International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction
International Geographic Variation in Event Rates in Trials of Heart Failure With Preserved and Reduced Ejection Fraction
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DOI：
10.1161/circulationaha.114.012284
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发表时间：
2015-01-06
期刊：
影响因子：
37.8
通讯作者：
McMurray, John J. V.
中科院分区：
文献类型：
--
作者：
Kristensen, Soren L.;Kober, Lars;McMurray, John J. V.
背景：心力衰竭和射血分数降低（HF-REF）的临床试验结果可能存在国际地理差异，但射血分数保留（HF-PEF）的临床试验结果却很少。方法和结果：我们按国际地理区域分析了厄贝沙坦在保留收缩功能的心力衰竭试验（I-Preserve）、坎地沙坦在心力衰竭中降低死亡率和发病率的评估(CHARM)-保存试验、CHARM-替代和CHARM-添加HF-REF试验以及瑞舒伐他汀对照HF-REF多国试验（CORONA）的结果。心力衰竭住院率因地理区域而异，HF-PEF比HF-REF的差异更大。HF- pef患者的发生率在美国/加拿大最高（I-Preserve的HF住院率为7.6 /100患者-年，CHARM-Preserved为8.8 /100），西欧居中（4.8/100和4.7/100），东欧/俄罗斯最低（3.3/100和2.8/100）。在调整关键预后变量后，美国/加拿大与东欧/俄罗斯的差异仍然存在：I-Preserve的调整风险比为1.34(95%可信区间，1.01-1.74，P=0.04)，而charm - preserve的调整风险比为1.85（95%可信区间，1.17-2.91，P=0.01）。在HF- ref中，西欧的HF住院率略低于其他地区。对于HF-REF和HF-PEF，在全因死亡率或心血管死亡率方面几乎没有区域差异。结论：观察到的事件发生率差异表明，在HF-PEF的定义和诊断、入组患者的风险概况和住院阈值等一项或多项方面存在国际地理差异，这对未来开展全球试验具有重要意义。
Background-International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction (HF-REF), but there are few data for those with preserved ejection fraction (HF-PEF).Methods and Results-We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial (I-Preserve), the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity (CHARM)-Preserved trial, the CHARM-Alternative and CHARM-Added HF-REF trials, and the Controlled Rosuvastatin Multinational Trial in HF-REF (CORONA). Crude rates of heart failure hospitalization varied by geographic region, and more so for HF-PEF than for HF-REF. Rates in patients with HF-PEF were highest in the United States/Canada (HF hospitalization rate 7.6 per 100 patient-years in I-Preserve; 8.8 in CHARM-Preserved), intermediate in Western Europe (4.8/100 and 4.7/100), and lowest in Eastern Europe/Russia (3.3/100 and 2.8/100). The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables: adjusted hazard ratios 1.34 (95% confidence interval, 1.01-1.74; P=0.04) in I-Preserve and 1.85 (95% confidence interval, 1.17-2.91; P=0.01) in CHARM-Preserved. In HF-REF, rates of HF hospitalization were slightly lower in Western Europe compared with other regions. For both HF-REF and HF-PEF, there were few regional differences in rates of all-cause or cardiovascular mortality.Conclusions-The differences in event rates observed suggest there is international geographic variation in 1 or more of the definition and diagnosis of HF-PEF, the risk profile of patients enrolled, and the threshold for hospitalization, which has implications for the conduct of future global trials.