Long-term results of using domestic drug-eluting stent in patients with acute coronary syndrome [Отдаленные результаты применения стента с лекарственным покрытием отечественного производства при остром коронарном синдроме]

Aim. To study long-term results of sirolimus-eluting stent “Calypso” in patients with acute coronary syndrome. Methods. The study includes 274 patients with acute coronary syndrome who underwent percutaneous coronary revascularization with implantation either sirolimus-eluting stent “Calypso” (Angioline, Russia), n = 140, or everolimus-eluting stent “Xience Prime” (AbbottVascular, USA), n = 134. Their status was monitored by phone up to a 36-month's period. Patients who were diagnosed with or suspected of having myocardial ischemia underwent coronary angiography. Primary safety parameter major adverse cardiac events (MACE) was assessed as a composite of all-cause death, nonfatal myocardial infarction, and clinically indicated coronary revascularization. Efficacy analysis was performed as an incidence of repeat coronary angiography due to coronary artery disease progression or new ischemic events occurrence and the incidence of restenosis, defined as >50% lumen diameter reduction of previously stented target lesion. The incidence of late stent thrombosis was also assessed. Results. Major adverse cardiac events were observed in 13.6% of patients in “Calypso” group and in 14.2% of patients in “Xience Prime” group (р = 0.999; RR 0.96 [0.53; 1.72]). Coronary angiography due to recurrence or exacerbation of cardiac angina was performed in 85 (60.7%) and 77 (57.5%) patients, respectively. No case of late stent thrombosis was observed. Conclusion. Sirolimus-eluting coronary stent “Calypso” used in patients with acute coronary syndrome is effective and safe. Results of the trial can be used to recommend this stent in routine clinical practice for managing the patients with acute coronary syndrome. Copyright: © 2019 Cherniaev et a

Отдаленные результаты применения стента с лекарственным покрытием отечественного производства при остром коронарном синдроме

Aim. To study long-term results of sirolimus-eluting stent "Calypso” in patients with acute coronary syndrome. Methods. The study includes 274 patients with acute coronary syndrome who underwent percutaneous coronary revascularization with implantation either sirolimus-eluting stent "Calypso” (Angioline, Russia), n = 140, or everolimus-eluting stent "Xience Prime” (AbbottVascular, USA), n = 134. Their status was monitored by phone up to a 36-month's period. Patients who were diagnosed with or suspected of having myocardial ischemia underwent coronary angiography. Primary safety parameter major adverse cardiac events (MACE) was assessed as a composite of all-cause death, nonfatal myocardial infarction, and clinically indicated coronary revascularization. Efficacy analysis was performed as an incidence of repeat coronary angiography due to coronary artery disease progression or new ischemic events occurrence and the incidence of restenosis, defined as >50% lumen diameter reduction of previously stented target lesion. The incidence of late stent thrombosis was also assessed. Results. Major adverse cardiac events were observed in 13.6% of patients in "Calypso” group and in 14.2% of patients in "Xience Prime” group (р = 0.999; RR 0.96 [0.53; 1.721). Coronary angiography due to recurrence or exacerbation of cardiac angina was performed in 85 (60.7%) and 77 (57.5%) patients, respectively. No case of late stent thrombosis was observed. Conclusion. Sirolimus-eluting coronary stent "Calypso” used in patients with acute coronary syndrome is effective and safe. Results of the trial can be used to recommend this stent in routine clinical practice for managing the patients with acute coronary syndrome.Цель Изучить отдаленные результаты применения стента с лекарственным покрытием отечественного производства при остром коронарном синдроме. Методы В исследование включено 274 пациента с острым коронарным синдромом, которым имплантированы стенты «Калипсо» (ОАО «Ангиолайн», Россия), n = 140, и Xience Prime (AbbottVascular, США), n = 134. Состояние здоровья всех больных контролировалось по телефону до 36 мес. Пациентам, у которых по результатам обследования выявлена или заподозрена ишемия миокарда, выполнена контрольная коронарография. Оценивался основной параметр безопасности - частота серьезных неблагоприятных кардиальных явлений (англ. Major Adverse Cardiac Events, MACE), определяемых как смерть от любой причины, нефатальный инфаркт миокарда и любая реваскуляризация коронарных артерий по клиническим показаниям. В качестве параметра эффективности оценивался показатель потребности в селективной коронарографии ввиду прогрессирования ишемической болезни сердца или развития ишемических изменений в сердце и частоты рестеноза, определяемого как повторный стеноз стентированного сегмента артерии более 50%. Также оценивалась частота позднего тромбоза стентов. Результаты Частота серьезных неблагоприятных кардиальных явлений (MACE) составила 13,6% в группе стента «Калипсо» и 14,2% в группе стента Xience Prime (р = 0,999; отношение рисков 0,96 [0,53; 1,721). Контрольная ангиография вследствие возврата или ухудшения стенокардии выполнена у 85 (60,7%) и 77 (57,5%) пациентов в группах исследования, соответственно. Случаев позднего тромбоза стентов не наблюдалось. Выводы Применение отечественных стентов с лекарственным покрытием при остром коронарном синдроме эффективно и безопасно. Результаты исследования позволяют рекомендовать стент «Калипсо» для применения у пациентов с острым коронарным синдромом

SuperB: A High-Luminosity Asymmetric e+e- Super Flavour Factory. Conceptual Design Report.

May 18, 2007. 480pp., Available on the World Wide Web, with figures in full color, at http://www.pi.infn.it/SuperB/?q=CDRThe physics objectives of SuperB, an asymmetric electron-positron collider with a luminosity above 10^36/cm^2/s are described, together with the conceptual design of a novel low emittance design that achieves this performance with wallplug power comparable to that of the current B Factories, and an upgraded detector capable of doing the physics in the SuperB environment

SuperB: A High-Luminosity Asymmetric e+e- Super Flavour Factory. Conceptual Design Report.

May 18, 2007. 480pp., Available on the World Wide Web, with figures in full color, at http://www.pi.infn.it/SuperB/?q=CDRThe physics objectives of SuperB, an asymmetric electron-positron collider with a luminosity above 10^36/cm^2/s are described, together with the conceptual design of a novel low emittance design that achieves this performance with wallplug power comparable to that of the current B Factories, and an upgraded detector capable of doing the physics in the SuperB environment

SuperB: A High-Luminosity Asymmetric e+ e- Super Flavor Factory. Conceptual Design Report.

The physics objectives of SuperB, an asymmetric electron-positron collider with a luminosity above 10^36/cm^2/s are described, together with the conceptual design of a novel low emittance design that achieves this performance with wallplug power comparable to that of the current B Factories, and an upgraded detector capable of doing the physics in the SuperB environment