CARDIOVASCULAR JOURNAL OF AFRICA • Volume 35, No 2, May – August 2024 AFRICA 103 Ethical approval was obtained from the Non-Invasive Research Ethics Committee of the Faculty of Medicine before the study (approval no. 04-11.2022). Informed consent forms were signed by all participants, and their consent to participate in the study was obtained. Demographic variables, concomitant diseases, patency rates, main blood tests for determining the pre-treatment blood levels of patients and bleeding complications (major and minor) were recorded. Each patient, whose lesion had previously been detected using computed tomographic angiography, was taken to a conventional angiography room. A 7-F sheath was placed using the Seldinger method after local anaesthesia. It was placed in the ipsilateral antegrade or retrograde position or on the contralateral limb, depending on the position of the lesion, as the intervention site. Thereafter, each lesion was passed using 0.035 hydrophilic wires (InWIRE; INVAMED, Ankara, Turkey), and in all patients, percutaneous transluminal angioplasty was applied with an appropriately sized Extender drug-eluting balloon (INVAMED, Ankara, Türkiye). Finally, an appropriately sized balloonexpandable cobalt–chromium stent was implanted in each lesion site (Myra BMS, Meril Life Sciences, Gujarat, India). Dual antiplatelet treatment was initiated for all patients after the procedure. The 71 patients were divided randomly into two groups. A single tablet containing 75 mg of ASA and 75 mg of clopidogrel (Klogel-A 75/75 mg, Neutec İlac San, Sakarya, Turkey) was prescribed to the patients in group 1 (n = 40). Meanwhile, group 2 (n = 31) received 75 mg of clopidogrel in the morning (Planor; Koçak Farma, Tekirdağ, Turkey) and 81 mg of ASA separately in the evening (Ecopirin Pro, Abdi İbrahim İlaç Sanayi ve Ticaret AŞ, İstanbul, Turkey). Our clinic’s usual procedure is to continue this dual antiplatelet treatment for at least six months. However, this period was extended to one year in the patients who participated in this study. Statistical analysis In this study, continuous data were subjected to normal distribution analysis by evaluating five parameters (mean ± standard deviation, kurtosis/skewness, Q-Q plot, histogram and Shapiro–Wilk test results). Parameters with scores of 3.5 or above were considered normally distributed and presented as means ± standard deviation, and the independent samples t-test was applied in pairwise comparisons. Parameters with scores below 3.5 in the normal distribution analysis were assumed not to be normally distributed and are presented as medians (minimum–maximum), and the Mann–Whitney U-test was applied in pairwise comparisons. In the expected and observed frequency analysis of discrete data, the chi-squared test was applied in 2 × 2 tables, while a multi-eyed chi-squared test was applied in 3 × 2 tables. In the study, α = 0.05 was accepted and p < α was evaluated as statistically significant. The SPSS 23.00 package program was used in the statistical analysis. Results There were no gender or age differences between the groups (p > 0.05). The groups were found to be similar in terms of concomitant situations (hypertension, diabetes mellitus, family history and smoking habits) and main blood parameters, except triglycerides. There were 36 (87.8%) patients in group 1 and 23 (76.7%) in group 2, for whom this was the first interventional procedure. The participants’ demographical variables are presented in Table 1. When we looked at the stent patency rates, the early patency was found to be 100% in both groups, and it was above 90% at the sixth month. When the one-year patency rates were compared, although the first group had higher rates (85.3%), no significant difference was found. A comparison of patency rates is provided in Table 2. There were 10 (24.4%) bleeding events in group 1, five (12.2%) of which occurred in the gastrointestinal system (GIS), resulting Table 1. Comparison of demographical variables between the groups Variables Group I (n = 41) Group II (n = 30) p-value* Age (years), mean ± SD 61.30 ± 9.22 61.40 ± 12.51 0.972 Gender (male), n (%) 36 (87.8) 25/80.0 0.120 0.729** Hypertension, n (%) 15 (36.5) 12/40.0 0.000 0.999** Diabetes mellitus, n (%) 15 (36.5) 12/40.0 0.000 0.999** Smoking history, n (%) 20 (48.7) 13/43.3 0.269 0.604** Family history, n (%) 17 (41.4) 9/30.0 1.232 0.267** 5 (12.8) 7/23.3 0.445 0.505** Blood tests Haemoglobin (g/dl), mean ± SD 12.87 ± 1.97 13.20 ± 1.88 0.511 Platelets (10-3/μl), mean ± SD 255.93 ± 72.14 259.13 ± 58.62 0.851 Main corpuscular volume (fl), mean (median) 87.90 (71.70–102.90) 86.75 (32.80–97.50) 0.584 Main platelet volume (fl), mean (median) 8.60 (6.70–14.50) 8.30 (6.90–11.70) 0.329 Platelet distribution width (fl), mean (median) 16.70 (15.70–19.30) 16.50 (15.40–18.70) 0.168 Creatinine (mg/dl), mean (median) 1.05 (0.50–3.20) 0.90 (0.60–7.70) 0.121 Low-density lipoprotein cholesterol, mg/dl, (mean ± SD) 132.27 ± 43.27 136.65 ± 46.68 0.720 High-density lipoprotein cholesterol (mg/dl), mean ± SD 35.31 ± 7.94 38.50 ± 8.58 0.238 Triglycerides (mg/dl), mean (median) 135 (84–679) 103 (51–317) 0.017 *p < 0.05 is statistically significant, **Chi-squared test (Yates). SD, standard deviation. Table 2. Comparison of follow-up findings between the two groups Follow up Group I (n = 41) Group II (n = 30) p-value* One-month patency, n (%) 41 (100) 30 (100) 0.000 1.000** Six-month patency, n (%) 39 (95.6) 29 (96.6) 0.0019 0.892** One-year patency, n (%) 35 (85.3) 24 (80.0) 0.120 0.729** Total bleeding complaints, n (%) 10 (24.4) 2 (6.7) 4.32 Minor bleeding (ecchymosis, bruising) 5/12.2 0/0 0.038$ Major GIS bleeding (leading to reduced haemoglobin levels) 5/12.2 2/6.7 0.237# *p < 0.05 is significant, **Chi-squared test (Yates), $Pearson’s test, #Fisher’s exact test. GIS, gastrointestinal system.
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