Cioppa.qxp 16/10/08 11:58 am Page 70
Peripheral
Figure 1: The Chromis Deep Stent Before Deployment (A) and Figure 2: Percutaneous Transluminal Implantation of a
Expanded (B) Chromis Deep Stent in a Patient with a Tight Stenosis
of the Proximal Anterior Tibial Artery
A
ABC
B
A: baseline; B: during implantation of the stent; C: after stenting and distal balloon dilation.
Table 2: Characteristics of Patients Treated with the
Chromis Deep Stent
Table 1: Previous Reports on Infrapopliteal Stenting for
Critical Limb Ischaemia
Number of patients 20
Male gender 15 (75%)
Study Number of Design Stent Type
Age (years) 67±16
Patients
Hypertension 15 (75%)
Bosiers et al., 2005 20 Registry BE bioabsorbable stent
Dyslipidaemia 10 (50%)
Smoking status
Bosiers et al., 2006 18 Registry Sirolimus DES
Previous smoker 12 (60%)
Bosiers et al., 2007 47 Registry SE nitinol stent
Current smoker 8 (40%)
Commeau et al., 2006 30 Registry Sirolimus DES
Diabetes mellitus
Feiring et al., 2004 82 Registry BE BMS
Non-insulin-dependent 6 (30%)
Feiring et al., 2007 5 Case series Sirolimus DES
Insulin-dependent 6 (30%)
Kickuth et al., 2007 35 Registry SE nitinol stent
Renal failure
Morgan et al., 2005 6 Case series BE BMS
Serum creatinine >2.0mg/l 9 (45%)
Rand et al., 2006 24 Randomised BE BMS
Dialysis 3 (15%)
clinical trial (versus PTA)
Rutherford class at admission Nr (%) of patients ABPI
Scheinert et al., 2006 60 Non-randomised Sirolimus DES
10–
controlled study (versus BE BMS)
20
Siablis et al., 2005 29 Non-randomised Sirolimus DES
3 1 (5%) 0.65±0.11
controlled study (vs BE BMS)
4 6 (30%) 0.48±0.12
Siablis et al., 2007 29 Registry Paclitaxel DES
5 10 (50%) 0.3±0.06
Tepe et al., 2007 18 Registry SE nitinol stent
6 3 (15%) 0.26±0.20
BE = balloon-expandable stent; BMS = bare-metal stent; DES = drug-eluting stent;
ABPI = Ankle Brachial Pressure Index.
SE = self-expandable stent.
minor (below the ankle) amputation, occurrence of restenosis or with CLI: six (30%) under Rutherford class 4, 10 (50%) under Rutherford
re-occlusion, change in Rutherford class and repeat revascularisations. class 5 and three (15%) under Rutherford class 6, and only one patient
(5%) presented with LLC under Rutherford class 3.
For statistical analysis, continuous variables are reported as mean ±
standard deviation and categorical variables as n (%). Ankle Brachial The target lesion was the proximal portion of the tibial artery (in overlap
Pressure Index (ABPI) changes are evaluated by a pair student t-test. with the popliteal artery) in three of the patients (15%), the anterior tibial
Rutherford class changes are evaluated by two-way analysis of variance artery in eight (40%), the tibio-peroneal trunk in four (20%) and the
(ANOVA). For both tests, p<0.05 is taken as statistically significant. posterior tibial artery in five (25%). Total occlusions were common (14
[70%]), as were long and diffusely diseased lesions (13 [66.7%]). Most
Results stents had a diameter of 3.0mm (10 [50%]) and a length of 76mm
Between June 2006 and September 2007, a total of of 40 patients (15 [75%]). Deployment pressure was 9±3atm (see Table 4). Short, non-
underwent BTK revascularisation in our institution: 29 (72.5%) with CLI compliant balloons were also employed in cases of calcific or fibrotic
and 11 (27.5%) with life-limiting claudication (LLC). A total of 20 patients lesions to optimally expand the stent.
were treated with 23 Chromis Deep stents in the same period due to
failed PTA. Baseline and procedural characteristics are reported in Tables All procedures were angiographically and clinically successful. After eight
2 and 3, respectively. Specifically, there were 15 men (75%), average age months (246±101 days) of follow-up, all patients showed clinical
was 67±16 years and 12 of the patients (60%) had diabetes, of whom improvement in their functional status (see Tables 5 and 6): the median
six (30%) were insulin-dependent. Most patients (19 [95%]) presented Rutherford class change was from 5 to 3 (p<0.01), with most patients
70 INTERVENTIONAL CARDIOLOGY
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