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CorSalud 2014 Jan-Mar;6(1):36-46
Cuban Society of Cardiology Original Article
Clinical and angiographic assessment of coronary bare-metal
stent restenosis
Max G. Sánchez Manzanaresa MD; Francisco L. Moreno-Martínezb, MD, MSc; Iguer F. Aladro Mirandab, MD, MSc; Luis F. Vega Fleitesb, MD; Rosendo S. Ibargollín Hernándezb, MD, MSc; José R. Nodarse Valdiviab, MD; Norge R. Lara Pérezb, MD; Alejandro Agüero Sánchezb, MD; Reinaldo C. Gavilanes Garcíac, MD; Lill D. Vega Plác, MD; Leonardo Pérez Gonzálezc, MD; Maribel I. Noda Valledord, MSc; Ricardo Oroz Morenoe, MD; and Wanda Báez La Rosaf, BN a Arnaldo Milian Castro University Hospital. Vil a Clara, Cuba. b Interventional Cardiology Unit. Cardiocentro Ernesto Che Guevara. Vil a Clara, Cuba. c Faculty of Medicine. Dr. Serafín Ruiz de Zárate Ruiz University of Medical Sciences. Vil a Clara, Cuba. d Faculty of Nursing. Dr. Serafín Ruiz de Zárate Ruiz University of Medical Sciences. Vil a Clara, Cuba. e Faculty of Medicine. Navarra University. Pamplona, España. f Municipal Health Office of Santa Clara. Vil a Clara, Cuba. * Graduated from the Latin American School of Medicine in Vil a Clara, Cuba. ARTICLE INFORMATION ABSTRACT
Introduction: Ischemic heart disease is the leading cause of death in Cuba. Coronary
Received: August 14, 2012 angioplasty with stenting is an excellent treatment option, but restenosis overshadows Modified: May 21, 2013 its prognosis and is more common with the use of bare metal stents. Accepted: June 13, 2013 Objective: To characterize restenosis after coronary bare-metal stent from the clinical
and angiographic points of view. Competing interests
Method: A descriptive cross-sectional study was conducted in 59 patients with a diag-
The authors declare no competing nosis of restenosis after coronary bare-metal stent confirmed by angiography in the Interventional Cardiology Unit of Cardiocentro Ernesto Che Guevara of Vil a Clara, Cuba, from February 2010 to April 2012. The variables analyzed were age, sex, coro- nary risk factors, previous history of angina or heart attack, vessel involved, type of CRF: coronary risk factors
restenosis and treated lesion, vessel diameter and lesion length. PTCA: Percutaneous transluminal
Results: Predominance of male patients (76.27 %), aged 60-69 years (40.66 %). The
coronary angioplasty most common risk factors were hypertension (76.27 %), smoking (37.28 %) and type II diabetes mellitus (33.89 %). The most affected vessel was the left anterior descending On-Line Versions: (28.81 %), arterial diameters were predominantly ≤ 2.5 mm (54.2%) and lesion length > 20 mm (65, 97). Type B injuries (52.5) and focal restenosis (57.62 %) were more MG Sánchez Manzanares Hospital Manolo Morales Peralta Conclusions: Patients with restenosis were predominantly male, between 60-69 years
Pista Portezuelo s/n. Managua, old, with a history of hypertension, smoking and diabetes mel itus type II. Left ante- Nicaragua. E-mail address: rior descending disease, diameter ≤ 2.5 mm, lesion length > 20 mm, type B coronary lesion and focal restenosis were more frequent. RNPS 2235-145 2009-2014 Cardiocentro Ernesto Che Guevara, Villa Clara, Cuba. All rights reserved. Sánchez Manzanares MG, et al. Key words: Coronary artery disease, Angioplasty, Bare metal stent, Restenosis, Risk

Valoración clínica y angiográfica de la reestenosis del stent coronario
convencional

RESUMEN
Introducción: La cardiopatía isquémica es la principal causa de muerte en Cuba. La
angioplastia coronaria con stent es una excelente opción terapéutica, pero la reeste- nosis ensombrece su pronóstico y es mucho más frecuente con el uso de stents con- Objetivo: Caracterizar clínica y angiográficamente la reestenosis del stent coronario
Método: Se realizó un estudio descriptivo y transversal en los 59 pacientes con diag-
nóstico de reestenosis del stent coronario convencional confirmado por angiografía en la Unidad de Cardiología Intervencionista del Cardiocentro "Ernesto Che Guevara" de Vil a Clara, Cuba, durante el período febrero 2010 – abril 2012. Las variables anali- zadas fueron edad, sexo, factores de riesgo coronario, historia previa de angina o infarto, vaso afectado, tipo de reestenosis y de lesión tratada, diámetro del vaso y longitud de la lesión. Resultados: Predominaron los pacientes del sexo masculino (76,3 %), con edades
comprendidas entre 60-69 años (40,7 %). Los factores de riesgo más frecuentes fue- ron la hipertensión arterial (76,3 %), el hábito de fumar (37,3 %) y la diabetes mel itus tipo II (33,9 %). El vaso más afectado fue la descendente anterior (59,3 %), los diáme- tros arteriales eran predominantemente ≤ 2,5 mm (54,2 %) y la longitud de las lesio- nes > 20 mm (66,1 %). Las lesiones tipo B (52,5 %) y la reestenosis focal (57,6 %) fueron más frecuentes. Conclusiones: Los pacientes con reestenosis eran predominantemente hombres, entre
60-69 años de edad, con antecedentes de hipertensión arterial, tabaquismo y diabetes mellitus tipo II. La enfermedad de la descendente anterior, el diámetro del vaso ≤ 2,5 mm, la longitud de las lesiones > 20 mm, la lesión coronaria tipo B y la reestenosis fo- cal fueron más frecuentes. Palabras clave: Cardiopatía isquémica, Angioplastia coronaria, Stent convencional,
Reestenosis, Factores de riesgo
INTRODUCTION
These plaques, which may have different dimen- sions, present concomitant degrees (total or partial) of Ischemic heart disease is a major cause of morbidity arterial obstruction, may be vulnerable or not, and and mortality worldwide. In Cuba it represents about lead to the corresponding stages of the disease clinical 75 % of cardiovascular disease and about 25 % of overall mortality1. Its main cause is coronary atheros-
Percutaneous transluminal coronary angioplasty clerosis, which is a multifactorial disease and appears (PTCA) is an excellent treatment option for patients by the association of multiple coronary risk factors with chronic stable angina or any type of acute coro- (CRF) producing vascular endothelium disorders, nary syndrome. This therapeutic modality, with stent which leads to the accumulation of lipids, macro- implantation has reduced mortality from acute myo- phages, platelets and T lymphocytes in the subintimal cardial infarction (AMI) and maintained patency of the space and stimulate the migration and proliferation of affected vessel, ensuring the mechanical support that smooth muscle cells, with extracel ular matrix for- prevents elastic recoil of the wall of the artery treated mation originating atheroma2-4.
with the consequent reduction of recurrent ischemia CorSalud 2014 Jan-Mar;6(1):36-46 Clinical and angiographic assessment of coronary bare-metal stent restenosis and cardiac arrhythmias, al with a short hospital stay in Santa Clara, Vil a Clara, Cuba, from February 2010 to Since stents were first use in Palmaz Schatz, in the late '80s and to the present, the changes in their structures have been impressive, as an evidence of the Inclusion criteria
evolution of new and more sophisticated geometric shapes, with less material in its metal structure that Al patients with coronary artery disease undergoing will not weaken its radial strength but also maintain PTCA in the period mentioned, who presented coro- and even increase its flexibility, all of which gives nary stent restenosis were included. stents ever better features to favor its implantation in increasingly tortuous and distal arteries6-9.
Simultaneous to this development, drug-eluting Technique description
stents have emerged and developed, which have a polymer on its metal frame, wherein an antiprolife- Conventional coronary angiography via femoral was rative substance (sirolimus or paclitaxel and its ana- performed to the 59 patients who had showed myo- logs) is placed that significantly reduces the risk of cardial ischemia in any of the usual tests for this restenosis. But its high cost prevents widespread use purpose. PTCA was performed there and then. The in developing countries such as Cuba, where only a stenting procedure was guided by the visual analysis few series of patients with this type of device have of angiograms. Once PTCA was initiated an unfrac- been reported, and where the use of bare-metal tionated sodium heparin bolus was administered at stents predominates9.
100 IU/kg. PTCA catheter was passed with the stent Restenosis usual y occurs in the first 6 months after until it was placed in the injury site; its ful expansion PTCA has been performed and its frequency has was achieved by inflating the bal oon to pressures ranged from 30-45 % in the beginning, to 15-20 % in equal or greater than 14 atmospheres, depending on the current era9-11.
vessel diameter and hardness of the lesion. The coronary stent implantation has helped im- prove the restenosis rate by control ing two of the components of the vascular response: early elastic Information col ection
recoil and late vascular constriction. However, intimal proliferation seems to be exacerbated after stent im- The primary data was col ected through a question- plantation. The most frequently associated predictive naire prepared for this purpose, through the inter- factors are diabetes mellitus, increased length of the view, medical history of patients and the reports of lesion treated, history of prior revascularization (either the Interventional Cardiology Unit. The variables were: percutaneous or surgical), a smaller reference dia- age (in years), sex (male or female), CRF (hyperten- meter of vessel, location in the left anterior des- sion, diabetes mellitus, dyslipidemia, smoking, obesi- cending artery and a smal er lumen diameter after the ty)2,4,14,15, previous history of angina or AMI, affected
vessel (left anterior descending, circumflex, right coro- The objective of this research was to characterize nary artery ), type of restenosis (focal or diffuse)12,16,17,
coronary bare metal stent restenosis compared to vessel diameter and lesion length (in millimeters), and clinical and angiographic variables. type of lesion (A, B, C)17.
Statistical analysis
A descriptive cross-sectional study was performed in The collected data were entered and processed using 59 patients with a diagnosis of restenosis of coronary the SPSS statistical software, version 15.0. Absolute stents in the Interventional Cardiology and Cathe- frequencies (number of cases) and relative (percent- terization Unit of Cardiocentro Ernesto Che Guevara, age) were determined. CorSalud 2014 Jan-Mar;6(1):36-46 Sánchez Manzanares MG, et al. For the analysis and interpretation of results, sta- tistical techniques according to a descriptive study design were used, which included the test of homo- geneity of independent groups and goodness of fit test for the comparison of percentages based on the Chi- squared distribution. As a result of these statistical hypothesis tests, the value of the corresponding statistic for its p signifi- cance (value) was presented. According to the p value, the difference or association was classified as signi- ficant (p < 0.05) and not significant (p ≥ 0.05).
Bioethical considerations
Although no personal information from patients or Figure 1. Coronary risk factors.
relatives was required, the research complied with the 5 ethical principles and confidentiality of data was guaranteed. This study was approved by the Research Ethics Committee of the Cardiocentro Ernesto Che The distribution of patients by sex and age groups (Table 1) shows that there is a male predominance
with a total of 45 patients (76.3%) and the most affected age group was between 60-69 years (40.7%). Only 14 women (23.7 %) had restenosis, without clear Figure 2. Distribution of patients by sex and type of
ischemic heart disease. Table 1. Distribution of patients by sex and age groups.
predominance among age groups. Although Age groups
there were three times more men than wo- men, there were no significant differences in general (p=0.683). The most frequent coronary risk factor was high blood pressure (Figure 1), present in
45 of patients studied (76.3%), fol owed by smoking (37.3%), diabetes mellitus (33.9%), dyslipidemia (16.9% ) and obesity in a lower percentage (6.8%). There were no significant differences in distribution by sex. The distribution of patients according to sex and type of ischemic heart disease (Fig-
χ2=2.29; p=0.683 ure 2) shows that old infarction (28 males
Source: Interventional Cardiology and Catheterization Unit Database. Cardiocentro Ernesto Che Guevara. Villa Clara, Cuba. and 8 females) and stable angina (24 men CorSalud 2014 Jan-Mar;6(1):36-46 Clinical and angiographic assessment of coronary bare-metal stent restenosis order of frequency. Other data show that the most affected segments were the middle of the anterior descending artery (28.8%), fol owed by the proximal of right coronary artery ( 14.6%), and distal of circumflex artery (11.3%). Vessel diameter ≤ 2.5 mm and lesion length of> 20 mm (42.4%) predominated, fol owed by diameter of 2.6 - 3,0 mm and > 20 mm of lesion length (18.6% ), where significant differences p = 0.028 (Table 2) were
found. Note that there were no patients with smal Figure 3. Affected arteries and type of coronary lesion.
lesions and good vessel caliber. When age groups and type of restenosis were com- pared (Table 3) no significant differences were found
and 11 women) predominated. A minority of cases (p = 0.937). There was a predominance of focal res- had suffered a recent infarction. Male predominance tenosis with a total of 34 patients (57.6%), and the age in all types of ischemic heart disease studied is clearly group 60-69 years was more frequently affected (40.6%), fol owed by those aged 50-59 (27.1%). Figure 3 shows that the left anterior descending
The association between restenosis and CRF (Table
artery (59.3%), fol owed by the right coronary (23.7%) 4) showed no significant differences either (p = 0.561).
and the circumflex (16.9%), were the most affected The percentages were similar in the assessed CRF ex- arteries by restenosis with significant differences (p = cept in patients with dyslipidemia, where focal res- 0.042). And the types of lesion treated on restenosis tenosis predominated (8 of 10 patients), representing occurred were, B (52.5%), C (28.9%) and A (18.6%) in 13.6% of al patients and 80% of those with this lipid Of the 59 patients with res- Table 2. Distribution of patients, according to vessel diameter and lesion length.
tenosis, the new percutaneous Lesion length (mm)
revascularization could only be diameter
performed in 28 patients, 17 stent PTCA (stent-intrastent) and 11 bal oon PTCA. Of the remaining 31, 28 were referred to surgery and 3 remained with medical therapy, due to the co- morbidities and high preopera- tive risk, pending the implanta- χ2=2.852; p=0.028 tion of a drug-eluting stent. Table 3. Distribution of patients by age and type of restenosis.
Restenosis
DISCUSSION
groups (years)
The predominance of males can be attributed to the smal sample size, because although ischemic heart disease predominates in men at younger ages, this difference is equated as age advances, after a woman loses estrogen protection. Regarding the predominating age group, our results are consistent with the literature18-20, as this disease is more com-
χ2=0.813; p=0.937 mon in patients older than 60 years. In fact, CorSalud 2014 Jan-Mar;6(1):36-46 Sánchez Manzanares MG, et al. Table 4. Distribution of patients according to risk factors and restenosis rate (n=59).
that restenosis is common in insulin-dependent diabetics, for, Restenosis
in general, these patients have Risk Factors
diffuse and small vessel dis- ease29-30.
López y Cortés-Bergoderi31
Type I diabetes mellitus did not find that dyslipidemia and obesity constitute significant clinical variables of restenosis. However, another study of cli- nical predictors32 found that of
χ2=2.98; p=0.561 all patients with restenosis, 21.6 % were diabetic, 59.2% hyper- most of the new cases are seen in patients over 65 tensive, 25.5% dyslipidemic, and years, especially in females20,21.
37.5% active smokers. Ischemic heart disease in women has a similar Although obesity is an independent risk factor for incidenceas in men, but with 6-10 years of delay, so cardiovascular disease, no relation with restenosis31,
that from 70-75 years it is essentially the same. This has been found which coincides with our results. fact, known since the '50s of last century, has caused The findings of this study on the prevalence of CRF to consider the hypothesis of a protective effect of are consistent with other national and international research9,24,30,33-36. Hypertension is a global health pro-
In a study performed in Hermanos Amejeiras Hos- blem; in Cuba its prevalence in patients who had un- pital, in Havana, Cuba, that aimed to characterize the dergone coronary angiography is high9. According to
behavior of the different variables of clinical reste- Byrne et al.37, cardiac events fol owing a successful
nosis, male gender and the age group of 50-59 years coronary angioplasty were more frequent in hyper- were found to be the most affected17. Previous studies
tensive patients, and according to Alonso Martín et have indicated that male gender is an independent al.38, hypertension and diabetes type II often coexist,
factor of poor prognosis24.
with a prevalence of hypertension in diabetics approxi- Hypertension is an important CRF and could be a mately twice that in non-diabetics. Both CRF stimulate contributing factor in stent restenosis, which is the endothelial dysfunction (fundamental process that Achilles heel of interventional cardiology9. In this re-
relates them to restenosis)9,39,40. Type II diabetics may
search, a high prevalence of hypertension was ob- have a chance of 50% or more of angiographic res- served, which is in line with the epidemiological profile tenosis, so it has been established that this disease is of the current Cuban population and the frequent an independent and major risk factor for the develop- association of this disease with the coronary atheros- ment of this complication41,42.
Most cases of Silber et al.43 were referred for un-
Diabetes mellitus has been the most described stable angina and many of them had an association of clinical predictive factor because of a greater hyper- three or more CRF. Ximenes Meireles et al.44 observed
plastic response of the vascular wall25-27, but this does
that a history of AMI was present in 18.4% of patients, not correspond with our results, which is also due to stable angina in 43.3% and 68.1% were male. And in a the small sample size and to the fact that many Cuban study, with the purpose of monitoring patients diabetic patients are referred to surgery. Many of the with Firebirg30 stent, there was a male predominance
mechanisms described, favoring both restenosis and and history of AMI in the 52 patients included. progression of coronary artery disease in diabetics, In the studies of López Pérez et al.30 and Byrne et
dependent on hyperglycemia and on the coexistence al.37, complex lesions predominated (B and C), which
of other risk factors27,28. However, in the study by
coincides with our results. The incidence of restenosis Jiménez-Quevedo et al.29, diabetes was not significant-
is closely related to PTCA and type of coronary lesion ly associated with restenosis. Other studies indicate treated, the criteria in the guidelines of the American CorSalud 2014 Jan-Mar;6(1):36-46 Clinical and angiographic assessment of coronary bare-metal stent restenosis Col ege of Cardiology and the American Heart Asso- sions, greater than 20 mm need a new intervention ciation indicate moderate success (60-85%) in type B during monitoring and Planas-del Viejo et al.58 re-
lesions and low (<60%) on the C45-47 type, although it
ported that over 30% of lesions commonly treated by must be acknowledged that most chronic total occlu- PTCA correspond to small vessel disease. sions as well as long, angled and heavily calcified With the current experience it has become clear lesions are currently successful y treated, as tech- that vessel diameter and lesion length are powerful nological advances and the emergence of new intra- predictors of restenosis23,44,61.
vascular devices have facilitated our work. Relationship with age has not been established. In Valencia et al.48 studied patients with stenosis of
our study no association was found either, however, the left anterior descending artery treated with stents depending on the type of injury and patient comorbid- and repeat revascularization rate was low, however, dities different types of restenosis will be presented, the propensity of this artery to restenosis is known, so although according to Byrne et al.37 and Ximenes Mei-
the involvement of its proximal segment represents a reles et al.44 the focal pattern is predominant.
special subset of patients. In vivo studies with intra- The fact that in this study only 29 patients under- vascular ultrasound have shown a predominantly went the new percutaneous revascularization is due to eccentric involvement of this type of injury43,48. In our
the limited availability of drug-eluting stents (bare- study the most treated ones were those of the middle metal stent restenosis should not be treated with segment with length > 20 mm. It is evident that the another of the same characteristics), and favorable absence of patients with lesions smaller than 10 mm in results of coronary surgery at the hospital where the our series is because, no matter the caliber of the study was conducted. vessel, these very short lesions are unlikely to res- Multiple factors have been associated with the incidence of restenosis, among them are clinical Other anatomical factors have been associated factors (diabetes mellitus, unstable angina, previous with an increased risk of this complication. Various restenosis), angiographic (proximal left anterior des- studies have identified a relationship between total cending artery, small vessel diameter, total occlusion, occlusion and severe stenosis prior to angioplasty with ostial disease, bifurcations, long lesion and saphenous the development of restenosis after the procedure. It vein graft) procedure-related (significant residual has also been associated with long, eccentric, of proxi- stenosis, smaller minimum luminal diameter, smaller mal location, calcified, ostial and bifurcated lesions43,49.
acute postprocedural gain and prior restenotic be- González et al.17 describe lesions of predominantly
havior) and genetic factors47,49,59,62-68.
ostial location and in the anterior descending artery. New antiproliferative drugs are being investigated When Astin and Jones50 studied the evolution of these
in order to reduce restenosis, stents with selective lesions they showed that stent expansion was lower in eluting systems and the ability to deliver different the branch, with greater neointimal hyperplasia in the drugs, and biodegradable stents. Undoubtedly, the ostium than in its distal segment or in the main vessel. future development of these devices is wide and will They also stated that a minimal luminal area of less surely benefit patients. than 4.8 mm2 in the ostium of the branch after PTCA, with subsequent neointimal growth, makes this the most frequent site of restenosis. CONCLUSIONS
A significant association was found when vessel diameter and lesion length were related, which is con- Patients with restenosis were predominantly male, sistent with various research18,41,51-55, as it is acknow-
between 60-69 years old, with a history of ledged that these situations are predictors of res- hypertension, smoking and diabetes mellitus type II. tenosis. The smaller vessel size and the greater lesion Left anterior descending disease, vessel diameter ≤ 2.5 length are independent risk factors of restenosis 53,54.
mm, lesion length> 20 mm, type B coronary lesion and This ratio decreases but does not disappear with the focal restenosis were more frequent. use of active drug-eluting stents10,11,56-59.
According to Serruys et al.60, 10-30% of diffuse le-
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