First-in-man experience of self-expanding nitinol stents combined with drug-coated balloon in the treatment of femoropopliteal occlusive disease

Purpose The present study aimed to determine the safety and efficacy of a drug-coated balloon inflated within a thin-strut self-expanding bare-metal stent in patients with severe and complex femoropopliteal occlusive disease. Methods This prospective study used the Pulsar-self-expanding stent and Passeo-18 Lux drug-coated balloon in patients with severe and complex femoropopliteal occlusive disease. The primary endpoint was the 12-month primary patency, and the secondary endpoints included 24-month primary patency, assisted primary patency, secondary patency, and clinically associated target lesion revascularisation. Results The study included 44 patients (51 limbs). The mean age of the patients was 67.6 ± 10.2 years, with 73% men. Chronic limb severity was classified as Rutherford Category III in 41% of the patients, stage IV in 31%, and stage V in 27%. Lesions were predominantly Trans-Atlantic Inter-Society Consensus (TASC 2007) D (51%) and C (45%), with 32 (63%) chronic total occlusions. Procedural success was obtained in all cases. The mean lesion length was 200 ± 74.55 mm (95% CI = 167.09–208.01) with a mean number of stents per limb used of 1.57 ± 0.70 (95% CI = 1.37–1.76). Distal embolisation occurred in two patients. The primary patency rates at the 12- and 24-month follow-up were 94% (95% CI = 82.9–98.1) and 88% (95% CI = 75.7–94.5), respectively. The assisted primary was 94% (95% CI = 82.9–98.1) and secondary patency was 96% (95% CI = 85.2–99.0) at 24-month follow-up. The cumulative stent fracture rate at the 24-month follow-up was 10%. Freedom from clinically driven target lesion revascularisation was 94% (95% CI = 83–98%) at 12-month follow-up and 88% (95% CI = 76–94%) at 24-month follow-up, with two patients requiring a bypass graft. Conclusion Our novel approach involving the combination of a thin-strut bare-metal stent and a drug-coated balloon may be safe and effective, with sustainable and promising clinical outcomes up to 24 months after treatment.

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Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system – 12-month results from the LOCOMOTIVE EXTENDED study

VASA ◽

10.1024/0301-1526/a000927 ◽

2020 ◽

pp. 1-8

Author(s):

Klaus Amendt ◽

Thomas Zeller ◽

Robert Proczka ◽

Ulrich Beschorner ◽

Nicola Troisi ◽

...

Keyword(s):

Delivery System ◽

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Target Lesion Revascularisation ◽

Extended Study ◽

Femoropopliteal Artery ◽

The Mean ◽

Drug Coated Balloon

Summary: Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- and 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drug-coated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions.

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Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial

Journal of Endovascular Therapy ◽

10.1177/1526602820952413 ◽

2020 ◽

Vol 27 (6) ◽

pp. 936-945

Author(s):

Koen Deloose ◽

Marc Bosiers ◽

Patrick Peeters ◽

Jürgen Verbist ◽

Lieven Maene ◽

...

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Bare Metal Stents ◽

Bare Metal Stent ◽

Primary Patency ◽

Metal Stents ◽

Bare Metal ◽

Metal Stent ◽

Drug Coated Balloon

Purpose: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial ( ClinicalTrials.gov identifier NCT02211664). Materials and Methods: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. Results: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). Conclusion: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

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Drug-eluting stents for treatment of focal infrapopliteal lesions

VASA ◽

10.1024/0301-1526/a000170 ◽

2012 ◽

Vol 41 (2) ◽

pp. 90-95 ◽

Cited By ~ 10

Author(s):

Rastan ◽

Noory ◽

Zeller

Keyword(s):

Limb Salvage ◽

Bare Metal Stents ◽

Target Lesion ◽

Drug Eluting Stents ◽

Metal Stents ◽

Target Lesion Revascularisation ◽

Randomized Studies ◽

Drug Eluting ◽

The Mean

We have investigated the role of drug-eluting stents on patency rates after treatment of focal infrapopliteal lesions in patients with intermittent claudication and critical limb ischemia. Reports indicate that drug-eluting stents reduce the risk of restenosis after percutaneous infrapopliteal artery revascularization. A Pub Med, EMBASE, Cochrane database review search of non-randomized studies investigating patency rates, target lesion revascularisation rates, limb salvage rates and mortality rates in an up to 3-year follow-up period after drug-eluting stent placement was conducted. In addition, preliminary results of randomized studies comparing drug-eluting stents with bare-metal stents and plain balloon angioplasty in treatment of focal infrapopliteal lesions were included in this review. A total of 1039 patients from 10 non-randomized and randomized studies were included. Most commonly used drug-eluting stents were sirolimus-eluting. The mean follow-up period was 12.6 (range 8 - 24). The mean 1-year primary patency rate was 86 ± 5 %. The mean target lesion revascularization rate and limb salvage rate was 9.9 ± 5 % and 96.6 %±4 %, respectively. Results from non-randomized and preliminary results from prospective, randomized trials show a significant advantage for drug-eluting stents in comparison to plain balloon angioplasty and bare-metal stents concerning target lesion patency and in parts target lesion revascularisation. No trial reveals an advantage for drug-eluting stents with regard to limb salvage and mortality.

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Treatment of juxta-anastomotic stenoses for failing distal radiocephalic arteriovenous fistulas: Drug-coated balloons versus angioplasty

The Journal of Vascular Access ◽

10.1177/1129729818793102 ◽

2018 ◽

Vol 20 (2) ◽

pp. 209-216 ◽

Cited By ~ 8

Author(s):

Domenico Patanè ◽

Giovanni Failla ◽

Giovanni Coniglio ◽

Giorgio Russo ◽

Walter Morale ◽

...

Keyword(s):

Percutaneous Transluminal Angioplasty ◽

Type A ◽

Target Lesion ◽

Transluminal Angioplasty ◽

Primary Patency ◽

Secondary Patency ◽

Type B ◽

Arteriovenous Fistulas ◽

Percutaneous Transluminal ◽

Drug Coated Balloon

The aim of our study is to report the results of two types (type A, type B) paclitaxel drug-coated balloon compared with standard percutaneous transluminal angioplasty in the treatment of juxta-anastomotic stenoses of mature but failing distal radiocephalic hemodialysis arteriovenous fistulas. Two groups of 26 and 44 patients treated with two different drug-coated balloon are compared with a control group of 86 treated with standard percutaneous transluminal angioplasty. A color Doppler ultrasound was performed to evaluate stenosis and for treatment planning. We assess primary patency, defined as the absence of dysfunction of the arteriovenous fistulas, patent lesion or residual stenosis < 30% and no need for further reintervention of target lesion. Primary patency and secondary patency are evaluated after 12 months with color Doppler ultrasound for the whole arteriovenous fistulas, defined as absolute (absolute primary patency, absolute secondary patency) and target lesion. Postprocedural technical and clinical success was 100%. After 12 months, absolute primary patency is 81.8% for type A, 84.1% type B, and 54.7% for standard percutaneous transluminal angioplasty; target lesion primary patency is 92% type A, 86.4% type B, and 62.8% standard percutaneous transluminal angioplasty; absolute secondary patency is 95.4% type A, 95.5% type B, and 80.7% standard percutaneous transluminal angioplasty; target lesion secondary patency is 100% type A, 97.7% type B, and 80.7% standard percutaneous transluminal angioplasty. All the patients treated with drug-coated balloon (type A + type B) have an absolute primary patency of 83.3%, a target lesion primary patency of 87.9%, an absolute secondary patency of 95.5%, and a target lesion secondary patency of 98.4%. Our study confirms that the use of drug-coated balloon, indiscriminately among different brands, improves primary patency with statistically significant difference in comparison with standard percutaneous transluminal angioplasty and decreases reintervention of target lesion in juxta-anastomotic stenoses of failing distal arteriovenous fistulas maintaining the radiocephalic fistula as long as possible.

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Patients with in-stent restenoses

Nuklearmedizin ◽

10.1160/nukmed-0084 ◽

2007 ◽

Vol 46 (05) ◽

pp. 185-191 ◽

Cited By ~ 3

Author(s):

T. Nusser ◽

B. J. Krause ◽

M. Kochs ◽

T. Habig ◽

F. M. Mottaghy ◽

...

Keyword(s):

Primary Endpoint ◽

Bare Metal Stents ◽

Target Lesion ◽

Bare Metal Stent ◽

Metal Stents ◽

Bare Metal ◽

Metal Stent ◽

Post Intervention ◽

Angiographic Restenosis

SummaryAims: We compared the intracoronary β-brachytherapy using a liquid rhenium-188 filled balloon with the slow-release, polymer-based, paclitaxel-eluting Taxus-Express stent for treatment of in-stent restenoses. Patients, methods: During the same study period, patients with restenoses in bare-metal stents were either treated with Taxus- Express stents (n = 50) or β-brachytherapy after successful angioplasty (n = 51). For brachytherapy 30 Gy in 0.5 mm tissue depth were administered. The irradiated segment exceeded the traumatized segment 7.5 mm on both sides. Primary endpoint was the minimal lumen diameter (MLD) at the target lesion at six months follow-up. Angiographic follow-up was available in 78% (n = 79/101) and clinical follow-up in all patients. Results: Baseline parameters did not differ statistically. The Taxus-Express stent resulted in a significantly larger MLD and a significantly lower percent diameter stenosis post intervention compared to β-brachytherapy, which both maintained until angiographic follow-up (primary endpoint 2.44 ± 0.74 mm versus 1.73 ± 0.74 mm, p <0.0001). Therefore, Taxus- Express stents were associated with a lower angiographic restenosis rate compared with β-brachytherapy, both for the target lesion (6.1% versus 17.4%) and the total segment (9.1% versus 23.9%). Moreover, use of Taxus-stent was associated with a clinical benefit based on a significantly lower MACE rate compared with β-brachytherapy (p <0.05). Conclusions: Paclitaxel-eluting Taxus- Express stents resulted in superior clinical and angiographic outcomes compared to intracoronary β-brachytherapy with a liquid 188Re filled balloon for treatment of restenosis within a bare-metal stent.

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P1339ARTERIOVENOUS FISTULA AND BASILIC VEIN TRANSPOSITION IN ELDERLY PATIENTS ON HEMODIALYSIS: AN OBSERVATIONAL STUDY

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfaa142.p1339 ◽

2020 ◽

Vol 35 (Supplement_3) ◽

Author(s):

Vinant Bhargava ◽

Priti Meena ◽

Ambrish Satwik ◽

Apurv Srivastava ◽

A K Bhalla ◽

...

Keyword(s):

Elderly Patients ◽

Vascular Access ◽

Elderly Population ◽

The Elderly ◽

Primary Patency ◽

New Delhi ◽

Secondary Patency ◽

Basilic Vein ◽

The Mean

Abstract Background and Aims With the increase in the line expectancy of chronic kidney disease in the older population (>60 years), the numbers requiring haemodialysis is progressively rising. The elderly population may be different from the younger in terms of non-suitable vessels for access creation, non-maturation, and vascular calcifications, and this may alter the outcomes of use of arteriovenous fistula (AVF). This study was conducted to analyse the outcomes of AVF in elderly patients (>60 years). Method Retrospective study was conducted in the Department of Nephrology at Sir Ganga Ram Hospital, New Delhi. Patients of more than 60 years of age in whom AVF was created from 1st January 2012 to 31st December 2016 were included in the study. Follow-up data of 3.5 years was analysed. The primary endpoint was to assess primary and secondary patency rates. Results A total of 300 patients were included in the study. The mean age was 63.8 years. Radiocephalic AVF (RCAVF) was the most common site of [69.8% (n = 210)], followed by brachiocephalic (BCAVF) in 25.2% (n = 75) and basilic vein transposition (BVT) in 5% (n = 15). At 12 months, overall survival of the AVF was 66.8%. At 42 months, the primary patency rate of RCAVF, BCAVF, and BVT was 50.6%, 52.6%, and 50.4% respectively. The commonest cause of access failure was thrombosis (20.4%) followed by non-maturation (9%). Vascular access abandonment was found least in BCAVF. Conclusion AVF remains the preferred vascular access for haemodialysis in the elderly population. Brachiocephalic AVF has higher primary and secondary patency rates. Thrombosis and failure of maturation are major concerns in the elderly AVF.

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Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose “3D” Study

Journal of Endovascular Therapy ◽

10.1177/1526602819884062 ◽

2019 ◽

Vol 27 (1) ◽

pp. 34-41

Author(s):

Fabrizio Fanelli ◽

Alessandro Cannavale ◽

Michele Citone ◽

Mariangela Santoni ◽

Marianna Gazzetti ◽

...

Keyword(s):

Primary Patency ◽

Drug Eluting Stent ◽

Secondary Patency ◽

Systemic Complications ◽

Aneurysm Formation ◽

Drug Eluting ◽

Provisional Stenting ◽

Zilver Ptx ◽

Drug Coated Balloon

Purpose: To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. Materials and Methods: A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Results: Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Conclusion: Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.

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Preliminary six-month outcomes of LIMBSAVE (treatment of critical Limb IscheMia with infragenicular Bypass adopting in situ SAphenous VEin technique) registry

Vascular ◽

10.1177/1708538120966126 ◽

2020 ◽

pp. 170853812096612 ◽

Cited By ~ 1

Author(s):

Nicola Troisi ◽

Giovanni De Blasis ◽

Mauro Salvini ◽

Stefano Michelagnoli ◽

Carlo Setacci ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Saphenous Vein ◽

Limb Ischemia ◽

Primary Patency ◽

Secondary Patency ◽

Bypass Patency ◽

The Mean

Objectives Guidelines recommend open bypass surgery for long occlusions of infrainguinal arteries. In situ saphenous vein bypass is a standardized technique. The aim of this study was to report preliminary six-month outcomes of a national, multicenter, observational, prospective registry based on the examination of treatment of critical Limb IscheMia with infragenicular Bypass adopting the in situ SAphenous VEin technique (LIMBSAVE). Methods From January 2018 until October 2019, 428 patients from 41 centers were enrolled in the LIMBSAVE registry. Data were prospectively collected in a dedicated database, including demographics, preoperative risk factors, clinical and diagnostic preoperative assessments, intraoperative measures (including safety and effectiveness of the valvulotome during the surgical procedures), and 30-day follow-up data. Furthermore, estimated six-month outcomes according to Kaplan–Meier curves in terms of primary patency, primary assisted patency, secondary patency, and limb salvage were evaluated. Results Patients were predominantly male ( n = 332, 77.6%) with a mean age of 73.3 years (range 39–95). Technical success, defined as bypass pulse after use of the valvulotome, was obtained in all cases. The proximal anastomosis could be reached by the valvulotome in all cases. The mean number of valvulotome uses was 2.5 (range 1–5). No vein perforation was reported. In nine cases (2.1%), a vein lesion with intramural hemorrhage occurred. The mean length of hospital stay was 11.1 days (range 1–60). At 30-day follow-up, the overall bypass patency rate was 97.4%, and the rate of open or endo reinterventions for failing bypass was 5.4%. At six-month follow-up, the estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 78.1%, 86.2%, 92.1%, and 94.7%, respectively. Conclusions Preliminary intraprocedural outcomes of the LIMBSAVE registry show that the in situ technique with the valvulotome is safe and effective in disrupting valves and obtaining pulsatility in the saphenous vein. The complication rate related to the use of the valvulotome is low. The six-month preliminary outcomes in terms of overall patency and limb salvage are promising. Further examinations and continuous follow-up are needed to evaluate long-term outcomes.

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Endovascular bypass for salvage of vascular access in hemodialysis catheter-consigned patients

The Journal of Vascular Access ◽

10.1177/1129729818764132 ◽

2018 ◽

Vol 19 (6) ◽

pp. 585-592 ◽

Cited By ~ 3

Author(s):

Matt Chiung-Yu Chen ◽

Mei-Jui Weng ◽

Huei-Lung Liang

Keyword(s):

Vascular Access ◽

Clinical Success ◽

Primary Patency ◽

Secondary Patency ◽

Success Rates ◽

Access Site ◽

Hemodialysis Catheter ◽

Kaplan Meier ◽

The Mean

Purpose: This study was performed to retrospectively assess the efficacy of percutaneous creation of an intervascular bypass with or without stent graft deployment (endovascular bypass) for salvage of abandoned vascular access sites in hemodialysis catheter-consigned patients. Methods: Salvage of abandoned vascular access sites was attempted in 16 patients with hemodialysis catheters. These vascular access sites were salvaged using endovascular bypass techniques to redirect the access flow to a nonarterialized vein as a new outflow conduit or cannulation segment. The postintervention primary, assisted primary, and secondary patency rates of the access site and bypass were calculated using the Kaplan–Meier method. Results: The procedural and clinical success rates were both 100%. The postintervention primary patency rate of the bypass and access site at 360 days was 75.7 ± 12.5% and 56.8 ± 14.9%, respectively. The mean follow-up period was 461.9 days (range: 121–900 days). No major complications were observed. One bare bypass tunnel rupture and one pseudoaneurysm were noted during the procedure. Conclusion: Salvage of abandoned vascular access sites for hemodialysis catheter-consigned patients can be technically feasible and clinically successful using endovascular bypass techniques in selected patients when surgical revision is not considered or is not possible.

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Outcomes of covered expandable stents for the treatment of TASC D aorto-iliac occlusive lesions

Vascular ◽

10.1177/1708538114568479 ◽

2015 ◽

Vol 23 (6) ◽

pp. 630-636 ◽

Cited By ~ 7

Author(s):

Robert Tewksbury ◽

Lupe Taumoepeau ◽

Andrew Cartmill ◽

Anna Butcher ◽

Toby Cohen

Keyword(s):

Large Diameter ◽

Clinical Signs ◽

Primary Patency ◽

Occlusive Disease ◽

Critical Limb Ischaemia ◽

Secondary Patency ◽

Limb Ischaemia ◽

Vascular Insufficiency ◽

Good Patency

Introduction Aortoiliac arterial occlusive disease is frequently encountered in the management of lower limb vascular insufficiency. We report our experience with covered balloon-expandable stents for treatment of TASC D lesions of the abdominal aorta and common iliac arteries. Methods A retrospective study of 30 patients who underwent aortoiliac stenting with the Atrium Advanta V12 from March 2010 to September 2012 was conducted. Patient demographic data, clinical signs and symptoms and procedural details were recorded. Outcomes assessed were primary patency, secondary patency, technical success, complications, limb salvage and survival. Results Median age was 67 years (range 48–84) and 40% of patients underwent treatment for critical limb ischaemia. Median follow-up was 13 months (range 3–38 months). Stent configuration comprised of long iliac stents in 20 patients, a large diameter aortic stent with iliac stenting in six patients, and aortic stent alone in four patients. Radiological success was achieved in 100% and the complication rate was 6%. Primary patency at 6, 12 and 24 months was 97%, 90% and 79%, respectively. Four cases of in-stent stenosis were reported, with three of these undergoing re-interventions resulting in a secondary patency rate of 97% at the end of follow-up. One patient death occurred within the follow-up period. Discussion This case series demonstrates that treatment of complex aortoiliac occlusive disease with covered balloon-expandable stents can have acceptable results with good patency and good clinical outcome. Secondary patency rates are comparable to open surgical revascularisation, with lower morbidity.

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