Marden Tabet ING.pmd - Revista Brasileira de Cardiologia Invasiva

Rev Bras Cardiol Invas 2007; 15(3).
Tebet MA, et al. Primary Angioplasty Using the Radial Access With High Bolus Dose of Tirofiban: a Safe and Effective Technique.
Rev Bras Cardiol Invas 2007; 15(3).
SUMMARY
Primary Angioplasty Using the Radial Access
With High Bolus Dose of Tirofiban:
a Safe and Effective Technique
Marden Andre Tebet 1,2 , Pedro Beraldo de Andrade 1,2 , Milena Gentile 1 ,
Luiz Alberto Mattos 1,3 , André Labrunie 1,2
Background: The use of the transradial access for primary
angioplasty is efficient and safe, even with aggressive
antithrombotic regimen. The aim of this study is to perform
an analysis of the safety and effectiveness of primary
angioplasty using the radial access and a high bolus dose
of tirofiban. Method: From January 2006 to April 2007, 73
patients were submitted to primary angioplasty in our
service using the radial access. The in-hospital and late
major adverse cardiovascular events were retrospectively
evaluated particularly in respect to the occurrence of
hemorrhagic and vascular complications. Results: The use
of the radial access was 100% successfully. Angiographic
success was obtained in 95.8% of the patients. The right
coronary was treated in 50% of the cases. A high bolus
dose of tirofiban was used in 75% of the patients. There
were 3 in-hospital cardiac deaths, but no cause of major
bleeding. Local hematomas occurred in 5.4% of the cases.
In the late follow-up (average of 7 months), the mortality
rate was 5.4% with no complications related to the arterial
puncture site or major bleeding. Conclusion: The systematic
use of the transradial approach for primary angioplasty
is highly efficient and safe despite the use of an
aggressive anticoagulation and antithrombotic regimen
including a high bolus dose of tirofiban.
DESCRIPTORS: Angioplasty, transluminal, percutaneous
coronary. Radial artery. Tyrosine, analogs & derivatives.
1 Serviço de Hemodinâmica da Santa Casa de Marília, Marília, SP.
2 Hospital do Coração de Londrina, Londrina, PR.
3 Instituto Dante Pazzanese de Cardiologia, São Paulo, SP.
Correspondence: Marden André Tebet. Avenida Carlos Artêncio, 356
- Apto. 43B - Marília, SP - CEP 17519-255
E-mail: mardentebet@uol.com.br
Recepted in: 10/6/2007 Acept in: 27/7/2007
RESUMO
Original Article
Angioplastia Primária via Radial com Doses
Aumentadas de Tirofiban: uma Técnica
Segura e Efetiva
Introdução: O acesso transradial para a realização de
angioplastia primária é eficaz e seguro, mesmo com utilização
de um regime agressivo de anticoagulação e antiagregação.
O objetivo dessa série histórica de casos é avaliar a segurança
e a efetividade da angioplastia primária via radial associada
à utilização de bolus com dose aumentada de tirofiban.
Método: Foram avaliados, retrospectivamente, no período
de janeiro de 2006 a abril de 2007, 73 pacientes submetidos
à angioplastia primária, em nosso serviço, pelo acesso
radial, com análise dos resultados hospitalares e tardios,
com enfoque nas complicações hemorrágicas e vasculares.
Resultados: Obteve-se sucesso de 100% na utilização da
via de acesso radial. Sucesso angiográfico ocorreu em
95,8% dos pacientes. A artéria coronária direita foi tratada
em 50% dos casos. Tirofiban com bolus aumentado foi
utilizado em 75% dos pacientes. Durante a fase hospitalar,
houve três óbitos de causa cardíaca e nenhum caso de
sangramento maior. Hematomas localizados ocorreram em
5,4% dos casos. No seguimento tardio (média de 7 meses),
a taxa de mortalidade foi de 5,4%, sem nenhuma complicação
relacionada ao sítio de punção arterial ou sangramento
maior. Conclusão: No nosso serviço de cardiologia intervencionista,
que utiliza a via radial sistematicamente, seu
emprego na angioplastia primária é altamente eficaz e
seguro, a despeito do uso de um regime de anticoagulação
e antiagregação agressivos.
DESCRITORES: Angioplastia transluminal percutânea
coronária. Artéria radial. Tirosina, análogos & derivados.
Primary angioplasty is the reperfusion strategy of
choice in patients with acute myocardial infarction
with elevation of the ST segment. (AMI) 1-3 .
The coronary intervention is typically performed
through the transfemoral access. Hemorrhagic and vascular
complications in the site of the femoral punction
1

Tebet MA, et al. Primary Angioplasty Using the Radial Access With High Bolus Dose of Tirofiban: a Safe and Effective Technique.
Rev Bras Cardiol Invas 2007; 15(3).
can bring about a significant increase of complications,
time of stay in hospital and cost of the procedure,
especially when the angioplasty is performed under
the aggressive regime of anticoagulation and antiplatelet
therapy, especially with the use of glico-protein inhibitors
Iib/IIIa (GPI) 4 .
The use of the transradial access is based on the
reduction of hemorrhagic complications in the vascular
access site and long rest in bed. Several studies have
confirmed its applicability and potential advantages
over the femoral approach 5-9 , with equal success and
less hemorrhagic complications, even with the use of
an aggressive anti thrombotic regime, including GPI 4.
In spite of some conflicting results, studies have
established the safety and efficacy of GPIs during primary
angioplasty 10-13 . The current guidelines specifically recommend
the use of abciximab during primary PCI as
a class I 3 indication.
In patients with acute coronary syndromes, the TAR-
GET 14 study showed less efficacy of tirofiban when compared
to abciximab. It is believed that this is due to, mainly,
to an inadequate platelet inhibition in the first hours after
administering tirofiban during the procedure 14-19 . The use
of bolus with an increased dose of tirofiban have shown
platelet inhibition and similar clinical results to those
found with abciximab 20-22 . The substitution of abciximab
for tirofiban, administered with a bolus regime with increased
dose, is a promising strategy, which might show itself to
be cost effective.
The objective of this study is to assess the effectiveness
of primary angioplasty through the radius associated
to the use of bolus with an increased dose of
tirofiban.
METHOD
Between January 2006 and May 2007, 79 patients
with AMI with augmented ST segment were submitted
to primary angioplasty in our service. Seventy-three
patients made up the sample (92%). Six patients were
excluded from the sample due to the non-use of the
radial technique: three for lack of radial pulse (two for
previous use of the Sones technique and one due to
previous catheterism and angioplasty through direct
radial approach), two for cardiogenic shock and total
atria ventricular blockage with the need of a temporary
pacemaker, and another patient who evolved with
coronary embolization during an hemodynamic study
for mitral valvulopathy.
Late follow up was obtained in all the patients, either
through their case histories or through telephone calls.
The choice vessel was the right radial. The choice
of the radial technique occurred through the Allen
modified test. If the test were negative, the other vessel
used was the left radial. Short introducers (8 cmts)
were used: French 6. A solution with 5000 UI of heparin
2
sulfate and 10 mg of issosorbide mononitrate was
injected through the introducer. The procedures were
performed with the habitual techniques. Stents were
implanted with the direct or conventional technique.
The removal of the introducers was performed immediately
after the procedure; the haemeostasis was done
with a porous compressive elastic bandage (Tensoplast ® ),
for about four hours. After this period, compression was
relaxed and a small sticking plaster was used during
24 hours. There was no need of haemostatic devices.
The functional circulation of the hand was verified
after one hour.
All patients received 300 mg of aspirin in the
emergency room. Clopidogrel was administered in the
hemodynamic room, using a dose of 300 mg or 600 mg
respectively, with or without tirofiban. Non-fractioned
Heparin was used in all the patients in a total dose of
100 U/kg. Tirofiban was used at the discretion of the
operator, in the dose of 25 u/kg in 3-minute bolus and
in the maintenance dose of 1.5 u/kg/min for 12 – 18
hours. A catheter for the aspiration of coronary thrombi
was also used at the operator’s discretion (Pronto ® ).
The outcomes used were: angiographic success
(percentual of the diameter of the stenosis of the target
vessel < 20% and coronary flux in the target vessel
TIMI 3), general in-hospital death, complications in
the arterial access – such as major bleeding (determiners
of a long hospital stay, surgical intervention, blood
transfusion or hemorrhagic stroke), arterio-venous fistulae,
ischemia of the limb with the need of vascular
surgery and failure of the procedure, defined as the
need of a second vessel entry or failure of the procedure
due to the impossibility of canalization of the radial
artery or conclusion of the coronary angioplasty or
due to a major complication in the site of the arterial
punction.
The continuous variables were expressed in medians
and standard deviation and, the categorical variables,
in absolute numbers and their percentual.
RESULTS
The majority (73.8%) of the patients were male.
There was a low incidence of patients with a previous
history of myocardial infarction, coronary angioplasty
and myocardial revascularization surgery. The demographic
data is in Table 1. Most of the patients were
unilateral and there was a higher striking of the right
coronary artery (Table 2). Angiographically visible
thrombi occurred in 18 (24.6%) of the patients but
thrombectomy was performed in only 22% of that
population, beginning in October 2006). The bolus
regime, with increased dose of tirofiban, was used in
74% of the patients. In our sample, seven (9.5%) of the
patients were 75 years old or more and out of these,
four (5.4%) used tirofiban without any bleeding episodes,
neither major nor minor. Heparin was not used

Tebet MA, et al. Primary Angioplasty Using the Radial Access With High Bolus Dose of Tirofiban: a Safe and Effective Technique.
Rev Bras Cardiol Invas 2007; 15(3).
after the procedure. Stents were implanted in 69 (94.5%)
of the patients. All exams were performed successfully
through the radial access. The catheters used for the
left and right coronary arteries were the extra back-up
(85%) for the left and Judkins for the right artery (86%),
respectively. Angiographic success took place in 70
(95.8%) of the patients.
Table 3 shows the occurrence of major adverse
events. There were three in-hospital deaths. One hap-
TABLE 1
Basic Characteristics
Basic Characteristics Total (n=73)
Mean age 60.8±10.4
Male gender (%) 51 (69.8)
HAS (%) 50 (68.4)
Diabetes (%) 15 (20.5)
Dislipidemia (%) 26 (35.6)
Family History of ICO (%) 8 (10.9)
Previous AMI (%) 4 (5.4)
Smoking (%) 35 (47.9)
Revascularization surgery (%) 0 (0)
Previous Angioplasty (%) 1 (1.3)
TABLE 2
Angiographic and Total
Procedural Characteristics
Angiographic and procedural Total (n=73)
characteristics
Number of vessels treated
Single artery (%) 35 (47.9)
Bi-artery (%) 23 (31.5)
Tri-artery (%) 15 (20.5)
Vessels treated
DA (%) 30 (41.1)
CX (%) 6 (8.2)
CD (%) 37 (50.6)
Angiographic Thrombus (%) 18 (24.6)
Balloon time (min) 84.3±26.5
Pre TIMI Flux
TIMI 0/1 pre (%) 61 (83.5)
TIMI 2/3 pre (%) 12 (16.4)
Tirofiban Bolus 25 µ/Kg. (%) 54 (74)
Aspiration Catheter (%) 4 (5.4)
Stent implant (%) 69 (94.5)
Post TIMI Flux
TIMI 0/1 post (%) 3 (4.1)
TIMI 2/3 post (%) 70 (95.8)
Angiographic Success (%) 70 (95.8)
pened 12 hours after angioplasty, which was angiographically
successful, due to refractory ventricular fibrillation.
The second death occurred on the fourth day of
hospitalization, after an unsuccessful angiography (noreflow),
due to refractory cardiogenic shock. The last
patient, admitted for extensive anterior AMI with a 10hour
evolution, presented an angiographic thrombi, more
than 15 mm in extension, without solution through thrombectomy,
GPI and coronary angioplasty, with no-reflow,
died on the second day due to cardiogenic shock.
The late follow up was obtained in 70% of the
patients. During the intermediate follow up, at seven
months, four (5.4%) more deaths took place. Of these,
3 happened in the third month after the acute episode
and probably due to a cardiac etiology; one patient
presented acute inflammatory abdomen and died in
the fourth month after the AMI. There were no other
complications. There was one episode of subacute
stent thrombosis, during the first week after the procedure,
treated through a new coronary angioplasty, with clinical
success (Table 3).
No major bleeding was identified during the inhospital
period. There was no need of a surgical procedure
in the site of the radial punction, blood transfusion,
lengthening of the hospitalization period, no
hemorragic brain stroke episode or bowel bleeding.
There were four cases of hematoma in the site of the
punction, however, without edema or hand ischemia.
There was one case of localized flebitis which responded
to clinical treatment.
DISCUSSION
The results of this analysis prove the safety and
efficacy of the transradial access in primary angioplasty,
even with the use of tirofiban, in bolus regime, with
increased dose.
The success of the transradial approach in this
sample is due to the systematic use in our service.
During the same period of the analysis, we performed
327 elective angioplasties (Figure 1). The radial approach
was used in 302 (92.4%) patients, and the femoral in
TABLE 3
Occurrence of events
Clinical Events Total (n=73)
Hospital death (%) 3 (4.1)
Late follow up (%) 51 (69.8)
Time of follow up (months) 7.26±4.9
Late death (%) 4 (5.4)
Re-infarction (%) 1 (1.3)
Emergency revascularization (%) 1 (1.3)
Major bleeding 0
Minor bleeding 4 (5.4)
3

Tebet MA, et al. Primary Angioplasty Using the Radial Access With High Bolus Dose of Tirofiban: a Safe and Effective Technique.
Rev Bras Cardiol Invas 2007; 15(3).
Figure 1 - Means of access used in elective angioplasties during
the period from January 2006 until May 2007.
the rest. The success in the elective angioplasties was
98.5%, with ballon angioplasties only in only 5 (1.5%)
patients. The 6F caliber introducers were used in 294
patients (97.3%0, in 3 (0.9%) of patients we used 5F
introducers and, in 5 (1.5%), 7F caliber introducers.
When the right radial approach was not possible, we
opted for the left radial artery for the performance of
the procedure. In cases on which a temporary pacemaker
was necessary, we used the radial access associated
to punction of the jugular vein or even to the
punction of the femoral vein.
This routine access, for the performance of primary
angioplasty, was only implanted after a learning curve
period of the operators, in accordance with several
studies that highlight its importance 23-26 .
In our patients group, there was a predominance
of AMI of the lower wall, clinically stable in most
cases. An eventual major clinical instability, would
potencially contribute negatively to the clinical success
and would determine a higher necessity for the use of
intra-aorta balloon use, which might result in a lower
use of the radial access.
In spite of it having become an option over ten
years ago, for the performance of coronary angioplasty,
in our midst, the radial access is still not much used.
Araújo and Mangione 27 assesed 53.777 patients submitted
to coronary intervention enrolled in the CENIC
(Centro Nacional de Intervenciones Vasculares – National
Center of Vascular Intervention). Out of these, 48.455
patients underwent elective coronary angioplasty and
5.322 in the course of infarct. The radial access was
used only in 10.1% of the elective cases and in 4.6%
in the infarct case patients, with the femoral approach
used in 87.7% of the elective cases and in 91.7 of the
emergencies. It was noticed, that in our country, the
radial access is used in selected patients (Male, with
only one lesion and who had not undergone previous
surgical revascularization). Patients with more serious
illness are selected for femoral access.
After its introduction by Kiemeneij and Laarman 28 ,
the benefits of the radial technique have been clearly
demonstrated in several studies 7 . Hemorragic complications
in the access site are virtually eliminated. After
the procedure, walking and hospital discharge are more
precocious 8 . The morbidity of the procedure is lower
4
and the patients deffinitely prefer this approach to the
transfemoral one 8,29 .
Several studies prove the efficacy and safety of the
radial approach in patients submitted to primary angioplasty
4, 30, 31 . Saito et al. 31 , randomized 213 patients
with AMI within the first 12 hours of the beginning of
the symptoms: 77 were treated with the radial approach
(RTI) and 72 with the femoral approach (FTI). The success
rate of reperfusion and the incidence of major cardiac
events (death, non-fatal AMI, repeated revascularization),
during hospitalization, were similar (96.1% and 5.2%
vs. 97.1% and 8.3%) in the TRI and TFI groups respectively
(p = 0.624 and p = 0.444).
Philippe et al. 4 also compared the clinical results
of the transradial intervention (TRI) and transfemoral
intervention (TFI), in primary angioplasty with the use
of abciximab. One hundred and nineteen patients were
prospectively assessed (TRI n = 64 and TFI n = 55). In
that non-randomized study, the free of events overlife was
similar for both techniques (97%0 vs. 94.5%; p = 0.19).
There were no major hemorragic complications in the
TRI group, the opposite to what was found in the TFI
group (5.5%, p = 0.03). The hospital stay was also significantly
longer in the TFI group 5.9 +/- 2.1 vs. 4.5 +/- 1.2
days; p = 0.05).
The glicoprotein inhibitors of the Iib/IIIa are an
adjunct therapy of the utmost importance in the treatment
of AMI, in spite of conflicting results do not show
benefits in the reduction of the mortality rate, when
compared to stent implantation 12 . Abciximab has been
indicated as the class I drug but, due to its high cost
is little used. In comparison to abcximab, tirofiban in
the customary doses (bolus of 10 ug/kg and infusion
of 0.15 ug/kg/min) were less effective, specially in patients
with acute coronary syndrome 14 . The lower event incidence
provided by abciximab in that study is due to
the lower incidence of periprocedure AMI. Differences
were apparent within the next 12 hours, 24 hours at
the most, after the procedure. It was found that the
extension of the inhibition of the agregation was higher
from 15 to 60 minutes from the beginning of the
treatment with abciximab. Schneider et al. 16 assessed
the dose of the bolus of tirofiban cappable of producing
an agregation inhibition higher than 90%, during the
first hour of treatment, in patients with accute coronary
syndrome, that underwent PCI. Two dossages where
tested: bolus of 20 ug/kg and infusion of 0.15 ug/kg/min
during 18 to 24 hs or bolus of 25 ug/kg with the same
infusion. The second dossage showed an agregation
inhibition higher than 90% in the first hour. With the
regime used in the TARGET study, the average extention
(bolus of 10 ug/kg and infusion of 0.15 ug/kg/min) gives
an inhibition of the agregation in response to 20 uM
of ADP was 90-94%, in the period of 15 to 60 minutes
after the beginning of treatment with abciximab, and
60 – 66%, after tirofiban 17,18 . The interval of 15 to 60
minutes after the beginning of the treatment, is a critical

Tebet MA, et al. Primary Angioplasty Using the Radial Access With High Bolus Dose of Tirofiban: a Safe and Effective Technique.
Rev Bras Cardiol Invas 2007; 15(3).
period, during which artery lesion takes place due to
the balloon and a metal foreign object, potentially
thrombogenic (stent), is frequently implanted. In this
way, the maximum inhibition of platelet agregation,
during this period, would bring about an added benefit.
Srinivas et al. 32 assessed the registry of 7.321 patients
that underwent primary PCI in the state of New York;
78.5% of which used IGP. The in-hospital mortality
was significantly lower in the patients who used IGP
(3% vs. 6.2%, p < 0.0001). In 2.837 patients, the type
of agent used in primary angioplasty was assessed:
33% received abciximab, 46% eptifibatide or tirofiban
and 21% did not receive any medication. The mortality
rate was lower in those abciximab and eptifibatide or
tirofiban compared to patients who did not receive
IGP (3.1% vs. 2.4% vs. 4.7% respectively, p = 0.03).
The limitations of the study are its retrospective
character and late partial clinical follow up of the
population. The number of older patients, in theory
more propense to complications with the use of the
IGPs, was small. Due to the systematic use of the radial
approach in our service, the femoral approach was
not possible to compare.
CONCLUSION
In our Interventionist cardiology service, which
uses the radial approach systematically, its use in
primary angioplasty is highly efficient and safe, in spite
of the use of an aggressive anticoagulation and
antiagregation regime.
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