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

Angiology ◽  
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.

scholarly journals 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

2017 ◽  
Vol 16 (4) ◽  
pp. 276-284 ◽  
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.

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

2017 ◽  
Vol 51 (2) ◽  
pp. 60-66 ◽  
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.

scholarly journals BioMimics 3D vascular stent system for femoropopliteal interventions

VASA ◽  
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.

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

2017 ◽  
Vol 24 (3) ◽  
pp. 311-316 ◽  
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.

Drug-Coated Balloon Angioplasty Compared With Uncoated Balloons in the Treatment of Infrapopliteal Artery Lesions (AcoArt II–BTK)

2020 ◽  
pp. 152660282096968
Author(s):  
Xin Jia ◽  
Baixi Zhuang ◽  
Feng Wang ◽  
Yongquan Gu ◽  
Jiwei Zhang ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
De Novo ◽  
Randomized Study ◽  
Balloon Catheter ◽  
Target Lesion ◽  
Primary Patency ◽  
Control Group ◽  
Lesion Length ◽  
Significant Difference ◽  
Drug Coated Balloon

Purpose To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods The prospective, multicenter, randomized study AcoArt II–BTK study ( ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up.

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

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.

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

2014 ◽  
Vol 8s2 ◽  
pp. CMC.S15224
Author(s):  
Michael Lichtenberg ◽  
Birgit Hailer ◽  
Matthias Kaeunicke ◽  
Wilhelm-Friedrich Stahlhoff ◽  
Dirk Boese ◽  
...  
Keyword(s):  
Renal Insufficiency ◽  
Patency Rate ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Target Lesion Revascularization ◽  
Walking Distance ◽  
Lesion Length ◽  
Nitinol Stent

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.

Mid-term outcome after endovascular therapy in the superficial femoral and popliteal artery using long stents

VASA ◽  
2012 ◽  
Vol 41 (1) ◽  
pp. 49-56 ◽  
Author(s):  
Schoenefeld ◽  
P. Donas ◽  
Schönefeld ◽  
Osada ◽  
Austermann ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Popliteal Artery ◽  
Primary Patency ◽  
Stent Fracture ◽  
Fracture Rate ◽  
Term Outcome ◽  
Technical Success Rate ◽  
Endovascular Interventions ◽  
Artery Disease

Background: Peripheral artery disease (PAD) affecting the femoropopliteal artery is treated by endovascular interventions [2, 5, 13] increasingly. Aim of the study was to evaluate mid-term efficacy and patency of long stents in the superficial femoral and popliteal artery. Patients and methods: Between September 2006 and September 2007 103 patients received 128 stents for endovascular treatment of femoropopliteal vascular stenosis or occlusion. Clinical and hemodynamic parameters were collected. Risk factors, popliteal involvement and TASC classification, were documented and evaluated. Results: Immediate outcome was satisfactory with a technical success rate of 100 %. After a mean follow-up period of 21 months, primary patency was 83.6 %. Potential risk factor analysis for restenosis and fracture demonstrated hypertension to have borderline significance (P = 0.06). In normotensive patients no restenosis occurred. Further pre-conditions, e.g. smoking, metabolic syndrome, age, gender and previous intervention did not show any influence on restenosis or stent fracture. TASC C and D lesion had similar patency rates compared to TASC A and B lesions. Most of the restenoses (13 out of 16) were observed within the first six months of follow-up. Six stent fracture were observed (4.7 %). Conclusions: Long stents had convincing results after endovascular treatment of the femoropopliteal PAD. The used stent was an efficacious endovascular tool for long athersclerotic lesions in the superficial femoral and popliteal artery. Fracture rate was low with an incidence of 4.7 %. Most restenoses occurred within the first six months so that careful follow-up would be necessary.

scholarly journals A meta-analysis of everolimus-eluting stents versus sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hang Ouyang ◽  
Xuehui Zeng ◽  
Chunlei Zhang ◽  
Linli Song ◽  
Jiarui Xu ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Diabetic Patients ◽  
Controlled Trials ◽  
Target Vessel ◽  
Target Vessel Revascularization ◽  
Randomized Controlled ◽  
All Cause Mortality ◽  
Late Luminal Loss

Abstract Objective We performed this meta-analysis to determine which stent among everolimus eluting stents (EES), sirolimus eluting stents (SES) and paclitaxel eluting stents (PES) should be preferred for the treatment of DM patients. Methods A systematic search of publications about randomized controlled trials (RCTs) focused on diabetic patients received EES, SES or PES was conducted. We evaluated the following indicators: target vessel revascularization (TVR), target lesion revascularization (TLR), late luminal loss (LLL), stent thrombosis (ST), myocardial infarction (MI), all-cause mortality and cardiac mortality. Results EES showed obvious advantages over SES for DM patients, as it induced the lowest rate of target vessel revascularization and target lesion revascularization (TLR) (p = 0.04). In addition, EES induced lower in-segment LLL than PSE and SES and lower in-stent LLL than PES in DM patients (all p < 0.05). Moreover, EES effectively reduced all-cause mortality compared to SES (RR = 0.71, 95% CI: 0.52–0.99, p = 0.04) and MI rates compared to PES (RR = 0.44, 95% CI: 0.26–0.73, p = 0.0002). Furthermore, EES could reduce the ST rate compared with both SES (RR = 0.53, 95% CI: 0.28–0.98, p = 0.04) and PES (RR = 0.18, 95% CI: 0.07–0.51, p = 0.001). Conclusion Among those three types of stents, EES should be the first recommended stent for DM patients.

scholarly journals Association between post-balloon angioplasty dissection and primary patency in complex femoropopliteal artery disease: 2-year clinical outcomes of the AcoArt I trial

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110065
Author(s):  
Hao Ren ◽  
Jie Liu ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
Weiguo Fu ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Cox Regression ◽  
Target Lesion ◽  
Transluminal Angioplasty ◽  
Outcome Data ◽  
Primary Patency ◽  
Cox Regression Analysis ◽  
Femoropopliteal Artery ◽  
Artery Disease

Objective To assess the association between post-balloon angioplasty dissection and the mid-term results of the AcoArt I trial evaluating complex femoropopliteal artery disease. Methods The outcome data for 144 patients from the AcoArt 1 trial were reanalysed. These patients were randomly divided into percutaneous transluminal angioplasty (PTA) and drug-coated balloons (DCB) groups. The primary endpoint was the primary patency (PP) rate and clinically-driven target lesion revascularisation at 24 months. Results After 24 months of follow-up, the PP rate of dissection cases in the PTA group was lower vs non-dissection cases. In patients receiving a bailout stent for dissection, the PP rate in the PTA group was lower vs the DCB group. Cox regression analysis showed that dissection decreased the PP rate; mild dissection reduced the PP rate as follows: 52%, PTA group and 19%, DCB group. With severe dissection, the PP rate reduction was as follows: 75%, PTA group and 73%, DCB group. Conclusions The mid-term follow-up showed that post-balloon angioplasty dissection reduced the PP rate in the PTA group but not in the DCB group. Additionally, in patients receiving a bailout stent for dissection, the DCB group had a better PP rate than the PTA group.

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