RESUMO
BACKGROUND: Venoactive drugs (VADs) based on Vitis vinifera extract are widely used in Korea. However, studies on the clinical effects and head-to-head comparisons with other groups of VADs are limited. This trial aimed to evaluate whether Vitis vinifera seed extract was noninferior to the micronized purified flavonoid fraction (MPFF) in relieving venous symptoms and improving quality of life in patients with chronic venous disease. METHODS: In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8 weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8 weeks from baseline. Moreover, the change in leg circumferences was measured at 8 weeks and compared to baseline. RESULTS: In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n = 154) or MPFF (n = 149). The CIVIQ-20 scores at 8 weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8 weeks from baseline was observed (-8.31 ± 14.63 vs. -10.35 ± 14.38, P = 0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8 weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8 weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract. CONCLUSIONS: Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.
RESUMO
BACKGROUND: Although obese patients seem to be susceptible to chronic diseases, obesity paradox has been observed in the field of vascular surgery, in which many previous studies have reported that overweight patients have good postoperative outcomes and underweight patients have poor postoperative outcomes. The purpose of our study is to evaluate the impact of body mass index (BMI) and serum albumin levels, which are evaluated as indicators of nutritional status, on outcomes of open abdominal aortic aneurysm (AAA) repair. METHODS: We reviewed the vascular surgery database of a single tertiary referral center for all patients who underwent open AAA repair due to degenerative etiology from 1996 to 2021. To analyze the effect of BMI, patients were classified into 4 groups according to the Asian-Pacific classification of BMI: underweight (UW) (<18.5 kg/m2), normal weight (NW) (18.5-22.9 kg/m2), overweight (OW) (23-24.9 kg/m2), and obese (OB) (≥25 kg/m2). The χ2, Fisher's exact, and Kruskal-Wallis tests were used to compare demographics, comorbidities, radiologic findings, surgical details, and 1-year mortality rates between the 4 groups. We also compared the preoperative serum albumin levels of each group to assess nutritional status indirectly. Cox's proportional hazards model was performed to determine factors associated with mortality. A Kaplan-Meier survival analysis was performed, and the differences were analyzed by a log-rank test. We did not perform an analysis for 30-day mortality because cases of 30-day mortality in UW patients were rare due to the unbalanced distribution of the number of patients in the 4 groups. RESULTS: Among a total of 678 patients, 22 were classified as UW (3.2%), 200 as NW (29.5%), 183 as OW (27.1%), and 273 as OB (40.1%). The median age was 70 (64-75) years and 577 of 678 (85.1%) patients were male gender. Higher serum albumin level was associated with decreased 1-year mortality (hazard ratio [HR], 0.3; 95% confidence interval [CI], 0.15-0.63; P = 0.001). UW patients had a higher 1-year mortality rate than NW patients (HR, 3.67; 95% CI, 1.02-13.18; P = 0.046). OB patients had a lower overall mortality rate than NW patients (HR, 0.73; 95% CI, 0.53-1; P = 0.05). CONCLUSIONS: Low BMI (<18.5 kg/m2) and low serum albumin level were associated with poor 1-year survival after elective open AAA repair. These patients also need more careful preoperative intervention, like weight gain or nutritional support, for better outcomes. The obesity paradox existed in our study; high BMI (≥25 kg/m2) was associated with better overall survival after elective open AAA repair.