JetStream Atherectomy for the Treatment of In-Stent Restenosis of the Femoropopliteal Segment: One-Year Results of the JET-ISR Study

2020 ◽  
pp. 152660282095191
Author(s):  
Nicolas W. Shammas ◽  
Nicholas Petruzzi ◽  
Steven Henao ◽  
Ehrin J. Armstrong ◽  
Thomas Shimshak ◽  
...  
Keyword(s):  
Target Lesion ◽  
Lesion Length ◽  
Chronic Total Occlusions ◽  
Stent Restenosis ◽  
Kaplan Meier ◽  
Class D ◽  
Secondary Endpoints ◽  
Drug Eluting ◽  
One Year ◽  
In Stent Restenosis

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR ( ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR.

scholarly journals Laser Atherectomy Combined With Drug-Coated Balloon Angioplasty Is Associated With Improved 1-Year Outcomes for Treatment of Femoropopliteal In-Stent Restenosis

2017 ◽  
Vol 25 (1) ◽  
pp. 81-88 ◽  
Author(s):  
Damianos G. Kokkinidis ◽  
Prio Hossain ◽  
Omar Jawaid ◽  
Bejan Alvandi ◽  
T. Raymond Foley ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Cox Regression ◽  
Multivariable Analysis ◽  
Limb Ischemia ◽  
Target Lesion ◽  
Lesion Length ◽  
Stent Restenosis ◽  
Kaplan Meier ◽  
Laser Atherectomy ◽  
In Stent Restenosis

Purpose: To examine whether laser atherectomy combined with drug-coated balloons (laser + DCB) can improve the outcomes of femoropopliteal (FP) in-stent restenosis (ISR). Methods: A dual-center retrospective study was conducted of 112 consecutive patients (mean age 70.3±10.6 years; 86 men) with Tosaka class II (n=29; diffuse stenosis) or III (n=83; occlusion) FP-ISR lesions. Sixty-two patients (mean age 68.5±10 years; 51 men) underwent laser + DCB while the other 50 patients (mean age 72.5±10.8 years; 35 men) had laser atherectomy plus balloon angioplasty (laser + BA). Critical limb ischemia was the indication in 33% of the interventions. The average lesion length was 247 mm. A Cox regression hazard model was developed to examine the association between laser + DCB vs laser + BA; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). One-year target lesion revascularization (TLR) and reocclusion were estimated using the Kaplan-Meier method. Results: Overall procedure success was 98% and was similar between groups. Bailout stenting was less often required in the laser + DCB group (31.7% vs 58%, p=0.006). The combination of laser + DCB was associated with improved 12-month estimates for freedom from TLR (72.5% vs 50.5%, p=0.043) and freedom from reocclusion (86.7% vs 56.9%, p=0.003). Among patients with Tosaka III FP-ISR, combination therapy with laser + DCB was also associated with increased freedom from reocclusion (87.1% vs 57.1%, p=0. 028). On multivariable analysis, treatment with laser + DCB was associated with a significantly reduced risk of reocclusion (HR 0.08, 95% CI 0.17 to 0.38; p=0.002). Conclusion: When used for treatment of complex FP-ISR lesions, DCB angioplasty combined with laser atherectomy is associated with significantly reduced 1-year TLR and reocclusion rates.

scholarly journals Drug-eluting balloon treatment in femoropopliteal in-stent restenosis of different lengths

2020 ◽  
Vol 28 (3) ◽  
pp. 460-466
Author(s):  
Berkan Özpak
Keyword(s):  
Stent Restenosis ◽  
Significant Difference ◽  
Stent Length ◽  
Drug Eluting ◽  
Group 3 ◽  
Group 2 ◽  
Drug Eluting Balloon ◽  
One Year ◽  
In Stent Restenosis ◽  
Group 1

Background: In this study, we present one-year results of drug-eluting balloon treatment of femoropopliteal in-stent restenosis. Methods: A total of 62 patients (48 males, 14 females; mean age 64.2±9.1 years; range, 54 to 81 years) who underwent drug-eluting balloon stenting for femoropopliteal in-stent restenosis between August 2013 and October 2017 were included in the study. The patients were classified into three groups based on the narrowing length of stenosis in the stents. Group/Class 1 (n=17): narrowing <1/2 of the stent length; Group/Class 2 (n=22): narrowing >1/2 of the stent length, not totally occluded; and Group/Class 3 (n=23): totally occluded. In-stent restenosis was treated with drug-eluting balloon treatment. Results: There was a significant difference among all classes in terms of in-stent restenosis. The length of stenosis was a predictor for in-stent restenosis. The mean stent length was 107.7±24.6 mm in Group 1, 164.6±17.9 mm in Group 2, and 180±19.3 mm in Group 3. For non-occluded in-stent restenosis, restenosis rate at one year after balloon angioplasty was 47.1% in Group 1, 86.4% in Group 2, and 95.7% in Group 3. Femoropopliteal bypass was performed in five patients in whom treatment failed. None of the patients required amputation. Conclusion: The length of in-stent restenosis in the femoropopliteal arterial stents is an important predictor for recurrent stenosis, when re-flow is achieved with drug-eluting balloons.

scholarly journals Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

2020 ◽  
Vol 27 (5) ◽  
pp. 693-705
Author(s):  
Giovanni Torsello ◽  
Konstantinos Stavroulakis ◽  
Marianne Brodmann ◽  
Antonio Micari ◽  
Gunnar Tepe ◽  
...  
Keyword(s):  
Real World ◽  
Popliteal Artery ◽  
Limb Amputation ◽  
Lesion Length ◽  
Stent Restenosis ◽  
Kaplan Meier ◽  
Global Study ◽  
Drug Coated Balloon ◽  
Major Target ◽  
In Stent Restenosis

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.

Abstract 17459: Drug Eluting Balloon Angioplasty is a Safe Treatment Option for In-stent Restenosis: Meta-analysis of Current Evidence

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Sainath Gaddam ◽  
Bhavi Pandya ◽  
Mustafain Meghani ◽  
Vratika Agarwal ◽  
Armaghan Soomro ◽  
...  
Keyword(s):  
Balloon Angioplasty ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Current Evidence ◽  
Stent Restenosis ◽  
Number Of Patients ◽  
Drug Eluting ◽  
Drug Eluting Balloon ◽  
Plain Old Balloon Angioplasty ◽  
In Stent Restenosis

Introduction: Drug eluting balloons (DEB) were recently approved by FDA for peripheral artery interventions only. For coronary in-stent restenosis (ISR), the ACC/AHA/SCAI 2011 PCI guidelines have no recommendations on role for DEB. While ESC/EACTS 2010 PCI guidelines, have level IIa recommendation for DEB for ISR after a bare metal stent. The drug delivery kinetics with DEB allows shorter duration of dual anti-platelet therapy and has a potential role in ballooning side branches of a bifurcating lesion after stenting. Aim: To compare safety and efficacy of DEB angioplasty vs. plain old balloon angioplasty (BA) or drug eluting stent (DES) for treating coronary ISR. Methods and Results: A thorough search was performed on Pubmed, Embace and Google scholar databases for randomized control trials (RCT) comparing DEB vs. BA or DES for ISR. We compared target lesion revascularization (TLR) and MACE events for these groups. We also pooled data from registries and observation studies on DEB for outcome analysis. Total number of patients with DEB’s in our study was 3465, with 693 DEB’s in 8 RCT’s. Mean follow up period was 11 months. Pooled analysis showed significant benefit for DEB compared to plain old BA, for events of target lesion revascularization (OR= 0.25, p<0.0001), and death (OR=0.31, p<0.0001). Comparing DEB to DES, there was no statistical difference in outcomes comparing TLR (OR=1.4, p=0.14), MI or death (OR=0.65, p=0.39). Cumulative incidence of target lesion revascularization (TLR) with DEB was 6.7%. Conclusions: For coronary ISR, drug eluting balloon angioplasty is superior to plain old balloon angioplasty in terms of safety and outcomes. However, comparing drug eluting balloons vs. drug eluting stents in ISR, the outcomes are comparable and will need larger studies powered to make definitive recommendation.

Modified drug-eluting balloon angioplasty to treat high-risk carotid in-stent restenosis

Perfusion ◽  
2017 ◽  
Vol 32 (5) ◽  
pp. 409-412 ◽  
Author(s):  
Chih-Hung Lai ◽  
Chieh-Shou Su ◽  
Wen-Lieng Lee ◽  
Yuang-Seng Tsuei
Keyword(s):  
Carotid Artery ◽  
Artery Occlusion ◽  
Carotid Artery Occlusion ◽  
Difficult Case ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
Contralateral Internal Carotid Artery ◽  
Drug Eluting Balloon ◽  
One Year ◽  
In Stent Restenosis

Carotid artery stenting is commonly used to treat carotid artery stenosis. However, carotid in-stent restenosis remains a challenging problem. Herein, we report a difficult case of recurrent severe carotid in-stent restenosis with total contralateral internal carotid artery occlusion treated with repeat drug-eluting balloon inflations. The outcome after one year of follow-up showed a good result.

scholarly journals Long-Term Outcomes Following Drug-Eluting Balloons Versus Thin-Strut Drug-Eluting Stents for Treatment of In-Stent Restenosis (DEB-Dragon-Registry)

2021 ◽  
Author(s):  
Wojciech Wańha ◽  
Jacek Bil ◽  
Rafał Januszek ◽  
Natasza Gilis-Malinowska ◽  
Tomasz Figatowski ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiac Death ◽  
Coronary Intervention ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Target Vessel ◽  
End Point ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
In Stent Restenosis

Background: Data regarding the use of percutaneous coronary intervention with drug-eluting balloons (DEB) versus thin-strut drug-eluting stents (thin-DES) for treating DES in-stent restenosis in everyday clinical practice is scarce. Our goal was to evaluate the efficacy and safety profile of DEB versus thin-DES in DES in-stent restenosis. Methods: Consecutive patients with DES in-stent restenosis who underwent percutaneous coronary intervention between 2008 and 2019 entered the multicenter DEB-DRAGON Registry with a follow-up of 3 years. Patients who received DEB at the index procedure (n=557, 49.9%) were compared with those who received thin-DES (n=560, 50.1%). Results: Analysis of the unmatched cohort revealed lower rates of target lesion revascularization (9.1% versus 13.6%; hazard ratio [HR], 0.58 [95% CI, 0.41–0.83], P =0.003), target vessel revascularization (11.8% versus 16.7%; HR, 0.62 [95% CI, 0.45–0.84], P =0.003) and device-oriented composite end point, defined as a composite of cardiac death, target lesion revascularization, and target vessel myocardial infarction (12.7% versus 16.0%; HR, 0.69 [95% CI, 0.50–0.94], P =0.018) in the thin-DES group compared with the DEB group. The incidence of cardiac death, target vessel-myocardial infarction, and myocardial infarction were similar in both groups. However, after propensity score matching, there were no significant differences in target lesion revascularization (11.2% versus 11.2%; HR, 0.91 [95% CI, 0.55–1.51], P =0.707), target vessel revascularization (13.4% versus 14.2%; HR, 0.86 [95% CI, 0.55–1.36], P =0.523), and device-oriented composite end point (14.2% versus 14.2%; HR, 0.91 [95% CI, 0.58–1.42], P =0.667) between the thin-DES and DEB group, respectively. Conclusions: This analysis of a real-life registry revealed similar long-term outcomes of thin-DES and DEB in DES in-stent restenosis regarding target lesion revascularization, myocardial infarction, cardiac death, and device-oriented composite end point. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04415216.

Abstract 177: Impact of a Drug-eluting Stent Guideline on Clinical Practice

2013 ◽  
Vol 6 (suppl_1) ◽  
Author(s):  
Vanessa Lee ◽  
Nicholas Cox
Keyword(s):  
Clinical Practice ◽  
Clinical Decision Making ◽  
Guideline Implementation ◽  
Public Hospitals ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Stent Restenosis ◽  
Number Of Patients ◽  
Drug Eluting ◽  
In Stent Restenosis

Introduction: In Victorian public hospitals drug-eluting stents (DES) are reserved for patients at high-risk of in-stent restenosis. A hospital guideline was developed in consultation with cardiologists following systematic review of the literature to improve the consistency of percutaneous coronary intervention (PCI) practice and the clinical decision-making behind stent implantation. Indications for DES deployment were Diabetes Mellitus; Lesion Length >20mm or Diameter <2.5mm; Chronic Total Occlusion; In-stent Restenosis; Saphenous Vein Graft; Left Main; Proximal Left Anterior Descending Artery; Bifurcation or Ostial Lesion; Chronic Renal Failure. Method: Retrospective study involving a 4-week audit conducted pre-guideline implementation in April 2009 and two subsequent audits post-guideline implementation in September 2011 and April 2012. The guideline was introduced in February 2011. Results: The number of patients in each cohort was 38 (2009), 45 (2011) and 47 (2012). Overall there was an increase in DES usage from 39.5% (2009) to 62.2% (2011) and 59.6% (2012). However, the percentage of patients meeting one or more indication for DES use without a documented contraindication also increased from 31.6% (2009) to 62.2% (2011) and 59.6% (2012). Following guideline implementation the percentage of patients that received a DES without indication decreased from 7.9% to 0% (both 2011 and 2012), and those indicated for DES who subsequently received a bare-metal stent (BMS) also decreased from 18.4% to 2.2% (2011) and 2.1% (2012). Conclusion: Introduction of the guideline did not reduce the rate of DES deployment. However, it significantly improved clinical practice and appropriateness of DES and BMS usage. This improvement was again measurable and sustained 12 months following guideline implementation.

scholarly journals The Predictors of Target Lesion Revascularization and Rate of In-Stent Restenosis in the Second-Generation Drug-Eluting Stent Era

2019 ◽  
Vol 2019 ◽  
pp. 1-13
Author(s):  
Chengbin Zheng ◽  
Jeehoon Kang ◽  
Kyung Woo Park ◽  
Jung-Kyu Han ◽  
Han-Mo Yang ◽  
...  
Keyword(s):  
Target Lesion ◽  
University Hospital ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
2Nd Generation ◽  
Stent Restenosis ◽  
Significant Difference ◽  
Drug Eluting ◽  
In Stent Restenosis

Objectives. The aim of our study was to investigate the predictors of target lesion revascularization (TLR) and to compare the in-stent restenosis (ISR) progression rates of different 2nd-generation drug-eluting stents (DES). Background. The predictors of early and late TLR after 2nd-generation DES implantation have not been fully evaluated. Methods. We analyzed 944 stented lesions from 394 patients who had at least two serial follow-up angiograms, using quantitative coronary angiography (QCA) analysis. The study endpoints were TLR and the velocity of diameter stenosis (DS) progression. Results. TLR occurred in 58 lesions (6.1%) during the first angiographic follow-up period and 23 de novo lesions (2.4%) during the following second interval. Independent predictors for early TLR were diabetes mellitus (DM) (HR 2.58, 95% CI 1.29–5.15, p=0.007), previous percutaneous coronary intervention (PCI) (HR 2.41, 95% CI 1.03–5.65, p=0.043), and postprocedure DS% (HR 1.08, 95% CI 1.05–1.11, p<0.001, per 1%), while predictors of late TLR were previous PCI (HR 9.43, 95% CI 2.58-34.52, p=0.001) and serum C-reactive protein (CRP) (HR 1.60, 95% CI 1.28-2.00, p<0.001). The ISR progression velocity (by DS%) was 12.1 ±21.0%/year and 3.7 ±10.1%/year during the first and second follow-up periods, respectively, which had no significant difference (p>0.05) between the four types of DESs. Conclusions. Our data showed that predictors for TLR may be different at different time intervals. DM, pervious PCI, and postprocedure DS could predict early TLR, while previous PCI and CRP level could predict late TLR. Contemporary DESs had similar rates of ISR progression rates. Trial Registration. This study was retrospectively registered and approved by the institutional review board of Seoul National University Hospital (no. 1801–138-918).

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