Background .The availability of drug-eluting stents with evidence-based clinical safety and efficacy produced in the Russian Federation is one of the relevant goals for successful treating of patients with coronary artery disease, including acute coronary syndrome. Aim To confirm clinical rationale and experimental feasibility of the first Russian drugeluting stent, Calypso (Angioline, LLC, Russian Federation), for the clinical practice. Methods. The study included four phases. The first phase was aimed at selecting the optimal stent platform with superior healing properties. Then, the selected Russian coronary stents based on the optimal platforms underwent preclinical studies. The third phase included the clinical assessment using optical coherence tomography (OCT) in order to confirm the preclinical results. The last phase was focused on assessing clinical safety and efficacy of the Russian coronary stent based on the comparative analysis of angiographic findings within the 12-months follow-up. Results. At the first phase, biodegradable polymer sirolimus-eluting stent showed superior healing properties in comparison with the healing score of 18±14.97 for Orsiro stents (Biotronik, Germany) versus 25.6±1.0 for Xience stents (Abbott Vascular, USA) versus 32.5±20.3 for Synergy (Boston Scientific, USA), p<0.001. The Russian stent consistently demonstrated a high healing profile in preclinical and OCT clinical studies. The results of the comparative clinical study proved the clinical safety and efficacy of the Russian stent that was similar to the best foreign stents. None of the differences in the incidence of binary restenosis were found between the groups (p<0.05). Conclusion. The biodegradable polymer sirolimus-eluting stent Calypso manufactured in the Russian Federation demonstrated superior neointimal healing pattern with no signs of chronic inflammation in the experiment. This stent reported high neointimal healing properties according to the clinical OCT study. According to the angiographic findings, the incidence of binary restenosis between the Russian biodegradable polymer sirolimus-eluting stent and durable polymer everolimuseluting stents was similar at the 12-months follow-up (p>0.05).

Background. In 30% to 87% patients undergoing carotid artery stenting (CAS), new ischaemic lesions (NILs) of the brain are detected on magnetic resonance imaging (MRI). According to some authors, in 60% cases who undergo CAS via transfemoral (TF) access, NILs are also found in the contralateral and other vascular pools of the brain that are not directly related to the target carotid artery, most likely a result of the endovascular manipulation of the catheter on the aortic arch. An alternative access site for CAS is transradial (TR) access. Theoretically, with TR access, the catheter’s contact with the aortic arch is reduced, particularly with an intervention on the right internal carotid artery, and the risk of embolic events is possibly reduced. However, this aspect has not yet been explored.Aim. The aim of this study was to identify the predictors of NILs of the brain in patients undergoing CAS via the TR and TF approaches.Methods. The study included 96 patients with indications for CAS. Patients were randomised in a 1:1 ratio to either the TR (n = 48) or TF (n = 48) groups. All patients underwent diffusion-weighted imaging MRI before and 12 to 24 hours after the procedure. Multiple logistic regression with step-by-step turning off of variables was used to determine the predictors of NIL.Results. A total of 40 clinical, demographic, instrumental and intraoperative variables were analysed. Based on the results of single regression analysis, 6 predictors (age, male sex, hypertension, history of percutaneous transluminal coronary angioplasty, intersection of the aortic arch and type II/III aortic arch) were included in the multivariate model. From the final multivariate analysis, it was found that age, intersection of the aortic arch and type II/III aortic arch are independent predictors of NILs after CAS.Conclusion. Patient age, type II/III aortic arch and need for a catheter to cross the aortic arch are independent predictors of NILs during carotid stenting. Received 9 January 2020. Revised 21 February 2020. Accepted 25 February 2020. Funding: The study did not have sponsorship. Conflict of interest: Authors declare no conflict of interest.

Peripheral artery disease (PAD) is one of the most common cardiovascular diseases with serious sequelae. Every year, 120–500 amputations are performed per 1 million people worldwide. The severe consequences of amputation include the mental trauma caused by loss of a limb, disability and a real risk of death for the patient, since the mortality rate associated with the development of gangrene remains extremely high. PAD is most frequently located in the femoral-popliteal segment, which is the longest vascular segment in the human body. Over the past decade, the endovascular approach has become the main therapeutic strategy for PAD, given its lower risk of complications and comparable efficacy to open interventions. Femoral-popliteal stenting provides advantages over balloon angioplasty, preventing vessel wall recoil and providing necessary frame support.This review aims to describe the latest progress of endovascular surgery for the treatment of femoral-popliteal artery disease and to discuss its limitations.The introduction of nitinol stents and new drug coated stents into clinical practice has improved the results of femoral-popliteal endovascular treatment. Despite this, stent failure remains a pressing problem that significantly impacts the results of endovascular treatment of atherosclerotic lesions of lower limb arteries.Received 6 June 2019. Revised 8 October 2019. Accepted 10 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.Author contributionsConception and design: D.U. Malaev, A.R. Tarkova, A.A. Prokhorkhin, A.A. BoykovDrafting the article: D.U. Malaev, A.A. Prokhorkhin, A.A. BoykovCritical revision of the article: D.L. Merson, A.Yu. Vinogradov, V.I. Baystrukov, E.I. KretovFinal approval of the version to be published: D.U. Malaev, A.R. Tarkova, A.A. Prokhorkhin, D.L. Merson, A.Yu. Vinogradov, V.I. Baystrukov, A.A. Boykov, E.I. Kretov, M.V. Pryamov

In this review, various achievements in the field of development of tissue-engineered scaffolds with the electrospinning approach were observed. Through the appropriate selection of electrospinning parameters, such as solution viscosity, the type of solvent, voltage, the distance between a tip and a collector etc., scaffolds with a high degree of porosity and pore size applicable for optimal cell infiltration can be obtained. These tissue-like materials can be produced from both synthetic and natural polymers and their mixtures. Based on the characteristics specific for the desirable tissue – vascular, bone or cardiac – materials providing the required mechanical properties, architecture, degradation kinetics and biocompatibility are selected for scaffold synthesis. In different studies, electrospun fibers were modified by adding biologically active agents or nanoparticles. This article also describes the particularities of the extracellular matrix of different tissues and approaches used for specific tissue imitation. Repopulation of the matrices with autologous cells before transplantation is the most commonly used method to improve the biocompatibility of the scaffold and the recipient.

Background. Ischaemic stroke is one of the leading causes of death and disability worldwide. Selective intracarotid cerebral hypothermia is one of the promising methods to prevent ischaemic stroke. However, currently available studies do not allow us to conclude the effectiveness of applying this method in humans and assess its effect on the system temperature.Aim. To investigate the effect of selective intracarotid cerebral hypothermia on the size of ischaemic stroke in large pigs, determining the optimal period of hypothermia and the severity of the effects of intracarotid hypothermia on the system temperature.Methods. The study was conducted on mini-pigs weighing 30–70 kg and included two stages. During the first stage, pigs were divided into two groups: control (n = 4) and intracarotid hypothermia for 3 h, exciting periods before and after reperfusion (n = 2). During the second stage, animals were also divided into two groups: hypothermia group within 1.5 h before reperfusion (n = 2) and hypothermia group within 1.5 h after reperfusion (n = 2). The technique for modelling ischaemic stroke was the same as in all groups and consisted of frontotemporal craniotomy and compression of the middle cerebral artery for 3 h. Intracarotid hypothermia was performed by infusing + 4 °C NaCl solution in the ascending pharyngeal artery. At 48 h after starting the experiment, a brain magnetic resonance imaging scan was performed to determine the size of the stroke.Results. The mean size of the stroke focusing in the control group was 10.75%, in the hypothermia group before reperfusion (10.95%) and in the hypothermia group after reperfusion (1.65%) of the volume of the cerebral hemisphere. The stroke size in the hypothermia group for 3 h could not be determined due to complications that developed in animals intraoperatively and postoperatively. The effect of intracarotid hypothermia on the systemic temperature in an animal weighing 65 kg was 0.4 °C.Conclusion. Based on the study results, a marked decrease in the focus of ischaemic stroke was found with the use of intracarotid hypothermia within 1.5 h after reperfusion. Intracarotid hypothermia was found to do not have a pronounced effect on the system temperature. Received 2 May 2020. Revised 20 May 2020. Accepted 25 May 2020. Funding: The work is supported by a grant of the Russian Foundation for Basic Research (project No. 18-415-540025). Conflict of interest: Authors declare no conflict of interest. Author contributionsConception and study design: E.I. Fartakov, V.V. Lomivorotov, E.I. Kretov, A.R. TarkovaData collection and analysis: D.U. Malaev, A.A. Boykov, A.A. Prokhorikhin, D.V. Volchenko, I.S. Zykov, P.O. SeleznevDrafting the article: E.I. Fartakov, D.U. Malaev, A.R. TarkovaCritical revision of the article: E.I. Kretov, V.V. Lomivorotov, V.I. Baystrukov, N.I. Grachev, D.S. Sergeevichev, A.M. ChernyavskiyFinal approval of the version to be published: E.I. Fartakov, V.V. Lomivorotov, D.U. Malaev, A.R. Tarkova, A.A. Boykov, A.A. Prokhorikhin, D.V. Volchenko, I.S. Zykov, P.O. Seleznev, V.I. Baystrukov, N.I. Grachev, D.S. Sergeevichev, A.M. Chernyavskiy, E.I. Kretov

Страница 36 СРАВНИТЕЛЬНОЕ ИССЛЕДОВАНИЕ СИСТЕМЫ БЕСКОНТРАСТНОЙ КТ-ДИАГНОСТИКИ ОСТРОГО ИШЕМИЧЕСКОГО ИНСУЛЬТА НА БАЗЕ НЕЙРОННЫХ СЕТЕЙ ГЛУБОКОГО ОБУЧЕНИЯ Прохорихин А.А. 1 , Байструков В.И. 1 , Бойков А.А. 1 , Малаев Д.У. 1 , Таркова А.Р. 1 , Шаяхметова С.В. 1 , Гришков А.В. 1 , Казанцев А.С. 1 , Шигаев В.В. 1 , Кох В.Н. 2 , Аветисян М.С. 2 , Умеренков Д.Е. 2 , Кретов Е

Background. Since 1996, thrombolytic therapy with tissue plasminogen activator has traditionally been the first-line treatment for patients with ischaemic stroke. However, the results of recent randomised trials have shown the advantage of mechanical thrombectomy over thrombolytic therapy for successful revascularisation of brain arteries and improvement of clinical outcomes. Owing to the development of endovascular surgery, mechanical thrombectomy has now become an effective and safe method for treating ischaemic stroke resulting from the occlusion of large cerebral arteries.Aim. The main aim of this study was to develop a prototype for a combined transcatheter system to be used for mechanical thrombectomy.Methods. During the implementation of the project, we first analysed the data on the problems to justify the choice of standard sizes of a stent retriever and an aspiration catheter and to determine the basic set of physical–mechanical, functional and biomedical characteristics of the system. A prototype of a combined transcatheter system for mechanical thrombectomy, which comprises an aspiration catheter and a stent retriever, was manufactured. Moreover, preclinical tests were conducted to study the physical properties of the developed prototype and assess its effectiveness. Results. Data from preclinical tests showed a level of radial stiffness of the prototype that was comparable to that of a similar device on the market, satisfactory visualisation under angiography and high efficiency while performing mechanical thrombectomy in vitro and in vivo tests.Conclusions. Studies on the prototype of the combined transcatheter system for thrombectomy have shown positive results in preclinical trials.Received 5 December 2019. Revised 18 December 2019. Accepted 20 December 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure. Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients. Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Background. Metallic stent implantation is associated with an increased risk of adverse events, such as prolonged endothelial dysfunction, constant traumatisation of the vessel wall, chronic local inflammation and thrombosis. Thus, the development and manufacturing of bioresorbable stents, which maintain the required support during the vessel healing period and completely dissolve without any side effects, is highly relevant. At present, magnesium alloys are regarded the most applicable for this purpose due to their low corrosion resistance and high biocompatibility.Aim. To assess the cytotoxicity of different magnesium alloys in vitro.Methods. Using strain tempering, seven samples with different yield stress levels were produced: sample 1, MgZnZr (ZK60) 310 МPа; sample 2, MgZnCa (ZX10) 60 МPа; sample 3, MgZnCa (ZX40) 130 МPа; sample 4, MgYZn (WZ31) 300 МPа; sample 5, MgYZn (WZ31) 275 МPа; sample 6, MgYZn (WZ20) 340 МPа and sample 7, MgZnZr (ZK60) 180 МPа. The samples were incubated in a culture medium to obtain the extract, which was further tested on immortalised human fibroblasts. The cytotoxicity of the obtained extract was assessed using 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) assay, flow cytometry, optical microscopy and pH test.Results. In MTT assay, sample 7 was significantly cytotoxic (mean cell survival: 48% [2% ± 1%]), whereas sample 5 was slightly cytotoxic (mean cell survival: 81% [4% ± 14%]). In optical microscopy, the same samples showed the lowest cell density. In flow cytometry, the number of necrotic cells significantly increased in sample 7 (8.25%) and only slightly increased in samples 1 and 5 (3.449% and 3.626%, respectively). Furthermore, samples 5 and 7 showed the highest medium pH.Conclusion. The composition and strain tempering method magnesium alloys are directly correlated with the degree of cell necrosis, change in morphology and medium pH in vitro.Received 7 June 2019. Revised 28 October 2019. Accepted 6 November 2019.Funding: The work is supported by the Ministry of Science of Russian Federation (project RFMEFI58317X0070).Conflict of interest: Authors declare no conflict of interest.

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; 1,72]). 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.Поступила в редакцию 15 августа 2018 г. Исправлена 22 ноября 2018 г. Принята к печати 26 ноября 2018 г.Финансирование Исследование не имело спонсорской поддержки.Конфликт интересов Авторы заявляют об отсутствии конфликта интересов.

Aim. The paper demonstrates the interim analysis of efficacy and safety after everolimus-eluting bioresorbable vascular scaffold (BVS) Absorb implantation in “real-world patients” with coronary artery disease.Methods. A cohort of 500 consecutive patients who underwent percutaneous coronary intervention for stable chest pain or acute coronary syndrome with implantation of at least one BVS (Absorb, Abbott Vascular) and followed up by telephone interview and review of medical charts were included in a singlecenter, prospective, all-comers, first in Russia registry. The primary endpoint, target vessel failure, defined as the combination of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization and secondary endpoints, MACCE (composite of cardiovascular death, myocardial infarction, coronary artery bypass surgery, target vessel revascularization, stroke) and stent thrombosis, were assessed during 6-month follow-up.Results. A total of 500 patients with coronary artery disease (CAD) (stable CAD 54.4%, acute coronary syndrome 45.6%) and different amount of affected vessels (1 vessel CAD 40.8%, n = 204; 2-vessel CAD 32.8%, n = 164; 3-vessel CAD 26.4%, n = 132) received 664 scaffolds and 55 stents in 603 stenoses. Procedure success, defined as a residual stenosis less than 30% and TIMI 3 flow in target vessel at the end of procedure, was observed in 98.51% (n = 594). At the moment of 6-month follow-up 4.2% (n = 24) of patients were lost to contact. After 6 months, incidence of target vessel failure and MACCE was 4.2% (n = 21) and 5% (n = 25). The cumulative rate of definite/probable scaffold thrombosis was 1.6% (n = 8).Conclusion. The interim analysis of Gabi-R: Russia registry, the largest trial of BVS Absorb implantation in routine clinical practice, showed high procedural success and low incidence of adverse events during follow-up. However, a tendency to high incidence of scaffold thrombosis compared to drug-eluting stents can be observed. Considering the long-term results of randomized trials retrospective registries, safety in terms of BVS routine use is of big concern. Longterm 24-month data regarding safety endpoints are required to test the afore-mentioned suggestion. Received 5 January 2019. Revised 28 March 2019. Accepted 29 March 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.

Questions of the occurrence of transprosthesis regurgitation after transcathether prosthetization of the aortic valve are discussed. We present results from hydrodynamic tests of prototype transcatheter aortic valve prostheses with different methods of attachment of the valve leaflets in conditions of deformation of the fibrous ring. Prototype prostheses with attachment of the leaflets of the valve apparatus above the seating zone of the frame of the prosthesis demonstrated optimal hydrodynamic characteristics.

Cardiovascular diseases are the leading causes of mortality worldwide. There is the only method to treat the severe heart valve defects is heart valve prosthetics. Nowadays, there is an active introduction of artificial materials into medicine. The use of polymeric materials to make a leaflet for the valve prostheses can solve the problems of biological prostheses by providing greater durability with the keeping of positive properties as low risk of thrombosis and the absence of the need for continuous anticoagulants administration. Firstly, it needs to find the most suitable polymer for heart prosthesis. The investigation of the elastic characteristics of artificial materials in comparison with the biomaterial used in the valve prosthesis manufacture is presented in the article. Tests for polymers aortic heart valve prosthesis were performed.

Aim. To compare transradial (TR) and transfemoral (TF) approach for carotid artery stenting (CAS) with an emphasis on the detection of micro-embolization with diffusion-weighted magnetic resonance imaging (DW-MRI).Methods. 96 patients were included in the study in the period from January 2015 to October 2017 with further randomized 1 : 1 to the TR and TF groups. The inclusion criteria were the following: symptomatic stenosis ICA >70%; or asymptomatic stenosis ICA >80%. The positive history of stroke, myocardial infarction or open heart surgery <1 month were the exclusion criteria for the study. The primary endpoint was the incidence of new cerebral ischemic lesions as assessed by DW-MRI. All CAS procedures were performed by two experienced operators according to the approved protocol.Results. Procedural success with TR approach was 46 (96%) versus 48 (100%) with TF approach (p = 0.495). Crossover rate was 4% in the TR group. The rate of primary endpoint in the TR and TF groups was 50 and 52%, respectively. The absolute risk difference was -2% (95% CI [-0.21, 0.17], p (non-inferiority) = 0.03). An «on-treatment» analysis revealed a tendency towards a reduced microembolic foci when intervening on the right ICA via TR approach compared to TF (44% vs. 68%, p = 0.478), and a reverse trend when intervening on the left ICA via TR compared to TF approach (57% versus 36%, respectively, p = 0.437).Conclusion. Carotid stenting via transradial approach is noninferior for cerebral embolism to transfemoral approach. The rates of MACCE and vascular complications were similar in both groups. There was no significant difference in the procedural success rate in the transfemoral and transradial groups. The fluoroscopy time during transradial carotid stenting was higher in comparison with transfemoral carotid stenting, though the procedure duration was similar in both groups.

Adequate guide support is crucial for percutaneous coronary interventions complicated by unfavorable coronary artery anatomy, pronounced calcification, or the presence of chronic total occlusion. A clinical case presents a novel technique for guide support during stenting chronic coronary occlusion via transradial approach originally proposed in the TransRadial Ultra Support Technique trial.

Aim. To assess the results of transcatheter aortic valve implantation (TAVI) in patients with symptomatic aortic valve stenosis in routine clinical practice. Material and methods. From 2015 to 2018 based on the Meshalkin National Medical Research Center in the prospective register of patients undergoing TAVI, 191 patients were included. The patients were divided into low surgical risk group (EuroSCORE II <4%) — 137 patients, and increased surgical risk group (EuroSCORE II >4%) — 54 patients. We defined incidence of serious adverse cardiovascular events (all­cause death, non­fatal myocardial infarction and non­fatal stroke/ transient ischemic attack (TIA)), as well as the incidence of permanent pacemaker implantation (PPI).Results. In the postoperative period, cardiac death was observed in 3 (2,2%) and 2 (3,7%) cases in the low­risk and high­risk groups, non­fatal stroke/TIA — in 7 (5,1%) and 2 (3,7%) cases. The frequency of the composite endpoint was 10 (7,3%) and 4 (7,4%), respectively (p>0,999). During the hospitalization non­fatal myocardial infarction cases in the groups were not registered. The incidence of PPI due to the complete atrioventricular block was 10,9% and 13%, respectively.Conclusion. This prospective register demonstrates good results of TAVI in patients with different surgical risk. Relative frequency of lethality, non­fatal myocardial infarction, non­fatal stroke/TIA and PPI did not differ significantly in the low and high surgical risk groups.

Approximately 20% of ischemic strokes are provoked by stenotic carotid artery lesions. With the growing experience of surgeons and the continued improvement of devices, carotid artery stenting has become an effective alternative to carotid endarterectomy. Traditional access to carotid artery stenting is transfemoral approach. However, due to peripheral artery disease and challenging anatomy of the aortic arch, transfemoral approach may be problematic. A number of randomized trials have proven the effcacy and safety of transradial access for coronary interventions. A similar technique was adapted for coronary artery stenting. The article provides a review of the major studies dedicated to coronary artery stenting via transradial approach, discusses all benefts and limitations as well as provide the guide to select an optimal vascular access, depending on the patient's anatomical characteristics. Transradial approach is shown to be a good alternative to transfemoral approach for coronary artery stenting. However, it is accompanied by a high rate of unsuccessful procedures compared to transfemoral approach. Nevertheless, transradial approach is accompanied by a decrease in the rate of vascular complications, and is preferable for intervening on the right ICA, or on the left with bovine aortic arch.

OBJECTIVE:We aimed to assess early neointimal healing by optical coherence tomography (OCT) 3 months after implantation of the ultrathin Orsiro® sirolimus-eluting stent with biodegradable polymer.BACKGROUND:New generations of drug-eluting stents with biodegradable polymer have been developed to avoid the continued vascular irritation of durable polymers.METHODS:In this prospective, open-label study, 34 patients received an Orsiro® sirolimus-eluting stent with biodegradable polymer. In a subgroup of patients (n = 15), the intervention was performed under OCT guidance. All patients underwent OCT-examination at three months. The primary endpoint was 3-month neointimal healing (NIH) score, calculated by weighing the presence of filling defects, malapposed and uncovered struts. Secondary endpoint was maturity of tissue coverage at 3 months.RESULTS:At 3 months, NIH score was 13.7 (5.4-22), covered struts per lesion were 90% (84-97%), malapposed struts were 2.7% (0.8-5.4%) and rate of mature tissue coverage was 47% (42-53%). No target lesion failure occurred up to 12 months. Patients with OCT-guided stent implantation demonstrated a trend toward earlier stent healing as demonstrated by superior NIH scores (angio guided: 17.6% [8.8-26.4]; OCT-guided: 9.8% [4.0-15.5]; mean difference -8, [95%CI: -18.7-2.9], P = 0.123). This group had significantly more covered struts per lesion (angio-guided: 86% [82-90]; 95% [92-99]; mean difference 9% [95%CI: 3-15], P = 0.001).CONCLUSION:The Orsiro® sirolimus-eluting stent with biodegradable polymer shows early vascular healing with a high rate of strut coverage at 3-month follow-up. OCT guided stent implantation had a positive impact on early vascular healing.