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To evaluate early patency rate of the heparin-bonded stent grafts in atherosclerotic long femoropopliteal occlusive disease, and to identify factors that affect outcome. Heparin-bonded Viabahn stent grafts were placed in 33 limbs in 33 patients during 2009-2010. The stents were deployed to rescue failed conventional balloon angioplasty. Mean age was 69 (range 44-88) years, and 67 % (22 of 33) were men. Most procedures (21 of 33, 64 %) were performed for critical limb ischemia (33 % for rest pain, 30 % tissue loss). Kaplan-Meier plots and Cox regression analysis were used to identify significant risk factors. The average length of lesions treated was 25 ± 10 cm, and they were predominantly TASC (Transatlantic Intersociety Consensus) D (n = 13) and C (n = 17) lesions. The median primary patency was 5.0 months (95 % confidence interval 1.22-8.77). The mean secondary patency was 8.6 months (95 % confidence interval 6.82-10.42). Subsequently, 4 patients underwent bypass surgery and 5 patients underwent major amputation. One patient died. There were 5 in-stent or edge-stent stenoses. Cox multivariate regression analysis identified TASC D lesions to be a significant risk factor for early occlusion (p = 0.035). TASC D lesions of femoropopliteal occlusions have poor patency rates with the use of heparin-bonded stent grafts after failed conventional angioplasty. Alternative options should be considered for these patients.
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Early Results with the Use of Heparin-bonded Stent Graft
to Rescue Failed Angioplasty of Chronic Femoropopliteal
Occlusive Lesions: TASC D Lesions Have a Poor Outcome
Ganesh Kuhan Said Abisi Bruce D. Braithwaite
Shane T. R. MacSweeney Simon C. Whitaker
Said B. Habib
Received: 5 October 2011 / Accepted: 8 April 2012 / Published online: 14 June 2012
ÓSpringer Science+Business Media, LLC and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012
Purpose To evaluate early patency rate of the heparin-
bonded stent grafts in atherosclerotic long femoropopliteal
occlusive disease, and to identify factors that affect
Methods Heparin-bonded Viabahn stent grafts were
placed in 33 limbs in 33 patients during 2009–2010. The
stents were deployed to rescue failed conventional balloon
angioplasty. Mean age was 69 (range 44–88) years, and
67 % (22 of 33) were men. Most procedures (21 of 33,
64 %) were performed for critical limb ischemia (33 % for
rest pain, 30 % tissue loss). Kaplan–Meier plots and Cox
regression analysis were used to identify significant risk
Results The average length of lesions treated was
25 ±10 cm, and they were predominantly TASC (Trans-
atlantic Intersociety Consensus) D (n=13) and C
(n=17) lesions. The median primary patency was
5.0 months (95 % confidence interval 1.22–8.77). The
mean secondary patency was 8.6 months (95 % confidence
interval 6.82–10.42). Subsequently, 4 patients underwent
bypass surgery and 5 patients underwent major amputation.
One patient died. There were 5 in-stent or edge-stent ste-
noses. Cox multivariate regression analysis identified
TASC D lesions to be a significant risk factor for early
occlusion (p=0.035).
Conclusion TASC D lesions of femoropopliteal occlu-
sions have poor patency rates with the use of heparin-
bonded stent grafts after failed conventional angioplasty.
Alternative options should be considered for these patients.
Keywords Occlusion Patency Peripheral arterial
disease Stent graft
Peripheral arterial disease affects 12–14 % of the general
population, and its prevalence increases with age, affecting
up to 20 % of patients over the age of 75 years [1]. En-
dovascular therapy is an attractive option for patients
because of low morbidity and mortality compared with
open surgery. Endovascular options for the treatment of
femoropopliteal disease include balloon angioplasty, stents,
and stent grafts.
Improved patency rates with bare metal stents compared
with balloon angioplasty have been hampered by intimal
hyperplasia and stent fractures [2]. Drug-eluting stents to
halt intimal hyperplasia have been successfully used in the
coronary system [3]. A previous randomized, controlled
trial failed to find a benefit for drug-eluting stents in the
femoropopliteal artery compared with bare metal stents [4].
A recently published randomized, controlled trial indicated
better early patency rates with drug-eluting stents for short
superficial femoral artery occlusions [5]. Stent grafts
appear to have properties that are resistant to neointimal
hyperplasia and stent fractures [6]. Heparin has an anti-
coagulation and antiproliferative effect on smooth muscle
cells [7]. Addition of heparin as a bioactive surface can
provide sustained thromboresistance. The outcome of
heparin-bonded stent grafts on an unselected group of
G. Kuhan (&)S. Abisi B. D. Braithwaite
S. T. R. MacSweeney
Vascular and Endovascular Unit, Queens Medical Centre,
Nottingham University Hospitals, Nottingham NG7 2UH, UK
S. C. Whitaker S. B. Habib
Department of Radiology, Queen’s Medical Centre, Nottingham
University Hospitals, Nottingham NG7 2UH, UK
Cardiovasc Intervent Radiol (2012) 35:1023–1028
DOI 10.1007/s00270-012-0400-6
patients with long femoropopliteal arterial occlusions is not
The aim of this study was to determine the early patency
rate of the heparin-bonded covered stents in challenging
atherosclerotic femoropopliteal occlusions and to identify
factors that affected outcome.
Heparin-bonded Viabahn stent grafts (W. L. Gore Asso-
ciates, Flagstaff, AZ) were placed in 33 limbs in 33 patients
during 2009 and 2010. Most procedures (21 of 33, 64 %)
were performed to treat critical limb ischemia (33 % for
rest pain, 30 % tissue loss), and the rest were for lifestyle-
limiting claudication (12 of 33, 36 %). All patients
underwent duplex scans of the arterial system before the
procedure to determine inflow to the femoral artery, the
anatomical extent of the occluded segment, and the calf
vessel runoff.
All patients with femoropopliteal occlusive disease were
considered for the study. The use of stents to correct failed
angioplasty using bare nitinol stents and non-heparin-
bonded stent grafts is a well-established practice at our
study center. Separate ethics approval for the study was not
considered necessary by the ethics committee. Failure of
conventional balloon angioplasty was the main indication
to consider stent graft deployment. Stents were deployed
when the vascular radiologist thought that leaving the
patient with a failed or poor angioplasty result would result
in reocclusion of the treated section. These included lesions
with significant recoil, residual ([30 %) stenosis, and flow-
limiting dissection flaps. End points were primary and
secondary patency rates. Primary patency was defined as
no evidence of significant restenosis (peak systolic velocity
ratio of [2) or occlusion based on velocity criteria on
duplex ultrasound at follow-up. Secondary patency was
defined by reintervention after occlusion or significant
stenosis of the treated segment of the artery. Immediate
technical success of the procedure was defined by \30 %
residual stenosis at the end of the procedure in the treated
segment with no flow impedance. Data were collected
prospectively and entered into a database. Lesions were
categorized according to the TASC (Transatlantic Interso-
ciety Consensus) working group definitions [8]. Demo-
graphic data and data on length of the lesion, presence of
calcification, inflow disease, and outflow disease were
obtained. Outflow scores were calculated from the angio-
graphic findings as described by Rutherford et al. [9]. The
scoring system was based on the degree of stenosis and the
degree of contribution to outflow of each runoff vessel.
The stent grafts were placed percutaneously either via a
retrograde (over the aortic bifurcation) or an antegrade
approach to the common femoral artery with 10–15 %
oversizing for the diameter of the superficial femoral
artery. Only lesions with poor technical success after sub-
intimal balloon angioplasty were considered for stent
grafting. These included lesions with significant recoil,
residual stenosis, and multiple dissection flaps compro-
mising flow. Inflow and outflow were assessed during
angiography, and if necessary, additional procedures were
performed to improve flow. At least a single runoff vessel
was considered adequate for stent graft placement.
Most patients stayed overnight and were discharged
with dual antiplatelet agents (aspirin 75 mg and clopido-
grel 75 mg) or warfarin for life. Patients were brought back
for clinical assessment and duplex scan of the treated
artery, as well as for assessment of compliance for anti-
platelet agents and statins at 1, 3, and 6 months after the
procedure. Clinical status was assessed at the follow-up
visit on the basis of criteria set by Rutherford et al. [9], to
learn whether patients were better, the same, or worse.
Kaplan–Meier survival analysis was performed to plot
primary and secondary patency. Statistical analysis was
performed by SPSS software, version 16 (SPSS, Chicago,
IL). Median or mean patency (in months) was compared
for primary and secondary patency plots. The log rank test
was performed to identify significant factors that might
affect patency rates. Cox regression analysis was per-
formed to identify multiple factors influence on the
Mean age was 69 (range 44–88) years, and 67 % (22 of 33)
were men; patients had a high prevalence of hypertension
and hypercholesterolemia (Table 1). Smokers and patients
with diabetes comprised a third of the study group (11
patients). Patients receiving statins and antiplatelet or
anticoagulants were 73 and 81 %, respectively.
Mean ±standard deviation length of occlusion treated
was 25.3 ±10.5 cm, with 70 % requiring [2 stent grafts
(15 cm long and 5 or 6 mm in diameter each). An overlap
of 1 cm was considered adequate when [1 stent graft was
used. TASC C and D lesions were prevalent in 91 % of the
population, and 43 % of the procedures were for recurrent
disease after previous failed angioplasty. Severe calcifica-
tion was present in 24 %, and 49 % had flush occlusion of
the entire length of the superficial femoral artery. A sub-
intimal route was used to recanalize the artery in 67 % of
the patients. Severe outflow disease (score of [10) was
present in 21 %, while inflow disease was present in 15 %.
A stent graft was deployed extending into the popliteal
artery without crossing the knee in 12 patients. Flush
occlusions were recanalized subintimally, and stent grafts
1024 G. Kuhan et al.: Stent Graft for Femoropopliteal Occlusions
were placed at the bifurcation without compromising flow
to the profunda femoris artery.
Good technical success was initially achieved in all
procedures. Dual antiplatelet agents or warfarin was pro-
vided in 96 % of the patients after the procedure. One
patient did not receive dual antiplatelet agent to minimize
bleeding. The median primary patency was 5.0 months
(95 % confidence interval 1.22–8.77) (Fig. 1). The mean
secondary patency was 8.6 months (95 % confidence
interval 6.82–10.42) (Fig. 2). Of the 12 patients with life-
style-limiting claudication, the symptoms of 10 improved.
The remaining 2 patients with claudication went on to
undergo successful bypass surgery. The first patient had
stent graft occlusion at 5 months, and despite thrombolysis,
it reoccluded. The second patient had in-stent stenosis and
residual inflow stenosis.
Of the 21 patients with critical limb ischemia, 12 had
improved symptoms. One patient had successful bypass
surgery, and 5 had major amputations. There was 1 death,
unrelated to the procedure, in a patient with critical
ischemia. There were 2 in-stent or edge-stent stenoses
requiring further intervention. There were no stent graft
Analysis by log rank test identified TASC D lesions and
flush occlusions to be significant risk factors (p\0.05)
(Table 2). The significant risk factors were entered into a
risk model to identify their combined effect on secondary
patency. Cox multivariate regression analysis identified
Table 1 Patient characteristics Characteristic Value pvalue
Log rank test for
primary patency
Log rank test for
secondary patency
Age [70 y 52 % (17/33) 0.78 0.36
Male gender 67 % (22/33) 0.30 0.46
Critical limb ischemia 63 % (21/33) 0.59 0.20
Smoker 33 % (11/33) 0.25 0.73
Diabetes 36 % (12/33) 0.75 0.80
Heart disease 33 % (11/33) 0.49 0.23
Hypercholesterolemia 72 % (24/33) 0.40 0.38
Renal failure 0 % (0/33) NA NA
Hypertension 68 % (24/33) 0.75 0.60
Statin use 73 % (24/33) 0.21 0.50
Antiplatelet or warfarin use 81 % (26/33) 0.57 0.27
Fig. 1 Primary patency. Kaplan–Meier survival analysis was per-
formed; primary patency (y-axis) is plotted against months after
procedure (x-axis). ?indicates censored data. Censored data indicate
that the period of observation was cut off before the event of interest
has occurred—in this case, significant stenosis or occlusion
Fig. 2 Kaplan–Meier survival analysis was performed; secondary
patency (y-axis) is plotted against months after procedure (x-axis). ?
indicates censored data
G. Kuhan et al.: Stent Graft for Femoropopliteal Occlusions 1025
TASC D lesions to be the only significant risk factor
(p=0.035) (Fig. 3), with an odds ratio of 0.23 (range
This study identified TASC D lesions to have a poor outcome
when treated with heparin-bonded stent grafts. The presence
of TASC D lesions in claudicants and critically ischemic
limbs were 25 % (3 of 12) and 47 % (10 of 21), respectively.
The median primary patency was 5 months, and the mean
secondary patency time was 8.6 months (Fig. 2). Previous
studies have revealed patency rates of[80 % at 1 year with
the non-heparin-bonded stent graft [1014]. These studies
used strict inclusion and exclusion criteria, and there were
fewer TASC D category patients. The study we present here
included acute admissions, calcified arteries, flush occlu-
sions, recurrent disease, inflow disease, and outflow disease.
Stent grafts were used only if a poor result was obtained with
conventional angioplasty. This study reflects real-life clini-
cal practice in an unselected group of patients, which may
explain the poor patency rate.
Previous studies have identified length of lesion, renal
failure, diabetes, runoff scores, and occlusion, as opposed
to stenosis, to be significant factors affecting treatment
outcome [10,1520]. None was significant in our study
group. A poor patency rate for TASC D lesions has been
reported previously with non-heparin-bonded stent graft
with primary patency rates of 39 % at 3 years [21,22].
Table 2 Angiographic
characteristics Characteristic Value pvalue
Log rank test for
primary patency
Log rank test for
secondary patency
B 9 % (3/33)
C 52 % (17/33)
D 39 % (13/33) 0.62 0.05
Repeated procedure 43 % (14/33) 0.80 0.37
Subintimal percutaneous
transluminal angioplasty
67 % (22/33) 0.57 0.86
Flush occlusions 49 % (16/33) 0.40 0.05
Severe calcified plaque 24 % (8/33) 0.56 0.39
Inflow disease 15 % (5/33) 0.72 0.56
Outflow score
[10 27 % (9/33) 0.55 0.48
1–10 36 % (12/33)
0 36 % (12/33)
Length of lesion (cm), mean ±SD 25 ±11 0.54 0.42
No. of stents
1 24 % (8/33) 0.71 0.91
2 45 % (15/33)
3 30 % (10/33)
Technical success 100 % (33/33) 0.25 0.51
Postprocedure antiplatelet/warfarin use 96 % (32/33) 0.41 0.54
Fig. 3 Secondary patency for TASC D vs. B and C. Secondary
patency for TASC category B, C is compared with D by Cox
multivariate regression analysis. Three significant risk factors (flush
occlusions, no statin use, TASC D lesions) were entered into
the analysis. TASC D lesions were the only significant risk factor.
?indicates censored data
1026 G. Kuhan et al.: Stent Graft for Femoropopliteal Occlusions
This study further supports those findings. Despite the
addition of a heparin bioactive surface for stent grafts, the
endovascular therapy results for TASC D lesions remain
poor, particularly in unselected cases.
There were 5 major amputations after stent graft inser-
tion. All 5 patients had critical limb ischemia. The ampu-
tation rate of 23 % (5 of 21) at 6 months in this study is
similar to the BASIL (Bypass versus Angioplasty in Severe
Ischaemia of the Leg) trial data (46 of 224, 20 %) [23]. The
BASIL trial did not find a difference in amputation-free
survival between angioplasty and surgery before 2 years.
Irrespective of the intervention, a fifth of the patients had
lost limbs at 6 months.
The ideal lesions for stent graft insertion are shorter
lesions, lesions not involving the popliteal artery or trifur-
cation, nonflush occlusions of the superficial femoral artery,
and noncalcified arteries with no significant inflow or out-
flow disease. A good 1-cm normal artery above and below
the lesion is necessary for stent graft placement. Only a small
proportion of patients matched these criteria in our study
population. Our study had predominantly longer lesions
([20 cm) and flush occlusions. When an angioplasty fails to
improve flow or it appears that the site will occlude in these
lesions, it is tempting to use a stent graft to improve the
patient’s chance of a successful outcome. If bypass surgery is
not an option, endovascular therapy can be attempted. Cur-
rently the use of a longer-length single stent graft is preferred
to multiple shorter stent grafts at our study center. The use of
short drug-eluting stents at the edges of the stent graft to
prevent edge stenosis is also currently evaluated. Surveil-
lance by duplex scanning is needed for TASC D lesions with
stent grafts. Patients and primary care clinicians should be
informed of the importance of the patients’ receiving anti-
platelet agents and statins, and compliance should be
assessed regularly. In the study group, 33 % of the patients
were smokers; needless to say, this needs to be addressed in
the primary care setting.
This study demonstrates that the placement of a stent graft
can be done without additional complications, but the cli-
nician and the patient should be realistic about the outcome
when a TASC D lesion is treated. Surgical bypass remains
the treatment of choice for TASC D lesions. However, in the
presence of multiple comorbidities or no suitable conduit,
endovascular therapy is an option, provided that the clinician
and the patient can accept a poor outcome.
Acknowledgments W. Tennant, S. Chandresekar, and A. Oluwole
contributed patients to the study. G. Ramjas and R. Oneil performed
some of the procedures. Vascular technologists performed all the
duplex scans.
Conflict of interest The authors declare that they have no conflict
of interest.
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1028 G. Kuhan et al.: Stent Graft for Femoropopliteal Occlusions
... and the bare metal nitinol stent cohort (75.2%) in the VIASTAR trial. 18 Contrary to these promising outcomes, Kuhan et al. 20 reported disappointing results for the heparin-bonded Viabahn stent-graft when used for bailout after failed balloon angioplasty in TASC C and D lesions with a mean length of 25610 cm. In their observational study involving 33 limbs (64% of them in critical limb ischemia), the median primary patency was only 5 months. ...
... However, graft thrombosis has been observed in former trials as well as in the present study. 18,20 It remains a concern that acute occlusion of long covered stents may result in limb-threatening acute limb ischemia. In this study, however, only one patient underwent major amputation above the ankle due to disease progression. ...
Full-text available
Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery. Methods: The 25-cm Gore Viabahn Endoprosthesis study ( identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 +/- 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 +/- 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within 610% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year. Results: The median follow-up was 12.3 months (mean 12.3 +/- 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/ device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement. Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. Oneyear primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
... Peripheral arterial disease affects 15-20% of aging population above 75 years of age [1]. Due to the low morbidity and mortality compared with open surgery, endovascular therapy is a desirable primary option [2]. Percutaneous transarterial angioplasty (PTA) for revascularization of diseased superficial femoral artery (SFA) can achieve initial technical success rates above 95% with a low risk for complications [3]. ...
Full-text available
Articles describe a retrospective cohort study to assess the feasibility of reducing neointimal hyperplasia following interventions in chronic total occlusive peripheral vascular disease. The " sandwich " technique implemented is a novel modified angioplasty technique that combines heparin-bonded (Viabahn) stents with drug-eluting stents (Zilver PTX) deployed during arterial recanalisation. A review of 46 cases underwent this procedure at our institution as a limb saving procedure is conducted to determine mid-long-term patency outcomes and identify any subsequent interventions. Followup demonstrates favourable mid-long-term patency in 50% of TASC-C cases. No documented postprocedural complications were noted with unrelated observed mortality rates in either TASC-C or TASC-D subgroups. An observed advantage could be gained by using this new stenting technique via the subintimal recanalisation route. Albeit not statistically significant, type II diabetics and patients on aspiring had better sustained patency angioplasties. The sandwich technique has been shown to effectively offer symptoms relief and reduce total duration of hospital stay. Study findings support the need to evaluate the long-term efficacy through a larger longitudinal prospective study. However, to overcome the encountered study limitations, a well-structured methodology for comparison with conventional angioplasty techniques is essential to assess the synergetic potential of the sandwich technique.
... The issue of longer endograft lengths being a negative predictor of patency, remains open to question, as larger endografts are used in EVPAR in general, likely offsetting this aspect; the concerns from the occlusive scenario suggesting patency is length-related do not apply. 6 The Viabahn is quite kink-resistant even at 90-degree knee flexion, but we certainly advise patients to avoid prolonged periods of hyperflexion, for example kneeling for a long time. Delayed PAA rupture as is known with OSR, is also not reported. ...
Objectives We present the technical description and preliminary results of a hybrid approach for the treatment of chronic total occlusions of superficial femoral artery in the setting of critical limb-threatening ischemia (CLTI). Methods A retrospective analysis of selected case series was performed. A trans-popliteal hybrid technique was carried out in seven limbs (six patients). Open exposure of above-the-knee popliteal artery was performed over its maximum calcification zone. After retrograde recanalization and graft-stenting of the entire superficial femoral artery, endarterectomy of the popliteal artery was performed for debulking and widening of the distal landing zone of the endoprosthesis. The latter is included in the bovine patch suture to avoid leaving a segment untreated. Results Technical success, haemodynamic and clinical improvement were achieved in all procedures. Median length of treated occlusion was 19.8 cm. After a mean follow-up of 12 months (range 6–26 months), the primary patency was 85.7% (only one asymptomatic occlusion occurred). There were no major cardiovascular or limb adverse events. No re-interventions were required. Conclusion This less-invasive, one-incision technique is safe and effective for the restoration of in-line flow from groin to ankle, currently recommended in CLTI revascularization. It could be especially useful in highly calcified popliteal artery lesions, hostile groins or those at high risk of infection and in cases of vein absence for bypass surgery.
Purpose Advancements in the endovascular treatment of femoropopliteal atherosclerotic lesions have led to treatment of more complex lesions, particularly long lesions. The aim of this study was to determine the meta-analytic primary patency and need for re-intervention among patients treated for very long lesions (>200 mm) at the femoropopliteal segment and to identify potential risk factors for loss of patency. Methods This study was performed according to the PRISMA guidelines. A random effects model meta-analysis was conducted, and the I-square was used to assess heterogeneity. Results Fifty-one studies comprised of 3029 patients were included. The mean lesion length was 269 mm. The primary patency rate at 30 days, 6 m, 1-, 2- and 5-years of follow-up was 98%, 76%, 62%, 55%, and 39% respectively. The incidence of TLR was 16% at one year and 32% at two years. The secondary patency rate at 1, 2, 3 and 5 years was 85%, 71%, 64%, and 64% respectively. Heparin bonded ePTFE covered stents (69%) and paclitaxel eluting stents (73%) demonstrated higher 1-year primary patency rates than self-expanding nitinol stents (55%) or uncoated percutaneous transluminal angioplasty (PTA) with provisional stenting (54%). Lesions treated with a heparin bonded ePTFE covered stent had statistically significant higher odds of remaining patent at 1-year of follow-up (OR: 2.74; 95%CI: 1.63–4.61; p < 0.001) than lesions treated with BMS or PTA. Patients with long femoropopliteal lesions causing critical limb ischemia (CLI) developed restenosis or occlusion more often than patients treated for claudication (HR: 1.63; 95%CI: 1.06–2.49; p = 0.026) during an average follow-up of 26 months. Conclusion Primary stenting of femoropopliteal TASC D lesions using drug eluting stents or covered stents results in sustained patency over time. PTA or uncoated nitinol stents demonstrated lower patency rates. However, additional comparative studies are needed to determine the efficacy of newer technologies for the treatment of complex femoropopliteal lesions and provide evidence for the most optimal treatment approach.
Opinion statement: Femoropopliteal (FP) disease is a common presentation of peripheral arterial disease (PAD), and a challenging anatomic region for durable treatment. Surgical bypass has historically been the primary therapeutic modality, but has been supplanted in the last decade by endovascular therapy, even with the most complex presentation of disease. Endovascular therapy has the advantage of a more favorable and rapid recovery, while preserving future treatment options. Endovascular management of FP disease, initially with "Plain Old" balloon angioplasty (POBA) has yielded over the years to bare metal stents (BMS), and more recently, to technologies seeking to limit BMS use due to difficult-to-treat patterns of in-stent restenosis (ISR). Despite a myriad number of endovascular devices and strategies, the approach to FP intervention lends itself to an algorithmic schema largely predicated on lesion length, severity of calcification, recanalization method, and clinical goals based upon individual patient status. In addition, treatment costs are a growing consideration in device selection. These criteria can be summarized into what we have termed as a "CADENCE" approach to treatment, an acronym representing the following factors: Clinical scenario, Anatomy, Device performance specifications, Experience/Ease, Novelty, Cost, and Evidence-base (Fig. 1). While the individual components of the CADENCE strategy are not always hierarchical, they combine to give a framework for reasonable interventional strategies for a given patient presentation and lesion appearance. Since there is a notable lack of prospective data for FP interventions, most notably with regard to direct device comparisons, actual practice is often experiential, and further data to guide optimal patient care are needed.
The purpose of the study was to assess the safety and midterm effectiveness of endovascular treatment in Trans-Atlantic Inter-Society Consensus II (TASC-II) D femoropopliteal occlusions in patients with critical limb ischemia (CLI). Patients with CLI who underwent endovascular treatment for TASC-D de novo femoropopliteal occlusive disease between September 2008 and December 2013 were selected. Data included anatomic features, pre- and postprocedure ankle-brachial index, duplex ultrasound, and periprocedural complications. Sustained clinical improvement, limb salvage rate, freedom from target lesion revascularization (TLR), and freedom from target extremity revascularization (TER) were assessed by Kaplan-Meier estimation and predictors of restenosis/occlusion with Cox analysis. Thirty-two patients underwent treatment of 35 TASC-D occlusions. Mean age was 76 ± 9. Mean lesion length was 23 ± 5 cm. Twenty-eight limbs (80 %) presented tissue loss. Seventeen limbs underwent treatment by stent, 13 by stent-graft, and 5 by angioplasty. Mean follow-up was 29 ± 20 months. Seven patients required major amputation and six patients died during follow-up. Eighteen endovascular and three surgical TLR procedures were performed due to restenosis or occlusion. Estimated freedom from TLR and TER rates at 2 years were 41 and 76 %, whereas estimated primary and secondary patency rates were 41 and 79 %, respectively. Endovascular treatment for TASC II D lesions is safe and offers satisfying outcomes. This patient subset would benefit from a minimally invasive approach. Follow-up is advisable due to a high rate of restenosis. Further follow-up is necessary to know the long-term efficacy of these procedures.
The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only. A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group. The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively. At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).
Objectives To assess the clinical outcomes of VIABAHN® stent grafts deployed across the knee to those deployed above the knee.Background The placement of stent-grafts across the knee joint and extending into the distal popliteal artery has been avoided due to a perceived higher risk of stent fractures, restenosis, and thrombosis due to the unique hemodynamic forces in this region.MethodsA retrospective evaluation was conducted of 114 patients in 127 limbs. Patients were divided into two groups based on the location of the distal end of the deployed VIABAHN® stent: above knee (AK) (n = 89) in which the VIABAHN® implant ended at or above the femoral condyles and below the knee (BK) (n = 38) with extension of the graft into the below knee popliteal segment. Study end points were loss of primary, assisted, and secondary patency.ResultsOne year primary, assisted, and secondary patency rates in the AK versus BK group were 67.7% vs. 47.2% (P = 0.0092), 77.1% vs. 53.7% (P = 0.0022), and 86.3% vs. 59.8% (P = 0.0035), respectively. Univariate analysis demonstrated an increased relative risk of a primary [RR = 2.07 (P = 0.001)], assisted [RR = 2.34 (P = 0.002)], or secondary events [RR = 2.98 (P = 0.002)] in patients when the stent was placed below the femoral condyles. Major amputations occurred in 10% of AK and 34% of BK patients (P = 0.002).ConclusionsVIABAHN® stent grafts have a significantly lower clinical patency and higher rates of amputation when they extend across the knee joint. © 2014 Wiley Periodicals, Inc.
Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease. Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary DES and PTA groups. Compared with the PTA group, the primary DES group exhibited superior 12-month event-free survival (90.4% versus 82.6%; P=0.004) and primary patency (83.1% versus 32.8%; P<0.001), satisfying the primary hypotheses. In the secondary evaluations, (1) the primary DES group exhibited superior clinical benefit compared with the PTA group (88.3% versus 75.8%; P<0.001), (2) the provisional DES group exhibited superior primary patency (89.9% versus 73.0%; P=0.01) and superior clinical benefit (90.5% and 72.3%, P=0.009) compared with the provisional BMS group, and (3) the stent fracture rate (both DES and BMS) was 0.9% (4/457). Femoropopliteal peripheral artery disease treatment with the paclitaxel-eluting stent was associated with superior 12-month outcomes compared with PTA and provisional BMS placement.
Coronary artery stents are tiny tubular devices used to 'scaffold' vessels open during percutaneous transluminal coronary angioplasty (PTCA). Restenosis (re-narrowing) of vessels treated with stents is a problem; in order to reduce restenosis, stents that elute drugs over time are now available. However these drug-eluting stents are more expensive and there is a need to assess their clinical benefits prior to recommending their use. To examine evidence from randomised controlled trials (RCTs) to assess the impact of drug eluting stents (DES) compared to bare metal stents (BMS) in the reduction of cardiac events. The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2008, Issue 4), MEDLINE (1990 - April 2009) and EMBASE (1980 - January 2009) were searched. We carried out handsearching (electronic and manual) up to January 2008. We included RCTs comparing DES with BMS used in conjunction with PTCA techniques in the review. Participants were adults with stable angina or acute coronary syndrome (ACS). We considered published and unpublished sources and included them if they reported outcome data of interest. Three review authors independently extracted data, assessed trial quality assessment and checked decisions within the group. Data extraction included composite event rates (major adverse cardiac event, target vessel failure); death; acute myocardial infarction (AMI); target lesion revascularisation (TLR); target vessel revascularisation (TVR) and thrombosis. Data synthesis included meta-analysis of composite event rate, death, AMI and revascularisation rates, presented as odds ratios with 95% confidence intervals (CI) using a fixed-effect model. We assessed heterogeneity between trials. We included more than 14,500 patients in 47 RCTs. There were no statistically significant differences in death, AMI or thrombosis between DES and BMS. For composite events, TLR and TVR reductions were evident with use of sirolimus, paclitaxel, everolimus, dexamethasone, zotarolimus and (to a limited extent) tacrolimus-eluting stents. These effects are demonstrated in the longer term follow up. Subgroup analyses (e.g. diabetics) largely mirrored these findings. Drug-eluting stents releasing sirolimus, paclitaxel, dexamethasone and zotarolimus reduce composite cardiac events. However, this reduction is due largely to reductions in repeat revascularisation rates as there is no evidence of a significant effect on rates of death, MI or thrombosis. The increased cost of drug-eluting stents and lack of evidence of their cost-effectiveness means that various health funding agencies are having to limit or regulate their use in relation to price premium.
Subintimal endovascular intervention has been used widely in the treatment of symptomatic superficial femoral artery (SFA) occlusion. The relative effectiveness of subintimal placement of a covered stent (CS) versus balloon-only subintimal angioplasty (SIA) remains uncertain. We performed a retrospective cohort study of consecutive patients with symptomatic SFA occlusions (>15 cm) who underwent subintimal endovascular intervention, either CS or SIA, in a single institution. Primary patency was the primary outcome. Secondary outcomes included complication rates, freedom from re-intervention, and limb salvage rates. Patency was ascertained with followup duplex or clinically. We evaluated 57 patients in the SIA group and 31 patients in the CS group. At 1 year the SFA primary patency for the SIA and CS groups was 28% versus 75% (P < .001), whereas the primary assisted patency was 37% versus 84% (P < .001), respectively. Need for bypass was 13% versus 0% (P = .05) in the SIA and CS groups, respectively. Placement of a covered stent improves patency after subintimal intervention for long SFA occlusion.
While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of runoff on long-term outcomes of these interventions in patients with rest pain and tissue loss is unclear. Runoff is known to negatively effect graft patency. The aim of this study is to examine the impact of distal runoff on long-term outcomes of SFA interventions for critical ischemia. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classification 4, 5, and 6 were selected. Patients with concomitant tibial interventions were excluded. Pre-operative angiograms were reviewed in all cases to assess distal popliteal and tibial runoff and were scored according to modified Society of Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1 and maximum 19). Three runoff score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. Three hundred six limbs in 241 patients (57% male, mean age 68 years) underwent endovascular treatment for critical ischemia (44% rest pain and 56% tissue loss.) Technical success was 96% with 61% SFA undergoing angioplasty, 37% SFA primary stenting and 2% SFA an atherectomy. Overall mortality was 1% and overall morbidity was 16% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly worse cumulative patency (82 +/- 9%, 56 +/- 4%, and 52 +/- 7% for good, compromised, and poor runoffs, respectively, mean +/- standard error of the mean [SEM]). Freedom from recurrent symptoms (65 +/- 8%, 39 +/- 9%, and 18 +/- 9% for good, compromised, and poor runoffs, respectively) and limb salvage (65 +/- 5%, 41 +/- 4%, and 20 +/- 6% for Good, Compromised, and Poor runoffs, respectively) were incrementally curtailed by worsening runoff with significant decreases as runoff category deteriorated. In patients presenting with rest pain and tissue loss who are treated with SFA percutaneous interventions, patency is negatively affected by compromised and poor runoffs in keeping with the bypass literature. More importantly, freedom from recurrent symptoms and limb salvage are incrementally curtailed as runoff scores worsen. These findings are consistent with the bypass literature.
INTIMAL smooth muscle cell (SMC) proliferation dominates the early phase of healing after arterial endothelial injury1-6 what growth factors are responsible for this mitotic activity of an otherwise quiescent cell is not known. SMC growth in vitro is enhanced by platelet factors, insulin and lipoproteins7-11 and, according to some reports, can be diminished in vivo with various antiplatelet agents. Harker et al.6 have reported decreased myointimal thickening in homocystinaemic baboons treated with dipyridamole, and Friedman et al.11 and Moore et al.12 have reported suppression of SMC proliferation in the injured arteries of rabbits injected with anti-platelet serum. Intimal thickening was not diminished, however, in the injured carotid arteries of rats given various anti-platelet drugs13. Because the clotting system is inextricably linked to arterial injury and because thrombin is used to generate the platelet growth factor9 and may itself be a mitogen14,15, we speculated that heparin might inhibit myointimal thickening. We report here the use of heparin to suppress intimal SMC hyperplasia in a rat model of arterial endothelial injury and suggest possible mechanisms for the heparin effect.
The author presents an alternative statistical analysis of the results of the University of Toronto series of percutaneous transluminal angioplasty (PTA) of the femoral and popliteal arteries (n = 254). After recalculation of the data with the Kaplan-Meier method, the postprocedure success rate ranged from 88.8% +/- 2.0 at 1 month to 35.7% +/- 4.8 at 6 years. With Cox multiple regression analysis, the type of femoropopliteal lesion and the runoff were the variables that were useful to predict late results. For stenoses with good runoff, the success rate was 53% at 5 years; with poor runoff, 31% at 5 years. For occlusions with good runoff, the success rate was 36% at 5 years; with poor runoff, 16% at 5 years. In initially successful cases, ongoing clinical success at 1, 3, and 5 years was better in patients with good runoff at the time of PTA than in those with poor runoff. Now that more recent studies have documented improved technical success in femoropopliteal PTA, a comparative study of the relative safety, long-term clinical efficacy, and cumulative cost of PTA versus surgery seems warranted.
Prospective data was recorded on 217 percutaneous transluminal angioplasty (PTA) procedures performed in the superficial femoral and popliteal arteries over an 8-year period. After the initial procedure, patients were followed with serial noninvasive studies and, in 71 patients, repeat angiography. The mean follow-up period was 7 years (range, 2-11 years). Standard life-table survival analysis was used to assess the factors potentially affecting long-term outcome. Excluding an initial technical failure rate of 10%, overall patencies at 1, 3, and 5 years were 81%, 61%, and 58%, respectively. After the first year, the prognosis (i.e., failure rate) appears to be linear over the long term (i.e., up to 10 years). Factors negatively influencing long-term patency include the presence of diabetes mellitus, diffuse atherosclerotic cardiovascular disease, or threatened limb loss. Technical factors correlated with failure include lesion length, moderate eccentricity, and a poor post-PTA appearance.
The ankle/brachial systolic blood pressure index (ABI), a noninvasive measure of peripheral arterial disease (PAD), is widely used in epidemiological studies. However, the normal ranges of the ABI in healthy populations and ABI criteria for the diagnosis of PAD in large population studies have not been critically evaluated. The San Luis Valley Diabetes Study (SLVDS) was designed to evaluate the prevalence and complications of non-insulin-dependent diabetes mellitus (NIDDM) in a biethnic population. The present study was conducted as part of the SLVDS to assess the prevalence of vascular disease in 1280 nondiabetic control subjects and 430 patients with NIDDM. The ABI criteria for PAD were developed in 403 healthy individuals with a low risk for cardiovascular disease. In these low-risk subjects, the average resting ABI value was 0.07 lower in women than in men. In both sexes, the dorsalis pedis ABI was 0.04 lower than in the posterior tibial artery, and the left leg ABI was 0.02 lower than the right leg ABI (all differences, P < .05). In the low-risk subjects, ABI values were lower after exercise than at rest and had similar differences by sex and leg as observed at rest. Using specific abnormal cutoff points for the ABI, we evaluated three criteria for PAD in the overall population: two abnormal vessels in the same leg at rest (both dorsalis pedis and posterior tibial arteries), one abnormal vessel per leg at rest, and an ABI abnormality only after exercise. Subjects classified with PAD by the two-vessel criterion had a higher frequency of claudication and the physical finding of an absent pulse compared with subjects without PAD or patients with PAD defined by the one-vessel or exercise criterion. Use of the two-vessel criterion identified an increased risk of PAD with increasing age, NIDDM, smoking, hypertension, and elevated cholesterol levels. In contrast, the one-vessel PAD criterion was associated only with increasing age and smoking, and exercise-diagnosed PAD was not associated with any cardiovascular risk factor except for male sex. In low-risk subjects, the normal distribution and lower abnormal cutoff point values of the ABI differed by type of test, sex, ankle vessel, and leg. When these specific abnormal cutoff points were applied to the SLVDS population, the two-vessel abnormal criterion described patients with typical clinical characteristics of PAD and the expected associations of PAD with cardiovascular risk factors. These clinical characteristics and cardiovascular risk factor associations were less evident with PAD diagnosed by the one-vessel or exercise criterion. Therefore, an abnormal dorsalis pedis and posterior tibial ABI in the same leg at rest should be used for the diagnosis of PAD in epidemiological studies.