Evaluation of the 4-French Pulsar-18 Self-expanding Nitinol Stent in Long Femoropopliteal Lesions

Purpose To evaluate the patency and the freedom of target lesion revascularization of the 4-French Pulsar-18 self-expandable (SE) nitinol stent for the treatment of long femoropopliteal occlusive disease in a two-center, prospective, all-comers registry with a follow-up period of 12 months. Methods This registry enrolled 36 patients with symptomatic femoropopliteal long lesions for recanalization and implantation of the 4-French Pulsar-18 SE nitinol stent. Routine follow-up examination including duplex ultrasound was performed after 6 and 12 months. Primary patency was defined as no binary restenosis on duplex ultrasound (Peak systolic velocitiy ration (PSVR) <2.5) and no target lesion revascularization was performed within 12 months' follow-up. No drug-eluting devices were allowed in this registry. Results Average lesion length of the femoropopliteal segment was 182.3 ± 51.8 mm. Mean stent implantation length was 181.5 ± 35.4 mm. Total occlusion was present in 46 of the 48 (95.8%) treated lesions. Involvement of popliteal segment I–III was present in 3 (6.3%) lesions. The primary patency after 6 and 12 months was 87.5% and 85.4%, respectively. The clinically driven overall freedom from target lesion revascularization (fTLR) was 89.6% after 6 months and 87.5% after 12 months. ABI, pain-free walking distance and Rutherford category, all improved significantly ( P < 0.001) after 6 and 12 months. The primary patency rate in patients with diabetes ( P = 0.18) and renal insufficiency ( P = 0.3) was not significantly lower as compared to the overall primary patency. Conclusions In this two-center, all-comers registry, the use of the Pulsar-18 SE nitinol stent for endovascular intervention of femoropopliteal disease with a mean lesion length of 182.3 ± 51.8 mm showed promising primary patency and fTLR rates after 6 and 12 months. Diabetes and renal insufficiency had no negative impact on the patency rate.

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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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Everolimus-Eluting Stent for Patients With Critical Limb Ischemia and Infrapopliteal Arterial Occlusive Disease

Vascular and Endovascular Surgery ◽

10.1177/1538574416689429 ◽

2017 ◽

Vol 51 (2) ◽

pp. 60-66 ◽

Cited By ~ 1

Author(s):

Alessia Giaquinta ◽

Ardita Vincenzo ◽

Ester De Marco ◽

Massimiliano Veroux ◽

Pierfrancesco Veroux

Keyword(s):

Wound Healing ◽

Limb Ischemia ◽

Target Lesion ◽

Major Amputation ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Lesion Length ◽

Free Survival ◽

Tibial Arteries

Background: Critical limb ischemia (CLI), despite revascularization, may result in minor or major amputations with devastating psychological effects and a negative impact on patient survival. Randomized clinical trials demonstrated that drug-eluting stents improve 1-year primary patency and decrease target lesion revascularization, compared to standard angioplasty and bare-metal stents, in patients with short occlusive below-the-knee lesions. Objectives: This prospective clinical study was designed to evaluate if one straight-line flow revascularization to the foot, using Xience-Prime Everolimus-Eluting Stent (EES), is an effective treatment of patients in Rutherford-Becker category 4 to 5 with distal popliteal and proximal tibial arteries long occlusive lesions up to 10 cm. Methods: All patients with angiographic documented segment P3 of popliteal artery and proximal tibial arteries stenosis >70%, and lesion length between 20 mm and 100 mm, meeting the inclusion criteria, were included in the Etna Registry. The end points assessed were 1- and 3-year primary patency, major amputation-free survival, target lesion revascularization, and wound healing rates. Results: Between June 2011 and April 2014, 122 patients were included in the study, with mean lesion length of 52.7 mm (range: 20-100 mm). The 1- and 3-year primary patency rates were 88.9% and 80.1%, respectively. The survival, major amputation-free survival, and target lesion revascularization rates were 88.1%, 93%, and 91.5% at 1-year and 70.4%, 89.3%, and 85.1% at 3-year follow-up, respectively. Primary patency influenced major amputation rate, which was 60% in patients with no target artery patency versus 5.4% in patients with patency ( P = .022). At 1-year follow-up, 78 (88.6%) of 88 patients improved 1 or more of their Rutherford-Becker category, and 48 (80%) of 69 patients had wound healing. Conclusions: The results of our study suggest that a conservative approach, with EES, seems feasible in selected patients with CLI and infrapopliteal artery occlusive disease.

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Analysis of Interwoven Nitinol Stenting for the Treatment of Critical Limb Ischemia: Outcomes From an Average 3-Year Follow-up Period

Angiology ◽

10.1177/00033197211043406 ◽

2021 ◽

pp. 000331972110434

Author(s):

Prakash Krishnan ◽

Arthur Tarricone ◽

Allen Gee ◽

Serdar Farhan ◽

Haroon Kamran ◽

...

Keyword(s):

Cohort Study ◽

Retrospective Cohort ◽

Limb Ischemia ◽

Target Lesion ◽

Complete Healing ◽

Target Lesion Revascularization ◽

Free Survival ◽

Nitinol Stent ◽

Effective Treatment Modality

We assessed the clinical outcomes of patients with critical limb-threatening ischemia (CLTI) who underwent interwoven nitinol stent (Supera) implantation for significant stenoses of the femoropopliteal segment. In this retrospective cohort study, 116 consecutive patients with CLTI who were treated with Supera stents between September 2015 and March 2020 were included in this analysis. Primary endpoint analysis was completed for amputation-free survival, target lesion revascularization (TLR), and mortality. After a mean follow-up time of 3.4 years, 21 (18%) patients had undergone amputations, 3 (2.6%) died, and, overall, the amputation-free survival rate was 81%. TLR occurred in 21 (18%) patients, resulting in the freedom from target lesion revascularization of 82%. The average Wagner score for all patients was 2.8 ± 1.1. A subgroup analysis of 57 patients revealed a median ulcer size of 3.0 cm2 [1.65, 9.0], with complete healing for 45 patients by 20 months. The Wagner score of this subgroup decreased by an average of 3.4 ± .9 points. Supera stents can be used together with other endovascular therapies and are a safe and effective treatment modality for CLTI.

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BioMimics 3D vascular stent system for femoropopliteal interventions

VASA ◽

10.1024/0301-1526/a000980 ◽

2021 ◽

Author(s):

Michael Lichtenberg ◽

Thomas Zeller ◽

Peter Gaines ◽

Michael Piorkowski

Keyword(s):

Real World ◽

Target Lesion ◽

Primary Patency ◽

Distribution Functions ◽

Target Lesion Revascularization ◽

Limb Amputation ◽

Lesion Length ◽

Vascular Stent ◽

Safety Outcome ◽

Stent System

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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Three-Year Results of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold in Infrapopliteal Arteries

Journal of Endovascular Therapy ◽

10.1177/1526602818799736 ◽

2018 ◽

Vol 25 (6) ◽

pp. 694-701 ◽

Cited By ~ 14

Author(s):

Ramon L. Varcoe ◽

Shannon D. Thomas ◽

Andrew F. Lennox

Keyword(s):

Duplex Ultrasound ◽

Primary Patency ◽

Tissue Loss ◽

Lesion Length ◽

Bioresorbable Vascular Scaffold ◽

Binary Restenosis ◽

Antiplatelet Medication ◽

Scaffold Thrombosis ◽

Vascular Scaffold

Purpose: To investigate the midterm performance of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS) for the treatment of symptomatic infrapopliteal atherosclerotic disease. Methods: A single-center study prospectively enrolled 48 symptomatic patients (mean age 82.1±8.0 years; 27 men) between September 2013 and February 2018 to evaluate the Absorb everolimus-eluting BVS system in distal popliteal and tibial lesions. Mean lesion length was 20.1±10.8 mm. Following predilation, up to 2 BVS were implanted in target lesions in 55 limbs. Clinical and duplex ultrasound follow-up was performed at 1, 3, 6, 12, 24, 36, and 48 months to determine 30-day morbidity and midterm Kaplan-Meier estimates of binary restenosis, clinically-driven target lesion revascularization (CD-TLR), amputation, and mortality. Results: Seventy-one scaffolds were implanted to treat 61 lesions. Technical success was achieved in all patients, with no amputation, death, or target limb bypass surgery within 30 days of the index procedure. There was 1 early thrombotic occlusion of 2 BVS in a previously anticoagulated patient not given antiplatelet medication after the procedure. During a mean follow-up of 24.0±15.3 months, 11 (23%) patients died; the remaining 37 were available for follow-up. Binary restenosis (50%–75%) was detected in 6 (8%) scaffolds. Primary patency estimates at 12, 24, and 36 months were 92.2%, 90.3%, and 81.1%; freedom from CD-TLR estimates were 97.2%, 97.2%, and 87.3% at the same time points. No late scaffold thrombosis has been observed. The majority of the 55 limbs (51, 93%) were clinically improved; 4 (7%) were unchanged. Thirty-six (92%) of 39 limbs treated for tissue loss achieved complete wound healing, with no major amputation (limb salvage 100%). Conclusion: Midterm follow-up demonstrates excellent safety, patency, and freedom from CD-TLR rates using the Absorb bioresorbable vascular scaffold below the knee.

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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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One-Year Outcomes Following Directional Atherectomy of Popliteal Artery Lesions: Subgroup Analysis of the Prospective, Multicenter DEFINITIVE LE Trial

Journal of Endovascular Therapy ◽

10.1177/1526602817740133 ◽

2017 ◽

Vol 25 (1) ◽

pp. 100-108 ◽

Cited By ~ 8

Author(s):

Aljoscha Rastan ◽

James F. McKinsey ◽

Lawrence A. Garcia ◽

Krishna J. Rocha-Singh ◽

Michael R. Jaff ◽

...

Keyword(s):

Popliteal Artery ◽

Duplex Ultrasound ◽

Limb Ischemia ◽

Clinical Results ◽

Major Amputation ◽

Primary Outcome Measure ◽

Primary Patency ◽

Walking Distance ◽

Lesion Length ◽

Directional Atherectomy

Purpose: To report the effectiveness of directional atherectomy for the treatment of popliteal artery occlusive disease. Methods: This subset of the prospective, multicenter, single-arm DEFINITIVE LE trial included 158 patients (mean age 72.0±10.9 years; 82 men) who underwent directional atherectomy in 162 popliteal artery lesions between 2009 and 2011. Forty-eight (30.4%) patients were suffering from critical limb ischemia (CLI). The mean lesion length was 5.8±3.9 cm; 38 (23.5%) arteries were occluded. The primary outcome measure for patients with intermittent claudication (IC) was duplex ultrasound–defined primary patency at 1 year; the outcome for subjects with CLI was freedom from major amputation of the target limb at 1 year. Outcomes and adverse events were independently assessed. Results: Procedure success (≤30% residual stenosis) was achieved in 84.4% of treated lesions; adjunctive stenting was required in 6 (3.7%) of the 162 lesions. The 1-year primary patency rate was 75.0% (IC patients 78.2% and CLI patients 67.5%, p=0.118). The freedom from major amputation in both cohorts was 100%. In both IC and CLI patients, significant improvements were demonstrated at 1 year in the Rutherford category, walking distance, and quality of life in comparison to baseline. Conclusion: This study indicates that directional atherectomy in popliteal arteries leads to favorable technical and clinical results at 1 year for claudicant as well as CLI patients.

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Abstract 13533: 1-Year Results of Paclitaxel-Coating Nitinol Stent Placement for Chronic Total Occlusion in the Femoropopliteal Artey

Circulation ◽

10.1161/circ.130.suppl_2.13533 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Naotaka Murata ◽

Yoshimitu Soga ◽

Yusuke Tomoi ◽

Seiichi Hiramori ◽

Yohei Kobayashi ◽

...

Keyword(s):

Chronic Total Occlusion ◽

Ankle Brachial Index ◽

Primary Patency ◽

Lesion Length ◽

Total Occlusion ◽

Femoropopliteal Artery ◽

Nitinol Stent ◽

Kaplan Meier ◽

Zilver Ptx

Introduction: The mid-term outcomes of paclitaxel-coating nitinol stent (Zilver PTx) placement for chronic total occlusion (CTO) in the femoropopliteal artery have not been assessed. Hypothesis: Zilver PTx placement for CTO in the femoropopliteal artey is reliable. Methods: All patients enrolled in this prospective, single center study underwent Zilver PTx placement for de novo or restenotic CTO and non-CTO in the superficial femoral and/or popliteal artery. Baseline and follow-up Rutherford classification and Ankle-brachial index (ABI) measurements were obtained. Follow-up was completed at 3, 6, 12 months. Results: There were 61 of CTO and 58 of non-CTO treated. Mean age was 74 ± 8 years and male was 82 % in overall. Patients characteristics and degree of lesion calcification was not different significantly between two groups. CTO group had a longer mean lesion length than non-CTO group (209 mm ± 93 mm vs 131 mm ± 87 mm, P < .0001). Procedural success in both treatments was over 98 %. The operative complications were 3 cases in CTO group and 2 cases in non-CTO group. The primary patency of CTO group was significantly lower than non-CTO group in Kaplan-Meier estimate curves at 12 months (75 % vs 82 %, Log-rank P < 0.05). There were no significant differences in event-free survival or freedom from target lesion revascularization in Kaplan-Meier estimate curves at 12 months (68 % vs 70 %; Log-rank P = 0.82, 63 % vs 65 %; Log-rank P = 0.47, respectively). Both groups experienced a significant improvement in Rutherford classification and ABI after treatment, and these improvements were sustained to 12-months follow-up. Based on multivariate analysis, CTO was the negative predictor for primary patency at 12 months (HR 2.37, 95 % CI 1.02 to 5.9, adjusted P < 0.05). Conclusions: CTO influences negatively the primary patency of Zilver PTx placed in the femoropopliteal artery. However, Improvement of Rutherford classification and ABI at 12-months after CTO- intervention is sustained.

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Thirty-six-month outcomes of drug-eluting balloon angioplasty in the infrapopliteal arteries

Vascular ◽

10.1177/1708538118759416 ◽

2018 ◽

Vol 26 (5) ◽

pp. 457-463 ◽

Cited By ~ 6

Author(s):

Berkan Ozpak ◽

Sahin Bozok ◽

Mustafa Cagdas Cayir

Keyword(s):

Balloon Angioplasty ◽

Patency Rate ◽

Ankle Brachial Index ◽

Target Lesion ◽

Primary Patency ◽

Target Lesion Revascularization ◽

Primary Patency Rate ◽

Drug Eluting ◽

Drug Eluting Balloon ◽

Infrapopliteal Arteries

Objectives To evaluate 36-month outcomes of drug-eluting balloons in infrapopliteal (=below-the-knee) arterial segments, we made a prospective registry enrolling patients (Rutherford class 2 to 5, ankle–brachial index 0.4–0.7) who were revascularized with drug-eluting balloon from August 2011 to December 2014. Methods Three hundred and seven infrapopliteal arteries were revascularized only with drug-eluting balloon. Endpoints included target lesion revascularization, primary patency rate, and changes in ankle–brachial index and Rutherford class. Results Both ankle–brachial index improvement and Rutherford reduction were statistically significant (p < 0.001). At 36 months control, ankle–brachial index improvement was 59.3% (p = 0.032). The clinically driven target lesion revascularization rate was 28% at 36 months. Limb salvage was accomplished in 73.6% of the critical limb ischemia cases, and complete wound healing was detected in 67.8% of cases with Rutherford category 5. Overall, the 1-year primary patency rate was 32.5%. Conclusions Drug-eluting balloons have shown successful performance in infrapopliteal arteries in mid-term, and evidence regarding clinical effectiveness and safety supports drug-eluting balloon angioplasty as the first line therapy in this segment.

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