Abstract 16283: Ranolazine Improves Angina in Women with Evidence of Ischemia but No Obstructive Coronary Artery Disease: A Pilot, Randomized-Controlled Trial
Background: Women with angina, evidence of ischemia but no obstructive coronary artery disease (CAD) often have microvascular coronary dysfunction (MCD). The impact of ranolazine on angina in women with MCD is unknown.
Methods: A pilot randomized, double-blind, placebo-control, cross-over trial was conducted in 20 women with angina, no obstructive CAD, and ischemia defined as ≥ 10% perfusion abnormality on adenosine stress cardiac magnetic resonance imaging (CMR). Participants were randomly assigned in a crossover design to ranolazine (treatment A) 1000 mg bid or placebo (treatment B) each for 4 weeks separated by a 2 week wash-out. Seattle Angina Questionnaire (SAQ) and CMR were evaluated after each treatment. CMR (1.5 T) protocol was highly standardized and semi-quantitative visual summed difference score (SDS) utilized the standard 17 segment, 5 score model. Quantitative myocardial perfusion reserve index (MPRI) was calculated using PIE Medical software (Netherlands). Absolute differences between treatments were assessed in mixed effect model with random subject effect.
Results: Demographics: age 57 ± 11 yrs, 20% non-Caucasians, 50% hypertension, 60% dyslipidemia, mean left ventricular ejection fraction 71 ± 6%, 65% had invasive coronary flow reserve (CFR) determination. Compared to placebo, ranolazine resulted in a significant improvement in SAQ physical limitation and changes in the hypothesized directions for SAQ angina stability, SDS and MPRI (Table 1). Subgroup analyses showed that women with lower CFR 2.6–3.0 had significant MPRI improvement on ranolazine compared to women with CFR >3.0 (average MPRI change 0.48 vs. −0.82, respectively, p=0.04).
Conclusions: In women with angina, no obstructive CAD, and ischemia by CMR, ranolazine improves SAQ angina and may improve CMR perfusion, particularly among women with lower CFR. A larger clinical trial of ranolazine as an anti-anginal and anti-ischemia therapy in women with MCD is warranted.
- © 2010 by American Heart Association, Inc.