AM J CARDIOL:心肌球来源自体干细胞逆转心室功能障碍

　　背景  临床前模型显示，心肌球来源细胞（CDC）可减少心肌梗死后瘢痕形成、增加存活心肌、增强心功能。本研究旨在评价这种方法治疗心肌梗死后左室功能障碍患者的安全性。

　　方法  在心肌球来源自体干细胞逆转心室功能障碍（CADUCEUS）前瞻性、随机试验中，我们纳入美国2个医学中心的心肌梗死后2~4周患者[左室射血分数（LVEF）为25%~45%]。一个独立数据协调中心按2:1比例将患者随机分配，接受CDC或标准治疗。对于分配接受CDC的患者，于心肌梗死后1.5~3个月时，将心内膜心肌活检标本源性自体细胞注入梗死相关动脉内。主要终点为6个月时死于室性心动过速、室颤或意外猝死的患者比例，或在细胞注入后出现心肌梗死、MRI提示新的心脏肿瘤形成或主要心脏不良事件（MACE；死亡及因心力衰竭或非致死性心肌梗死再发住院的组合）。研究还评价了6个月时的MRI初步有效性终点。数据分析人员不知晓患者分组情况。

　　结果  2009年5月5日至2010年12月16日，研究将31例符合纳入标准的患者随机分配，其中25例进入符合方案分析（17例CDC组患者和8例标准治疗组患者）。平均基线LVEF为39%（SD 12），瘢痕占左室质量的比例为24%（10）。活检样本在36天（SD 6）内产生指定的细胞量。CDC注入后24小时内无并发症报告。6个月时，各组均无患者死亡，无心脏肿瘤形成或MACE。CDC组4例（24%）患者出现严重不良事件，而对照组为1例（13%；P=1.00）。6个月时，与对照组相比，CDC组患者MRI分析显示瘢痕质量减小（P=0.001），存活心脏质量增加（P=0.01），且局部收缩力增强（P=0.02），局部室壁收缩期增厚（P=0.015）。然而，6个月时，两组的舒张末期容积、收缩末期容积和LVEF变化无差异。

　　结论  本研究表明，心肌梗死后冠状动脉内注入自体CDC是安全的，有必要对此疗法开展2期研究。研究还注意到，存活心肌细胞前所未有地增加，与治疗后心肌再生相符，值得进一步评估该疗法的临床转归。

Prognostic Utility of BCIS Myocardial Jeopardy Score for Classification of Coronary Disease Burden and Completeness of Revascularization

Abstract

Several coronary disease scoring systems have been developed to predict procedural risk during revascularization. Many vary in complexity, do not specifically account for myocardium at risk, and are not applicable across all patient subsets. The Balloon pump-assisted Coronary Intervention study (BCIS-1) myocardial jeopardy score (BCIS-JS) addresses these limitations and is applicable to all patients, including those with coronary artery bypass grafts or left main stem disease. We assessed the prognostic relevance of the BCIS-JS in patients undergoing percutaneous coronary intervention (PCI). A total of 663 patients who underwent PCI with previous left ventricular function assessment were retrospectively assessed for inclusion, incorporating 221 with previous coronary artery bypass grafting. Blinded observers calculated the BCIS-JS, before (BCIS-JSPRE) and after (BCIS-JSPOST) PCI, using the revascularization index (RI) (RI = [BCIS-JSPRE − BCIS-JSPOST]/BCIS-JSPRE), quantifying the extent of revascularization, 1 indicating full revascularization and 0 indicating no revascularization. The primary end point was Office of National Statistics tracked, all-cause mortality. A total of 660 patients were included (66 ± 10.7 years), with 43 deaths (6.5%) during 2.6 ± 1.1 years after PCI. All-cause mortality was directly related to BCIS-JSPRE (hazard ratio [HR] 2.96, 95% confidence interval [CI] 1.71 to 5.15, p = 0.001) and BCIS-JSPOST (HR 4.02, 95% CI 2.41 to 6.68, p = 0.001). A RI of <0.67 was associated with increased mortality compared to a RI of ≥0.67 (HR 4.13, 95% CI 1.91 to 8.91, p = 0.0001). On multivariate analysis, a RI <0.67 (HR 1.99, 95% confidence interval 1.03 to 3.87, p = 0.04), left ventricular dysfunction (HR 2.03, 95% CI 1.25 to 3.30, p = 0.004) and renal impairment (HR 3.75, 95% CI 1.48 to 8.64, p = 0.005) were independent predictors of mortality. In conclusion, the BCIS-JS predicts mortality after PCI and can assess the degree of revascularization. with more complete revascularization conferring a survival advantage in the medium term.