EFFECT OF NICORANDIL IN PATIENTS WITH REFRACTORY ANGINA AND ADVANCED CORONARY ARTERY DISEASE

BACKGROUND: Refractory angina (RFA) is a chronic morbid condition hampering the quality of life of thousands of Canadians and effective therapies are desperately needed. Nicorandil is a nicotinamide vasodilator with cardioprotective effects that has been shown to improve cardiac outcomes in patients with stable coronary artery disease (CAD). Nicorandil has never been studied in patients with refractory angina. METHODS: We investigated the safety and efficacy of nicorandil in patients with advanced coronary artery disease unsuitable for revascularization and persistent angina (CCS Class II to IV) despite maximal tolerable doses of two anti-angina agents, and compared it with similar control patients not exposed to nicorandil. Consecutive patients were selected from our RFA clinic from August 2009 to August 2013 and followed-up for at least 6 months. Nicorandil was available via the Health Canada’s special access program, and a pharmacist dedicated to the program monitored observance to nicorandil and the occurrence of drug-related adverse effects. We assessed the association between nicorandil and cardiovascular outcomes (1 endpoint) and CCS angina class (2 endpoint) in patients with RFA. RESULTS: Forty patients treated with maximum orally tolerated dose ofNicorandil (up to 30mg three times daily)were compared to 38 control patients (total n1⁄4 78). Baseline characteristics and cardiovascular status were similar in both groups as shown in Table 1. Over a median follow-up of 15 months, fewer patients treated with nicorandil experienced the combined occurrence of death or heart transplant + acute coronary syndrome + coronary revascularization + hospitalization rates at 1-year for angina compared to control patients (37.5% vs. 71.1%, p < 0.05). Nicorandil was associated with a significant improvement in the functional status, as shown in the figure.