Cardiovascular Journal of Africa: Vol 27 No 4 (July/August 2016)

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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 27, No 4, July/August 2016 238 AFRICA
Clinical features and patency rates of Remedy®
biodegradable peripheral stents
Selma Kenar Tiryakioglu, Osman Tiryakioglu, Oguz Karahan, Sinan Demirtas, Fatih Gokalp, Kamuran
Erkoc, Hakan Özkan, Ahmet Ozyazicioglu
Objective: The aim of this study was to investigate the mid-term
results of Remedy® biodegradable stents, which have recently
come into use for lower-extremity arterial occlusive disease.
Methods: Sixty-five patients, who underwent surgical inter-
vention in various cardiovascular surgery clinics throughout
Turkey, were included in the study. The total number of stents
used was 92. The mean age of the patients was 64.11 ± 24.13
years (20–82), and 16 (24.6%) were female. The mean number
of stents per patient was 1.42, and 70.7% of the lesions
were TASC type A. Patients were followed for a mean of 32
months. Sixty-five patients underwent a control examina-
tion using either digital subtraction angiography or colour
Doppler ultrasonography. 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%.
Results: During the follow-up period, restenosis (≥ 50%
stenosis) was observed in seven patients (10.7%). The patency
rate after secondary intervention was 100%, and there was
no loss of limbs in any patient. Restenosis was observed in
six patients with superficial femoral artery stents, and in one
patient with a popliteal arterial stent.
Conclusion: Our experience shows that Remedy® biodegrad-
able peripheral stents were safe and effective in our cohort of
patients, with acceptable patency rates.
Keywords: biodegradable stent, peripheral vascular disease, clini-
cal outcomes, patency rates, restenosis
Submitted 17/9/15, accepted 8/1/16
Published online 26/1/16
Cardiovasc J Afr 2016; 27: 238–241
DOI: 10.5830/CVJA-2016-002
The clinical use of stents for the treatment of peripheral artery
disease is favoured for both long-term primary and secondary
patencies, as well as shorter hospitalisation periods.1 The major
stent types include bare-metal, nitinol, drug-eluting (for example,
Sirolimus), ePTFE + nitinol (Viabahn) and biodegradable stents.2
Biodegradable stents contain the biologically degradable
PLLA (poly-L-lactic acid) polymer. A few years after their
implantation, biodegradable stents dissolve into water and
carbon dioxide, and are absorbed by the arterial tissue. 3-5 The
development of restenosis in the stented segment does not limit
the use of other procedures, and it is suitable for re-ballooning.6
In addition, when compared to metal stents, PLLA stents are
more suitable as a platform for drug-releasing stents.7,8
This study investigated the mid-term results of Remedy®
biodegradable stents.
Methods
Sixty-five symptomatic patients were included in this study
during a mean 32-month period between January 2010 and
December 2014. The mean age of patients was 64.11 years
(20–82). Biodegradable peripheral stents (Remedy®, Kyoto
Medical, Japan) were used.
The stent-application procedure was performed in
symptomatic patients who had ≥ 70% stenosis of the native
artery diameter. An informed consent form was obtained from
all patients prior to the procedure. Additionally, ethical approval
was obtained from the local ethics committee of the University
(2014-160).
An exclusive stent-application team was used to place the
peripheral stents into appropriate patients (according to diameter
of vessel and length of lesion) in different cities. Only selected
lesions were studied due to the limited diameter (5–8 mm) and
length (36 mm) of the stents.
Patients excluded from the study were those with long
segments of stenosis, upper-extremity arterial interventions,
large-diameter lesions, and if more than one stent was required.
TASC type C and D patients who had had previous surgery
and had appropriate vessel diameters and lesion lengths were
included in the study. All patients were included in the study
prospectively. In addition, some of the cases were re-evaluated
retrospectively (especially patients with stent re-stenosis).
The peripheral arterial lesions of patients were classified in
accordance with the TASC classification scheme.9 All procedures
Department of Cardiology, Bursa State Hospital, Bursa, Turkey
Selma Kenar Tiryakioglu, MD
Department of Cardiovascular Surgery, Bahçeşehir
University Medical Faculty, Istanbul, Turkey
Osman Tiryakioglu, MD,
Department of Cardiovascular Surgery, Dicle University
Medical Faculty, Diyarbakir, Turkey
Oguz Karahan, MD
Sinan Demirtas, MD
Department of Cardiovascular Surgery, Ş işli Etfal
Education and Research Hospital, Istanbul, Turkey
Fatih Gokalp, MD
Department of Cardiovascular Surgery, Medicalpark Bursa
Hospital, Bursa, Turkey
Kamuran Erkoc, MD
Department of Cardiology, Bahçeşehir University Medical
Faculty, Istanbul, Turkey
Hakan Özkan, MD
Department of Cardiovascular Surgery, Bursa Yüksek
Ihtisas Education and Research Hospital, Bursa, Turkey
Ahmet Ozyazicioglu, MD