
作者：
Bartunek J;Terzic A;Davison BA;Filippatos GS;Radovanovic S;Beleslin B;Merkely B;Musialek P;Wojakowski W;Andreka P;Horvath IG;Katz A;Dolatabadi D;El Nakadi B;Arandjelovic A;Edes I;Seferovic PM;Obradovic S;Vanderheyden M;Jagic N;Petrov I;Atar S;Halabi M;Gelev VL;Shochat MK;Kasprzak JD;Sanz-Ruiz R;Heyndrickx GR;Nyolczas N;Legrand V;Guédès A;Heyse A;Moccetti T;Fernandez-Aviles F;Jimenez-Quevedo P;Bayes-Genis A;Hernandez-Garcia JM;Ribichini F;Gruchala M;Waldman SA;Teerlink JR;Gersh BJ;Povsic TJ;Henry TD;Metra M;Hajjar RJ;Tendera M;Behfar A;Alexandre B;Seron A;Stough WG;Sherman W;Cotter G;Wijns W;CHART Program
通讯作者：
CHART Program
影响因子：
18.2
作者：
Teerlink, John R.;Metra, Marco;Cotter, Gad
通讯作者：
Cotter, Gad
影响因子：
24
作者：
Bartunek, Jozef;Behfar, Atta;Terzic, Andre
通讯作者：
Terzic, Andre
影响因子：
9.3
作者：
Terzic A;Behfar A
通讯作者：
Behfar A