雷诺嗪改善有心肌缺血证据但无阻塞性冠状动脉疾病的女性心绞痛。
Ranolazine improves angina in women with evidence of myocardial ischemia but no obstructive coronary artery disease.
机构信息
Women's Heart Center, Cedars-Sinai Heart Institute, Los Angeles, California, USA.
出版信息
JACC Cardiovasc Imaging. 2011 May;4(5):514-22. doi: 10.1016/j.jcmg.2011.03.007.
OBJECTIVES
We conducted a pilot study for a large definitive clinical trial evaluating the impact of ranolazine in women with angina, evidence of myocardial ischemia, and no obstructive coronary artery disease (CAD).
BACKGROUND
Women with angina, evidence of myocardial ischemia, but no obstructive CAD frequently have microvascular coronary dysfunction. The impact of ranolazine in this patient group is unknown.
METHODS
A pilot randomized, double-blind, placebo-controlled, crossover trial was conducted in 20 women with angina, no obstructive CAD, and ≥ 10% ischemic myocardium on adenosine stress cardiac magnetic resonance (CMR) imaging. Participants were assigned to ranolazine or placebo for 4 weeks separated by a 2-week washout. The Seattle Angina Questionnaire and CMR were evaluated after each treatment. Invasive coronary flow reserve (CFR) was available in patients who underwent clinically indicated coronary reactivity testing. CMR data analysis included the percentage of ischemic myocardium and quantitative myocardial perfusion reserve index (MPRI).
RESULTS
The mean age of subjects was 57 ± 11 years. Compared with placebo, patients on ranolazine had significantly higher (better) Seattle Angina Questionnaire scores, including physical functioning (p = 0.046), angina stability (p = 0.008), and quality of life (p = 0.021). There was a trend toward a higher (better) CMR mid-ventricular MPRI (2.4 [2.0 minimum, 2.8 maximum] vs. 2.1 [1.7 minimum, 2.5 maximum], p = 0.074) on ranolazine. Among women with coronary reactivity testing (n = 13), those with CFR ≤ 3.0 had a significantly improved MPRI on ranolazine versus placebo compared to women with CFR > 3.0 (Δ in MPRI 0.48 vs. -0.82, p = 0.04).
CONCLUSIONS
In women with angina, evidence of ischemia, and no obstructive CAD, this pilot randomized, controlled trial revealed that ranolazine improves angina. Myocardial ischemia may also improve, particularly among women with low CFR. These data document approach feasibility and provide outcome variability estimates for planning a definitive large clinical trial to evaluate the role of ranolazine in women with microvascular coronary dysfunction. (Microvascular Coronary Disease In Women: Impact Of Ranolazine; NCT00570089).
目的
我们开展了一项大型确证性临床试验的先导研究，评估雷诺嗪对心绞痛、心肌缺血证据但无阻塞性冠状动脉疾病（CAD）的女性的影响。
背景
有绞痛、心肌缺血证据但无阻塞性 CAD 的女性常伴有微血管性冠状动脉功能障碍。雷诺嗪在该患者群体中的影响尚不清楚。
方法
对 20 名患有心绞痛、无阻塞性 CAD 和腺苷应激心脏磁共振（CMR）成像上 ≥ 10%缺血性心肌的女性进行了一项先导性随机、双盲、安慰剂对照、交叉试验。参与者被随机分配至雷诺嗪或安慰剂治疗 4 周，然后进行为期 2 周的洗脱期。每次治疗后均评估西雅图心绞痛问卷和 CMR。在进行了临床提示的冠状动脉反应性测试的患者中，获得了冠状动脉血流储备（CFR）。CMR 数据分析包括缺血性心肌的百分比和定量心肌灌注储备指数（MPRI）。
结果
研究对象的平均年龄为 57 ± 11 岁。与安慰剂相比，雷诺嗪组患者的西雅图心绞痛问卷评分显著更高（更好），包括躯体活动受限（p = 0.046）、心绞痛稳定性（p = 0.008）和生活质量（p = 0.021）。雷诺嗪组的 CMR 室中部 MPRI 更高（更好），有趋势意义（2.4[2.0 最小值，2.8 最大值] vs. 2.1[1.7 最小值，2.5 最大值]，p = 0.074）。在进行了冠状动脉反应性测试的女性中（n = 13），与 CFR > 3.0 的女性相比，CFR ≤ 3.0 的女性在雷诺嗪治疗时 MPRI 显著改善（MPRI 差值 0.48 vs. -0.82，p = 0.04）。
结论
在有绞痛、缺血证据但无阻塞性 CAD 的女性中，这项先导性随机对照试验显示雷诺嗪可改善心绞痛。心肌缺血也可能改善，尤其是在 CFR 较低的女性中。这些数据证明了方法的可行性，并为计划一项大型确证性临床试验以评估雷诺嗪在微血管性冠状动脉功能障碍女性中的作用提供了结果变异性估计。（微血管性冠状动脉疾病：雷诺嗪的影响；NCT00570089）。
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