PROPORTION OF TECHNICALLY SUCCESSFUL IMPLANTATIONS OF THE DOMESTIC DRUG-COATED CALIPSO STENT IS COMPATIBLE WITH THAT OF ITS FOREIGN ANALOGUE, XIENCE PRIME
At the E.N. Meshalkin’s Novosibirsk Research Institute of the Ministry of Public Health of RF, selection of patients within the PATRIOT randomized study aimed at comparing efficiency of the first Russian drug-coated CALIPSO coronary stent and its foreign analogue, Xience Prime, was completed. According to the selection results, the technical success of implantation of the domestic drug-coated CALIPSO stent manufactured by ANGIOLINE Company is completely compatible with that of the foreign analogue, Xience Prime (Abbot Vascular, the USA).
The study, having no precedent in Russia, was initiated by ANGIOLINE Company, the domestic manufacturer of consumables for the X-Ray endovascular diagnostics and treatment of cardiovascular diseases, in 2015 in order to support the hypothesis on the CALIPSO stent non-inferior clinical performance and safety as compared to Xience Prime. A number of patients, required for the hypothesis to be confirmed, was calculated according to the international standards.
Six Russian medical centers located in Moscow, Orenburg, Kemerovo, Novosibirsk, Krasnoyarsk and Vladivostok are participating in the study; the national coordinating investigator of the study is FSBI the Academician E.N. Meshalkin’s NRPC of the Ministry of Public Health of RF. Altogether, 610 patients suffering from ischemic heart disease have been selected: the domestic stents being implanted to 406 patients, and the foreign analogues - to 204. Control check-ups of the patients are performed immediately before the procedure, on discharge, and then in 3, 6, 9, and 12 months.
“The study results will become known approximately in a year, after the final visits of the patients, and we will have full statistical information,” says Evgeny Kretov, Principal Coordinating Investigator, FSBI the Academician E.N. Meshalkin’s NRPC of the Ministry of Public Health of RF. “However, now we can already say that implantation was technically successful in both groups. No difference between the pure technical skills and technical outcomes, when implanting one and another stent, was revealed. This result is essential for the purpose of that the PATRIOT is a study with minimal personal limitation for patient inclusion. Since our task is to show that the Russian device is completely comparable with the best foreign analogues, the study should include patients with the most various possible peculiarities of anatomy and lesions.”
About ANGIOLINE Company
ANGIOLINE Company is one of the key Russian developers and manufacturers of medical devices, namely: coronary stents and catheters for rendering medical aid to the patients with ischemic heart disease. The range of products contains over 15 items of medical devices. Currently, the company’s devices are used in more than 126 medical and preventive treatment institutions from 65 regions of the Russian Federation. For the period from 2010 to 2015, more than 35 thousand stent placement surgeries were performed using ANGIOLINE products. As of the end of 2014, ANGIOLINE’s share of the stent market in Russia is about 10%. Meanwhile, the production capacities allow at least five-fold increase in the coronary stent output. The company’s manufacturing facilities are located in Novosibirsk, in the industrial park of Akademgorodok. Further information about the Company is available at the following Internet address: http://www.angioline.ru