Division of Cardiology, Portland Veterans Affairs Medical Center and Oregon Health and Science University, Portland, OR 97239, USA.
Circ Arrhythm Electrophysiol. 2012 Aug 1;5(4):739-47. doi: 10.1161/CIRCEP.112.970566. Epub 2012 Jul 7.
Previous studies have suggested that aldosterone blockade can reduce the incidence of ventricular tachycardia (VT) or ventricular fibrillation (VF) in patients with heart failure. The SPIronolactone to Reduce ICD Therapy (SPIRIT) trial was designed to test the hypothesis that spironolactone reduces the incidence of VT/VF in patients with implantable cardioverter-defibrillators (ICDs) who are at moderately high risk for recurrent VT/VF.
Ninety patients who had ICDs who were at moderately high risk for recurrent VT/VF and who were not candidates for spironolactone by current heart failure guidelines were randomized to receive spironolactone 25 mg daily or placebo in a double-blind fashion. All patients had previously received ICD therapy (shock or antitachycardia pacing) for VT/VF within 2 years of randomization or an ICD for secondary prevention of VT/VF within 6 months of randomization. The primary end point was time to first recurrence of VT/VF requiring ICD therapy. After a median follow-up of 35 months, the Kaplan-Meier probability estimates for VT/VF requiring ICD therapy were 68.7% in the placebo group and 84.7% in the spironolactone group. Compared with placebo, spironolactone was associated with a similar risk of VT/VF (hazard ratio, 1.01; 95% CI, 0.64-1.83; P=0.71). There was no significant difference between the median times to first VT/VF recurrence requiring ICD therapy in the 2 groups.
In patients with ICDs who were at moderately high risk for recurrent VT/VF on account of a recent VT/VF event that was either sustained or treated by the ICD and who were not candidates for spironolactone by current heart failure guidelines, spironolactone did not delay the first recurrence of VT/VF or reduce the risk of recurrent VT/VF.
先前的研究表明，醛固酮阻断剂可降低心力衰竭患者室性心动过速（VT）或心室颤动（VF）的发生率。SPIronolactone 降低 ICD 治疗（SPIRIT）试验旨在检验这样一个假设，即螺内酯可降低植入式心脏复律除颤器（ICD）患者 VT/VF 的发生率，这些患者 VT/VF 复发的风险处于中度偏高。
90 名患有 ICD 的患者，他们的 VT/VF 复发风险处于中度偏高，且不符合现行心力衰竭指南中螺内酯的使用标准，他们被随机分为两组，分别接受每日 25 毫克螺内酯或安慰剂治疗，采用双盲法。所有患者均在随机分组后 2 年内因 VT/VF 接受过 ICD 治疗（电击或抗心动过速起搏），或在随机分组后 6 个月内因 VT/VF 接受过 ICD 二级预防。主要终点为首次因 VT/VF 需 ICD 治疗的复发时间。在中位随访 35 个月后，安慰剂组 VT/VF 需 ICD 治疗的 Kaplan-Meier 概率估计值为 68.7%，而螺内酯组为 84.7%。与安慰剂相比，螺内酯治疗 VT/VF 的风险无显著差异（风险比，1.01；95%置信区间，0.64-1.83；P=0.71）。两组首次因 VT/VF 需 ICD 治疗的复发时间中位数无显著差异。
在近期因 ICD 治疗的持续性或 ICD 处理的 VT/VF 事件而导致中度偏高的 VT/VF 复发风险的 ICD 患者中，且不符合现行心力衰竭指南中螺内酯的使用标准，螺内酯并未延迟 VT/VF 的首次复发，也未降低 VT/VF 的复发风险。
