Design and rationale of studies of neurohormonal blockade and outcomes in diastolic heart failure using OPTIMIZE-HF registry linked to Medicare data
Design and rationale of studies of neurohormonal blockade and outcomes in diastolic heart failure using OPTIMIZE-HF registry linked to Medicare data
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DOI：
10.1016/j.ijcard.2011.10.089
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发表时间：
2013-06-05
影响因子：
3.5
通讯作者：
Ahmed, Ali
中科院分区：
文献类型：
--
作者：
Zhang, Yan;Kilgore, Meredith L.;Ahmed, Ali
背景：心力衰竭(HF)是医疗保险受益人住院的主要原因。近一半的心衰患者存在舒张性心衰或射血分数保留的心力衰竭(HF-PEF)。由于这些患者被排除在心力衰竭神经激素阻断的主要随机临床试验之外，因此几乎没有证据表明他们在心力衰竭-PEF中的作用。方法：美国复苏与再投资法案资助的国家心、肺和血液研究所赞助的“神经激素阻断和舒张性心力衰竭的结果”的目的是研究血管紧张素转换酶抑制剂、血管紧张素受体阻滞剂、β-受体阻滞剂和醛固酮拮抗剂在OPTIMIZE-HF(在住院的心力衰竭患者中启动救命治疗的有组织计划)登记的四个不同倾向匹配的HF-PEF患者中的长期影响。在美国259家医院2003-2004年间发生的48,612例OPTIME-HF住院病例中，有20,839例是由于HF-PEF(EF>；=40%)。对于死亡率和住院率，我们使用了截至2008年12月31日的联邦医疗保险国家索赔数据。结果：采用两步(医院级和住院级)概率关联方法，我们收集了来自238家优化心力衰竭医院的11,997名心力衰竭患者的队列。这些患者的平均年龄为75岁，平均EF为55%，其中62%为女性，15%为非裔美国人，在关键基线特征上与基于社区的HF-PEF队列相似。结论：具有长期结果数据的联邦医疗保险关联的优化-HF-HF队列将提供独特的机会，利用倾向匹配设计研究各种神经激素拮抗剂的临床疗效与HF-PEF的结果，该设计允许结果盲的平衡队列集合，这是随机临床试验的关键特征。爱思唯尔爱尔兰有限公司出版。
Background: Heart failure (HF) is the leading cause of hospitalization for Medicare beneficiaries. Nearly half of all HF patients have diastolic HF or HF with preserved ejection fraction (HF-PEF). Because these patients were excluded from major randomized clinical trials of neurohormonal blockade in HF there is little evidence about their role in HF-PEF.Methods: The aims of the American Recovery & Reinvestment Act-funded National Heart, Lung, and Blood Institute-sponsored "Neurohormonal Blockade and Outcomes in Diastolic Heart Failure" are to study the long-term effects of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and aldosterone antagonists in four separate propensity-matched populations of HF-PEF patients in the OPTIMIZE-HF (Organized Program to Initiate Life-Saving Treatment in Hospitalized Patients with Heart Failure) registry. Of the 48,612 OPTIMIZE-HF hospitalizations occurring during 2003-2004 in 259 U.S. hospitals, 20,839 were due to HF-PEF (EF >= 40%). For mortality and hospitalization we used Medicare national claims data through December 31, 2008.Results: Using a two-step (hospital-level and hospitalization-level) probabilistic linking approach, we assembled a cohort of 11,997 HF-PEF patients from 238 OPTIMIZE-HF hospitals. These patients had a mean age of 75 years, mean EF of 55%, were 62% women, 15% African American, and were comparable with community-based HF-PEF cohorts in key baseline characteristics.Conclusions: The assembled Medicare-linked OPTIMIZE-HF cohort of Medicare beneficiaries with HF-PEF with long-term outcomes data will provide unique opportunities to study clinical effectivenss of various neurohormonal antagonists with outcomes in HF-PEF using propensity-matched designs that allow outcome-blinded assembly of balanced cohorts, a key feature of randomized clinical trials. Published by Elsevier Ireland Ltd.