Ischemia – the largest ever randomized study in stable coronary artery disease. Baseline characteristics of enrolled patients in one Russian site

Abstract

Indications for coronary revascularization in patients with stable coronary heart disease (CHD), presented in the current interna- tional guidelines are largely based on the clinical trials conducted sometimes more than 30 years ago. ISCHEMIA is the major multi- center international randomized trial intended to answer the question about the optimal treatment strategy in stable coronary artery disease at the present time. Purpose. To analyze the most important baseline characteristics of patients enrolled in the ISCHEMIA study in one Russian site. Methods. The principal inclusion criteria are a positive stress test (in our center, exercise stress echocardio- graphy) of at least moderate risk and obstructive coronary heart disease confirmed by coronary computed tomography angiography (CCTA). Main exclusion criteria are a significant stenosis of the left main coronary artery by CCTA, clinical progression/destabili- zation of the ischemic heart disease, angina of IV CCS class, left ventricular ejection fraction (EF) <35%. Enrolled patients are ran- domized into the conservative or invasive treatment groups. Results. We analyzed the data of 28 randomized patients who completed at least 6 months of follow-up. Mean pts age is 62.6±5.5 years, 75% are males. The prevalence of risk factors (RFs) is the following: arterial hypertension – 93%, diabetes mellitus –29%, history of smoking – 64%, family history of CHD – 36%. 36% of pts have the his- tory of myocardial infarction; the median duration of clinical CHD is 24 months. Mean EF is 65%. 100% of patients are taking aspirin, >80% -beta blockers, >80% – ACE inhibitors/ARBs. They are at well controlled resting heart rate (<70 bpm in 82%) and blood pres- sure (<140/90 mm Hg in 82%). The level of depression by the PHQ-8 scale is 5.35±4.11 (average for chronic diseases). The lipids control and lipid-lowering therapy are inadequate: low density lipoprotein cholesterol (LDL C) is 2.55 (2.04–4.08) mmol/l, LDL C is below 1.8 mmol/l in 18%, only 33% of pts are taking a high-intensity statin. At the end of the 6-month follow-up, LDL C was 2.07 (1.79–2.53), a decrease of 19 (0.58–43.5) %, p=0.003. LDL C was <1.8 mmol/l in 28% of patients and 63% were taking a high- intensity statin. Mean angina CCS class at baseline was 1.8±0.6, 79% of patients having the 2nd CCS class. At the stress test, 78% completed the load of ≥5 METs, the median ischemic area was 4.0 (3.5–5.5) segments, in 71% the ischemia in the left anterior descen- dent artery region was provoked. The ratio of interventional to surgical revascularization in the invasive group was 1.2, indicating ana- tomically diffuse CHD in 45% of these patients. Conclusion. In ISCHEMIA pts enrolled in our center, the main RFs, except the lipid- related, were well controlled at baseline; the lipid-related RFs improved after 6 months. Ischemic symptoms were mild or moderate, but the variables of the stress test and low PCI:CABG ratio indicate the study pts are moderate or high risk pts.