Clinical Implications of Nicorandil Combined with Trimetazidine in Patients with Coronary Heart Disease: A Real-World Observational Study.

ABSTRACT

INTRODUCTION: Coronary heart disease (CHD) remains the leading cause of mortality in China. The treatment strategies, especially for patients with ischemic angina pectoris, are still far from satisfactory. Hence, this study was carried out to evaluate the long-term potential of nicorandil in Chinese patients with CHD. METHODS: Adult patients with CHD were reviewed retrospectively from three hospitals in Central China to obtain relevant data. The primary outcome was the rate of major adverse cardiovascular events (MACE) which is the composite outcome of stroke, myocardial infarction (MI), and mortality at 3 years while the secondary outcomes included rates of MACE, stroke, MI, and mortality at 1 and 2 years. The rates of MACE were estimated using Kaplan-Meir survival curves and compared by log-rank test. The association between various treatment regimens and hazards of MACE was estimated using Cox proportional hazards model. All analyses were carried out using SAS 9.4. RESULTS: A total of 5504, 1674, and 3923 patients treated with the nicorandil-trimetazidine combination, nicorandil, and trimetazidine were included in the study, respectively. At 3-year follow-up, the rate of MACE [hazard ratio (HR) 0.85; 95% CI 0.74-0.97; P = 0.017] and stroke (HR 0.58, 95% CI 0.48-0.71; P < 0.0001) was lower in the combination group compared to trimetazidine group. Similarly, the rate of stroke was significantly lower (HR 0.69; 95% CI 0.52-0.93; P = 0.0146) at 3 years in the nicorandil group compared to the trimetazidine group. The rate of stroke (HR 0.65; 95% CI 0.52-0.83; P = 0.0004) was significantly lower among the combination group compared with the trimetazidine group at 1-year follow-up. Similarly, the rate of stroke was significantly lower at 1 year (HR 0.70; 95% CI 0.50-0.97; P = 0.03) but not at 2 years (HR 0.70; 95% CI 0.52-0.94; P = 0.0177), while the rate of other outcomes, though lower in the nicorandil group than the trimetazidine group, was not statistically significant at 1 and 2 years respectively. CONCLUSION: Nicorandil in combination with trimetazidine can be considered as an effective and potential treatment strategy in reducing the rate of MACE in patients with CHD in the Chinese population.