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ORIGINAL ARTICLE
Year : 2016  |  Volume : 35  |  Issue : 4  |  Page : 403-407

Role of drug-eluting balloon in infragenicular angioplasty


Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, Egypt

Date of Submission09-May-2016
Date of Acceptance23-May-2016
Date of Web Publication28-Nov-2016

Correspondence Address:
Ahmad M Tawfik
Department of Vascular Surgery, Faculty of Medicine, Zagazig University, Zagazig, 11114
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1110-1121.194742

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  Abstract 


Introduction Below knee arterial occlusive disease occurs more commonly in diabetic patients and leads to critical limb ischemia (CLI). Infragenicular angioplasty is considered as one of the most attractive lines of treatment in cases of below knee arterial occlusive disease with CLI. This study was designed to evaluate the short-term results of the use of drug-eluting balloons (DEBs) in infragenicular angioplasty procedure for treating CLI.
Patients and methods This study was conducted on 35 patients from the attendees to the vascular surgery outpatient clinic, Zagazig University, during the period from December 2014 to February 2016.
Results There was a significant difference in the percentage of binary stenosis in favor of the DEB group, leading to less clinically driven target lesion revascularization.
Conclusion DEB angioplasty has shown less binary stenosis and less need for clinically driven target lesion revascularization in comparison with standard angioplasty in infragenicular arterial disease.

Keywords: angioplasty, balloon, ischemia, revascularization


How to cite this article:
Salem A, Tawfik AM, Elboushi A. Role of drug-eluting balloon in infragenicular angioplasty. Egypt J Surg 2016;35:403-7

How to cite this URL:
Salem A, Tawfik AM, Elboushi A. Role of drug-eluting balloon in infragenicular angioplasty. Egypt J Surg [serial online] 2016 [cited 2020 Jun 4];35:403-7. Available from: http://www.ejs.eg.net/text.asp?2016/35/4/403/194742




  Introduction Top


Below knee arterial occlusive disease occurs more commonly in diabetic patients and leads to critical limb ischemia (CLI). The incidence of CLI in those patients is four-fold higher than that in nondiabetic patients, and it seems to be worse in diabetic patients than in patients without diabetes, with limb salvage rate six times lower than that in nondiabetic patients [1].

Infragenicular angioplasty is considered as one of the most attractive lines of treatment in cases of below knee arterial occlusive disease with CLI. The results of percutaneous transluminal angioplasty with conventional balloons are not very good due to the high rate of restenosis, which leads most probably to recurrence of the ischemic manifestations [2].

Drug-eluting stents were considered as one of the strategies to prevent restenosis; however, because of the complex and diffuse pattern of the infragenicular atherosclerosis, its use remains highly limited [3]. Delivery of paclitaxel through drug-eluting balloons (DEBs) has recently shown promising results in the treatment of femoropopliteal and infragenicular areas, with reduction in restenosis rates [4].

DEBs have recently been used instead of drug-eluting stents. The advantage of these balloons over stents is that they offer the antiproliferative effect of local drug without leaving a metallic platform inside the arteries. This leads to reduction in restenosis rates and makes future reinterventions easier, especially in anatomical locations where stent is not recommended [5].

This study was designed to evaluate the short-term results of the use of DEBs in infragenicular angioplasty procedure for treating CLI.


  Patients and methods Top


This study was conducted on 35 patients from the attendees to the vascular surgery outpatient clinic in Zagazig University during the period from December 2014 to February 2016. Certain criteria were followed.

Inclusion criteria were as follows: CLI of grades III and IV and categories 5 and 6; intact femoral and popliteal pulsation and absent pedal pulsations; normal kidney and liver function tests; angiographic appearance showing no significant lesions above the knee with trans -Atlantic society consensus (TASC) (type A, B, or C lesions) at below knee vessels; and single-vessel (at least) runoff.

Exclusion criteria were as follows: impaired kidney and liver function tests; heart failure or low ejection fraction (<50%); recent myocardial infarction; life expectancy less than 1 year; bleeding disorders; unsalvageable foot; and dye hypersensitivity. Approval of the ethical committee was obtained, and consent was obtained from all patients.

For all cases, detailed medical history, clinical examination, full preoperative laboratory tests, radiograph of the foot, arterial duplex examinations for both lower limbs and both carotid arteries, full cardiac assessment including echocardiogram, and computed tomography angiogram for both lower limbs using a multislice machine were carried out.

Control of the blood glucose level, control of blood pressure, discontinuation of smoking, starting of antihyperlipidemic medications, and loading with antiplatelet drugs were carried out preoperatively when needed. All cases were operated under local anesthesia for the endovascular part and under sedation for foot debridement.

After local infiltration anesthesia (lidocaine 2%), the seldinger technique (antegrade approach) was performed to obtain femoral artery access. Through 6 F sheaths, angiogram was performed by means of Omnipaque (GE healthcare Medical diagnostics, Ohio, USA) injection (under C-arm) for above knee vascular tree to ensure good inflow.

A 0.035 guidewire (hydrophilic) was introduced accompanying angiocath 4 F until the level of the popliteal artery. The wire was first introduced 2 cm distal to the catheter. Thereafter, the wire was withdrawn and then angiogram through the catheter for below knee vascular tree was performed. After dye was injected, heparinaized saline flush was carried out. A 0.018 guidewire was introduced and along with the wire and the catheter was maneuvered to bypass the lesion. The catheter was withdrawn and the semicompliant balloon (3 and 120 mm) was introduced until the lesion (guided by the road map). If there were multiple lesions, dilatation was started from distal to proximal (with 5 mm overlap); if there were more than one diseased vessel, all vessels were treated, provided the presence of patent distal segment. Dilatation time was 2 min, except if there was residual stenosis more than 30%, or flow-limiting dissection redilatation was carried out until 3 min. All cases were unilateral, and until this point the same procedure was performed for all cases ([Figure 1] and [Figure 2]).
Figure 1 Kaplan–Meier survival curve Group 1 DEBS, Group 2 PTA.

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Figure 2 Total occlusion of PTA.

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Nineteen cases after this point were redilated with DEBs (3 and 120 mm; IN-PACT Admiral; Medtonic, Dublin, Ireland) which was loaded with paclitaxel to deliver the drug to the wall of the vessels. The dilatation time was 2 min. Finally, angiogram was obtained. Thereafter, foot debridement was performed and postprocedure antiplatelet therapy was continued.

Follow-up

In our outpatient clinic, weekly visit was scheduled for dressing, pulse examination with hand-held Doppler, and duplex examination (stenosis was diagnosed if peak systolic velocity ratio was >2.5). If restenosis was suspected, computed tomography angiogram and revascularization was planned. During follow-up, rate of healing and duplex criteria were recorded. Primary endpoint was restenosis within 6 months or no stenosis until the end of follow-up period (6 months). Secondary endpoint was defined as when either major amputation or secondary revascularization procedure was performed.

Statistical analysis

Nominal variables were compared using the Fisher exact test; continuous variables were compared using the t-test. Six months’ restenosis rate, the primary endpoint of the study, was compared using the Fisher exact test. Kaplan–Meier estimates were used to assess the secondary endpoint. All statistical analyses were performed with SPSS (version 17; SPSS Inc., Chicago, Illinois, USA).


  Results Top


A total of 35 patients were included in our study and were divided into two groups: group A included 19 patients using semicompliant balloon followed by DEBs, and group B included 16 patients using the semicompliant balloon only.

History of medical disease such as diabetes mellitus, hypertension, ischemic heart disease, and carotid artery disease were similar between the two groups ([Table 1]).
Table 1 Medical history

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The preintervention data showed no significant difference between the two groups. Most of the cases were of category 5 with single-vessel runoff ([Table 2]).
Table 2 Preintervention evaluation in the both groups

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There was no significant difference in the intraoperative characteristics and the technical details between the two groups ([Table 3]). We used a 3 and 120 mm (IN.PACT Admiral) balloon in all cases, as this was the only available balloon in the market when this trial was conducted. For longer lesions, two balloons were used with overlap.
Table 3 Procedural and angiographic characteristics

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At the end of the follow-up period, there were no deaths recorded in both groups, and all patients were available for follow-up. There was a significant difference in the percentage of binary stenosis in favor of the DEB group, leading to less clinically driven target lesion revascularization (CD-TLR). Although wound healing was better in the DEB group, it was not statistically significant and there was no significant difference in the rate of major amputation, planned minor amputation, and time of CD-TLR between the two groups, as demonstrated in [Table 4].
Table 4 Clinical and angiographic outcome at 6 months

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Survival free from CD-TLR was in favor of the DEB group, as demonstrated using the Kaplan–Meier survival curve ([Figure 3] and [Table 5]).
Figure 3 Complete recanalization.

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Table 5 Kaplan–Meier analysis of data

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  Discussion Top


This study compared short-term results of DEB with standard semicompliant balloons in treating infragenicular peripheral arterial disease. We could not randomize our patients due to the fact that DEB are costly compared with standard balloons.

This short-term study showed the superiority of DEBs in reducing binary stenosis and CD-TLR, which was confirmed by other studies such as the DEBATE BTK trial [6] and other studies [7]. Although ulcer healing was better in the DEB group, it was not statistically significant.

Moreover, the rate of major amputation was not significant between the two groups, which is different from the results of IN.PACT DEEP trial [8], which was stopped due to unexplained higher rate of major amputation in the DEB group, but the cause of this finding was not clearly identified.

Laird and Armstrong [9] published an article discussing the impact of this negative trial, suggesting that this may be due to the manual nonuniform coating of the (IN.PACT Amphirion) balloon and suggested that further trial results should be awaited before reaching a final conclusion.

The IDEAS randomized controlled trial was also published in 2014 comparing DEBs with drug-eluting stents, which showed superiority of DES in long infrapopliteal lesions, but the limitations of this study were small number of patients, short follow-up period, and low number of complete occlusions [10].

Recently, a meta-analysis was published looking through all published randomized controlled trials up to October 2015 and it concluded that DEBs were beneficial in comparison with standard percutaneous transluminal angioplasty in infrapopliteal disease and also confirmed the need for further trials [11].

The limitations of our study included being a nonrandomized trial with a short follow-up period and with a small number of patients in both groups. Recruiting patients was difficult because we excluded patients with proximal disease to decrease the number of factors influencing patient outcome and also partially due to the cost of the DEBs and having only one size available.


  Conclusion Top


DEB angioplasty has shown less binary stenosis and less need for CD-TLR in comparison with standard angioplasty in infragenicular arterial disease.

However, it did not show a statistically significant improvement in wound healing; it also showed better survival free from CD-TLR. Our study is a nonrandomized study and further long-term controlled randomized trials are needed for establishing the clinical benefits, including wound healing and major amputation-free survival rate.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Adam DJ, Bradbury AW. TASC II document on the management of peripheral arterial disease. Eur J Vasc Endovasc Surg 2007; 33:1–2.  Back to cited text no. 1
    
2.
Jeffcoate WJ, Price P, Harding KG, International Working Group on Wound Healing and Treatments for People with Diabetic Foot Ulcers. Wound healing and treatments for people with diabetic foot ulcers. Diabetes Metab Res Rev 2004; 20(Suppl 1):S78–S89.  Back to cited text no. 2
    
3.
Alexandrescu V, Hubermont G, Coessens V, Philips Y, Guillaumie B, Ngongang C et al. Why a multidisciplinary team may represent a key factor for lowering the inferior limb loss rate in diabetic neuro-ischaemic wounds: application in a departmental institution. Acta Chir Belg 2009; 109:694–700.  Back to cited text no. 3
    
4.
Bosiers M, Hart JP, Deloose K, Verbist J, Peeters P. Endovascular therapy as the primary approach for limb salvage in patients with critical limb ischemia: experience with 443 infrapopliteal procedures. Vascular 2006; 14:63–69.  Back to cited text no. 4
    
5.
Faglia E, Clerici G, Clerissi J, Gabrielli L, Losa S, Mantero M et al. Long term prognosis of diabetic patients with critical limb ischemia: a population-based cohort study. Diabetes Care 2009; 32:822–827.  Back to cited text no. 5
    
6.
Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 2013; 128:615–621.  Back to cited text no. 6
    
7.
Schmidt A, Piorkowski M, Werner M, Ulrich M, Bausback Y, Bräunlich S et al. First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome. J Am Coll Cardiol 2011;58:1105–1109.  Back to cited text no. 7
    
8.
Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A et al. Drug-eluting balloon versus standard balloon angioplasty for infrapopliteal arterial revascularization in critical limb ischemia: 12-month results from the IN. PACT DEEP randomized trial. J Am Coll Cardiol 2014; 64:1568–1576.  Back to cited text no. 8
    
9.
Laird JR, Armstrong EJ. Drug-coated balloons for infrapopliteal disease: digging deep to understand the impact of a negative trial. J Am Coll Cardiol 2014; 64:1577–1579.  Back to cited text no. 9
    
10.
Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv 2014; 7:1048–1056.  Back to cited text no. 10
    
11.
Ansari M, Garica D, Cardoso R, Mendoza C, Mustapha J. Meta-analysis of drug-coated balloon versus standard balloon angioplasty for treatment of infrapopliteal lesions in critical limb ischemia. J Am Coll Cardiol 2016; 67(13S):2254–2254.  Back to cited text no. 11
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]



 

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