Characteristics of the basal psychoautonomous indicators in patients after coronary artery stent placement at various stages of rehabilitation

Background: Clinically significant psychoautonomous syndrome, along with other modifiable factors (obesity, dyslipidemia, low physical activity, smoking, arterial hypertension, etc.) increases the risk of development and progression of coronary artery disease (CAD). In particular, patients who have undergone coronary interventions and have a higher anxiety level are prone to the development of CAD complications. Aim: To characterize the basal parameters of clinically significant psychoautonomous syndrome and their changes over time under combination therapy, including anxiolytics, at various stages of rehabilitation of the patients after endovascular myocardial revascularization. Materials and methods: This open-label randomized controlled prospective study included 60 patients aged 45 to 75 years admitted to our in-patient department for rehabilitation treatment after coronary stent placement. The patients from the intervention group (n = 30), in addition to basic treatment for CAD, were administered anxiolytic therapy (alimemazine tartrate at daily dose of 12.5 to 25 mg i. m. at the early rehabilitation step and at 5 to 10 mg during their out-patient follow-up). The in-patient study period included 3 study visits (at admittance, i. e., Day 1, at Days 5 or 6, and at discharge at Day 10 to 14). Two further study visits were performed during the out-patient rehabilitation period at Days 30 and 60. At each visit, the emotional state, sleep quality, subjective signs of autonomous dysregulation, autonomous background and suprasegmental vegetative regulation, including temporal and spectral indicators of heart rate variability, were evaluated. Results: After endovascular myocardial revascularization (the in-patient study period, Day 1) patients of the intervention and control groups (n = 30 in both groups) demonstrated comparable moderate levels of state anxiety (median [Q1; Q3]: 42 [40; 46] and 42 [36; 43], respectively) and trait anxiety (45 [41; 48] and 42 [40; 46], associated with insomnia (PSQI score: 8 [6; 12] and 6 [3; 9]) and autonomous imbalance (SDNN: 73 [61; 89] and 70 [44; 95]) with a shift to sympathetic hyperactivity. Addition of an anxiolytic initiated the regression of psychoautonomous abnormalities already by the end of the early in-patient rehabilitation period) (Days 10 to 14), with a subsequent decrease in state anxiety to 36 [33; 39] and trait anxiety to 33 [32; 37] (p 0.001), regression of insomnia according to PSQI to 2 [2; 4] (p 0.001), and an improvement of autonomous balance (SDNN) to 113 [81; 132] (p 0.001) at days 45 to 60 of the outpatient follow-up. The only adverse event in the patients receiving the treatment for psychoautonomous dysfunction was increased sleepiness at daytime, which was registered in most of them at initiation of the therapy for 2 to 3 days and did not require any dose modification. There were no other clinically significant adverse events, including cardiovascular. Conclusion: Patients with an increased level of anxiety after endovascular myocardial revascularization are characterized by an autonomous imbalance with sympathetic hyperactivity. Addition of an anxiolytic to the basic treatment for CAD allows for a reduction of both components of the psychoautonomous syndrome, which may be an additional factor for successful patient rehabilitation and as a consequence for the prevention of CAD progression.