Browsing by Author "Stajic, Zoran (24170215000)"

Objective: We aimed to create a clinically usable probability risk score for prediction of no-reflow (NRF) phenomenon prior to primary percutaneous coronary intervention (PPCI). Patients and Methods: This single-center and retrospective study included 1254 patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent PPCI. Patients were randomly assigned into two groups in the ratio 2:1, the derivation dataset (n=840) and validation dataset (n=414). Independent predictors of NRF were identified and combined to create a prediction model using univariate and multivariate regression analysis in the derivation dataset. The risk score was tested and validated by calculating area under the receiver operating characteristic (ROC) curves in the derivation and validation datasets, respectively. Results: Five significant, independent predictors of NRF were identified: Age ≥ 65 years (odds ratio [OR]: 2.473, 95% confidence interval [CI]: 0.389-1.484, p < 0.01), heart rate ≥ 89 bpm (odds ratio [OR]: 1.622, 95% confidence interval [CI]: 0.024-0.945, p < 0.05), Killip class ≥ II (odds ratio [OR]: 1.914, 95% confidence interval [CI]: 0.024-1.306, p < 0.01), total ischemic time ≥ 268 min (odds ratio [OR]: 2.652, 95% confidence interval [CI]: 0.493-1.565, p < 0.01), and thrombus burden G≥4 (odds ratio [OR]: 8.351, 95% confidence interval [CI]: 0.344-15.901, p < 0.01). The risk score was created combining these predictors with assigned points. The overall score ranged from 0 to 17 points. The optimal cutoff value of the risk score was 11 points (area under curve [AUC]: 0.772, 95% confidence interval [CI]: 0.729-0.815, sensitivity 71.21%, specificity 70.34%, positive predictive value 30.92%, negative predictive value 92.91%, p < 0.001). The ROC curve for the validation group showed good discriminant power. Conclusions: We developed a novel risk score based on five clinical and angiographic parameters, which might be a useful clinical tool for prediction of NRF in STEMI patients prior to PPCI with an acceptable accuracy. © 2022 Verduci Editore s.r.l. All rights reserved.

This prospective, first-in-man, open-label multicenter study sought to assess the pharmacokinetics of sirolimus after Ultimaster drug-eluting stent implantation (coated with sirolimus and bioabsorbable co-polymer) in patients with de novo coronary artery disease (the TCD-10023 PK study). The primary endpoint was sirolimus concentration in peripheral whole blood at 28 days after stent implantation. In addition, safety, tolerability, therapeutic outcome and vasomotor response after stent implantation were studied. Twenty patients were enrolled in the study. Blood samples for the measurements of sirolimus concentration were collected at eight time points during first 48 h, at 7 days and 28 days after stent implantation. Patients underwent 6-month angiographic and up to 12 months clinical follow-up. At 28 days, only two of 20 patients had sirolimus concentrations above lower limit of quantification (20.0 pg/mL). The highest sirolimus blood concentration was 105 pg/mL. The median maximum concentration was 36.8 pg/mL (range 22.9-41.5 pg/mL) for stent 3.0 × 15 mm and 87.2 pg/mL (range 60.0-105.0 pg/mL) for 3 × 28 mm stent. The median systemic exposure, as measured by the area under the time-concentration curve, was 8.3 ng h/mL (range 6.47-28.0 ng h/mL). At 6 months, endothelial function was well preserved, and up to 12 months, there were no signs of sirolimus toxicity nor any other safety concerns. Our results demonstrate that implantation of Ultimaster stent resulted in almost nondetectable sirolimus in blood after 28 days. These findings were translated into exceptional safety profile, without any sign of systemic toxicity. © 2014 Société Française de Pharmacologie et de Thérapeutique.

This prospective, first-in-man, open-label multicenter study sought to assess the pharmacokinetics of sirolimus after Ultimaster drug-eluting stent implantation (coated with sirolimus and bioabsorbable co-polymer) in patients with de novo coronary artery disease (the TCD-10023 PK study). The primary endpoint was sirolimus concentration in peripheral whole blood at 28 days after stent implantation. In addition, safety, tolerability, therapeutic outcome and vasomotor response after stent implantation were studied. Twenty patients were enrolled in the study. Blood samples for the measurements of sirolimus concentration were collected at eight time points during first 48 h, at 7 days and 28 days after stent implantation. Patients underwent 6-month angiographic and up to 12 months clinical follow-up. At 28 days, only two of 20 patients had sirolimus concentrations above lower limit of quantification (20.0 pg/mL). The highest sirolimus blood concentration was 105 pg/mL. The median maximum concentration was 36.8 pg/mL (range 22.9-41.5 pg/mL) for stent 3.0 × 15 mm and 87.2 pg/mL (range 60.0-105.0 pg/mL) for 3 × 28 mm stent. The median systemic exposure, as measured by the area under the time-concentration curve, was 8.3 ng h/mL (range 6.47-28.0 ng h/mL). At 6 months, endothelial function was well preserved, and up to 12 months, there were no signs of sirolimus toxicity nor any other safety concerns. Our results demonstrate that implantation of Ultimaster stent resulted in almost nondetectable sirolimus in blood after 28 days. These findings were translated into exceptional safety profile, without any sign of systemic toxicity. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Introduction: P-wave abnormalities on the resting electrocardiogram have been associated with cardiovascular or pulmonary disease. So far, "Gothic" P wave and verticalization of the frontal plane axis is related to lung disease, particularly obstructive lung disease. Aim: We tested if inverted P wave in AVl as a lone criteria of P wave axis >70o could be screening tool for emphysema. Material and method: 1095 routine electrocardiograms (ECGs) were reviewed which yielded 478 (82,1%) ECGs with vertical P-axis in sinus rhythm. Charts were reviewed for the diagnosis of COPD and emphysema based on medical history and pulmonary function tests. Conclusion: Electrocardiogram is very effective screening tool not only in cardiovascular field but in chronic obstructive pulmonary disease. The verticality of the P axis is usually immediately apparent, making electrocardiogram rapid screening test for emphysema. © AVICENA 2013.