ABSTRACT
The aim of this study was to analyze the incidence and anamnestic characteristics of frail patients with stable coronary artery disease (CAD) and to evaluate the role of frailty in the development of complications and adverse outcomes in the perioperative period and early survival period after coronary artery bypass grafting (CABG). MATERIAL AND METHODS: The study included 387 patients admitted to the clinic for a scheduled primary CABG. A seven-item questionnaire, "PRISMA-7", was used to identify frail elderly patients before the procedure. We divided the study sample into two groups, taking into account the results of the survey: patients without frailty, n0 = 300 (77.5%), and patients with frailty, n1 = 87 (22.5%). The anamnestic and laboratory data, outcome of the surgical intervention, perioperative and early complications, and adverse outcomes were analyzed. RESULTS: We detected frailty in 22.5% of the patients with CAD before the procedure. According to the anamnestic data and paraclinical and intraoperative findings, the groups of patients with and without frailty were comparable. The differences were revealed in the intraoperative and early postoperative periods of CABG. Thus, postoperative rhythm disturbances (19.5% vs. 10.5%, p = 0.025, V = 0.115, respectively) and transient ischemic attacks/stroke (5.7% vs. 1.3%, p = 0.031, V = 0.122, respectively) occurred significantly more often among the frail patients. There were no significant differences between the groups in the frequency of other intraoperative and early postoperative complications. In the group of frail patients, four fatal outcomes due to early postoperative ischemia were recorded, and among patients without frailty, one fatal outcome was recorded (4.5% vs. 0.3%, p = 0.010, V = 0.156, respectively). At the 1-year follow-up visit, the presence of frailty in history served as a predictor of mortality (11.5% vs. 0.6%, p Ë 0.001, V = 0.290, respectively). CONCLUSION: The presence of frailty can be used as an independent predictor of an unfavorable prognosis in patients with CAD, both in the perioperative and early survival period after CABG. It should be taken into account during surgical risk assessment.
ABSTRACT
BACKGROUND: Many patients who recovered from COVID are still suffering from pulmonary dysfunction that can be persistent even for months after infection. Therefore, treatment to prevent irreversible impairment of lung function is needed. Treamid (bisamide derivative of dicarboxylic acid, BDDA) was shown to have anti-inflammatory and antifibrotic effects in animal models of pulmonary fibrosis. This study was designed to assess the safety, tolerability, and efficacy of Treamid in the rehabilitation of patients after COVID pneumonia. The aim was to establish whether Treamid could be effective in ameliorating post-COVID sequelae. METHODS: The phase 2, randomized, double-blind, placebo-controlled clinical trial was done at 8 medical centers in Russia. Patients with a diagnosis of COVID in the past medical history (with the first symptoms of COVID appear no earlier than 2 months before screening) and having fibrotic changes in the lungs, decreased lung function (percentage of predicted FVC and/or DLCO < 80%), and moderate or severe dyspnea according to mMRC scale were enrolled and randomly assigned in a 1:1 ratio (stratified by the initial degree of lung damage, age, and concomitant chronic diseases) by use of interactive responsive technology to peroral administration of Treamid 50 mg or placebo once a day for 4 weeks. The primary outcome was the proportion of patients who achieved clinically significant improvement in FVC and/or DLCO (defined as a relative increase in FVC of ≥ 10% or a relative increase in FVC in the range of ≥ 5 to < 10% plus a relative increase in DLCO of ≥ 15%) at week 4 compared with baseline. Secondary endpoints included changes from baseline in dyspnea scoring evaluated by the modified Borg and mMRC scales, pulmonary function (FEV1, FVC, FEV1/FVC ratio, DLCO, TLC, FRC), 6-min walk distance, the overall score of the KBILD questionnaire, and the proportion of patients with a reduction in the degree of lung damage assessed by CT scores. This trial was registered on ClinicalTrials.gov (Identifier: NCT04527354). The study was fully funded by PHARMENTERPRISES LLC. RESULTS: 12 out of 29 patients (41%) in Treamid group achieved clinically significant improvement in FVC and/or DLCO compared to 5 out of 30 patients (17%) in placebo group (p = 0.036). There was a significant decrease of dyspnea according to modified Borg scale observed in the Treamid group (- 0.9 ± 0.7 vs. - 0.4 ± 0.8, p = 0.018). No significant differences in the adverse events were noted. Exploratory analysis of the female population indicated superiority of Treamid over placebo by decreasing dyspnea and the extent of lung damage as well as increasing TLC. CONCLUSIONS: 4 weeks oral administration of 50 mg Treamid was associated with clinically significant improvement in the post-COVID patients, evident by an increase in FVC and/or DLCO as well as decreasing dyspnea. Treamid was well tolerated and can be safely administered to patients discharged after COVID. Treamid was more effective in women visible by superior improvement of COVID sequalae after 4 weeks treatment. Considering that female gender is a risk factor associated with the development of post-COVID symptoms, Treamid might offer a pharmacological treatment for long-term sequalae after COVID and supports further investigation in future clinical trials in post-COVID patients.
