Shaare Zedek Medical Center, Jerusalem, Israel; New York Presbyterian Hospital, Columbia University Medical Center, New York, NY, USA; Cardiovascular Research Foundation, New York, NY, USA.
Cardiovascular Research Foundation, New York, NY, USA; Hôpital du Sacré-Coeur de Montreal, Université de Montreal, Montreal, QC, Canada.
Lancet. 2016 Jan 9;387(10014):136-45. doi: 10.1016/S0140-6736(15)00459-6. Epub 2015 Oct 22.
Incomplete revascularisation is common after percutaneous coronary intervention and is associated with increased mortality and adverse cardiovascular events. We aimed to assess whether adjunctive anti-ischaemic pharmacotherapy with ranolazine would improve the prognosis of patients with incomplete revascularisation after percutaneous coronary intervention.
We performed this multicentre, randomised, parallel-group, double-blind, placebo-controlled, event-driven trial at 245 centres in 15 countries in Europe, Israel, Russia, and the USA. Patients (aged ≥18 years) with a history of chronic angina with incomplete revascularisation after percutaneous coronary intervention (defined as one or more lesions with ≥50% diameter stenosis in a coronary artery ≥2 mm diameter) were randomly assigned (1:1), via an interactive web-based block randomisation system (block sizes of ten), to receive either twice-daily oral ranolazine 1000 mg or matching placebo. Randomisation was stratified by diabetes history (presence vs absence) and acute coronary syndrome presentation (acute coronary syndrome vs non-acute coronary syndrome). Study investigators, including all research teams, and patients were masked to treatment allocation. The primary endpoint was time to first occurrence of ischaemia-driven revascularisation or ischaemia-driven hospitalisation without revascularisation. Analysis was by intention to treat. This study is registered at ClinicalTrials.gov, number NCT01442038.
Between Nov 3, 2011, and May 27, 2013, we randomly assigned 2651 patients to receive ranolazine (n=1332) or placebo (n=1319); 2604 (98%) patients comprised the full analysis set. After a median follow-up of 643 days (IQR 575-758), the composite primary endpoint occurred in 345 (26%) patients assigned to ranolazine and 364 (28%) patients assigned to placebo (hazard ratio 0·95, 95% CI 0·82-1·10; p=0·48). Incidence of ischaemia-driven revascularisation and ischaemia-driven hospitalisation did not differ significantly between groups. 189 (14%) patients in the ranolazine group and 137 (11%) patients in the placebo group discontinued study drug because of an adverse event (p=0·04).
Ranolazine did not reduce the composite rate of ischaemia-driven revascularisation or hospitalisation without revascularisation in patients with a history of chronic angina who had incomplete revascularisation after percutaneous coronary intervention. Further studies are warranted to establish whether other treatment could be effective in improving the prognosis of high-risk patients in this population.
Gilead Sciences, Menarini.
经皮冠状动脉介入治疗后常发生不完全血运重建，与死亡率和不良心血管事件增加相关。我们旨在评估雷诺嗪辅助抗缺血药物治疗是否会改善经皮冠状动脉介入治疗后不完全血运重建患者的预后。
我们在欧洲、以色列、俄罗斯和美国的 245 个中心进行了这项多中心、随机、平行组、双盲、安慰剂对照、事件驱动的试验。患有慢性心绞痛且经皮冠状动脉介入治疗后存在不完全血运重建的患者（定义为在 ≥2mm 直径的冠状动脉中存在一个或多个 ≥50%直径狭窄的病变）按 1:1 比例通过交互式网络分组随机分配（分组大小为 10），接受每日两次口服雷诺嗪 1000mg 或匹配安慰剂。随机分组按糖尿病史（存在或不存在）和急性冠状动脉综合征表现（急性冠状动脉综合征与非急性冠状动脉综合征）分层。研究调查人员（包括所有研究团队）和患者对治疗分配均不知情。该研究在 ClinicalTrials.gov 注册，编号为 NCT01442038。
2011 年 11 月 3 日至 2013 年 5 月 27 日期间，我们随机分配 2651 名患者接受雷诺嗪（n=1332）或安慰剂（n=1319）；2604 名（98%）患者纳入全分析集。中位随访 643 天（IQR 575-758）后，345 名（26%）接受雷诺嗪治疗的患者和 364 名（28%）接受安慰剂治疗的患者发生复合主要终点事件（风险比 0.95，95%CI 0.82-1.10；p=0.48）。两组间缺血驱动血运重建和缺血驱动住院治疗的发生率无显著差异。在雷诺嗪组 189 名（14%）患者和安慰剂组 137 名（11%）患者因不良事件而停止研究药物（p=0.04）。
雷诺嗪并未降低经皮冠状动脉介入治疗后存在慢性心绞痛且不完全血运重建患者的缺血驱动血运重建或无血运重建住院的复合率。需要进一步的研究来确定其他治疗方法是否能有效改善该人群高危患者的预后。
吉利德科学公司，美纳里尼。
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