Bavry Anthony A, Park Ki E, Choi Calvin Y, Mahmoud Ahmed N, Wen Xuerong, Elgendy Islam Y
Department of Medicine, University of Florida, Gainesville, FL, USA.
North Florida/South Georgia Veterans Health System, Gainesville, FL, USA.
Cardiol Ther. 2017 Jun;6(1):81-88. doi: 10.1007/s40119-016-0081-3. Epub 2017 Jan 2.
We aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia.
Eligible subjects had chronic stable angina and at least one coronary stenosis with fractional flow reserve (FFR) ≤0.80 or at least one chronic total occlusion (CTO) without attempted revascularization. Subjects were randomized to oral ranolazine 500 mg twice daily for 1 week, then ranolazine 1000 mg twice daily for 15 weeks versus matching placebo. The primary end point was change in angina at 16 weeks as assessed by the Seattle Angina Questionnaire (SAQ).
Between September 2014 and January 2016, 25 subjects were randomized to ranolazine versus 25 to placebo. The most common reason for eligibility was CTO (72%), while the remainder had myocardial ischemia documented by low FFR. The mean FFR was 0.57 ± 0.12. Sixty-eight percent of subjects were on two or more anti-angina medications at baseline. Study medication was discontinued in 32% (eight of 25) of the ranolazine group versus 36% (nine of 25) of the placebo group. By intention-to-treat, 46 subjects had baseline and follow-up SAQ data completed. Ranolazine was not associated with an improvement in angina compared with placebo at 16 weeks. The results were similar among 33 subjects that completed study medication. The incidence of ischemia-driven hospitalization or catheterization was 12% (three of 25) of the ranolazine group versus 20% (five of 25) in the placebo group (p > 0.05).
In subjects with chronic stable angina and documented myocardial ischemia, ranolazine did not improve angina symptoms at 16 weeks.
Gilead.
The study was registered at ClinicalTrials.gov (NCT02265796).
我们旨在评估雷诺嗪是否会改善有心肌缺血记录的患者的心绞痛症状。
符合条件的受试者患有慢性稳定型心绞痛，且至少有一处冠状动脉狭窄，其血流储备分数（FFR）≤0.80，或至少有一处慢性完全闭塞（CTO）且未尝试进行血运重建。受试者被随机分为两组，一组口服雷诺嗪500毫克，每日两次，持续1周，然后口服雷诺嗪1000毫克，每日两次，持续15周；另一组服用匹配的安慰剂。主要终点是16周时通过西雅图心绞痛问卷（SAQ）评估的心绞痛变化。
在2014年9月至2016年1月期间，25名受试者被随机分配至雷诺嗪组，25名受试者被随机分配至安慰剂组。符合条件的最常见原因是CTO（72%），其余受试者通过低FFR记录有心肌缺血。平均FFR为0.57±0.12。68%的受试者在基线时服用两种或更多抗心绞痛药物。雷诺嗪组32%（25名中的8名）和安慰剂组36%（25名中的9名）停用了研究药物。按照意向性分析，46名受试者完成了基线和随访SAQ数据。与安慰剂相比，16周时雷诺嗪未使心绞痛得到改善。在完成研究药物治疗的33名受试者中，结果相似。雷诺嗪组因缺血导致住院或进行导管插入术的发生率为12%（25名中的3名），安慰剂组为20%（25名中的5名）（p>0.05）。
在患有慢性稳定型心绞痛且有心肌缺血记录的受试者中，雷诺嗪在16周时未改善心绞痛症状。
吉利德公司。
该研究已在ClinicalTrials.gov（NCT02265796）注册。
