Generalizability of randomized controlled trials in heart failure with reduced ejection fraction.
Generalizability of randomized controlled trials in heart failure with reduced ejection fraction.
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DOI：
10.1093/ehjqcco/qcab070
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发表时间：
2022-10-26
影响因子：
5.2
通讯作者：
Koudstaal, Stefan
中科院分区：
文献类型：
--
作者：
Lim, Yvonne Mei Fong;Molnar, Megan;Vaartjes, Ilonca;Savarese, Gianluigi;Eijkemans, Marinus J. C.;Uijl, Alicia;Vradi, Eleni;Suzart-Woischnik, Kiliana;Brugts, Jasper J.;Brunner-La Rocca, Hans-Peter;Blanc-Guillemaud, Vanessa;Couvelard, Fabrice;Baudier, Claire;Dyszynski, Tomasz;Waechter, Sandra;Lund, Lars H.;Hoes, Arno W.;Tyl, Benoit;Asselbergs, Folkert W.;Gerlinger, Christoph;Grobbee, Diederick E.;Cronin, Maureen;Koudstaal, Stefan
关键词：
心力衰竭（HF）试验有严格的纳入和排除标准，但关于试验的可推广性的数据有限。我们在试验和观察性登记中比较了心衰和射血分数降低（HFrEF）患者的特征和结局。纳入了来自5项随机临床试验的16922例患者和来自2个心衰登记中心的46914例患者的个体患者数据。注册患者按照最常用的纳入和排除标准分为符合试验条件和不符合试验条件的两组。共有26104例（56%）登记患者符合入选标准。试验人群1年未调整的全因死亡率最低（7%），其次是符合试验条件的患者（12%）和不符合试验条件的登记患者（26%）。在调整年龄和性别后，试验参与者和符合试验条件的登记患者之间的全因死亡率相似[标准化死亡率（SMR） 0.97；95%可信区间（CI） 0.92-1.03]，但试验参与者的心血管死亡率更高（SMR为1.19;1.12-1.27）。在完全病例组合调整后，与符合rct的注册患者相比，试验中心血管死亡率的SMR仍然较高，为1.28（1.20-1.37）。在当前的心衰登记中，超过一半的HFrEF患者有资格参加试验。试验中的粗临床事件发生率较低，但是，在对病例组合进行调整后，试验参与者的生存率与登记组相似。尽管如此，他们的心血管疾病死亡率还是高出30%。年龄和性别是心衰试验和观察性心衰登记之间临床结果差异的主要驱动因素。
Heart failure (HF) trials have stringent inclusion and exclusion criteria, but limited data exist regarding generalizability of trials. We compared patient characteristics and outcomes between patients with HF and reduced ejection fraction (HFrEF) in trials and observational registries. Individual patient data for 16 922 patients from five randomized clinical trials and 46 914 patients from two HF registries were included. The registry patients were categorized into trial-eligible and non-eligible groups using the most commonly used inclusion and exclusion criteria. A total of 26 104 (56%) registry patients fulfilled the eligibility criteria. Unadjusted all-cause mortality rates at 1 year were lowest in the trial population (7%), followed by trial-eligible patients (12%) and trial-non-eligible registry patients (26%). After adjustment for age and sex, all-cause mortality rates were similar between trial participants and trial-eligible registry patients [standardized mortality ratio (SMR) 0.97; 95% confidence interval (CI) 0.92–1.03] but cardiovascular mortality was higher in trial participants (SMR 1.19; 1.12–1.27). After full case-mix adjustment, the SMR for cardiovascular mortality remained higher in the trials at 1.28 (1.20–1.37) compared to RCT-eligible registry patients. In contemporary HF registries, over half of HFrEF patients would have been eligible for trial enrolment. Crude clinical event rates were lower in the trials, but, after adjustment for case-mix, trial participants had similar rates of survival as registries. Despite this, they had about 30% higher cardiovascular mortality rates. Age and sex were the main drivers of differences in clinical outcomes between HF trials and observational HF registries.
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影响因子：
18.2
作者：
Anker SD;Colet JC;Filippatos G;Willenheimer R;Dickstein K;Drexler H;Lüscher TF;Mori C;von Eisenhart Rothe B;Pocock S;Poole-Wilson PA;Ponikowski P;FAIR-HF committees and investigators
通讯作者：
FAIR-HF committees and investigators
影响因子：
4.9
作者：
Loomis, D;Richardson, DB;Elliott, L
通讯作者：
Elliott, L
DOI：
10.1016/s1701-2163(16)32802-x
发表时间：
2008-04-01
影响因子：
1.8
作者：
Cheung, Angela M.;Lee, Yuna;Stewart, Donna E.
通讯作者：
Stewart, Donna E.
影响因子：
2.5
作者：
Kennedy-Martin T;Curtis S;Faries D;Robinson S;Johnston J
通讯作者：
Johnston J
影响因子：
3.4
作者：
Shah RU;Chang TI;Fonarow GC
通讯作者：
Fonarow GC