RANOLAZINE FOR SYMPTOMATIC MANAGEMENT OF MICROVASCULAR ANGINA IN A CANADIAN SPECIAL ACCESS PROGRAM

Abstract

Ranolazine is currently approved in the United States and Europe as a second-line agent for chronic stable angina but is available in Canada only through special access (SA). Microvascular angina (MVA) is defined as angina with no obstructive coronary artery disease (< 50% stenosis of a major epicardial artery) and is secondary to impaired vasodilation of arterioles leading to inadequate blood flow. Treatment of MVA consists of standard anti-anginal medications and risk factor management; however, 20-30% of patients remain symptomatic. Our objective was to assess the effectiveness of ranolazine at improving angina scores and quality of life (QOL) in Canadian patients with severe refractory angina due to MVA. We administered questionnaires consisting of the Seattle Angina Questionnaire (SAQ) and the Quality of Life Enjoyment and Satisfaction Questionnaire – Short Form (Q-LES-Q-SF) at baseline and after at least 6 weeks of ranolazine treatment in 31 patients with refractory angina secondary to MVA in the SA program. Refractory angina was defined as Canadian Cardiovascular Society (CCS) >3 angina after at least 2 anti-anginal medication trials. Validated, clinically significant changes for each SAQ domain were obtained from the literature and a Wilcoxon rank test was performed to test the change in scores between baseline and post-ranolazine use. Patients in our cohort were mostly female (27/31 patients) with a median age of 57. At baseline, 48.4% of the patients were on 3 anti-anginal medications. The median length of time on ranolazine at the time of the post-ranolazine questionnaires was 17 weeks. After initiation of ranolazine treatment, patients experienced a significant clinical improvement in Q-LES-Q-SF and in three of the four selected domains of the SAQ except for angina frequency (Table). 73.3% of patients reported improvement in physical limitation (P < 0.001), 80.6% of patients reported improved treatment satisfaction (P < 0.001), 77.4% of patients reported improved disease perception (P = 0.002) and 80.6% of patients had improved Q-LES-Q-SF scores (P < 0.001) compared to baseline. The Figure depicts the average change, as well as each patient’s experience on ranolazine, in three domains of the SAQ. Ranolazine obtained by a SA program in Canada significantly improves symptom control and QOL in patients with MVA and severe refractory angina after at least 6 weeks of use. Given the potentially debilitating effect of chronic angina in MVA, ranolazine is an effective treatment option.View Large Image Figure ViewerDownload Hi-res image Download (PPT)