Abstract
IntroductionWe aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia.MethodsEligible 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).ResultsBetween 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).ConclusionsIn subjects with chronic stable angina and documented myocardial ischemia, ranolazine did not improve angina symptoms at 16 weeks.FundingGilead.Clinical trial registrationThe study was registered at ClinicalTrials.gov (NCT02265796).
Highlights
We aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia
The most common reason for eligibility was chronic total occlusion (CTO) (72%), while the remainder had myocardial ischemia documented by low fractional flow reserve (FFR)
We aimed to assess whether ranolazine would improve angina symptoms and subjective well-being among patients with documented myocardial ischemia, defined by either low fractional flow reserve (FFR) or presence of a chronic total occlusion (CTO), and who did not undergo revascularization
Summary
We aimed to assess if ranolazine would improve angina symptoms among patients with documented myocardial ischemia. Revascularization by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) is feasible for the majority of patients with symptomatic ischemic heart disease, with resolution of their symptoms. Many of these patients continue to have angina symptoms due to residual ischemia, which can result in repeat revascularizations and adverse cardiovascular events [1, 2]. Multicenter randomized trial, ranolazine failed to reduce ischemia-driven hospitalization or ischemia-driven revascularization in chronic angina patients with incomplete revascularization [5]. Incomplete revascularization was assessed angiographically, which is known to only modestly correlate with underlying myocardial ischemia [6, 7]
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