A narrative overview: Have clinical trials of PCI vs medical therapy addressed the right question?
In RCTs about revascularization, the terms "coronary artery disease" and "ischemic heart disease" are sometimes used interchangeably. This can create confusion concerning inclusion and exclusion criteria, which may lead to uncertain results. Our purpose is to investigate whether the study populations in randomized controlled trials (RCTs) which compared percutaneous coronary revascularization to medical therapy for stable ischemic heart disease specifically enrolled patients with demonstrable ischemia, and how many patients were included in trials with evidence of coronary atherosclerosis but without evidence of ischemia. Trial published data were obtained from ACME I, ACME II, RITA I, RITA II, MASS I, MASS II, AVERT, ACIP, COURAGE and FAME2. Published data were used to calculate the number of patients included in the trials with a negative stress test but significant coronary artery stenosis and the number of patients excluded from the trials with a positive stress test or angina, but without significant coronary artery stenosis at the time of angiography. A total of 196,433 patients were screened between 1998 and 2011. Overall about 30% of patients were excluded if they did not meet the angiographic criteria, even though the presence of inducible ischemia or angina, and, about 20% of patients were included without inducible ischemia. RCTs have contributed to the confusion between coronary artery disease and ischemic heart disease. This may limit the ability to interpret the results and apply them in practice.