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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 27, No 4, July/August 2016
AFRICA
239
were performed under spinal or local anaesthesia. The anaesthesia
protocol was selected according to patient compliance.
During the procedure, anticoagulation was provided by the
administration of 100–300 U/kg of heparin. Following the
procedure, 150 mg of clopidogrel (Plavix
®
, Sanofi, Turkey)
was used as the anti-aggregant treatment protocol for patients
who did not have any contraindications, and the treatment was
subsequently continued with a dose of 75 mg/day.
The patients were monitored post-operatively in the first
week, and second and sixth months. After one year, there were
no significant clinical symptoms in any of the 43 patients. The
mean follow-up period was 32 months. Digital subtraction
angiography (DSA) was used to examine nine randomly selected
patients, whereas colour Doppler ultrasonography (USG) was
used to examine 52 randomly selected patients. Four symptomatic
patients were evaluated separately.
Statistical analysis
For analysis of the demographic, pre-operative, operative and
postoperative data, and comparison of the median
±
t
standard
deviation results of the group, categorical data chi-squared
tests were performed using the Statistical Package for the Social
Sciences (SPSS Inc, Chicago, Illinois, USA) 17.0 statistics
software;
p <
0.05 was considered significant.
Results
Twenty-seven patients had diabetes, 38 had hyperlipidaemia,
and seven had chronic obstructive pulmonary disease. Fifteen
patients underwent coronary bypass surgery or were diagnosed
with coronary artery disease (Table 1).
Sixty-five patients were examined with DSA or colour
Doppler USG. DSA was performed in all symptomatic patients,
and Doppler USG was performed in all patients.
In-stent restenosis was defined as
≥
50% stenosis in the stent
area in asymptomatic patients. The procedure was repeated if the
degree of stenosis was
≥
70%. None of the nine asymptomatic
patients who were examined with DSA had
≥
50% lesions. Three
patients who were examined with colour Doppler USG had
50–70% lesions (two patients had a superficial femoral artery
lesion; one had a popliteal arterial stent). None of the patients
had
≥
70% lesions.
In total, 46 patients had type A lesions, 12 had type B lesions,
five had type C lesions, and two had type D lesions, according
to the TASC classification scheme.
9
Sixteen out of 65 patients
(24.6%) were female and 49 (75.4%) were male (Table 1).
The total number of stents used was 92, and the mean number
of stents per patient was 1.42.
1-3
The mean stent length was 53
mm per patient (36–108 mm). Twenty-two stents (24%) were
implanted into the right superficial femoral artery, 31 (33.7%)
into the left superficial femoral artery, 14 (15.2%) into the left
iliac artery, 17 (18.4%) into the right iliac artery, five (7.8%) into
the left popliteal artery, and three (3.2%) into the right popliteal
artery. The size of the stents ranged between 5 and 8 mm; the
most commonly used stent width was 6 mm.
The procedure was performed under spinal anaesthesia in
five patients (7.7%) and local anaesthesia in 60 patients (92.3%)
(Table 2). There was 100% success rate of the procedure. In all
patients, it was possible to palpate the pulse with a hand on the
distal part of the stent zone after the procedure. There was no
limb loss in any patient.
The mean follow-up period was 32 months (18–48 months),
and in-stent restenosis developed in three patients. These
patients received a secondary balloon dilatation procedure. The
superficial femoral artery stent was fully occluded in one patient,
and the patient underwent femoropoliteal bypass. The remaining
patients have had no complications from the stenting.
During the follow-up period, DSA was performed in all
patients who were admitted symptomatically (four patients).
Total occlusion was observed in one patient and 70–90% stenosis
was observed in three patients (all patients had a superficial
femoral artery stent) (Table 3). All patients were alive, so the
Kaplan–Meier life curve was not included in the text, and we
used single-group analysis.
Discussion
This was a unique study demonstrating the results of mid-term
peripheral application of biodegradable stents. The findings of
this study show that biodegradable stents had successful clinical
outcomes during an average of 32 months’ follow-up period.
It appears from this study that biodegradable stents have good
mid-term patency rates in peripheral arterial occlusions.
In patients with limb ischaemia, the first-line approach for
revascularisation has shifted over the past decade from bypass
surgery to endovascular intervention.
10
Stenting for the treatment
of lower-extremity arterial occlusive disease is an important tool
and continues to evolve, with new stent designs and technologies
being developed to provide superior patency rates and limb
salvage.
11,12
Table 1. Laboratory data and vascular pathology of patients.
Mean age
±
SD = 64.11
±
24.13 years
Parameters
n
%
Gender (M/F)
49/16 75.4/24.6
TASC type A lesion
46
70.7
TASC type B lesion
12
20.0
TASC type C lesion
5
8.3
TASC type D lesion
2
3.3
Diabetes mellitus
27
41.5
Hyperlipidaemia (LDL > 130 mg/dl or 3.37 mmol/l)
38
58.4
COPD
7
10.7
Coronary artery disease (diagnosed)
15
23
TASC: TransAtlantic Inter-Society Consensus; LDL: low-density lipoprotein
cholesterol; COPD: chronic obstructive pulmonary disease.
Table 2. Stent features and sites for stent therapy in patients
Stents
Total number of stents (
n
)
92
Mean stent diameter (mean
±
SD mm)
6.9
±
1.3
Stent length per patient (mean
±
SD mm)
53.0
±
14.6
Restenosis (
n
/%)
7/7.6
Application area (
n
/%)
Superficial femoral artery
53/57.6
Iliac artery
31/33.7
Popliteal artery
8/8.7
Anaesthesia (
n
/%)
Local
60/92.3
Spinal
5/7.7