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首页> 外文期刊>Journal of the American College of Cardiology >Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support)
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Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: A prospective study using the INTERMACS registry (interagency registry for mechanically assisted circulatory support)

机译：连续流左心室辅助装置进行目的地治疗的食品和药物管理后的批准研究结果：一项使用INTERMACS注册表（用于机械辅助循环支持的机构间注册表）的前瞻性研究

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Objectives A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial. Background New device technology developed in the clinical research setting requires validation in a real-world setting. Methods The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry. Results Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group. Conclusions Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).
机译：目的美国食品和药物管理局（FDA）要求对目的疗法（DT）进行批准后（PA）研究，以确定HeartMate（HM）II（Thoratec，Pleasanton，California）左心室辅助装置（LVAD）的结果）在商业环境中与DT多中心关键临床试验的结果相当。背景技术在临床研究环境中开发的新设备技术需要在实际环境中进行验证。方法PA研究是对前247例HMII患者进行的前瞻性评估，该患者在术前被国家INTERMACS（机械辅助循环支持机构间注册中心）登记为DT。患者于2010年1月至2010年9月在美国61个中心入组，并随访2年。一个历史比较组包括DT关键性试验（TR）中纳入主要数据队列的患者（在34个中心n = 133）。 PA组的存活率和不良事件可从INTERMACS注册中心获得。结果PA与TR的基线特征相似。 45％的PA患者的INTERMACS资料为1至2，而28％的资料为3。PA组的不良事件与TR组相似或更低，包括器械相关感染的改善（0.22 vs. 2。每位患者年（0.47）和需要手术的术后出血事件（0.09 vs.0.23）。 Kaplan-Meier组2年生存率为62％（PA组），而58％（TR组）。 INTERMACS配置文件4至7（n = 63）的PA组在1年和2年生存率分别为82±5％和69±6％，而配置文件1至3（n = 184）的PA组生存率为72±3％和60±4％。与TR组相比，PA组的术后中位住院时间缩短了6天。结论在DT人群的商业患者护理环境中的结果支持了关于HM II LVAD的功效和风险特征的最初关键性临床试验发现。不依赖inotrope的患者生存率最高（INTERMACS档案4至7）。

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