BioMimics 3D vascular stent system for femoropopliteal interventions

Summary: Background: The MIMICS-3D study aimed to assess the safety and effectiveness of the BioMimics 3D Vascular Stent System for the treatment of symptomatic femoropopliteal artery disease in a real-world patient population. Patients and methods: Consecutive participants who were scheduled for implantation of the BioMimics 3D stent were enrolled in the prospective, observational, multicenter study. The primary effectiveness outcome was freedom from clinically driven target lesion revascularization at 12 months and the primary safety outcome was a composite of major adverse events comprising death, major target limb amputation, or clinically driven target lesion revascularization at 30 days. Outcomes through 24 months are reported. Results: A total of 507 patients (70±10 years, 65.5% male sex) were enrolled and treated with the study stent. 24.0% had critical limb-threatening ischemia, lesion length was 127±92 mm, and 56.8% of lesions were totally occluded. The Kaplan-Meier (KM) estimate of freedom from clinically driven target lesion revascularization at twelve-months was 90.6% (95% CI: 87.9%–93.3%) and the 30-day primary safety outcome occurred in 1.2% (95% CI: 0.5%–2.7%) of participants. At 24 months, clinical improvement was achieved in 86.6% and the KM estimate of freedom from clinically driven target lesion revascularization was 82.8% (95% CI: 79.4%–86.4%). The KM estimate of freedom from loss of primary patency according to PSVR >2.4 was 78.6% (95% CI: 74.7%–82.4%). Survival distribution functions regarding primary patency were lower with long lesions (>150 mm; log-rank p<0.001) but did not differ significantly between participants with or without critical limb-threatening ischemia (log-rank p=0.07). Conclusions: Endovascular treatment of atherosclerotic femoropopliteal lesions with the BioMimics 3D Vascular Stent System is efficacious and safe in a real-world setting.

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Effectiveness of the Pulsar-18 self-expanding stent with optional drug-coated balloon angioplasty in the treatment of femoropopliteal lesions – the BIOFLEX PEACE All-Comers Registry

VASA ◽

10.1024/0301-1526/a000785 ◽

2019 ◽

Vol 48 (5) ◽

pp. 425-432 ◽

Cited By ~ 1

Author(s):

Michael Lichtenberg ◽

Frank Breuckmann ◽

Veronika Kramer ◽

Stefan Betge ◽

Sebastian Sixt ◽

...

Keyword(s):

Balloon Angioplasty ◽

Target Lesion ◽

Primary Patency ◽

Walking Distance ◽

Limb Amputation ◽

Lesion Length ◽

Nitinol Stent ◽

Safety Outcome ◽

Patient Reported ◽

Drug Coated Balloon

Summary. Background: Previous studies showed favorable results after treatment of femoropopliteal lesions with the Pulsar-18 self-expanding (SE) nitinol stent. The objective of this registry was to evaluate whether these results will be confirmed in a real-world setting with varying stenting strategies. Patients and methods: In this prospective, observational trial, 160 patients with 186 femoropopliteal lesions were treated with the Pulsar-18 SE nitinol stent at 9 German sites. Mean lesion length was 116 ± 103 mm, and 41.9 % of the lesions were moderately or heavily calcified. Eighty lesions were concomitantly treated with drug-coated balloon (DCB). Main effectiveness outcome was primary patency at 12 months, and main safety outcome was freedom from the composite of device or procedure related death, major target limb amputation, and clinically driven target lesion revascularization (TLR) at 30 days and 6 months. Results: Kaplan-Meier estimate of primary patency was 89.1 %, 67.3 %, and 57.1 % at 6, 12, and 24 months. Freedom from TLR was 95.5 %, 91.4 %, and 85.2 % at 6, 12, and 24 months, respectively. Lesions, which were additionally treated with DCB (plus DCB-group), were longer (150 versus 82 mm on average, p < 0.0001), and associated with lower primary patency estimates than those without DCB angioplasty (stent-only-group) (log-rank p = 0.006). However, there was no difference in freedom from TLR between groups (log-rank p = 0.542). Improvement by ≥ 1 Rutherford category was achieved in 84.8 %, 81.0 %, and 81.7 % of patients at 6, 12, and 24 months, respectively. Walking distance and patient-reported pain improved persistently through 24 months (p < 0.001). Hemodynamic improvement was achieved in 68.2 %, 73.7 %, and 70.7 % of the patients at 6, 12, and 24 months, respectively. Conclusions: The Pulsar-18 self-expanding nitinol stent with optional drug-coated balloon angioplasty can be considered an efficacious and safe therapy option for endovascular treatment of femoropopliteal artery disease.

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Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment

Jornal Vascular Brasileiro ◽

10.1590/1677-5449.007317 ◽

2017 ◽

Vol 16 (4) ◽

pp. 276-284 ◽

Cited By ~ 5

Author(s):

Marianne Brodmann ◽

Thomas Zeller ◽

Johnny Christensen ◽

Christoph Binkert ◽

Lubomir Spak ◽

...

Keyword(s):

Adverse Events ◽

Real World ◽

Limb Ischemia ◽

Target Lesion ◽

Target Lesion Revascularization ◽

Limb Amputation ◽

Lesion Length ◽

Infrainguinal Arteries ◽

Artery Disease ◽

Major Adverse Events

Abstract Background Endovascular management of atherosclerotic infrainguinal arteries recently shifted towards drug eluting devices, designed to locally prevent the restenosis process. Numerous clinical studies report an advantage of drug coated balloons over uncoated balloon angioplasty in treating lower extremity peripheral artery disease. However, as coating and balloon platforms are different, each device requires dedicated clinical evaluations. Objective The aim of the study is to further investigate the safety and effectiveness of a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries in a real-world setting. Methods 203 patients out of a final sample of 882 were enrolled in this prospective multicenter, observational, all-comers registry during the first 12 months. The primary endpoints were major adverse events (defined as procedure or device related death within 30 days post index procedure, clinically-driven target lesion revascularization or major target limb amputation) at 6 months and freedom from clinically-driven target lesion revascularization at 12 months. Both endpoints were adjudicated by a Clinical Events Committee. Results Mean patient age was 70.2±10.4 years (60.1% male). 47.3% of the patients were diabetic and 67.5% had a history of smoking. Severe claudication was reported in 37.4% and 40% had critical limb ischemia. 257 lesions, including 13.2% in the infrapopliteal territory, were treated with Passeo-18 Lux (mean lesion length 75.1 mm±69.4, 20% occlusions, 76.3% calcified). At 6 months, the rate of major adverse events was 5.5% (95%CI 3.1-9.7). Freedom from clinically-driven target lesion revascularization at 12 months was 93.2% (95%CI 89.1-95.8). All causes mortality was 6.5% (95%CI 3.8-11.0) and overall amputation rate was 4.2% (95%CI 2.1-8.3) at 12 months. Conclusion In a real-world environment, the BIOLUX P-III registry preliminary results confirm the safety and efficacy of the Paclitaxel-Coated Passeo-18 Lux balloon as a stand-alone treatment option for atherosclerotic infrainguinal arteries.

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Treatment of Femoropopliteal Lesions With the BioMimics 3D Vascular Stent System: Two-Year Results From the MIMICS-2 Trial

Journal of Endovascular Therapy ◽

10.1177/1526602820980419 ◽

2020 ◽

pp. 152660282098041

Author(s):

Timothy M. Sullivan ◽

Thomas Zeller ◽

Masato Nakamura ◽

Peter A. Gaines ◽

Keyword(s):

De Novo ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Stent Fracture ◽

Vascular Stent ◽

Stent Patency ◽

Kaplan Meier ◽

Stent System

Purpose To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial ( ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease.

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Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry

Journal of Endovascular Therapy ◽

10.1177/1526602819898804 ◽

2020 ◽

Vol 27 (2) ◽

pp. 304-315 ◽

Cited By ~ 4

Author(s):

Gunnar Tepe ◽

Thomas Zeller ◽

Matej Moscovic ◽

Jean-Marc Corpataux ◽

Johnny Kent Christensen ◽

...

Keyword(s):

Real World ◽

Target Lesion ◽

Performance Outcomes ◽

Limb Amputation ◽

Lesion Length ◽

Complication Rates ◽

Stent Restenosis ◽

And Performance ◽

Global Registry

Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry ( ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.

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PTA and Stenting of Femoropopliteal Trunk With Cordis Smartflex Stent System: A Single-Center Experience

Vascular and Endovascular Surgery ◽

10.1177/1538574419875551 ◽

2019 ◽

Vol 54 (1) ◽

pp. 17-24 ◽

Cited By ~ 1

Author(s):

Luca Garriboli ◽

Tommaso Miccoli ◽

Gianguido Pruner ◽

Antonio Maria Jannello

Keyword(s):

Limb Ischemia ◽

Primary Patency ◽

Lesion Length ◽

Acute Limb Ischemia ◽

Vascular Stent ◽

Stent Patency ◽

Stent Occlusion ◽

End Points ◽

Stent System ◽

Stent Length

Introduction: The aim of this study is to describe our experience in the treatment of femoropopliteal occlusive disease with percutaneous transluminal angioplasty (PTA) followed by stenting with S.M.A.R.T. Flex vascular stent system. Materials and Methods: From June 2014 to October 2018, 80 patients were treated at our Institution for intermittent claudication, critical, or acute limb ischemia due to total occlusion or long diffused lesions of the femoropopliteal segment. Main study end points are primary patency, target lesion revascularization, and stent fractures; secondary end points are major amputation rate, procedure-related bleeding, incidence of intrastent restenosis, and primary assisted patency after reintervention. Results: Mean follow-up time was 21 months (range 2-48 months). Primary patency rate was 80% (64 patients of 80), with mean covered lesion length of 8.2 cm. The deployment of a single stent was obtained for 57 (89%) patients, with a mean stent length of 9.86 cm. Of 80 patients, 2 (2.5%) had early stent occlusion within first 48 hours after the procedure, while 4 (5%) of 80 patients experienced stent occlusion within first 6 months. Of 80 patients, 6 (7.5%) had an intrastent restenosis detected at duplex ultrasound with a primary-assisted patency after simple re-PTA procedures of 83.3% at 12 months. Discussion: In the literature, primary patency after PTA and stenting of the femoropopliteal trunk seems to be related to several variables, such as number of stents used, specific stent length, diameters, type and length of lesions, type of pathology (if acute or chronic), and number of preoperatory patent below-the-knee vessels. In this study, we try to analyze each single factor in order to understand their role in predisposing specific stent restenosis. Conclusions: S.M.A.R.T. Flex vascular stent system has shown good results in terms of primary patency in the treatment of calcified lesions both at SFA and at popliteal level. However, in our experience, stent patency seems to be significantly poorer in patients presenting with acute limb ischemia associated with chronic atherosclerotic disease as well as for lesions located in the mid-distal part of the popliteal artery and both when number of stents increases or number of runoff vessel decreases.

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One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia

Journal of Endovascular Therapy ◽

10.1177/1526602817697319 ◽

2017 ◽

Vol 24 (3) ◽

pp. 311-316 ◽

Cited By ~ 6

Author(s):

Marc Bosiers ◽

Joren Callaert ◽

Koen Keirse ◽

Jeroen M. H. Hendriks ◽

Patrick Peeters ◽

...

Keyword(s):

Limb Salvage ◽

Critical Limb Ischemia ◽

Duplex Ultrasound ◽

Limb Ischemia ◽

Target Lesion ◽

Primary Patency ◽

Drug Eluting Stent ◽

Lesion Length ◽

Imaging Data ◽

Stent System

Purpose: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. Methods: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0–58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). Results: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. Conclusion: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

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The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population

Angiology ◽

10.1177/0003319721997314 ◽

2021 ◽

pp. 000331972199731

Author(s):

Ralf Langhoff ◽

Jawed Arjumand ◽

Matthias Waliszewski ◽

Peter Reimer ◽

Dirk Härtel ◽

...

Keyword(s):

Balloon Catheter ◽

Limb Ischemia ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Lesion Length ◽

Multicenter Observational Study ◽

Technical Success Rate ◽

All Cause Mortality ◽

Artery Disease

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)’s used was 99.6% (1.60 ± 0.79 DCB’s/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). Predictors for TLR were in-stent restenosis at baseline, vessel diameters ≤ 4.5 mm, lesion length, and post-DCB bailout stenting.

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Prospective Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm

Journal of Endovascular Therapy ◽

10.1177/1526602819862778 ◽

2019 ◽

Vol 26 (5) ◽

pp. 637-642 ◽

Cited By ~ 1

Author(s):

Martin Werner ◽

Fatemeh Gomari-Grisar ◽

Silvia Belalcazar ◽

Mirko Hirschl ◽

Georg Kalchhauser ◽

...

Keyword(s):

Velocity Ratio ◽

Treatment Algorithm ◽

Peak Systolic Velocity ◽

Target Lesion ◽

Primary Patency ◽

Lesion Length ◽

Secondary Patency ◽

Vascular Stent ◽

Modern Treatment

Purpose: To prospectively evaluate the safety and efficacy of the TIGRIS Vascular Stent in the superficial femoral artery (SFA) and proximal popliteal artery within a treatment algorithm that reserved stent usage for more challenging patients. Materials and Methods: This prospective, single-center study enrolled 97 patients (mean age 68.7 years; 66 men) who were treated for 100 de novo or nonstented restenotic femoropopliteal lesions (≥70% stenosis) and had recoil or dissection after plain balloon predilation. The average lesion length was 5.6±2.3 cm (maximum 8 cm per protocol). The composite primary efficacy outcome was 12-month primary patency, defined as a peak systolic velocity ratio ≤2.5 at the stented target lesion on duplex ultrasound, and no clinically-driven reintervention within the stented segment. The primary safety outcome was freedom from device- and procedure-related target vessel revascularization, target limb major amputation (above the metatarsals), or death through 30 days. Secondary outcomes included secondary patency, clinically-driven target lesion revascularization (TLR), Rutherford category change relative to baseline, and binary restenosis of the target lesion. Results: All devices were successfully implanted with no device-related complications at the time of implant or within the 30-day postimplant window. The average stented length was 7.0±2.5 cm; no stent elongation was observed during deployment. One patient was lost to follow-up before 12 months and another died of an unrelated cause, leaving 95 patients (98 lesions) available for 12-month follow-up and 77 patients/lesions for the 24-month preliminary analysis. The binary primary and secondary patency rates at 12 months were 92.9% and 100%. The binary freedom from TLR was 94.9%. At 24 months, the Kaplan-Meier estimate of primary patency was 90.0%. Conclusion: This prospective study demonstrated that the TIGRIS Vascular Stent is a safe and effective device in a modern treatment algorithm that reserved bare stent use for postangioplasty dissection or recoil in distal femoropopliteal arteries.

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IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population

Journal of Endovascular Therapy ◽

10.1177/1526602819852084 ◽

2019 ◽

Vol 26 (4) ◽

pp. 471-478 ◽

Cited By ~ 2

Author(s):

Zhong Chen ◽

Wei Guo ◽

Weiliang Jiang ◽

Feng Wang ◽

Weiguo Fu ◽

...

Keyword(s):

De Novo ◽

Limb Ischemia ◽

Chinese Patient ◽

Primary Patency ◽

Limb Amputation ◽

Lesion Length ◽

Chronic Total Occlusions ◽

Safety Outcome ◽

Drug Coated Balloon ◽

Chinese Subjects

Purpose: To confirm the safety and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for de novo and native artery restenotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery in Chinese subjects. Materials and Methods: IN.PACT SFA China ( ClinicalTrials.gov identifier NCT02118532) was a single-arm, independently adjudicated, prospective, premarket study that enrolled 143 subjects (mean age 66.8±7.7 years; 107 men) at 15 centers. The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The majority of subjects were classified as Rutherford category 2 or 3 [69 (48.3%) and 55 (38.5%), respectively]; 19 (13.3%) subjects had critical limb ischemia (Rutherford category 4). The mean lesion length was 10.4±6.51 cm; more than half of the lesions (75, 52.4%) were chronic total occlusions. Calcification was found in 66 (46.2%) lesions. Outcomes at 12 months were compared with DCB safety and effectiveness performance goals derived from the literature. The 30-day primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion revascularization (CD-TLR). Results: The primary safety outcome was 99.3% at 30 days. Follow-up compliance at 12 months was 92.6%. Estimated 1-year primary patency using Kaplan-Meier analysis was 90.9% and freedom from CD-TLR was 97.1%. The rate of CD-TLR at 12 months was 2.9%. The Rutherford category status improved significantly (p<0.001) between baseline and 12 months. Conclusion: Results from IN.PACT SFA China demonstrated high rates of patency and low rates of CD-TLR in Chinese subjects through 12 months despite patient and lesion complexity. These data are consistent with the results of other IN.PACT DCB trials.

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Drug-coated balloons versus 1ry stenting for TASC C and D femoropopliteal lesions

International Surgery Journal ◽

10.18203/2349-2902.isj20190390 ◽

2019 ◽

Vol 6 (2) ◽

pp. 492

Author(s):

Baker Ghoneim ◽

Ahmed Shaker ◽

Ahmed Karmoota ◽

Hany Abdelmola

Keyword(s):

Target Lesion ◽

Primary Patency ◽

Smoking History ◽

Limb Amputation ◽

Lesion Length ◽

Technical Success Rate ◽

Group I ◽

Safety Endpoint ◽

Primary Stenting ◽

Group Ii

Background: To compare the effectiveness and outcome of Drug-Coated Balloon (DCB) versus primary nitinol stenting for the treatment of long femoropopliteal lesions (TASC II C and D).Methods: This was retrospective study along 3 years included all the cases of femeropopliteal disease TASC C and D that was treated with DEB or primary stenting. The safety endpoint was 30-day free from major limb amputation and mortality. The primary end point was primary patency and freedom from clinically driven target lesion revascularization at 6 and 12 months, patient genders, demographics, co-morbidities, smoking history, indications for intervention were recorded.Results: PTA and post-dilation with paclitaxel-eluting balloons was done in 32 patients (group I) and 1ry stenting was done in 30 patients (group II) with either stenosis or occlusion. The mean lesion length was 18.43±2cm in group 1 and 18.8±2.32cm in group. The technical success rate was 100% in group II and 93.7% in group I. 6 months and 12-month patency rate for group I and II were 93.3% vs. 93.3% and 83.3% vs. 86.6%, respectively. There were no 30 days related major amputations or mortalities in either group.Conclusions: DCB for long femoropopliteal lesions showed a comparable result to primary stenting and provide durable results and lower incidence of target revascularization in patients with TASC C and D lesions.

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