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Patients experiencing chronic and disabling stable angina despite conventional forms of treatment represent a significant, rapidly growing, and “no option” patient population. “Refractory Angina” is the term used to describe these patients, and is characterized by myocardial ischemia and chronic, disabling stable angina despite conventional forms of treatment. Patients with refractory angina are no longer responsive to optimal medical therapy for angina (treatment with at least two classes of drug at maximally tolerated doses), and are not candidates for, and would receive no prophylactic therapeutic benefit from percutaneous coronary intervention (PCI), involving the use of balloon catheter angioplasty and stents, or coronary artery bypass graft surgery (CABG).
Patients suffering from Refractory Angina often avoid physical activity in order to avoid angina symptoms, resulting in an increasingly sedentary lifestyle which may promote further declines in functional capacity and quality of life. It is estimated that over 80% will make lifestyle changes to adapt to their angina, and compared to the general population, patients with refractory angina report higher rates of depression, loss of vitality, diminished physical function and overall health, and a reduced quality of life.
It is estimated that approximately 12% of patients with angina due to coronary artery disease have refractory angina. Available estimates suggest that refractory angina affects up to 1.8 million people in the U.S. It is anticipated that the incidence and prevalence of refractory angina will continue to increase as populations age and mortality from coronary heart disease decreases.