Browsing by Author "Hamilos, Michalis (23974406600)"

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.

Background: A considerable number of symptomatic patients leave the cardiac catheterization lab without a definitive diagnosis for their symptoms because no epicardial stenoses are found. The significance of disorders of coronary microvasculature and vasomotion as the cause of symptoms and signs of ischemia has only recently been appreciated. Today we have a wide spectrum of invasive coronary physiology tools but little is known about when and how these tools are used in clinical practice. Study design and methodology: SoutheAsTern eUrope microciRculATION (SATURATION) registry will study the regional practice of patient selection for coronary function testing, indications, non-invasive ischemia testing, medications, procedural aspects of invasive physiology evaluation, and treatment changes after testing. The registry is expected to include 1600 patients in participating centers in Southeastern Europe from 2024 to 2029, using the thermodilution technique for evaluation of microcirculation. Major adverse cardiovascular events as well as patient-centered outcomes such as burden of angina and quality of life using Seattle Angina Questionnaire (SAQ) and EQ-5D-5L will be recorded. The study will include patients with different stages of coronary artery disease (presence of disease or degree of stenosis) to elucidate the effect of coronary microcirculation on the outcomes in this broad group. Conclusion: The registry will provide information regarding the current practice of invasive coronary physiology assessment in populations at high cardiovascular risk in Southeastern Europe. This could lead to a better understanding of coronary microvascular dysfunction and its relationship to various degrees of coronary atherosclerosis together with potential interventions that can be beneficial. © 2024