Institute of Cardiology, University of Bologna, Bologna, Italy.
J Eval Clin Pract. 2010 Feb;16(1):82-91. doi: 10.1111/j.1365-2753.2008.01118.x. Epub 2009 Oct 27.
Randomized controlled trials have generated strong evidence on the efficacy of electrical device therapy in selected patients with heart failure (HF). The enrolment criteria of these three trials generated patient profiles that helped to shape current guidelines on chronic heart failure (CHF) treatment and sudden cardiac death (SCD) prevention. We investigated the prevalence of trial-generated profiles for implantable defibrillator or cardiac resynchronization therapy candidacy among HF outpatients; we explored differences between real-world and trial populations and we evaluated 1-year survival without device treatment.
We reviewed Italian Network on Congestive Heart Failure (IN-CHF) registry patients (n = 4977) enrolled in a period (1995-2000) roughly concurrent with the MADIT-II and SCD-HeFT trials.
Regarding device eligibility, 14.5% IN-CHF patients at entry satisfied MADIT-II criteria, 6.8% satisfied CARE-HF criteria and as many as 47.9% fulfilled SCD-HeFT criteria. One-year overall mortality among non-implanted patients was 1.5 to 2-fold higher in each of these subgroups than in control arms of the corresponding trials. Among registry patients, different trial-profile combinations were associated with a wide range of 1-year outcomes (mortality, 8-35%; SCD/total mortality ratio, 0.35-0.57). Despite clear differences between registry and trial patients in pharmacological therapy (and clinical characteristics), none of the main drug classes independently predicted 1-year mortality in any of the IN-CHF subgroups.
As many as half the IN-CHF outpatients fulfilled current criteria for device implantation. Various subgroups had higher 1-year mortality than patients in trial control arms - a finding that may not be entirely attributable to differences in drug therapy (especially beta blockers).
随机对照试验已经为特定心力衰竭（HF）患者的电设备治疗疗效提供了强有力的证据。这三项试验的入组标准生成了有助于塑造当前慢性心力衰竭（CHF）治疗和心脏性猝死（SCD）预防指南的患者特征。我们调查了心力衰竭门诊患者中植入式除颤器或心脏再同步治疗候选者的试验生成特征的患病率；我们探讨了真实世界和试验人群之间的差异，并评估了 1 年无设备治疗的生存率。
我们回顾了意大利充血性心力衰竭网络（IN-CHF）登记处（n = 4977）患者，这些患者在 MADIT-II 和 SCD-HeFT 试验期间（1995-2000 年）被纳入研究。
关于设备资格，4977 名 IN-CHF 患者中有 14.5%符合 MADIT-II 标准，6.8%符合 CARE-HF 标准，多达 47.9%符合 SCD-HeFT 标准。在这些亚组中，每个亚组未植入设备的患者 1 年总死亡率均比相应试验对照臂高 1.5 至 2 倍。在登记处患者中，不同的试验特征组合与广泛的 1 年结局（死亡率，8-35%；SCD/总死亡率比，0.35-0.57）相关。尽管登记处和试验患者在药物治疗（和临床特征）方面存在明显差异，但在任何 IN-CHF 亚组中，主要药物类别均未独立预测 1 年死亡率。
多达一半的 IN-CHF 门诊患者符合当前设备植入标准。与试验对照组相比，各个亚组的 1 年死亡率更高，这一发现可能不完全归因于药物治疗的差异（特别是β受体阻滞剂）。
