THE RESULTS SHOWN BY ANGIOLINE-MANUFACTURED CORONARY STENT CALIPSO ARE AS GOOD AS OF ITS FOREIGN ANALOGUE
ANGIOLINE Company declared positive results of the PATRIOT Multi-center Randomized Clinical Study aimed at comparing CALIPSO sirolimus-coated coronary stent with that of Xience Prime (Abbott Vascular, USA). According to the results obtained during tests, CALIPSO’s clinical performance and safety in treating patients with ischemic heart disease are as good as of the Xience Prime stent.
The study has been carried out from May 2015 to June 2017 in seven investigational centers of the Russian Federation with participation of 610 patients. The choice of the Xience Prime stent for comparison was due to the fact that it is one of the stents that had gone through the thoroughly clinical studies. Monitoring of the study data was performed by the independent contract research organization. Confirmation of the adverse events related to the primary end point of the study was performed by the independent committee set up on the basis of the Federal State Budgetary Institution the Academician E.N. Meshalkin’s National Medical Research Center of the Ministry of Public Health of Russia, in Novosibirsk.
The target lesion failure within 1 year was chosen as the end point of the study. Its occurrence was not significantly different in the CALIPSO and Xience Prime groups and amounted to 5.4% and 6.4%, respectively (non-inferiority p = 0.017). No difference between the groups in some aspects of the target lesion failure (cardiogenic death, myocardial infarction related to the target artery and target lesion revascularization by clinical indications) was revealed.
Detailed description of the study was published in the Circulation Pathology and Cardiac Surgery Journal, V. 21, No. 3 (2017) and is available by reference: http://journalmeshalkin.ru/index.php/heartjournal/article/view/505.