From Duke Clinical Research Institute and Duke University, Durham, NC (K.P.A., K.P., D.B.M., K.J.A., L.D.-R., E.M.O.); Shaare Zedek Medical Center, Jerusalem, Israel (G.W.); Cardiovascular Research Foundation, New York (G.W., O.B.-Y.); Department of Medical Sciences, Cardiology, Uppsala University, Sweden (S.J.); Department of Interventional Cardiology & Angiology, Institute of Cardiology, Warsaw, Poland (A.W.); Holy Name Medical Center, Hackensack, NJ (A.J.M.); Gilead Sciences Inc, Foster City, CA (A.O., R.F.-F.); and New York Presbyterian Hospital, Columbia University Medical Center (O.B.-Y., G.W.S.).
Circulation. 2016 Jan 5;133(1):39-47. doi: 10.1161/CIRCULATIONAHA.115.019768. Epub 2015 Nov 10.
Angina often persists or returns in populations following percutaneous coronary intervention (PCI). We hypothesized that ranolazine would be effective in reducing angina and improving quality of life (QOL) in incomplete revascularization (ICR) post-PCI patients.
In RIVER-PCI, 2604 patients with a history of chronic angina who had ICR post-PCI were randomized 1:1 to oral ranolazine versus placebo; QOL analyses included 2389 randomized subjects. Angina and QOL questionnaires were collected at baseline and months 1, 6, and 12. Ranolazine patients were more likely than placebo to discontinue study drug by month 6 (20.4% versus 14.1%, P<0.001) and 12 (27.2% versus 21.3%, P<0.001). Following qualifying index PCI, the primary QOL outcome (Seattle Angina Questionnaire [SAQ] angina frequency score) improved markedly, but similarly, in the ranolazine and placebo groups, respectively, from baseline (67.3±24.5 versus 69.7±24.0, P=0.01) to month 1 (86.6±18.1 versus 85.8±18.5, P=0.27) and month 12 (88.4±17.8 versus 88.5±17.8, P=0.94). SAQ angina frequency repeated measures did not differ in adjusted analysis between groups post baseline (mean difference 1.0; 95% CI -0.2, 2.2; P=0.11). Improvement in SAQ angina frequency was observed with ranolazine at month 6 among diabetics (mean difference 3.3; 95% CI 0.6, 6.1; P=0.02) and those with more angina (baseline SAQ angina frequency ≤60; mean difference 3.4; 95% CI 0.6, 6.2; P=0.02), but was not maintained at month 12.
Despite ICR following PCI, there was no incremental benefit in angina or QOL measures by adding ranolazine in this angiographically-identified population. These measures markedly improved within 1 month of PCI and persisted up to 1 year in both treatment arms.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01442038.
经皮冠状动脉介入治疗（PCI）后，心绞痛在人群中仍经常持续或复发。我们假设雷诺嗪可有效减少不完全血运重建（ICR）后 PCI 患者的心绞痛并改善生活质量（QOL）。
在 RIVER-PCI 中，2604 例有慢性心绞痛病史且 ICR 后行 PCI 的患者按 1:1 随机分为口服雷诺嗪组或安慰剂组；QOL 分析包括 2389 例随机患者。在基线和第 1、6 和 12 个月收集心绞痛和 QOL 问卷。雷诺嗪组患者在第 6 个月（20.4%比 14.1%，P<0.001）和第 12 个月（27.2%比 21.3%，P<0.001）时更有可能停用研究药物。在合格的索引 PCI 后，主要 QOL 结局（西雅图心绞痛问卷[SAQ]心绞痛发作频率评分）显著改善，但在雷诺嗪组和安慰剂组中，分别从基线（67.3±24.5 比 69.7±24.0，P=0.01）到第 1 个月（86.6±18.1 比 85.8±18.5，P=0.27）和第 12 个月（88.4±17.8 比 88.5±17.8，P=0.94）。调整后的基线后组间重复测量 SAQ 心绞痛发作频率无差异（平均差异 1.0；95%CI -0.2，2.2；P=0.11）。在第 6 个月时，糖尿病患者（平均差异 3.3；95%CI 0.6，6.1；P=0.02）和心绞痛更多的患者（基线 SAQ 心绞痛发作频率≤60；平均差异 3.4；95%CI 0.6，6.2；P=0.02）使用雷诺嗪治疗时，SAQ 心绞痛发作频率得到改善，但在第 12 个月时未维持。
尽管 PCI 后存在 ICR，但在该血管造影确定的人群中，加用雷诺嗪对心绞痛或 QOL 测量无额外获益。这些措施在 PCI 后 1 个月内明显改善，并在治疗臂中持续至 1 年。
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