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Figure 4. After stent implantation mean improvement of ABI at sixmonths remained at a similar level as after procedure. * p<0.001 (fordifference in means between baseline and 24 hours post-procedure)**p=0.001 (for difference in means between baseline and six monthspost-procedure)
ABI / mean values1
0.95
0.90
0.85
0.80
0.75
0.70
0.65baseline 24h post 6m post
0.70±0.21
0.94±0.12* 0.95±0.21**
Six months follow-up
Six months (±2 weeks) after the index procedure, systematic re-
examination could be performed in 47 out of 55 patients (one
patient died, three refused and four were lost to follow-up).
Clinical outcomes
At six months follow-up, 89 % of the patients were asymptomatic.
In 72.2% of the patients an improvement was demonstrated on the
Rutherford scale and no patient showed a deterioration of the
clinical symptoms (Table 3).
Haemodynamic non-invasive evaluation
Improvement of the ABI at six months was seen in 92.4% of
patients. Only one patient had the same ABI value as at the
baseline, and one patient showed deterioration on the ABI test. The
latter patient had restenosis at six months follow-up.
Mean improvement of ABI at six months remained at a similar level
as after the procedure (Figure 4). At six months, improved walking
capacity was observed in 87.5% of the assessed patients. Mean
Table 3. Rutherford Score. Percentage of patient distribution.
Rutherford scale at baseline (%) 6 months (%)
Rutherford scale 0 0 27.8
Rutherford scale 1 0 27.8
Rutherford scale 2 27.8 22.2
Rutherford scale 3 55.6 22.2
Rutherford scale 4 16.7 0
Rutherford scale 5/6 0 0
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[Abbott Vascular, Redwood City, CA, USA]).4,6-10 The length of
lesions treated in our trial was comparable or greater to the one
reported in those studies,6-9 with the high percentage of total
occlusions. Total occlusions are known to be associated with
markedly higher restenosis rates,4 and their high prevalence of
64% in our patients allowed us to challenge this new stent.
Overall the incidence of adverse events in our study shows a favourable
safety profile of the Misago stent up to six months follow-up.
The MISAGO stent is the first self-expandable nitinol stent on a RX
delivery system which can be used with a 0.035´´ wire. This delivery
system allows use of both normal and shorter wires which simplifies
stent deployment, especially when performed by a single operator.
The MISAGO-RX-stent could be considered as an alternative to
other self-expanding nitinol stents with respect to the easier
handling, but its place in the endovascular therapy will only be
determined by the long-term results of studies enrolling larger
number of the patients.
This study has several limitations, the main ones being the relatively
small number of patients, the lack of randomisation and follow-up
only until six months. Furthermore, four patients were lost to follow-
up and three patients refused visit to the hospital at six months after
the procedure. However, our study represents the first clinical
experiences with this new stent and has given important and
encouraging information about its safety and performance. A large
multi-centre study, which enrolled more than 700 patients to be
followed-up to one year is currently ongoing.
ConclusionsThe results of the MISAGO 1 clinical trial showed high procedural
success and promising short to medium-term safety and efficacy
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6. Krankenberg H, Schlüter M, Steinkamp H J, Bürgelin K, Scheinert D,Schulte K-L, Minar E, Peeters P, Bosiers M, Tepe G, Reimers B, Mahler F,Tübler T, Zeller T. Nitinol Stent Implantation Versus PercutaneousTransluminal Angioplasty in Superficial Femoral Artery Lesions up to10 cm in LengthThe Femoral Artery Stenting Trial (FAST) Circulation2007;116:285-292.
7. Duda HS, Bosiers M, Lammer J, Scheinert D, Zeller T, Tielbeek A,Anderson J, Weisinger B, Tepe G, Lansky A, Mudde C, Tielemans H,Bérégi JP. Sirolimus-eluting versus bare nitinol stent for obstructive super-ficial femoral artery disease: the SIROCCO II trial. J. Vasc. Interv. Radiol.2005;16:331-338.
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