CARDIOVASCULAR JOURNAL OF AFRICA • Volume 27, No 4, July/August 2016
240
AFRICA
Short- and long-term outcomes of peripheral artery stents
are available for metal, nitinol and e-PTFE-coated nitinol
stents. Initially, efforts were directed at overcoming the negative
outcomes of metal stents, especially in long lesions.
13
Owing to
the recent advances in stent technology, biodegradable stents
have been produced to avoid the undesirable outcomes of classic
stents, which lead to mechanical restenosis with stent fracture.
This technology has been extensively evaluated in the
coronary artery system, but not in peripheral arteries. The
outcome of bio-absorbable stents remains unclear.
14
We therefore
investigated the patency rates of this technology in the peripheral
arterial system.
Outcomes of even classical stents have not been sufficiently
documented. Short hospitalisation times, successful outcomes in
stent patency, higher secondary patency rates, and comparable
outcomes with grafts have increased the popularity of peripheral
stent applications in TASC type A and B lesions. The primary
and secondary patency rates of PTFE-coated stents in veins
above the knee have equal efficacy to PTFE grafts, and are
comparable with that of saphenous veins. Formation of the
neo-intima layer in closed stents prevents the development of
restenosis in the early period, and ensures that stents remain
patent for a longer period.
15,16
The use of stents for suitable lesions, especially in the case of
iliac artery lesions, protects the patient from possible abdominal
surgery and increases the incidence of long-term patency as the
vein diameter is also suitable. In the present study, stenosis was
not observed during the follow-up period after iliac artery stent
implantation.
The PLLA peripheral stent is the first fully bioresorbable stent
to be implanted in humans, with complete degradation taking
12 to 24 months. This resulted in less vessel wall injury during
implantation and therefore less initial thrombus formation and
reduced intimal hyperplasia.
The existing literature on the use of biodegradable peripheral
stents on coronary arteries is limited, and their superiority over
drug-releasing stents has not been proven to date. The existing
data regarding the use of biodegradable peripheral stents in
peripheral arteries is insufficient.
17
The application of biodegradable peripheral stents has
positive contributions to the collateral system in particular.
The collateral system in the application area does not close, but
rather increases in the long term, and supports development of
the existing systems.
18
Collateral closure was not observed during
the procedure in our patient group, and we also observed that
these veins stayed open in the patient group examined with DSA.
The major advantages of using biodegradable stents
include practical application, a suitable structure for secondary
interventions, their absorbable and non-depositing nature,
perfect tissue compatibility, and a lower rate of restenosis in
experimental studies. A feature of the biodegradable stent
is that it allows for re-intervention due to its structure (after
implantation of the stent, integration occurs between the stent
structure and vessel wall). Therefore re-intervention can easily
be carried out (balloon and stent or surgery) in TASC type
A lesions when they become TASC type C or D. Another
advantage is that there is no possibility of stent fracture, which
eliminates anti-aggregant use. They are also suitable for use in
patients with a metal allergy.
There are certain disadvantages, including insufficient number
of clinical studies investigating long-term outcomes. Moreover,
the length and diameter of the available stents are not suited for
every clinical scenario.
The absence of a control group was the main limitation of
this study. The ethics committee approved the study protocol,
which was created with the use of a single type of stent to avoid
bias and to provide similar opportunities for all patients. This
pilot study was therefore conducted without a control group.
Conclusion
In this study, primary implantation of a Remedy
®
biodegradable
stent for moderate-length lesions in lower-extremity arterial
occlusive segments of patients with claudication was associated
with better mid-term results. Our experience shows that the
Remedy
®
peripheral stents were safe and effective in our cohort
of patients, with acceptable patency rates.
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Table 3. Clinical imaging and severity of
stenosis according to symptoms
< 50%
stenosis
50–70%
stenosis
≥
70%
stenosis
Symptomatic patients: DSA (
n
= 4)
–
–
4*
Asymptomatic patients: DSA (
n
= 9)
9
–
–
Asymptomatic patients: USG (
n
= 52)
49
3**
–
Total
58
3
4
*All were superficial femoral artery (SFA) lesions.
**Two patients had SFA stents; one had a popliteal artery stent.
USG: ultrasonography; DSA: digital subtraction angiography.