Abstract

First experience with the use of extra-long (40 to 60 mm) sirolimus-eluting

stents in patients with diffuse long coronary lesions

Objectives: To assess the clinical outcome of one year follow-up in patients with
diffuse long lesions treated with extra-long sirolimus-eluting stents.
Methods and Results: 85 patients underwent implantation of very long BioMime
stents (Meril Life Sciences, India) for the period from March 2014 to February
2016.

Results: The angiographic success rate was 100%, clinical success was observed
in 98.8% cases (onepatientdevelopedperiprocedural MI). The additional back-up
support for stent delivery was used in 11 (12.9%) patients (the «buddy wire»
technique in 6 pts and Guidzilla catheter in 2 pts.).Cumulative MACE rate at 12
months was 9.4% with 1.1% myocardial infarction and 5.9% TLR. One patient
died 6 month after stent implantation from massive pulmonary thromboembolism.
None of the patients had subacute or late stent thrombosis. Follow-up angiography
was performed in 48 (68.5%) patients, 5 (10.4%) patients demonstrated restenoses.

Conclusion: The use of extra-long sirolimus-eluting stents is associated with good

procedural and one-year clinical outcomes in complex patients with long and
diffuse lesions.

Key words: Percutaneous coronary intervention; diffuse coronary lesions; long

drug-eluting stents.
The study of the possibilities of endovascular treatment of patients with complex
forms of lesions of coronary arteries (CA) is especially urgent for today [1,2,3]. It
is known that about 20% of all performed percutaneous coronary interventions
(PCI) occur in patients with prolonged stenoses of SC [4]. In this case, the
proportion of patients with diffuse lesions of the coronary bed is steadily
increasing and amounts to 40-50% [1]. At present, there are generally recognized
criteria for determining diffuse lesions of the coronary bed, which often creates
certain difficulties in choosing the optimal method of revascularization of the
cardiocardi [2]. Initially, diffuse lesions were used to count stenoses over 20 mm
long, but the connection with the development of interventional technologies
increased the criteria for the determination [5,6].
Up to now, in the arsenal of interventional cardiologists, there were mainly stents
with a length of up to 30-38 mm, which, in the treatment of prolonged coronary
artery constrictions, required the implantation of two or more stents "overlapping."
It is known that such an approach can be accompanied not only by an increase in
frequency and Stent thrombosis, but also the formation of aneurysm arterial
dilatations in the stent junction area due to the excessive concentration of the stent-
covering drug [7,8]. In recent years, new drug-stent stents with a length of 40-60
mm have appeared on the market of endovascular treatment tools [9]. The first
experience of using such stents is positive, however, in the few available studies,
the technical features of the procedure, as well as the long-term results of
treatment, have not been fully explained and studied [10].
The purpose of this study was to evaluate the immediate and long-term (one-year)
results of using very long stents (40-60 mm long) with a drug coating in the
treatment of patients with extensive and diffuse lesions of the coronary arteries.

Materials and methods:

During the period from May 2014 to February 2016, 85 patients with stable
development of coronary artery disease with coronary angiography (CAG) with
diffuse, extended stenoses were included in the study on a prospective basis. The
clinical characteristics of patients are presented in Table 1. The average age of
patients was 63.6 ± 9.8 years, 63 (74.1%) were Men. Arterial hypertension was
detected in 45 (52.9%) people, smoking - 21 (24.7%), diabetes mellitus - in 20
(23.5%), hyperlipidemia - in 76 (89.4%). In 60 (70.5%) patients in the anamnesis,
a myocardial infarction (MI); 5 patients (5.9%) underwent coronary artery bypass
grafting, 17 (20.2%) patients had angioplasty with stenting of the SC before.
Reduction of contractile function of the left ventricle (PV less than 40%) was
observed in 5 (5.8%) patients.

The inclusion criteria were: the presence of at least one stenosis of a QR with a
length of ≥40 mm with a degree of constriction ≥50% in diameter in combination
with attacks of angina of tension or rest and objective signs of myocardial ischemia
on a resting ECG, during a sample with a measured physical load or Holter ECG
monitoring .

The study did not include patients with stenosis of the left coronary artery (LCA) ≥
50%, acute coronary syndrome and multivessel lesions (with a value on the Syntax
scale33).

Coronarography:

The procedure was performed by radial or ulnararium access to the AlluraXpera

FD10 angiographic unit (Philips, the Netherlands), non-ion-based contrast
preparations Ultra-370 (BayerScheringPharmaAG, Germany) and Mallinckrodt
(Canada) were used. The degree and extent of arterial stenosis were determined
using automatic quantitative coronary analysis using the XceleraR2.2L1SP2
software (Philips, The Netherlands). For calculation, the final diastolic frame was
selected in the projection with the maximum degree of stenosis. For calibration, the
tip of the diagnostic catheter was used, unfilled with contrast material [11]. In the
analysis, the following parameters were determined: the extent of the impact (mm);
The reference diameter of the angiographically unchanged section of the artery is
proximal and distal to the stenosis (mm); The minimum diameter of the arterial
artery (MDAP) (mm) and the degree of stenosis by diameter (%). MDMA and the
degree of arterial narrowing were calculated before and after PCI, as well as with
controlled angiographic examination after 12 months. Angiographic carborenosis
was defined as artery stenosis more than 50%, revealed in control CAG.

Transilluminal balloon angioplasty (TBA) with stenting CA. All patients

underwent PCI with implantation of one long drug-eluting stent (BFS) - BioMime
(Meril Life Sciences, India). The third-generation cobalt-chromium platform with a
thickness of 65 μm, coated with a thin 2 μm by a layer of a biodegradable polymer
based on polylactate-glycolic acid, which provides release of sirolimus for 30 days.
Stenting was performed according to the conventional procedure [12]. In all cases,
stenosis was pre-dilation, the balloon diameter was selected from the balloon /
artery ratio of 0.8-0.9, in the presence of pronounced calcinosis Non-compliant
balloons were used. The size of the stent was selected according to the magnitude
of the distal reference diameter of the artery. Optimization of proximal stent
sections was carried out by non-compliant balloons, their diameter was selected
according to the size of the proximal reference segment. For 5-7 days before the
intervention, all patients received clopidogrel at a dose of 75 mg per day in
combination with aspirin at a dose of 75-100 mg per day. At the beginning of the
procedure, intravenous heparin was administered at a rate of 100 U / kg body
weight, followed by the determination of the activated clotting time. In the
subsequent every 30 minutes, repeated determinations of AST were carried out. To
maintain the AST at> 300, if necessary, heparin was re-administered at a rate of
35-50 units / kg body weight. After the procedure, all patients received a double
antiplatelet therapy (75 mg aspirin and 75 mg clopidogrel) for 12 months.

The criterion for the immediate success of the intervention was the elimination of
narrowing with a residual stenosis less than 20% and the degree of antegrade
TIMI-III without the occurrence of complications (death, MI, emergency PCI
surgery, CABG) during the hospital period. The long-term results of the study
were evaluated in an outpatient examination of patients, As well as for repeated
hospitalization. The testimony for the control CAG was a recurrence of the clinic
for stenocardia, a positive sample for the detection of latent ischemia of the
myocardium, as well as the noninformativeness of the results of a sample with a
dosed physical load or the impossibility of carrying it out.

To evaluate the results of the study, the following endpoints were accepted: death
from all causes, death from cardiovascular causes, myocardial infarction, repeated
revascularization of the target lesion.

Statistical processing: Continuous variables having a normal distribution were

represented as M ± σ, where M is the mean and σ is the standard deviation.
Continuous variables, the distribution of which differed from normal, represented a
median and 25% -75% percentiles. Logistic regression analysis was used to assess
the impact of clinical angiographic factors on the incidence of adverse
cardiovascular events. To determine the degree of contingency of each of these
factors, the Pearson criterion was used. At the same time, the exponential
coefficient of the regression equation was used as an estimate of the relative risk
associated with the action of the factor. The influence of the predictors included in
the model and the accuracy of the whole model were generally considered reliable
if the values of p criterion χ2 were less than 0.05. The statistical analysis was
carried out with the help of a package Statistical analysis of SPSS (Chicago, IL,
USA).

Results of the study:

Angiographic characteristics of patients are presented in Table 2. According to the

CAG data, 26 (30.5%) patients had a single-vessel lesion, 31 (36.4%) patients had
a two-vessel lesion and 28 (32.9%) patients had a three-vessel lesion. The major
part of lesions that underwent intervention was 45 (52.9%) localized in the right
coronary artery (PKA), 30 (35.3%) in the anterior descending artery (PNA), 10
(11.8%) were located in the envelope Arteries (OA). Of the 85 prolonged stenoses
subjected to revascularization, 40 (47.1%) lesions accounted for chronic occlusions
of the CA, and 47 (55.8%) cases accounted for the bifurcation lesions, of which 12
(255%) were true Bifurcations. In assessing the severity of coronary artery lesions
on the Syntax47 scale (55.3%), patients were assigned to the low-risk group
(Syntax≤22 points), and the average risk group (Syntax = 23-32) included 38
(44.7%) Patients. The main part of the procedures was performed in 77 patients
(90.6%) through radial, in 8 (9.5%) patients through the ulnar access. According to
the results of quantitative angiography, the average length of stenosis was 52.4 ±
9.4 mm, the average value of the reference artery diameter was 3 , 1 ± 0.7 mm, the
mean value of the minimum diameter of the lumen of the constriction before the
intervention is 0.92 ± 0.5 mm and the degree of narrowing of the interference -60.2
± 18.7%. During the procedure, 219.9 ± 95, on average, 9 ml x-ray contrast
medium per patient (from 80 to 500 ml) (see Table 3). 85 drug-eluting stents were
implanted, of which 22 (25.8%) were stents with variable diameter (with
"trapezoidal" constriction, In which the diameter of the proximal segment was 0.5
mm larger than the distal segment.) The number of stents 40 mm long was 16
(18.8%), 25 (29.4%) had a length of 44 mm, 24 (28.2% ) - 48 mm. The number of
stents with a length of 50 and 60 mm was 10 (11.8%) and 10 (11.8%), respectively
(Fig. 1).

The immediate angiographic success of the intervention was 100%, the immediate
success of the procedure was 98.8% (1 patient was diagnosed with type 4a MI).
Technical difficulties in the stent to the place of stenosis appeared in 11 (12.9%)
patients. To overcome them, in 6 (7.1%) the technique of the "additional
conductor" ("buddywire") was used, in 2 (2.3%) a deep intubation of the guide
catheter was performed, in 1 (1.2%) the method of "anchoring "In the lateral
branch with an inflated balloon catheter. In 2 (2.3%) patients, in connection with
the ineffectiveness of standard techniques for stenting, additional GuideZilla
extension catheters (BostonScientific, USA) were used.

The average period of observation of patients included in the study was 12.6 ± 2.5
months. 8 (9.4%) of cases (Table 4) were observed at the frequency of the
combined index of large cardiovascular events, including death, myocardial
infarction, and repeated revascularization of the target lesion. During the
observation, one patient died suddenly of massive pulmonary embolism (autopsy
was performed at the place of residence) , 1 (1.2%) patient underwent MI, repeated
revascularization of the target lesion was performed in 6 (7.1%) patients, there
were no cases of late thrombotic occlusions of the stent. The survival rate without
major cardiovascular events 1 year after the procedure was 91.6 % (Figure 2).

The control CAG was performed in 48 (68.5%) patients, the average percentage of
stented segment stenosis was 21.5 ± 3.2%, the minimum diameter of the
stentablenium was 2.46 ± 0.4 mm, the late lumen loss was 0.18 ± 0.2 Mm.
Angiographic restenosis (narrowing more than 50% of the diameter of the artery)
occurred in 5 of 48 patients with control CAG, which was 10.4% (Table 5). When
conducting a binary logistic regression, there was no correlation between clinical
and angiographic characteristics and long-term PCI. Factors such as age and sex of
the patient, smoking, diabetes, hypertension, hyperlipidemia, chronic occlusion,
diameter and length of the stent in our study did not affect the development of
cardiovascular complications (table 6).

Discussions:

It is known that PCI of complex forms of CA lesions is associated with a decrease

in the immediate success of the procedure and a high incidence of unfavorable
cardiac complications [11]. In our work, it was shown that the use of very long
stents with a drug coating (> 40 mm) in the treatment of diffuse and extended CA
lesions allows in most cases to achieve good immediate and long-term results with
a low level of cardiac complications. The immediate success of the procedure was
98.8%, while the overall incidence of adverse cardiovascular events was 1.2%.
Only 1 patient was diagnosed with MI development without a Q 4 type tooth in the
hospital period.

After the introduction of the drug-eluting stents into clinical practice, considerable
progress was made in the treatment of this category of patients [13]. In a
multicenter randomized trial, LONG-DESIII (PercutaneousTreatmentof
LongNativeCoronaryLesionsWithDrug-ElutingStent-III), a comparative analysis
was made of the use of everolimusisyrolimusclosed stent patients with prolonged
stenoses (≥25 mm). [14] At the 9th month of follow-up, the incidence of
angiographic restenosis in the everolimus-covered stent group was 7.3% And 2.7%
in patients in the sirolimus-coated stent group (p = 0.04); The late loss of lumen
inside the stented segment was 0.22 ± 0.43 mm in comparison with 0.18 ± 0.28
mm, respectively (p = 0.29). According to the meta-analysis, combining the results
of large trials of SPIRIT, XIENCE V, out of 323 patients with long SV lesions
(≥35 mm) after implantation of everolimus-coated stents, in the long-term follow-
up period the incidence of cardiac complications was 9.2%, the frequency of re-
revascularization of the target lesion was -8.9%, while the frequency of late stent
thrombosis was 1.6% [2]. Serious concerns today are associated with a high risk of
developing late thrombotic occlusions after SLP implantation, which may be due
to delayed endothelialization of the stent, as well as an increase in the extent of the
stented segment of the SC [14]. In a large register, SuJ. Et al., In which 3,157
patients were included after implantation of sirolimus and everolimus-coated
stents, an increase in late stent thrombosis with an extent of lesion of> 31.5 mm
was noted. [15] In these studies, the technique of stenting of long lesions by
several stents using the " "(" Overlapping "), as in the market of instruments at the
time there were no stents longer than 40 mm. Vulnerable to this technique is the
"joint" of the stents, which due to a double layer of metal in this area is the cause
of excessive hypertension neointima, and the allocation of a double dose of a
cytotoxic drug is the cause of the formation of aneurysmal expansions [16].
Polymer coatings of 1 generation, due to delayed endothelialization and increased
risk of late thrombosis, prompted researchers to find new ways to solve the
problem.
Stents with a drug coating of a new generation with a fully biodegradable polymer
based on polylactic acid are now developed [9,10]. In our work we used a stent
with a biodegradable polymer coated with sirolimus - BioMime (Meril Life
Sciences, India). The complete release of the drug from the surface of the stent
takes place after 30 days, and the complete resorption of the polymer from
polylactate acid - after 40-50 days. In the results of our one-year follow-up, the
overall mortality was 1.2% of cases; The frequency of repeated revascularization
of the target lesion is 7.1%, the incidence of restenosis is 10.4%; Late loss of
lumen inside the stent - 0,18 ± 0,2 mm. The cases of subacute and late thrombosis
were stenting. It should be noted that at the moment there is a small number of
publications evaluating the long-term results of implantation of very long stents (>
40 mm). In the study of Polavarapu RS and the co-author of 258 patients after
implantation of sirolimus-coated stents, with a biodegradable polymer 40 mm long
in a remote observation period, the combined frequency Cardiac complications was
2%, which was comparable to the results of our work-2.2% [10].

In the literature there are not enough consecrated questions concerning the
occurrence of complications, technical features of PCI for diffuse lesions of SC. In
our work, technical difficulties occurred during stent placement to the site of
stenosis in 11 (12.9%) patients, in spite of the fact that in most cases guide tubes
with extraback-up EBU, XB, AL were used. Extended stenoses in addition to the
standard technique of strengthening the support of the guide catheter ("buddywire",
deep intubation of the guide catheter, the technique of "anchoring") in 2 cases, we
used the new guide-extension guides-GuideZilla (BostonScientific, USA). The
Hydraulic Extender is a soft-tip monorail catheter compatible with a 0.014-in.
Coronary conductor. A flexible distal part (25 cm in length) allows a deep
intubation of the artery with the overcoming of technically complicated artery
sections [18].

It is known that a number of clinical and morphological factors, such as diabetes

mellitus, smoking, chronic CA occlusion, the length of the lesion increase the
technical complexity of the endovascular procedure and the risk of complications
in the near and distant periods [19,5]. In the regression analysis, we did not find a
correlation between the incidence of cardiac complications in the long-term period
and clinical-angiographic factors. This may be due to a relatively small sample, as
well as a low percentage of cardiovascular events.
At the same time, the use of very long stents to treat patients with prolonged
stenoses of the coronary arteries potentially can reduce the economic costs of the
procedure by reducing the number of implantable stents.

Conclusion.

The use of very long sirolimus-coated stents (40-60 mm) to safely and effectively
prolong the extensive lesions of the coronary arteries according to a one-year
observation is accompanied by a low risk of repeated revascularization of the
target lesion and the development of other adverse cardiovascular events.

References:
1. Bokeria LA, Alekyan B.G. X-ray endovascular diagnosis and treatment of
heart and vascular diseases in the RF-2014. Moscow: NTSTSH them.
Bakuleva RAMS, 2014. P.206.
2. LozanoI.,Capin E., de laHeraJ.M. et al.Diffuse Coronary Artery Disease Not
Amenable to Revascularization: Long-term Prognosis.Rev. Esp.
Cardiol.2015; 68(7): 629–640. DOI:10.2143/AC.68.2.2967272
3. Experience in the use of drugs for the treatment of cardiopulmonary bypass
and diffuse lesions of the coronary arteries. Cardiology. 2007. T. № 9. Pp.
41-46.
4. XuB., GaoR.L., ZhangR.Y. etal. Efficacy and safety of FIREHAWK
abluminal groove filled biodegradable polymer sirolimus-eluting stents for
the treatment of long coronary lesions: nine-month angiographic and one-
year clinical results from TARGET I trial long cohort. Chinese Medical
Journal 2013;126(6):1026–1032.DOI: 10.3760/cma.j.issn.0366-
6999.20123206
5. Klein L.W., Krone R.J. Angiographic characterization of lesion
morphology. Cardiac Interventions Today. 2008. Jul/Aug. P. 44-49.
6. Ryan T.J., Faxon D.P., Gunnar R.M., et al. Guidelines for percutaneous
transluminal coronary angioplasty.A report of the American College of
 Cardiology/American Heart Association Task Force on Assessment of
Diagnostic and Therapeutic Cardiovascular Procedures. Circulation. 1988.
Vol. 78. P. 486-502.
7. Räber L., Jüni P., Löffel L. et al. Impact of stent overlap on angiographic
and long-term clinical outcome in patients undergoing drug-eluting stent
implantation.Journal of the American College of Cardiology.
2010;55(12):1178–88.DOI: 10.1016/j.jacc.2009.11.052
8. Triantafyllou K. Spot Stenting Is Preferable in Long Diffuse Coronary
Lesions: Possible Incremental Value of Physiologic and Intracoronary
Imaging Modalities. Hospital Chronicles 2013;8:71-77.
9. Jain R.K., ChakravarthiP ., Shetty R. et al. One-yearoutcomes of
aBioMime™ Sirolimus-Eluting Coronary Stent System with a biodegradable
polymer in all-comers coronary artery disease patients: The meriT-3 study.
Indian Heart J2016;68(5): 599–603.DOI: 10.1016/j.ihj.2016.09.007
10. Polavarapu R.S., Prajapati J., Thakkar K. et al.Clinical outcomes from
unselected real-world patients with long coronary lesion receiving 40 mm
bioabsorbable polymer coated sirolimus-eluting stent. Abstracts EuroPCR.
2015. P.48.DOI: 10.1155/2015/613089
11. Mancini J. Quantitative coronary arteriographic methods in the
interventional catheterization laboratory: an update and perspective. Journal
of the American College of Cardiology 1991;17(6): 23–33.DOI:
10.1016/0735-1097(91)90935-3
12. 2014 ESC/EEACTS Guideline on myocardial revascularization. European
Heart Journal. 2014;35(37):2541-2619.DOI: 10.1093/eurheartj/ehu278
13. Gould K.L., Johnson N.P. Physiologic severity of diffuse coronary
artery disease: Hidden high risk. (Editorial) Circulation 2015; 131(1):4-
6.DOI: 10.1161/Сirculation AH A.114.013815
14. Park D.W., Kim Y.H., Song H.G. et al. Comparison of everolimus- and
sirolimus-eluting stents in patients with long coronary artery lesions: a
randomized LONG-DES-III (Percutaneous Treatment of LONG Native
 Coronary Lesions With Drug-Eluting Stent-III) Trial.JACC
CardiovascInterv 2011;4(10):1096-1103. DOI:10.1016/j.jcin.2011.05.024
15. Bouras G.,Jhamnani S.,Ng V.G.,et al.Clinical Outcomes After PCI
Treatment of Very LongLesions with the XIENCE V Everolimus Eluting
Stent: Pooled Analysis from the SPIRIT and XIENCE V USAProspective
Multicenter Trials.Catheter. Cardiovasc. Interv2016; Aug 22. DOI:
10.1002/ccd.26711
16. Suh J., Park D.W., Lee J.Y., et al. The relationship and thresholdof stent
length with regard to risk of stent thrombosis afterdrug-eluting stent
implantation. JACC CardiovascInterv 2010;3(4):383–389.DOI:
10.1016/j.jcin.2009.10.033
17. Kereiakes D.J., Wang H., Pompa J.J. et al. Periprocedural and late
consequences of overlapping Cypher sirolimus-eluting stents: pooled
analysis of five clinical trials. J Am. Coll. Cardiol 2006;48(1):4821-
4831.DOI:10.1016/j.jacc.2006.02.058
18. Waggoner T., Desai H., Sanghvi K. A unique complication of the
GuideZilla guideextension support catheter and the risk of stentstripping in
interventional & endovascularinterventions.Indian Heart J2014;67(4):381-
384. DOI:10.1016/j.ihj.2015.04.018
19. Huang Z., Chen H.W., Katoh O. et al. Evaluation of long stent implantation
in diffuse coronary lesions for octogenarians.Am JGeriatrCardiol
2005;2(1):29-35.
 Table 1. Clinical characteristics of patients included in the study (n = 85).
Index N %
Middle age, years 63.6±9.8
The Men 63 74.1
Women 22 25.9
Smoking at the moment 21 24.7
Arterial hypertension 45 52.9
Hyperlipidemia 76 89.4
Diabetes 20 23.5
Peaks 60 70.5
Previously transferred 17 20.2
PCI
Previously transferred 5 5.9
CABG
LVEF <40% 5 5.9
PEAKS - Post-infarction cardiosclerosis; KS-coronary bypass surgery; LVEF - left
ventricular ejection fraction

Table 2: Angiographic characteristics of patients (n = 85).

Index n %
Total number of stenoses 85 100
Type of blood supply of the myocardium
Right 59 69,4
Left 12 14,1
Balanced 14 16,5
Number of affected arteries
1 26 30,5
2 31 36,4
3 28 32,9
Localization
PHA 30 35,3
PCA 45 52,9
OA/ATC 10 11,8
Chronic occlusions 40 47,1
Bifurcation stenosis 13 15,2
Score on the Syntax scale (points)
Low risk (≤22) 47 55,3
Average risk (23-33) 38 44,7
 Table 3: Initial quantitative angiographic and procedural data, n = 85.
Characteristics n %
Extent of initial lesion, mm 52.4±9.4
Reference diameter of the artery, mm 3.1±0.7
Minimum diameter of lumen narrowing, mm:
Before the procedure 0.92±0.5
After the procedure 2.64±0.2
Degree of stenosis (%)
Before the procedure 60.2±18.7
After the procedure 17.1±5.6
Vascular access during PCI
Radial 77 90.6
Ulnarny 8 9.5
Time of procedure (min) 39.8±19.9
The dose of irradiation (mGy) 1934.8±740.5
Time of X-ray irradiation (min) 14.5±6.2
The average volume of contrast in-va
219.9±95.9
for 1 patient (ml)

Table 4: Remote clinical outcomes of PCI in 12 months (n = 85).

Characteristics n %
Combined endpoint 8 9.4
Death from all causes 1 1.2
Cardiac death 0 0
Myocardial infarction 1 1.2
Repeated revascularization of target
6 7.1
lesion
*Death from all causes + IM + revascularization of the target lesion.

Table 5: Quantitative angiographic data after 12 months (n = 48).

Characteristics n %
Minimum diameter of lumen stent, mm 2.46±0.4
Average degree of stenosis,% 21.5±3.4
Late loss of lumen diameter, mm* 0.18±0.2
Angiographic carcinogenesis,% 5 10.4
Late thrombosis of the stent 0 0
* Calculated as the difference between the minimum diameter of the artery lumen
after stent implantation and after 12 months.
 Table 6: Evaluation of the effect of predictors of cardiovascular complications
(binary logistic regression, n = 48)
Clinical and angiographic
OSH (95% CI) р*
factors
Age 2.27 (0.39-13.12) 0.35
Floor 1.60 (0.25-10.07) 0.61
Smoking 2.0 (0.21-18.95) 0.54
Diabetes 0.47 (0.07-3.01) 0.42
Hyperlipidemia 0.91 (0.82-0.99) 0.43
PCI, CABG in history 1.41 (0.15-13.62) 0.76
LVEF 1.12 (0.22-5.97) 0.88
Chronic occlusion 0.62 (0.49-0.78) 0.06
Stent length, mm 0.68 (0.74-6.12) 0.72
Diameter of the stent, mm 0.79 (0.86-7.22) 0.83
CI - confidence interval; CABG - aortocoronary bypass; LVEF - left ventricular
ejection fraction

Figure 1: Distribution of stents along the length (n = 85)

Figure 2: Survival curve (Kaplan-Mayer) without cardiovascular events in patients
with diffuse coronary arteries.
Figure 3: Angiograms of the patient H., 52 years old. A - the initial angiogram, the
arrow indicates subtotal stenosis on the verge of occlusion, the degree of antegrade
blood flow TIMI 2 (according to TIMI classification); B - after predilatation with
balloon 2.5x20 mm, arrows indicate extended residual stenosis of middle segment
of right coronary artery (PKA), B - The stage of positioning the stent BioMime
3.0x48 mm, indicated by arrows; T-final result (after stent implantation), no
residual stenosis; E-control angiogram of the APC at 12 months, the stented
segment is passable, with no signs of restenosis (indicated by arrows).
 Figure 4: Angiograms of the patient G., 74 let.A., B-source angiograms, arrows
indicate diffuse, extended lesion of anterior descending artery (PNA); B - after
predlatation balloons2.5x15 mm and 2.5x30 mm, the usual arrows indicate
extended residual stenosis of the proximal and middle segments of the PNA, bold
arrows indicate a dissection that has arisen after the predilatation, G - holding the
stent in the middle segment of the PNA with the aid of the GuideZilla extender,
The arrow shows the tip of the GuideZilla catheter in the middle segment of the
PNA, the usual arrows indicate the stents of the stent BioMime 3.0x48 mm; D-
implantation of the stent after removal of the GuideZilla catheter (indicated by
arrows); E-end result, arrows indicate stented segment, residual stenosis is absent.