Abstract:

Aim: was to study immediate and medium-term results of using of stent Calypso in patients with acute coronary syndrome (ACS).

Materials and methods: 274 patients with ACS were included in study and were divided into 2 groups. The first group consisted of 140 patients, who underwent implantation of Calypso (Angioline, Russia). The other group consisted of 134 patients who underwent revascularization with further implantation of Xience (Abbot Vascular, USA). During first 24 hours after admission to the hospital all patients underwent percutaneous coronarography intervention (PCI). Their health state was monitored by phone during the 6, 9-12 months period. The majority of patients underwent coronary angiography during 9-12 months period.

Results: immediate results of the first group: incomplete stent apposition - in 0,6% cases, difficulties of delivery - in 3 cases, artery dissection - 2, occlusion of the side branch - 2 cases, acute thrombosis - 0,6% cases. Immediate results of the second group: incomplete stent apposition - in 0,5% cases, difficulties of delivery - in 2 cases, artery dissection - 2, occlusion of the side branch - 1 case, acute thrombosis - none. Confirmatory angiography in 9-12 months was done in 89 patients from the first group and 94 patients from the second group. The frequency of MACE in first group was 4,3%, in second group was 3,7%.

Conclusions: taking into consideration immediate and medium-term results it can be concludec that domestic stents can be successfully used in different clinical situations in different severity of lesions of coronary arteries. Calypso could be used in urgent PCI and they have minor percentage of complications in medium-term results.

 Reference 

1.     Chernjaev M.V., Koledinskij A.G. i dr. Koronarnye stenty: proshloe, nastojashhee, budushhee. Otechestvennye razrabotki v jendovaskuljarnoj hirurgii (obzor literatury). [Coronary stents: past, present, future. Domestic elaborations in endovascular surgery (literature review)]. Diagnosticheskaja i intervencionnaja radiologija. 2016; 10(4):51-56 [In Russ].

2.     Kudrjashov A.N., Lopotovskij P.Ju. Sravnitel'naja ocenka mehanicheskih svojstv koronarnogo stenta «Sinus». [Comparative estimation of mechanical properties of coronary stent «Sinus»]. Diagnosticheskaja i intervencionnaja radiologija.. 2014; 8(1)1:70-77 [In Russ].

3.     Lopotovskij P.Ju., Parhomenko M.V., Kokov L.S. Predvaritel'nye rezul'taty Registra retrospektivnogo issledovanija praktiki primenenija rossijskih stentov «Sinus» i «Kalipso». [Preliminary results of a retrospective study register for the use of Russian stents «Sinus» and «Calypso»]. Vestnik Roszdravnadzora. 2015; 5:44-49 [In Russ].

Abstract:

Aim: was to evaluate mechanical properties of coronary stent «SINUS» and compare them with mechanical properties of coronary stents of foreign production.

Material and methods: experimental group included coronary stents «SINUS», made of cobalt-chromium alloy L605 laser cut (H design and L2). The comparison group included stents: MULTI-LINK Vision, MULTI-LINK 8 (Abbott Vascular), Presillion (Cordis, Medinol), Integrity (Medtronic). With the help of certified device tests were conducted on all stents: passage (ability to overcome the delivery system for corners) , the geometrical uniformity of diameter upon radial stability, rigidity on the long axis, the amount of self-reducing the diameter after removal of the pressure in the balloon («Recoil»); in relation to stents "SINUS" independent testing laboratory DynatekLabs (USA) was carried out endurance test under pulsating radial exposure for 380 million cycles in accordance with ASTM F2477-07, required to obtain the approval of FDA USA.

Results: а stents were successfully tested for passage through an angle of 90° with the radius of rotation from 30 mm to 7.5 mm. Indicator geometric irregularities along the length of the stent diameter for all stents in the range ±1,5%, which corresponds to the measurement error. Test results radial stability upon compression up to 80% of the nominal diameter of the stent have been least Multi-Link Vision 0,28±0,02 N / mm and the highest in stent Integrity 0,65±0,02 N/mm. Test results for radial stability of the stent, «SINUS» with H-design is similar to the results for the Multi-Link stent and stent 8 Presillion 0,37±0,02 N/mm , and the stent, «SINUS» with L2- close design 0.52±0,02 N/mm . Test results on the ability to repeat the curved shape of the stent showed the smallest vessel in stent rigidity «Sinus» H-design, the highest in the stent Multi-Link 8. Remaining stents ascending rigidity «SINUS» L2- design , Presillion, Integrity, Multi-Link Vision. Test «Recoil» showed the lowest value of 4.5% in the stent Multi-Link Vision, the largest in Multi-Link stent 8-5.4% , the variation of this parameter between stents insignificant - ±0,5%, within the error of measurement of diameter due to the complex geometry of the stent. Test results have shown persistence DynatekLabs mechanical integrity of the structure and the absence of stent migration«SINUS» after 380 million cycles (equivalent to 10 years of implantation with an average heart rate = 72 beats/min) radial pulsating effects .

Conclusion: this study showed that stents «SINUS» have significant differences from the comparison group of stents in terms of: Recoil, passage of 90° angular rotation, uniform diameter disclosed stent radial strength fatigue. In terms of radial stability stents «SINUS» meet or exceed stents comparison groups, second only to the stent «Integrity». In terms of adaptability, in the open state , the curved profile of the vessel stents «SINUS» have the best performance with respect to comparison groups. 

References

1.     Protopopov A.V., Kochkina T.A., Puzyr' A.P., Efremov S.P., Fedchenko Ja.O., Balan A.N., Kokov L.S. «Biomehanicheskie issledovanija stentov razlichnyh konstrukcij i materialov», v Rukovodstve «Sosudistoe i vnutriorgannoe stentirovanie» [«Biometric examination of stents with diffent construction and materials», in Manual «Vessel and intraorganic stenting» ]. 2003; 15-19 [In Russ].

2.     FDA: Federal Register/ Vol. 76, No. 49 / Monday, March 14, 2011 / Notices, page 13636. http://www.gpo.gov/fdsys/pkg/FR-2011-03-14/pdf/2011-5815.pdf

3.     Azarov A.A., Barbarash O.L., Ganjukov V.I., Barbarash L.S. Prediktory rannih trombozov stentov posle jekstrennogo chreskozhnogo koronarnogo vmeshatel'stva u pacientov s ostrym infarktom miokarda v sochetanii s saharnym diabetom 2-go tipa [Predictors of early stent trombosis after urgent PCI in patients with IM in combination with diabetes mellitus]. Diagnosticheskaja i intervencionnaja radiologija. 2012; 6(4): 43-50 [In Russ].

4.     Osiev A.G., Bajstrukov V.I., Birjukov A.V. Problema restenoza vnutri ranee implantirovannyh stentov koronarnyh artery [Problem in-stent restenosis in coronary artery]. Diagnosticheskaja iintervencionnajaradiologija. 2012; 6(4): 89-96 [In Russ].

5.     Barra J.A., Volant A., Leroy J.P., et al. Constrictive perivenous mesh prosthesis for presentation of vein integrity. J. Thorc. Cardiovasc. Surg. 1986; 92: 330-336.

6.     Barth K.H., Virmani R., Froelich J., Takeda Т., Lossef S.V., Newsome J., Jones R., Lindisch D. Pared comparision of vascular wall reactions to Palmaz stents, Strecker Tantalum stents and Wallstents in canine iliac and femoral arteries. Circulation. 1996; 93(12): 2161-2169.

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Abstract:

Ischemic coronary artery cardiovascular disease is one of the main causes of the population's disability and mortality in Russian Federation and abroad. One of the most important treatment methods of ischemic coronary artery disease is myocardial revascularizationwith with usage of coronary stents. Nowadays there exist about 500 of coronary artery stent types, which differ in backing material, polymer technology, architecture, etc.

The overwhelming majority of stents used in Russian Federation are foreign-made stents, thus their cost is really high. According to plans of medicine developing as part of import substitution it is crucial to pay more attention to domestically produced stents, in particular to the first Russian drug-eluting stent «CALYPSO». Domestic stents cause minor complications and can be successfully used in emergency cases and various clinical settings for affections of different complexity.

References

1.     Bokerija L.A., Alekjan B.G. Rentgenjendovaskuljarnaja diagnostika i lechenie zabolevanij serdca i sosudov v Rossijskoj Federacii - 2014 god [Endovascular diagnosis and treatment of diseases of the heart and blood vessels in the Russian Federation]. M.: NCSSH im.A.N. Bakuleva; 2015 [In Russ].

2.     Matini M., Koledinsky A.G. And ect. Coronary stenting using XIENCE V DES: general problem, perspectives (a review). Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2011; 26: 25-33 [In Russ].

3.     Zhigalina L.A., Koledinskij A.G. i dr. Blizhajshie i sredneotdalennye kliniko-angiograficheskie rezul'taty koronarnogo jendoprotezirovanija arterij pri ispol'zovanii stentov s razlichnym lekarstvennym pokrytiem u pacientov v rannie sroki infarkta miokarda [Early and mid-term clinical and angiographic results of coronary arteries stenting using stents coated with different drugs in patients in the early stages of myocardial infarction.]. Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2013; 35: 43a [In Russ].

4.     Mardanjan G.V. Klinicheskaja jeffektivnost' i bezopasnost' chreskozhnyh koronarnyh vmeshatel'stv s ispol'zovaniem stentov s raznymi tipamilekarstvennogo pokrytija [Clinical efficacy and safety of percutaneous coronary intervention with stents with different types of drug-eluting]: Disc. kand. med. nauk. M., 2014; 12 [In Russ].

5.     Mazurova E.C., Koledinskij A.G. i dr. Sravnitel'naja ocenka jeffektivnosti stentov s razlichnym lekarstvennym antiproliferativnym pokrytiem v otdalennye sroki nabljudenija[Comparative evaluation of the effectiveness of stents with various antiproliferative drug-eluting in a long-term follow.]. Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2011; 24: 82-82 [In Russ].

6.     Gromov D.G., Koledinskij A.G. i dr. Stenty s biodegradirujushhim polimernym pokrytiem: obshhee sostojanie voprosa I perspektivy [Stents with biodegradable polymer coating: general state of the problem and prospects.]. Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2011; 25: 42-46 [In Russ].

7.    Zeynalov R., Koledinsky A.G. And ect. Results of coronary stenting using the stents with biodegradable polymer and antiproliferative (biolimus A9) coating. Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2011; 26: 16-21 [In Russ].

8.    Kudrjashov A.N., Lopotovskij PJu. Sravnitel'naja ocenka mehanicheskih svojstv koronarnogo stenta «Sinus» [ Comparative evaluation of mechanical properties of coronary stent «Sinus»]. Diagnosticheskaja intervencionnaja radiologija. 2014; 8(1): 70-77 [In Russ].

9.     Ioseliani D.G., Koledinskij A.G. i dr. Neposredstvennye i sredneotdalennye rezul'taty stentirovanija koronarnyh arterij golometallicheskimi stentami «Sinus» (opyt NPCIK) [Immediate and mid-term results of coronary artery stenting bare metal stents, «Sinus» (experience NPTSIK)]. Mezhdunarodnyj zhurnal intervencionnoj kardiologii. 2013; 35: 47b. [In Russ].

10.   Lopotovskij PJu., Parhomenko M.V., Kokov L.S. Predvaritel'nye rezul'taty Registra retrospektivnogo issledovanija praktiki primenenija rossijskih stentov «Sinus» i «Kalipso» [Preliminary results of a retrospective study of the Register practice of Russian stents «Sinus» and «Calypso»]. Vestnik Roszdravnadzora. 2015, 5:44-49 [In Russ].