الفهرس 
contentsOnly 14 pages are availabe for public view
 |  | from | 216 |  |  |
| | | from | 216 | | |
Abstract
The PAMI study (primary angioplasty in myocardial infarction) which showed a higher success rate for establishing
reperfusion in the angioplasty group, the in-hospital mortality
was 6.5% for the thrombolytic group& 2.6% with the PTCA group.
Higher risk subgroups had a mortality rate of 10.4% with
rt-PA versus 2.6% with PTCA. Reinfarction or death in the
hospital occurred in 12 and 15% of patients treated with rt-PA&
PTCA respectively. Intracranial hemorrhage in the rt-PA group
was 2.5% which is considerably higher than that observed in
any other clinical trial (Girnes et al., 1998).
Another study GUSTO11-B (The GUSTO11-b Angioplasty
sub-study investigators 1997) randomized 1138 patients to
PTCA or rt-PA who presented within 12 hours of the onset of
symptoms. The primary end point was the composite outcome
of death, non-fatal reinfarction and disabling stroke at 30 days.
Of these patients assigned to angioplasty, 83% had a completely
occluded infarct related artery and TIMI flow was established in
73%. This patency was better than 55-60% (TIMI III flow
expected with rt-PA).
In 3.7% of the patients who underwent angioplasty,
surgery was also performed on the same day. The incidence of
the primary end point in the angioplasty group was 9.6% and
that of rt-PA 13.7% the difference was highly significant (P <
0.32). However the individual endpoints of death and disabling
032
strokes were not significantly different between the angioplasty
and rt-PA groups. In the 6 month follow up, the favorable effect
of angioplasty disappeared, with 14.1% in the angioplasty group
and 16.1% in the rt-PA group reaching the primary end point,
the difference was statistically So, this study showed that
primary angioplasty had a slight advantage over the rt-PA at 30
days, with most of the benefit observed between 5 and 10 days
after the onset of infarction. This benefit, however, was lost over
the next 6 months. The overall end points were the same for the
two groups.
Mortality
This study showed in hospital mortality of 2.7% (one
patient) of 37 patients who underwent primary PTCA. This
patient was a 72 years male who had failure of primary PTCA
with abrupt closure of the first diagonal branch. While mortality
occurred in two patients 4.7% of the thrombolytic group during
the first week in the CCU, due to cardiogenic shock, they did
not respond to treatment. (Table 9)
These results are in agreement with those of PAMI study
which showed in hospital mortality for primary PTCA of 2.6%
regarding both high risk and low risk groups and also with the
Zowlle study which showed in-hospital mortality of 2%.
Another study by Alferdo et al., 1996 reported in-hospital
mortality of 3% in 30 patients who underwent primary PTCA
033
and stenting because of sub-optimal results or threatening
occlusion.
Follow up
In this study, we followed the patient for one month.
In the PTCA group, four patients suffered from ischemic
myopathy with systolic dysfunction & systemic congestion.
Another patient was transferred to CABG. Three patients
suffered from reinfarction while six patients had an attack of
unstable angina. Twenty-three patients passed the whole period
of follow up without complication.
In the thrombolytic group, three patients suffered from
reinfarction, eight patients were readmitted by unstable angina,
nine patients suffered from ischemic myopathy.
While 22 patients passed the whole follow up period
without complication, angiography showed that 31 patients
(72%) needed revascularization (Table 9)
In PAMI study patients were assessed clinically after 6
months (Rogerio, et al., 2001).
Death occurred in 3.7% of patients in the angioplasty
group and in 7.9% in the thrombolytic group, and either death or
non fatal reinfarction developed in 8.5% and 16.8% of these
groups respectively.
While Alferedo et al., 1996 reported after follow up of 4-
24 months, that there were no death or myocardial infarction,
034
one patient underwent CABG while the other patients remained
free of angina.
Restenosis
Alfredo et al., 1996 reported restenosis after PCI in acute
myocardial infarction about 40-50%.
While in Zwolle study angiography was done after a mean
of 82 days after infarction. The infarct related artery was patent
in 68% of patients in the thrombolytic group and 91% of PCI
group (Zijlstra et al., 1993).
Reocclusion
In this study in the PTCA group stenting was done in 25
cases of the 37 patients, one stent was implanted in 20 cases
while five cases needed two stents. Dissection occurred in seven
cases (18.9%). (Table 7)
Alfredo et al., 1996 reported that acute vessel closure
occurred in 8-18% of patients undergoing emergency stent
placement for abrupt or threatened vessel closure, while Colomb
et al., 1995 stated that in-hospital re-occlusion may approach
10%.
Neumann et al., 1996 reported re-occlusion rate of 8.5% in
80 patients while Garcia Canta et al., 1996 mentioned that of
138 patients treated with coronary angioplasty during AMI, 35
patients (25%) had stent implantation, with no stent occlusion.
035
Cost
The present study showed that, the total cost of primary
PTCA in Egypt ranged from 8000 - 10000 pounds while
emergency stenting costs 3500 pounds for each stent. On the
other hand, the use of thrombolytic therapy in a private hospital
cost 500 pounds in addition to the hospital stay for 5 days is
around 5000 pounds (Fig. 9).
Gibbons et al., 1993 compared t-PA with primary PTCA.
They reported a trend towards a $ 4.589 reduction in estimated
hospital plus professional costs after PCTA, also as a result of
less recurrent ischemia and a shorter hospital stay. An additional
significant saving of $2.258 per patient was realized in the first
6 months after discharge as PTCA – treated patients required
fewer readmissions than t-PA treated patients.
Another study by de Boer et al., 1995 in which
streptokinase was used, total 12 month costs of primary PTCA
and thrombolytic therapy were similar. Clinical outcomes were
improved after reperfusion by PTCA compared with
streptokinase, however, thus despite these comparable costs,
cost efficacy analysis showed that the average cost for an event
– free survivor was $ 25.431 for patients assigned to PTCA
versus $ 36.798 for those assigned to thrombolytic therapy.
Hospital stay
In the present study, hospital stay had been reduced in the
primary PTCA group to 4.59 ± 1.98, while in the thrombolytic
031
group it was 6.00 ± 2.52, the difference was statistically
significant. (Table 9, Figure 8)
Many studies had been performed to examine the duration
of hospital stay in acute myocardial infarction patients. Young
and Cohen 1992 found that an increased duration of stay was
associated with advancing age, female gender, a larger number
of chronic diseases and admission to a teaching hospital.
Another study by Every et al., 1996 was done in-hospitals
with on-site catheterization facilities were associated with an
increased duration of stay.
Hellar et al., 1990 reported an increased duration to be
associated with elevation of creatine-kinase isoenzyme,
presence of anterior infarction and the use of either predischarge
stress testing or 24 hour ambulatory monitoring.
Chen and Nayler 1994. evaluated 11,411 patients, Data
were collected between 1990 & 1991 the mean duration of stay
was 9.9 days. Old age, female gender, infarct – related
complications and co-morbidity were reported to be associated
with increased duration hospital stay.
Ejection Fraction
In this study, In the PCI group (1): ejection fraction ranged
from 35 to 65 with a mean of 45.54 ± 7.43, while in the
thrombolytic group it ranged from 30 to 55 with a mean of
44.02 ± 6.91. (Table 5). There was a non-significant difference
031
between the two group regarding ejection fraction (t=0.933,
p>0.05). The incidence of heart failure in the primary PTCA
group was less than in the thrombolytic group, however (P value
>0.05 & the difference was statistically non significant
(Table 9).
Nicolas et al., 1997 performed cardiac catheterization in
856 patients with acute myocardial infarction including patients
with primary angioplasty left ventricular ejection fraction was
estimated in 517 of them. LVEF was determined within 5 days
of hospital admission. LVEF was 50% with 16% having
severely depressed left ventricular function.
In CAPTIM trial 2002, pre-hospital thrombolysis was
compared to primary PCI, no statistically significant benefit to
primary PCI was reported. However, it showed be pointed out
that this trial did not enroll the necessary sample size and was
prematurely stopped because of poor recruitment. Secondly,
26% of the thrombolytic patients required rescue angioplasty for
failed thrombolysis, which represents 10 times higher utilization
than other trials (keelly et al., 2003).
Finally
This study compared two groups primary PTCA ± stenting
and thrombolysis (SK). The primary PTCA group showed three
patients with reinfarction (8.1%) versus three patients with
reinfarction in the thrombolytic group.