BACKGROUND Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. METHODS This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. FINDINGS Between March 12, 2013, and May 10, 2016, we ; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). INTERPRETATION Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. FUNDING Bayer AG. Methods This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, i...

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Aim: to identify the patterns of coronary heart disease (CHD) clinical course and life quality of patients with comorbid depressive disorders (DD).Patients and Methods: an open-label clinical controlled study was conducted using a parallel comparison method. 93 patients with CHD (angina pectoris of the functional class II–III) were examined, 59 of them had DD (group 1), and 34 had no DD (group 2). The presence and level of depression, anxiety, and social adaptation were assessed using Hospital Anxiety and Depression Scale (HADS), Beck Depression Inventory (BDI), Sheehan Anxiety Rating Scale (ShARS), social adaptation (Bosc), exercise tolerance (6-minute walk test, bicycle ergometry), and heart rate variability (HRV) during Holter monitoring.Results: patients with DD versus patients without DD showed the following indications: increased levels of depression (HADS — 8.8±2.4 points vs. 4.8±1.9 points, p=0.000001; BDI — 21.2±4.4 points vs. 16.0±5.1 points, p=0.0000003) and anxiety (HADS — 9±3.2 points vs. 5.5±2.8 points, p=0.000002; ShARS — 37.3±19.2 points vs. 22.1±2.8 points, p=0.0006); a lower level of social functioning (Bosc — 33.4±6.4 points vs. 36.5±6.6 points, p=0.03); a greater number of anginal episodes (8 [6; 12] vs. 6 [4; 7], p=0.0005) and a greater need for nitroglycerin during the week (3.6±4.8 tablets vs. 1.6±2.3 tablets, p=0.0005); reduced exercise tolerance (according to bicycle ergometry — 52.8±26.8 W vs. 69±30.4 W, p=0.03; 6-minute walk test — 375.7±128.9 m vs. 410±100.3 m, p=0.09), HRV parameters reduction: pNN50% (5.2±4.8 vs. 8.8±7.5, p=0.03), SDANN (81.3±22.4 ms vs. 91±16.9 ms, p=0.04), SDNNindx (46 [36; 56] ms vs. 55 [48; 66] ms, p=0.005), rMSSD (29 [23; 38] ms vs. 33 [29; 41] ms, p=0.04), SDNN (98.2±24.7 MS vs. 112±20 MS, p=0.01).Conclusion: patients with CHD in combination with DD were characterized by an increased level of anxiety, a lower life quality, and a worsening of the coronary disease clinical course, which requires timely diagnosis and correction of mental disorders.KEYWORDS: depressive disorders, heart rate variability, coronary heart disease, myocardial infarction, life quality, angina of effort.FOR CITATION: Nonka T.G., Lebedeva E.V., Repin A.N. Clinical picture patterns of coronary heart disease and the life quality of patients with depressive disorders. Russian Medical Inquiry. 2020;4(7):412–417. DOI: 10.32364/2587-6821-2020-4-7-412-417.

The prevalence of depressive disorders at the population level is from 2,5 to 10% among patients with coronary heart disease - 20%. The presence of depressive disorders in patients with coronary artery disease leads to hypersympathicotonia decrease vagal activity, endothelial dysfunction and blood coagulation system, weighing down the disease. The most significant theories of pathophysiological mechanism of increased mortality in patients with cardiovascular disease in combination with mood disorders are increased thrombus formation and disturbance of the autonomic regulation of heart rhythm.

Objective: Comparison of anxiety and depressive disorders (ADD) among persons with chronic CHD. Material and methods: Patients (n=301) with chronic CHD were: men 73% and women 27%. Age of women was 64,1±9.9 years; men: 57.5±9.9 years (p=0,0000001). We used HADS, social adaptation and self-evaluation scales, and lipid range of blood. When anxiety and depression were more than 8 (HADS), diagnosis was verified by a psychiatrist (ICD-10). Results: In patients with CHD, anxiety (HADS) was 49.6%, and depression-41.6%. Intensity of ADD among women was higher, than among men: anxiety level (HADS) was 9.3±4.1 and 6.9±3.6 respectively (p=0,00005) and depression-8.4±3.4 and 6.6±3.2 (p=0,00009). Average score (social adaptation) was 34.9±7.2. Frequency of ADD among inpatients with CHD was 42.6% (n=130). Psychiatric diagnosis was: adaptation disorders 36.9% (n=48), depressive episode 20% (n=26), recursive depression 2.3% (n=3), bipolar disorder 1% (n=2), dysthymia 28.5% (n=37), organic anxiety disorder 4.6% (n=6), organic mood disorder 6.2% (n=8). Women displayed more ADD than men: 40% (n=32) vs. 22% (n=49) (p=0,05). Atypical depression was more often. Melancholic depression was less characteristic. Women displayed a higher total cholesterol than men: 6.4±1.28 mmol/l and 5.4±1.3 mmol/l respectively (p=0,0000013) and low-density lipoprotein: 4.4±1.11 mmol/l and 3.4±1.1 mmol/l (p=0,0007, respectively). 42.6% (n=130) of patients received medical correction of ADD. 97% of patients with chronic CHD on antidepressants, had stable rates of cardiovascular system. Conclusion: We need integrated inter-institutional rehabilitation programs for patients with cardiovascular diseases and anxiety and depressive disorders taking into account their gender features.