急性心力衰竭患者临床特征、治疗及预后的国际差异：PROTECT试验中，东欧和俄罗斯的患者短期预后更佳。
International differences in clinical characteristics, management, and outcomes in acute heart failure patients: better short-term outcomes in patients enrolled in Eastern Europe and Russia in the PROTECT trial.
作者信息
Mentz Robert J, Cotter Gad, Cleland John G F, Stevens Susanna R, Chiswell Karen, Davison Beth A, Teerlink John R, Metra Marco, Voors Adriaan A, Grinfeld Liliana, Ruda Mikhail, Mareev Viacheslav, Lotan Chaim, Bloomfield Daniel M, Fiuzat Mona, Givertz Michael M, Ponikowski Piotr, Massie Barry M, O'Connor Christopher M
机构信息
Duke University, Durham, NC, USA.
出版信息
Eur J Heart Fail. 2014 Jun;16(6):614-24. doi: 10.1002/ejhf.92. Epub 2014 Apr 25.
AIMS
The implications of geographical variation are unknown following adjustment for hospital length of stay (LOS) in heart failure (HF) trials that included patients whether or not they had systolic dysfunction. We investigated regional differences in an international acute HF trial.
METHODS AND RESULTS
The PROTECT trial investigated 2033 patients with acute HF and renal dysfunction hospitalized at 173 sites in 17 countries with randomization to rolofylline or placebo. We grouped enrolling countries into six regions. Baseline characteristics, in-hospital management, and outcomes were explored by region. The primary study outcome was 60-day mortality or cardiovascular/renal hospitalization. Secondary outcomes included 180-day mortality. Of 2033 patients, 33% were from Eastern Europe, 19% from Western Europe, 16% from Israel, 15% from North America, 14% from Russia, and 3% from Argentina. Marked differences in baseline characteristics, HF phenotype, in-hospital diuretic and vasodilator strategies, and LOS were observed by region. LOS was shortest in North America and Israel (median 5 days) and longest in Russia (median 15 days). Regional event rates varied significantly. Following multivariable adjustment, region was an independent predictor of the risk of mortality/hospitalization at 60 days, with the lowest risk in Russia (hazard ratio 0.39, 95% confidence interval 0.23-0.64 vs. Western Europe) due to lower rehospitalization; mortality differences were attenuated by 180 days.
CONCLUSIONS
In an international HF trial, there were differences in baseline characteristics, treatments, LOS, and rehospitalization amongst regions, but little difference in longer term mortality. Rehospitalization differences exist independent of LOS. This analysis may help inform future trial design and should be externally validated.
目的
在心力衰竭（HF）试验中，对住院时间（LOS）进行调整后，地理差异的影响尚不清楚，这些试验纳入了无论是否患有收缩功能障碍的患者。我们在一项国际急性HF试验中调查了区域差异。
方法和结果
PROTECT试验在17个国家的173个地点对2033例急性HF和肾功能不全患者进行了研究，随机分为rolfylline组或安慰剂组。我们将参与研究的国家分为六个区域。按区域探讨基线特征、住院管理和结局。主要研究结局为60天死亡率或心血管/肾脏住院。次要结局包括180天死亡率。2033例患者中，33%来自东欧，19%来自西欧，16%来自以色列，15%来自北美，14%来自俄罗斯，3%来自阿根廷。按区域观察到基线特征、HF表型、住院利尿剂和血管扩张剂策略以及LOS存在显著差异。北美和以色列的LOS最短（中位数5天），俄罗斯最长（中位数15天）。区域事件发生率差异显著。多变量调整后，区域是60天死亡率/住院风险的独立预测因素，俄罗斯风险最低（风险比0.39，95%置信区间0.23 - 0.64，与西欧相比），原因是再住院率较低；180天时死亡率差异减弱。
结论
在一项国际HF试验中，各区域在基线特征、治疗、LOS和再住院方面存在差异，但长期死亡率差异不大。再住院差异独立于LOS存在。该分析可能有助于为未来试验设计提供信息，应进行外部验证。
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