scholarly journals Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Kazunori Horie ◽  
Akiko Tanaka ◽  
Kenji Suzuki ◽  
Masataka Taguri ◽  
Naoto Inoue

Abstract Background The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. Methods After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. Results The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57–16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21–12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06–0.41; p < 0.001). Conclusions At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. Evidence-based medicine Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.

2020 ◽  
Vol 27 (4) ◽  
pp. 647-657
Author(s):  
Stefanos Giannopoulos ◽  
Sheila Ghanian ◽  
Sahil A. Parikh ◽  
Eric A. Secemsky ◽  
Peter A. Schneider ◽  
...  

Purpose: To investigate the safety and efficacy of drug-coated balloons (DCB) for the treatment of femoropopliteal or infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: A systematic literature search was conducted in PubMed, Scopus, and Cochrane Central up to January 2020 to identify randomized trials and observational studies presenting data on the effectiveness and safety of DCBs in the treatment of femoropopliteal or infrapopliteal lesions. A meta-analysis utilizing random effects modeling was conducted to investigate primary patency and all-cause mortality at 12 months; the results are reported as the odds ratios (ORs) and 95% confidence intervals (CIs). Secondary outcomes were procedural success, bailout stenting, target lesion revascularization (TLR), reocclusion, major amputation, wound healing, and major adverse limb events. Results: Twenty-six studies, 12 retrospective and 14 prospective, comprising 2108 CLTI patients treated with DCBs for femoropopliteal (n=1315) or infrapopliteal (n=793) lesions were analyzed. The average lesion lengths were 121±44 and 135±53 mm, respectively. The overall 12-month all-cause mortality and major amputation rates were 9% (95% CI 6% to 13%) and 5% (95% CI 2% to 8%), respectively. Primary patency rates were 82% (95% CI 76% to 87%) and 64% (95% CI 58% to 70%), respectively. A sensitivity analysis of the infrapopliteal lesions demonstrated no difference between DCB and balloon angioplasty in terms of primary patency, TLR, major amputation, or mortality over 12 months. However, patients with infrapopliteal lesions undergoing DCB angioplasty did have a significantly lower risk for reocclusion (10% vs 25%; OR 0.38, 95% CI 0.21 to 0.70, p=0.002). Conclusion: DCB angioplasty of femoropopliteal and infrapopliteal lesions in patients with CLTI results in acceptable 12-month patency rates, although comparative data have not shown a patency benefit for infrapopliteal lesions. The 12-month mortality rate of DCB vs balloon angioplasty was not significantly different, but studies with longer-term outcomes are necessary to determine any association between DCB use and mortality in patients with CLTI.


2017 ◽  
Vol 25 (1) ◽  
pp. 109-117 ◽  
Author(s):  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Kazushi Urasawa ◽  
Shigeru Saito ◽  
Michael R. Jaff ◽  
...  

Purpose: To assess the safety and effectiveness of the MDT-2113 (IN.PACT Admiral) drug-coated balloon (DCB) for the treatment of de novo and native artery restenotic lesions in the superficial femoral and proximal popliteal arteries vs percutaneous transluminal angioplasty (PTA) with an uncoated balloon in a Japanese cohort. Methods: MDT-2113 SFA Japan ( ClinicalTrials.gov identifier NCT01947478) is an independently adjudicated, prospective, randomized, single-blinded trial that randomized (2:1) 100 patients (mean age 73.6±7.0 years; 76 men) from 11 Japanese centers to treatment with DCB (n=68) or PTA (n=32). Baseline characteristics were similar between the groups, including mean lesion length (9.15±5.85 and 8.89±6.01 cm for the DCB and PTA groups, respectively). The primary effectiveness outcome was primary patency at 12 months, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) and freedom from restenosis as determined by duplex ultrasonography. The safety endpoint was a composite of 30-day device- and procedure-related death and target limb major amputation and clinically-driven target vessel revascularization within 12 months. Results: Patients treated with DCBs exhibited superior 12-month primary patency (89%) compared to patients treated with PTA (48%, p<0.001). The 12-month CD-TLR rate was 3% for DCB vs 19% for PTA (p=0.012). There were no device- or procedure-related deaths, major amputations, or thromboses in either group. Quality-of-life measures showed sustained improvement from baseline to 12 months in both groups. Conclusion: Results from the MDT-2113 SFA Japan trial showed superior treatment effect for DCB vs PTA, with excellent patency and low CD-TLR rates. These results are consistent with other IN.PACT SFA DCB trials and demonstrate the safety and effectiveness of this DCB for the treatment of femoropopliteal lesions in this Japanese cohort.


2017 ◽  
Vol 7 ◽  
pp. 31 ◽  
Author(s):  
Sizeph Edward Haddad ◽  
Jan Mohammad Shishani ◽  
Izzeddin Qtaish ◽  
Mohammad Abdelmajeed Rawashdeh ◽  
Belal Saleh Qtaishat

Objective: Conventional percutaneous transluminal angioplasty (PTA) for long lesions in the below-the-knee (BTK) arteries in patients presenting with critical limb ischemia (CLI) has high restenosis rates at 1 year. Our goal is to evaluate whether paclitaxel drug-eluting balloons (DEB) have higher 1 year primary patency rates compared to conventional PTA. Methods: This is a single-center, prospective, randomized trial that was conducted from June 2013 to December 2015. The aim of the study was to compare 1 year primary patency rates of DEB and PTA in BTK arteries in CLI patients. Inclusion criteria were patients presenting with CLI (Rutherford class 4 or greater), stenosis or occlusion ≥30 mm of at least one tibial artery, and agreement to 12-month evaluation. Exclusion criteria were life expectancy <1 year, allergy to paclitaxel, and contraindication to combined antiplatelet treatment. Follow-up was performed by clinical assessment, ankle brachial pressure index, Doppler ultrasound imaging, and conventional angiogram if indicated. Primary end point was 1 year primary patency, and secondary end points were target lesion revascularization (TLR) and major amputation. Statistical analysis was performed using Fischer's exact test. Results: Ninety-three patients with 106 lesions in the BTK arteries were enrolled in this study. One year primary patency was achieved in 26 (65%) and seven (17%) in the DEB and PTA groups (P = 0.006), respectively. TLR was performed in nine lesions (23%) and 29 lesions (71%) in DEB and PTA groups (P = 0.009), respectively. Major amputations occurred in one limb (2%) and two limbs (4%) in DEB and PTA groups (P = 0.6), respectively. Conclusion: Paclitaxel DEB has significantly higher 1 year primary patency rate associated with significantly less TLR than conventional PTA, following endovascular recanalization of BTK arteries in patients presenting with CLI.


2019 ◽  
Vol 26 (5) ◽  
pp. 613-620 ◽  
Author(s):  
Shigeo Ichihashi ◽  
Tsuyoshi Shibata ◽  
Naoki Fujimura ◽  
Satoru Nagatomi ◽  
Hiroshi Yamamoto ◽  
...  

Purpose: To evaluate the effect of vessel calcification on in-stent restenosis (ISR) after drug-coated stent (DCS) placement in the femoropopliteal segment. Materials and Methods: A retrospective multicenter study was undertaken involving 220 consecutive symptomatic patients (mean age 73.1±8.3 years; 175 men) with femoropopliteal lesions in 230 limbs treated with the Zilver PTX DCS and having duplex surveillance after the endovascular procedures. Mean lesion length was 16.4±9.8 cm (range 2–40); there were 104 (45.2%) total occlusions and 68 (29.6%) in-stent restenoses (ISR). Twenty (8.7%) vessels had no runoff. The majority of lesions (148, 64.3%) were calcified according to the peripheral arterial calcium scoring system (PACSS). Primary patency was evaluated by duplex. Lesions were classified as either PACSS 0–2 (none or unilateral wall calcification) or PACSS 3 and 4 (bilateral wall calcification). Multivariate analysis was performed to identify variables associated with ISR; the results are given as the hazard ratio (HR) and 95% confidence interval (CI). Results: The 1-, 2-, and 5-year primary patency and freedom from clinically-driven target lesion revascularization estimates were 75.9%, 63.6%, and 45.0%, and 84.7%, 73.7%, and 54.2%, respectively. Major amputations were performed on 4 limbs during follow-up. In multivariate analysis, vessel calcification (adjusted HR 1.718, 95% CI 1.035 to 2.851, p=0.036) was significantly correlated with the occurrence of ISR, along with lesion length (adjusted HR 1.041, 95% CI 1.013 to 1.070, p=0.003), and cilostazol administration (adjusted HR 0.476, 95% CI 0.259 to 0.876, p=0.017). Conclusion: This study suggested that bilateral vessel wall calcification was an independent risk factor for ISR in complex femoropopliteal lesions after Zilver PTX DCS placement, along with lesion length; cilostazol administration had a protective effect.


Circulation ◽  
2020 ◽  
Vol 142 (Suppl_3) ◽  
Author(s):  
Muhammad Khalid ◽  
Mahmoud El Iskandarani ◽  
Vijay Ramu ◽  
Michael Donovan ◽  
Terry Forrest ◽  
...  

Introduction: Studies have shown decrease rates of restenosis and target lesion revascularization (TLR) with drug eluting balloon (DEB) in diabetic patients with critical limb ischemia (CLI). Hypothesis: The aim of this meta-analysis to compare the efficacy of DEB versus Percutaneous transluminal angioplasty (PTA) below the knee peripheral intervention. Methods: Electronic databases including MEDLINE, ClinicalTrials.gov and the Cochrane Library were searched for all randomized controlled trials (RCTs) published until April 2020 comparing outcomes of DEB vs PTA in patients with CLI below the knee. End points were major amputation, major adverse events (MAEs), all-cause mortality, target lesion revascularization (TLR), myocardial infarction, and cerebrovascular accidents (CVA). The risk ratio (RR) with 95% confidence interval (CI) were computed and p <0.05 was considered as a level of significance. Results: A total of 4 RCTs (n=655) were included in the final analysis. There were no differences of major amputation (RR: 1.30; CI: 0.68-2.46; p=0.43), MAEs (RR: 0.86; CI: 0.60-1.23; p=0.41), all-cause mortality (RR: 0.91; CI: 0.69-1.19; p=0.48), TLR (RR: 0.65; CI: 0.30-1.44; p=0.29), MI (RR: 1.71; CI: 0.57-5.14; p=0.34) and CVA (RR: 0.66; CI: 0.19-2.26; p=0.50) between the 2 groups [Figure 1]. Conclusions: There were no significant differences of major amputation and TLR for DEB versus PTA . Major adverse cardiac, cerebrovascular events and all-cause mortality were not statistically different for drug coated balloon versus PTA in the management of below knee critical limb ischemia. Further studies needed to confirm these findings.


2019 ◽  
Vol 41 (38) ◽  
pp. 3715-3728 ◽  
Author(s):  
Daniele Giacoppo ◽  
Fernando Alfonso ◽  
Bo Xu ◽  
Bimmer E P M Claessen ◽  
Tom Adriaenssens ◽  
...  

Abstract Aims Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. Methods and results The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02–1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58–1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71–1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53–1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80–2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. Conclusions In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.


2021 ◽  
Vol 49 (4) ◽  
pp. 030006052110065
Author(s):  
Hao Ren ◽  
Jie Liu ◽  
Jiwei Zhang ◽  
Baixi Zhuang ◽  
Weiguo Fu ◽  
...  

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.


2017 ◽  
Vol 25 (1) ◽  
pp. 81-88 ◽  
Author(s):  
Damianos G. Kokkinidis ◽  
Prio Hossain ◽  
Omar Jawaid ◽  
Bejan Alvandi ◽  
T. Raymond Foley ◽  
...  

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.


2018 ◽  
Vol 20 (2) ◽  
pp. 209-216 ◽  
Author(s):  
Domenico Patanè ◽  
Giovanni Failla ◽  
Giovanni Coniglio ◽  
Giorgio Russo ◽  
Walter Morale ◽  
...  

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


Sign in / Sign up

Export Citation Format

Share Document