Browsing by Author "Nikolajevic, Ivica (55025577100)"

Aim: As a result of a higher prevalence of comorbidities, elderly adults are often underrepresented in clinical trials, and more often experience complications during percutaneous coronary intervention. Our aim was to evaluate clinical outcomes of patients older than 80 years, compared with their younger counterparts, when bioresorbable polymer biolimus A9 drug-eluting stent is used for their treatment. Methods: The prospective, observational e-Nobori registry was created to validate the safety and efficacy of bioresorbable polymer drug-eluting stent in unselected patients. The primary end-point of the study was freedom from target lesion failure defined as a composite of cardiac death, target vessel-related myocardial infarction and clinically-driven target lesion revascularization at 1 year. Results: There were 781 (7.8%) octogenarians, they were less frequently male (62% vs 77%; P < 0.0001) and more often presented as acute coronary syndrome (44% vs 39%; P = 0.0182). The index percutaneous coronary intervention success was lower in the elderly patients (98% vs 99%; P = 0.0398). One-year follow up was completed for 97% of the elderly patients and 99% of the younger patients. The difference in target lesion failure (3.33% vs 2.83%; log–rank P = 0.0114) was mainly driven by increased mortality in octogenarians (3.73% vs 1.47%; P < 0.0001). Elderly patients had more bleeding and vascular complications (2.67% vs 1.05%; P = 0.0001). Conclusions: Despite advanced age, multiple comorbidities and complexity of treated lesions, clinical outcomes are favorable in octogenarians treated by bioresorbable polymer biolimus A9 drug-eluting stent. Geriatr Gerontol Int 2016; 16: 1246–1253. © 2015 Japan Geriatrics Society

Aim: As a result of a higher prevalence of comorbidities, elderly adults are often underrepresented in clinical trials, and more often experience complications during percutaneous coronary intervention. Our aim was to evaluate clinical outcomes of patients older than 80 years, compared with their younger counterparts, when bioresorbable polymer biolimus A9 drug-eluting stent is used for their treatment. Methods: The prospective, observational e-Nobori registry was created to validate the safety and efficacy of bioresorbable polymer drug-eluting stent in unselected patients. The primary end-point of the study was freedom from target lesion failure defined as a composite of cardiac death, target vessel-related myocardial infarction and clinically-driven target lesion revascularization at 1 year. Results: There were 781 (7.8%) octogenarians, they were less frequently male (62% vs 77%; P < 0.0001) and more often presented as acute coronary syndrome (44% vs 39%; P = 0.0182). The index percutaneous coronary intervention success was lower in the elderly patients (98% vs 99%; P = 0.0398). One-year follow up was completed for 97% of the elderly patients and 99% of the younger patients. The difference in target lesion failure (3.33% vs 2.83%; log–rank P = 0.0114) was mainly driven by increased mortality in octogenarians (3.73% vs 1.47%; P < 0.0001). Elderly patients had more bleeding and vascular complications (2.67% vs 1.05%; P = 0.0001). Conclusions: Despite advanced age, multiple comorbidities and complexity of treated lesions, clinical outcomes are favorable in octogenarians treated by bioresorbable polymer biolimus A9 drug-eluting stent. Geriatr Gerontol Int 2016; 16: 1246–1253. © 2015 Japan Geriatrics Society

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.