Key result
Ranolazine did not significantly improve SAQ-7 overall angina scores compared to placebo in patients with coronary microvascular dysfunction (MD 1.31, 95% CI -1.56 to 4.17, P=0.37).
Why the study?
Does short-term late sodium current inhibition with ranolazine improve angina symptoms, myocardial perfusion reserve index, and diastolic filling compared with placebo in patients with coronary microvascular dysfunction and no obstructive coronary artery disease?
RCT (n=128)
Double-blind
1:1 ratio, blocked by clinical site, 2x2 crossover design
Yes
Does short-term late sodium current inhibition with ranolazine improve angina symptoms, myocardial perfusion reserve index, and diastolic filling compared with placebo in patients with coronary microvascular dysfunction and no obstructive coronary artery disease?
Answers are grounded in this paper and cite their sources.
Short-term ranolazine does not generally improve angina or myocardial perfusion reserve in patients with coronary microvascular dysfunction and no obstructive CAD, though changes in perfusion reserve directly correlated with symptom changes and a subgroup with severe CMD (CFR <2.5) showed benefit.
AIMS: The mechanistic basis of the symptoms and signs of myocardial ischaemia in patients without obstructive coronary artery disease (CAD) and evidence of coronary microvascular dysfunction (CMD) is unclear. The aim of this study was to mechanistically test short-term late sodium current inhibition (ranolazine) in such subjects on angina, myocardial perfusion reserve index, and diastolic filling. MATERIALS AND RESULTS: Randomized, double-blind, placebo-controlled, crossover, mechanistic trial in subjects with evidence of CMD [invasive coronary reactivity testing or non-invasive cardiac magnetic resonance imaging myocardial perfusion reserve index (MPRI)]. Short-term oral ranolazine 500-1000 mg twice daily for 2 weeks vs. placebo. Angina measured by Seattle Angina Questionnaire (SAQ) and SAQ-7 (co-primaries), diary angina (secondary), stress MPRI, diastolic filling, quality of life (QoL). Of 128 (96% women) subjects, no treatment differences in the outcomes were observed. Peak heart rate was lower during pharmacological stress during ranolazine (-3.55 b.p.m., P < 0.001). The change in SAQ-7 directly correlated with the change in MPRI (correlation 0.25, P = 0.005). The change in MPRI predicted the change in SAQ QoL, adjusted for body mass index (BMI), prior myocardial infarction, and site (P = 0.0032). Low coronary flow reserve (CFR <2.5) subjects improved MPRI (P < 0.0137), SAQ angina frequency (P = 0.027), and SAQ-7 (P = 0.041). CONCLUSIONS: In this mechanistic trial among symptomatic subjects, no obstructive CAD, short-term late sodium current inhibition was not generally effective for SAQ angina. Angina and myocardial perfusion reserve changes were related, supporting the notion that strategies to improve ischaemia should be tested in these subjects. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01342029.
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Merz et al. (2015) conducted an RCT in Coronary microvascular dysfunction (CMD) without obstructive coronary artery disease (n=128). Ranolazine vs. Placebo was evaluated on Seattle Angina Questionnaire-7 (SAQ-7) overall score change (co-primary alongside SAQ angina frequency and angina stability) (MD 1.31, 95% CI -1.56 to 4.17, p=0.37). Ranolazine did not significantly improve SAQ-7 overall angina scores compared to placebo in patients with coronary microvascular dysfunction (MD 1.31, 95% CI -1.56 to 4.17, P=0.37).
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