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Clinical and Procedural Evaluation of the Nile Croco
®
Dedicated Stent for Bifurcation
particularly complex scenario has been addressed in many ways
Table 3: Device Data – Nile Croco
depending on the techniques available at the time. Thus, the
angiographic result achieved using the initial simple balloon technique
1,2 MBC–SBC n, unless specified
was improved with the advent of the kissing-balloon technique, which
Diameter (mm)
minimises the plaque shift to the SB.
3,4
Thereafter, the athero-ablative
2.5–2.0 20
3.0–2.0 17
techniques (rotational and directional atherectomy) reduced the TLR rate,
3.0–2.5 26
but increased the procedural complications after the percutaneous
3.5–2.5 20
approach.
5–7
Next, the use of stents for the scaffolding of the plaque
3.5–3.0 10
became the treatment of choice. Although the use of one or two BMS Stent dilation Inflation pressure (atm) 11.0±2.7
for the treatment of bifurcation lesions was initially successful, this
Inflation time (sec) 23.8±10.7
method is now associated with high restenosis rates regardless of the
Post-kissing MBC Inflation pressure (atm) 12.4±4.0
technique used.
8,9
Inflation time (sec) 24.9±19.2
Post-kissing SBC Inflation pressure (atm) 12.4±8.9
Inflation time (sec) 27.2±17.7
Device Success
MBC = main branch cerebral; SBC = side branch cerebral.
The first bifurcated stents appeared in the 1990s, but their rigidity and
poor profile were associated with a low rate of success.
10
As a
Table 4: Follow-up Data
consequence, the idea of treating the MB while protecting the SB with
a single dedicated stent and delivery system emerged. The first
6-month Clinical Follow-up, n (%) Patients Followed All Patients
controlled study with angiographic control during follow-up was
Up (n=85) (n=93)
MI 0 (0) 0 (0)
carried out with the Multi-Link Frontier coronary bifurcation stent
Re-PTCA 6 (7) 6 (6)
system (Guidant Corp., Santa Clara, CA, US).
11
Using the first-
CABG 2 (2) 2 (2)
generation stent, this study reported a 91% device success rate and a
Death 2 (2) 2 (2)
very good safety profile (2.9% MACE at one month and 17.1% at six
MACE 10 (12) 10 (11)
months; 11.4% ischaemia-driven TLR at six months). Other devices
CABG = coronary artery bypass graft; MACE = major adverse cardiac event;
developed by various companies have also been studied, showing
MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
similar results in the initial feasibility studies.
12–15
Table 5: Univariate Analysis
The patients included in the Nile Croco Registry were older than initially
MACE No MACE p
expected (mean age 65±12 years; 11% of patients were over 80 years
(n=10) (n=75)
of age). One possible explanation for this is a possible selection bias
Age (mean±SD) 71.4±6 65.1±12.1 0.14
during recruitment. Thus, the patients included would likely be those Gender (% female) 3 (30%) 16 (21.3%) 0.68
who were not optimal candidates for a DES. Although we did not
Diabetes 3 (30%) 16 (21.3%) 0.68
record all prognostic factors to accurately determine the population
Bifurcation location
1
0.5
and arteries risk profile, the prevalence of diabetic patients (22%) as
LAD 7 (70%) 48 (64%)
LCX 1 (10%) 18 (24%)
RCA 2 (20%) 9 (12%)
Main branch diameter (mm, mean±SD) 3.02±0.3 3±0.4 0.9
The first Nile Croco Registry shows a Bifurcation type, Massy (Medina) 0.1
1 (1,1,1 + 1,0,1) 4 (50%) 36 (53.7%)
high rate of device success and
2 (1,1,0) 2 (25%) 24 (35.8%)
favourable acute and long-term clinical
3 (1,0,0) 0 4 (6%)
4 (0,1,1) 2 (25%) 3 (4%)
results, as measured by major adverse
Side branch diameter (mm, mean±SD) 2.3±0.3 2.3±0.3 0.9
cardiovascular events at 180 days.
Stent dilatation
Inflation presure (atm) 10.6±2.1 10.9±2.8 0.84
Inlation time (sec) 22.1±7.4 25.1±10.8 0.43
Post-kissing MBC
well as the mean diameter of the vessels treated indicate a low risk and Inflation presure (atm) 12.9±3.9 12±4 0.45
thus a favourable population for angiographic success and good clinical
Inflation time (sec) 24.5±20.5 26.2±19.6 0.36
outcomes. However, the prevalence of bifurcation lesions involving the
Post kissing SBC
LAD (67%) is clearly lower than that reported in previous studies (for
Inflation pressure (atm) 11.8±2.2 12.3±9.8 0.36
Inflation time (sec) 25.2±14.7 28.9±18.3 0.54
example, in the study by Lèfevre et al. the corresponding figure was
MACE = major adverse cardiac event; MBC = main branch cerebral; SCB = side branch
80%
11
) or initial experiences. This should have led to poorer results in
cerebral; SD = standard deviation.
our series, since bifurcation lesions involving the LAD have been shown
in other studies to be an independent predictive factor for angiographic balloon usage (97%) suggests easy SB access, which would have
and clinical success; however, this was not the case in our study. encouraged the operator to stent the SB if the angiographic result had
been poor. However, the residual stenosis at the SB was visually
The SB was stented in only 13% of cases despite the fact that 54% of estimated at below 30% in 80% of cases. This remarkably beneficial
the lesions involved the SB (on the Medina classification, 43 lesions effect of the device in the SB may be related to the design of the
were 1,1,1 + 1,0,1 and seven were 0,1,1). The rate of final kissing- dedicated stents. Therefore, the shape and structure of the Nile Croco
INTERVENTIONAL CARDIOLOGY 49
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