Drug-eluting Balloon Group Research Articles

Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial

This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs). This is a prospective, multicenter, open-label, randomized study comparing the use of drug-eluting balloon (DEB) versus second-generation everolimus-eluting stent for the treatment of DES ISR. The primary end point was in-segment late loss at 9-month routine angiographic follow-up. A total of 172 patients were enrolled, and 74 (43.0%) patients underwent the angiographic follow-up. The primary end point was not different between the 2 treatment groups (DEB group 0.15±0.49 mm vs DES group 0.19±0.41 mm, P=.54). The secondary end points of in-segment minimal luminal diameter (MLD) (1.80±0.69 mm vs 2.09±0.46 mm, P=.03), in-stent MLD (1.90±0.71 mm vs 2.29±0.48 mm, P=.005), in-segment percent diameter stenosis (34%±21% vs 26%±15%, P=.05), and in-stent percent diameter stenosis (33%±21% vs 21%±15%, P=.002) were more favorable in the DES group. The composite of death, myocardial infarction, or target lesion revascularization at 1 year was comparable between the 2 groups (DEB group 7.0% vs DES group 4.7%, P=.51). Treatment of DES ISR using DEB or second-generation DES did not differ in terms of late loss at 9-month angiographic follow-up, whereas DES showed better angiographic results regarding minimal MLD and percent diameter stenosis. Both treatment strategies were safe and effective up to 1year after the procedure.

Drug-eluting balloons and uncoated balloons perform equally to rescue infrainguinal autologous bypasses at risk

ObjectiveEndovascular treatment of a significant stenosis in an infrainguinal autologous bypass prevents bypass occlusion and improves bypass patency. Drug-eluting balloons (DEBs) have been proven to possess antirestenotic features in the treatment of femoropopliteal stenoses and occlusions. This study evaluated the effects of DEB angioplasty vs uncoated balloon (UCB) angioplasty to rescue infrainguinal autologous bypass grafts at risk (BAR). MethodsThe study included all consecutive patients treated endovascularly for BAR from December 1, 2012, to July 31, 2015. As of April 1, 2014, the primary treatment of BAR was changed from UCBs to DEBs. Patients treated with DEBs were prospectively recorded in a database and retrospectively analyzed. Patients treated with UCBs were retrospectively collected from a historical cohort with a similar inclusion period length as the DEB cohort. The follow-up scheme did not differ between the two groups. The primary end point was the combined end point of freedom from recurrent stenosis or bypass occlusion. Secondary end points were primary assisted patency, secondary patency, technical success, major amputation, and mortality. ResultsTwenty-one patients were treated in the DEB group and 18 were treated in the UCB group. The two groups were evenly distributed in demographics, bypass, treatment, and lesion characteristics. No statistically significant differences were found in the combined end point of freedom from recurrent stenosis and the occlusion rate after 1 year between the UCB group (77.8%) and the DEB group (80.0%; P = .76). After 1 year, the primary assisted patency rate was 88.2% in the UCB group vs 95.2% in the DEB group (P = .47), and the secondary patency rate was 94.1% in the UCB group vs 95.2% in the DEB group (P = .91). During follow-up, restenosis developed in four patients (22.2%) in the UCB group and in four patients (19.0%) in the DEB group (P = .80). One bypass (5.6%) in the UCB group and one bypass (4.8%) in the DEB group occluded during follow-up (P = .884). ConclusionsDEBs and UCBs perform equally in the treatment of significant stenosis in infrainguinal autologous bypasses with regard to freedom from restenosis or bypass occlusion, primary assisted patency, and secondary patency at 1 year. We suggest using a less expensive UCB in the treatment of BAR.

Drug-eluting balloons versus drug-eluting stents for the management of in-stent restenosis: A meta-analysis of randomized and observational studies

ObjectivesThe aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) with drug-eluting stents (DES) in patients with in-stent restenosis (ISR). BackgroundDES implantation and DEB were available strategies in percutaneous coronary intervention (PCI) for ISR, but the optimal management for ISR lesions remains controversial. MethodsElectronic databases were searched for randomized controlled trials and observational cohort studies which reported the clinical outcomes of using DEB comparing with DES implantation in patients with ISR. Clinical endpoints such as major adverse cardiovascular events (MACE), death, and myocardial infarction were assessed. ResultsFive randomized controlled trials and five observational cohort studies with 962 patients in the DEB group and 908 patients in the DES group met inclusion criteria. There was no significant difference between DEB and DES in major clinical outcomes, such as MACE (OR 1.01; 95% CI: 0.64–1.58; p=0.97; I2=0%), all-cause death (OR 1.04; 95% CI: 0.54–1.98; p=0.91; I2=0%), cardiovascular death (OR 1.44; 95% CI: 0.57–3.65; p=0.44; I2=0%), stent thrombosis (OR 0.61; 95% CI: 0.16–2.33; p=0.47; I2=0%), and myocardial infarction (OR 1.02; 95% CI: 0.53–1.94; p=0.96; I2=0%). DEB was associated with a significant increase in target lesion revascularization (OR 1.54; 95% CI: 1.10–2.15; p=0.01; I2=57%). ConclusionTreatment of ISR using DEB led to comparable clinical outcomes with DES implantation.

Systematic Review and Meta-Analysis of Drug-Eluting Balloon and Stent for Infrapopliteal Artery Revascularization

Drug-eluting balloon (DEB) and drug-eluting stent (DES) have been proposed for the treatment of infrapopliteal artery disease. We performed a systematic review and meta-analysis of the current available studies investigating outcomes of DEB and DES in the treatment of infrapopliteal artery disease. Multiple databases were systematically searched to identify studies investigating the outcomes of DEB and DES in the treatment of patients with infrapopliteal artery disease. The quality of studies was assessed by Cochrane Collaboration method. The demographic data, risk factors, outcomes, and antiplatelet strategy were extracted. Nine studies were identified with 707 and 606 patients in DEB/DES and standard percutaneous balloon angioplasty (PTA)/bare metal stenting (BMS) group, respectively. The risk of target lesion revascularization (TLR; odds ratio [OR] = 0.38, 95% confidence interval [CI]: 0.23-0.63, P < .01), restenosis rate (OR = 0.30, 95% CI: 0.18-0.50, P < .01), and amputation rate (OR = 0.49, 95% CI: 0.29-0.83, P < .01) significantly decreased in the DES group. The overall survival (OR = 0.86, 95% CI: 0.56-1.32, P = .50) was similar in DES and standard PTA/BMS group; TLR (OR = 0.59, 95% CI: 0.32-1.09, P = .09), restenosis rate (OR = 0.49, 95% CI: 0.11-2.14, P = .35), amputation rate (OR = 1.32, 95% CI: 0.51-3.40, P = .57), and overall survival (OR = 1.40, 95% CI: 0.72-2.71, P = .32) were similar in DEB and standard PTA group. The present meta-analysis suggests that compared with standard PTA/BMS, DES may decrease the risk of clinically driven TLR, restenosis rate, and amputation rate without any impact on mortality. However, DEB has no obvious advantage in the treatment of infrapopliteal disease. Due to the limitations of our study, more randomized controlled trials, especially those for DEB, are necessary.

Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial

Background: The drug-eluting balloon (DEB) is a promising tool to prevent restenosis after coronary angioplasty. However, data on the outcomes of DEB in de novo lesions are scarce. Vessel recoil and constrictive remodeling are the dominant causes of restenosis after angioplasty. The use of cutting balloons (CB) may effectively reduce elastic recoil after balloon dilation. In this study, we evaluate the efficacy and safety of DEB in treating de novo coronary artery lesions, using a predilation strategy with cutting balloon (CB) dilation before DEB angioplasty. Methods/Design: We present the design of a prospective, single-center, open-label, randomized, 2-arm clinical trial aiming to assess whether or not the strategy of CB dilation before DEB angioplasty reduces the primary end point of late lumen loss (LLL) compared with drug-eluting stent (DES) implantation alone for de novo coronary artery lesions. A total of 120 patients will be randomly enrolled into the DEB or DES group (1:1 ratio). The primary end point is insegment LLL at 12 months as measured by optical coherence tomography (OCT). Secondary end points include procedural success, such as angiographic success and device success, and clinical outcomes including all-cause death, myocardial infarction, target vessel revascularization, target lesion revascularization, and stent thrombosis. Discussion: The study will evaluate the clinical efficacy, angiographic outcomes, and safety of DEB after CB dilation compared with DES for the treatment of de novo coronary artery lesions guided by OCT.

The Relationship Between Neutrophil-Lymphocyte Ratio and Primary Patency of Percutaneous Transluminal Angioplasty in Hemodialysis Arteriovenous Fistula Stenosis When Using Conventional and Drug-Eluting Balloons.

The aim of this study is to investigate the potential association of neutrophil-lymphocyte ratio (NLR) between primary patency of percutaneous transluminal angioplasty (PTA) in hemodialysis arteriovenous fistula stenosis and type (Conventional and Drug-Eluting) of balloons used in PTA. This retrospective study consists of 78 patients with significant arteriovenous fistulas stenosis who were treated with PTA by using Drug-Eluting Balloon (DEB) (n=29) or Conventional Balloon (CB) (n=49). NLR was calculated from preinterventional blood samples. All patients were classified into two groups. Group A; primary patency<12months (43/78), Group B; primary patency≥12months (35/78). Cox regression analysis and Kaplan-Meier method were used to determine respectively independent factors affecting the primary patency and to compare the primary patency for the two balloon types. NLR ratio and balloon type of the two groups were significantly different (p=0.002, p=0.010). The cut-off value of NLR was 3.18 for determination of primary patency, with sensitivity of 81.4% and specificity of 51.4%. Primary patency rates between PTA with DEB and CB displayed statistically significant differences (p<0.05). The cut-off value was 3.28 for determination of 12-month primary patency with the conventional balloon group; sensitivity was 81.8% and specificity was 81.3%. There was no statistical relation between NLR levels and the drug-eluting balloon group in 12-month primary patency (p=0.927). Increased level of NLR may be a risk factor in the development of early AVF restenosis after successful PTA. Preferring Drug-Eluting Balloon at an increased level of NLR can be beneficial to prolong patency.

The Mid-Term Clinical Follow-Up Using Drug-Eluting Balloons on Tibial Artery "De Novo" Lesions in Patients With Critical Limb Ischemia: A Cohort Study.

Restenosis due to intimal hyperplasia (IH) is a major clinical issue that affects the success of lower limb endovascular surgery. After 1 year, restenosis occurs in 40% to 60% of the treated vessels. The possibility to reduce IH using local antiproliferative drugs, such as taxols, has been the rationale for the clinical applications of drug-eluting stents and drug-eluting balloons (DEBs). The purpose of this study was to evaluate the clinical and instrumental efficacy of DEBs versus simple percutaneous transluminal angioplasty (PTA) in patients affected by chronic limb ischemia (CLI) with tibial artery "de novo" lesions. A retrospective analysis was performed and included all consecutive patients who underwent endovascular treatment for CLI in our centers between January 2011 and March 2013. Inclusion criteria were (1) "de novo" tibial artery stenosis and (2) Rutherford class >4. Lesions were further divided by TransAtlantic Inter-Societal Consensus (TASC) classification into groups A, B, C, and D. Between January 2010 and March 2013, a total of 138 patients underwent simple PTA or DEB for CLI, and the groups were clinically and demographically homogenous. We decided to use DEBs in 70 cases. An improvement in the Rutherford Scale in cumulative and single TASC lesions classification was better in the DEB group (74% vs 51%; P = .024) at 24 months than in the PTA group. In the DEB group, the increase in ankle-brachial index was significantly higher than in the PTA group (P = .039). Our experience in addition to the existing literature supports the use of DEB in patients with CLI Rutherford class >3.

Management of drug eluting stent in-stent restenosis: A systematic review and meta-analysis.

The optimal management for coronary drug eluting stent in-stent restenosis (DES ISR) is unclear. We performed a meta-analysis of observational and randomized studies to compare the outcomes of management of DES ISR using DES, drug eluting balloon (DEB), or balloon angioplasty (BA). Eligible studies (25 single arm and 13 comparative, including 4 randomized studies with a total of 7,474 patients with DES ISR) were identified using MEDLINE search and proceedings of international meetings. Outcomes studied include major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis (ST), and mortality. Follow-up ranged from 0.5 to 3.5 years (mean 1.4 years). The rate of TLR was significantly lower in the DES (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.36-0.69) and DEB (OR 0.31, 95% CI 0.18-0.55) groups compared to BA. Similarly, TVR rate was significantly lower in the DES (OR 0.55, 95% CI 0.39-0.77) and DEB (OR 0.32, 95% CI 0.18-0.58) groups compared to BA. All other outcomes were similar between the DES/BA and DEB/BA comparisons. TLR was significantly lower in the DES group compared to BA for vessels < or > 2.75 mm. Treatment of coronary DES ISR with DES or DEB is associated with a reduction in the risk of TLR and TVR compared to BA alone. The relative risk reduction for TLR with DES is similar to DEB. DEBs have a potential role in the treatment of DES ISR by avoiding placement of another layer of stent. © 2015 Wiley Periodicals, Inc.

Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries

Purpose: To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls. Methods: From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009. Results: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004). Conclusion: Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Safety and efficacy of a novel iopromide-based paclitaxel-eluting balloon following bare metal stent implantation in rabbit aorta abdominalis.

BACKGROUND: Drug-eluting balloons (DEB) may be promising technology for treating atherosclerotic arterial disease. In fact, several DEBs have been clinically available for the treatment of coronary in-stent restenosis (ISR), de novo coronary lesions, and peripheral artery disease.OBJECTIVE: We sought to elucidate the mechanism of action and in vivo safety and efficacy of a novel iopromide-based paclitaxel-eluting balloon.METHODS: In vitro cytotoxicity of a novel DEB on human umbilical vein endothelial cells (HUVECs) and in vivo pharmacokinetics of DEB in a rabbit aorta abdominalis were assessed. Then, bare metal stents (BMS) were implanted at both the proximal and distal sites of the rabbit aorta abdominalis. Stented vascular segments were immediately dilated with a bare balloon (control group) or the DEB (DEB group) randomly. Histological evaluation was performed in all treated segments at 28 days. Because paclitaxel is a tubulin-disrupting agent that binds preferentially to β-tubulin, we measured β-tubulin expression in aortal stent specimens via immunohistochemistry.RESULTS: We observed that DEB was compatible and could reduce neointimal hyperplasia compared with the bare balloon. Meanwhile, immunohistochemistry revealed that β-tubulin expression in the DEB group increased compared with the control group, indirectly suggesting successful uptake of paclitaxel by vessel walls after DEB dilation.CONCLUSIONS: The novel DEB is safe and has a favorable vascular healing response on neointimal hyperplasia.

Drug-Eluting vs Standard Balloon Angioplasty for Iliac Stent Restenosis

Purpose: To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR). Methods: Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Follow-up examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months. Results: Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434). Conclusion: Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.

Comparison among drug-eluting balloon, drug-eluting stent, and plain balloon angioplasty for the treatment of in-stent restenosis: a network meta-analysis of 11 randomized, controlled trials.

A Bayesian network meta-analysis was performed comparing the efficacy and safety of drug-eluting balloons (DEB), drug-eluting stents (DES), or plain old balloon angioplasty (POBA) for treatment of in-stent restenosis (ISR). Optimal treatment options for ISR have not been well established. Randomized, controlled trials comparing DEB, DES, and POBA for the treatment of ISR after percutaneous coronary intervention with bare metal stent or DES were included. The primary outcome was target lesion revascularization (TLR). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR: 0.22, 95% CrI: 0.10 to 0.42) or DES (OR: 0.24, 95% CrI: 0.11 to 0.47) than in those treated with POBA in a random-effects model. In a comparison of DEB and DES, the risk of TLR (OR: 0.92, 95% CrI: 0.43 to 1.90) was similar. The risk of MI or all-cause mortality was lowest in the DEB group compared with the DES and POBA groups, which did not meet statistical significance. The risk of major adverse cardiac events, which was mainly driven by TLR, was also significantly lower in the DEB or and DES group (OR: 0.28, 95% CrI: 0.14 to 0.53) than in the POBA group, but it was similar between the DEB and DES groups (OR: 0.84, 95% CrI: 0.45 to 1.50). The probability of being ranked as the best treatment was 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas it was 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Local drug delivery by DEB or DES for ISR lesions was markedly better than POBA in preventing TLR, but not for MI or mortality. Among the 2 different strategies of drug delivery for ISR lesions, treatment with DEB showed a trend of less development of MI than did treatment with DES.

Colchicine Reduces Restenosis after Balloon Angioplasty Treatment for In-Stent Restenosis

Treatment of coronary in-stent restenosis (ISR) is hampered by a high incidence of recurrent ISR. Colchicine is an old drug with known anti-inflammatory and antiproliferative actions. We evaluated the strategy of colchicine combined with conventional balloon angioplasty for the treatment of ISR. Sixty coronary arteries of 60 mini-pigs underwent oversized bare-metal stent implantation to induce ISR. After 28 days, vessels with ISR (≥50% diameter stenosis) were randomly divided into three groups: control (conventional balloon angioplasty combined with placebo), colchicine (conventional balloon angioplasty combined with colchicine) and drug-eluting balloon (DEB). Restenosis and neointima formation were elevated with angiography and histological and morphometric analysis at 28 days after different interventions. Late lumen loss and percent area stenosis at follow-up were lower in colchicine group compared to control group but were similar to those of DEB group. There was no significant difference in proliferating cell nuclear antigen-positive vascular smooth muscle cells and inflammatory score between the colchicine group and the DEB group. The efficacy of colchicine combined with conventional balloon angioplasty for treatment of ISR was comparable to that of DEB. Treatment of ISR might not require a second stent implantation, and colchicine combined with conventional balloon angioplasty seemed to be another consideration.

A 2-year follow-up of a randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels the BELLO study

Background/objectivesA prospective, multi-center, randomized trial, BELLO (Balloon Elution and Late Loss Optimization), showed that the primary endpoint of in-stent (in-balloon) late loss was significantly less with drug-eluting balloons (DEB) as compared with paclitaxel-eluting stents (PES). At 6months, DEB and PES were associated with similar rates of angiographic restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as death, myocardial infarction and target vessel revascularization. The aim of this study was to report 2-year clinical outcomes after treatment of de novo small vessel disease with DEB as compared with PES. MethodsA total of 182 patients were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or PES (n=92) in 98 lesions. The study endpoint was the incidence of MACE at 2-year follow-up. ResultsTwo-year follow-up was achieved in almost all cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend towards a lower incidence of MACE in the DEB group as compared with the PES group (14.8% vs. 25.3%; p=0.08). TLR rates in the DEB group were acceptable at 6months, 1year and 2years and did not differ significantly from the PES group (4.4% vs. 7.6%, p=0.37; 6.7% vs. 12.1%, p=0.23; 6.8% vs. 12.1%, p=0.25, respectively). ConclusionsOur results suggest that treatment of small vessel disease with a paclitaxel DEB is associated with a trend for improved clinical outcomes as compared with PES up to 2years. Late catch-up phenomenon requiring repeat intervention after treatment with DEB was not evident in this study.

Abstract 11277: Comparison Among Drug-Eluting Balloon, Drug-Eluting Stent, and Plain Balloon Angioplasty for Treatment of In-Stent Restenosis: A Network Meta-Analysis of 11 Randomized Controlled Trials

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.

Comparison of drug-eluting balloon versus drug-eluting stent in patients with in-stent restenosis: Insight from randomized controlled trials

BackgroundsIn-stent restenosis (ISR) remains an important issue even in the current drug-eluting stent (DES) era. We performed a meta-analysis to assess the clinical efficacy and safety of drug-eluting balloon (DEB) as compared with DES for the treatment of ISR. MethodsThe published literature was scanned by formal searches of electronic databases from January 2005 to February 2014. All randomized controlled trials were eligible for inclusion if they compared DEB with DES in patients with ISR. ResultsPrespecified criteria were met by 4 trials involving 803 patients. There was no significant difference in the primary endpoint (12-month major adverse cardiac events) between the 2 groups (risk ratio [RR] 1.04, P=0.80). The incidence of death (RR 0.81, P=0.62), myocardial infarction (RR 0.66, P=0.29), and target lesion revascularization (RR 1.35, P=0.12) in the DEB group was also similar to those in the DES group. ConclusionsThis meta-analysis showed that DEB was associated with comparable clinical outcomes to DES for the treatment of ISR. DEB might be the preferred interventional strategy for patients with ISR by obviating the need of additional stent layer.

TCT-270 Comparison Among Drug-eluting Balloon, Drug-eluting Stent, and Plain Balloon Angioplasty for Treatment of In-Stent Restenosis: A Network Meta-analysis of 11 Randomized Controlled Trials

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.

Paclitaxel-Eluting Balloon vs. Standard Angioplasty to Reduce Recurrent Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries: The DEBATE-ISR Study

To test the ability of a drug-eluting balloon (DEB) to reduce recurrent in-stent restenosis (ISR) in diabetic patients with femoropopliteal stents. A prospective all-comers study [Drug-Eluting Balloon in Peripheral Intervention for In-Stent Restenosis (DEBATE-ISR); ClinicalTrials.gov identifier NCT01558531] of symptomatic diabetic patients with femoropopliteal ISR undergoing treatment with paclitaxel-eluting balloons was designed to compare their 12-month recurrent restenosis rate with that of historical diabetic controls. From January 2010 to December 2011, 44 consecutive diabetic patients (32 men; mean age 74±11 years) were treated with DEBs and enrolled in the study. The control group comprised 42 diabetic patients (23 men; mean age 76±7 years) treated with a conventional balloon for femoropopliteal ISR from 2008 to 2009. No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Lesion length was 132±86 mm in the DEB group vs. 137±82 mm in the BA group. Procedural success, defined as a residual stenosis <30% in the restenotic segment (stent +5 mm at proximal and distal edges), was obtained in all treated lesions. At 1-year follow-up, 6 patients died (3 in each group), and 1 patient in the BA group underwent major amputation. Recurrent restenosis, assessed by angiography (66%) or ultrasound (34%), occurred in 8/41 (19.5%) patients in the DEB group vs. 28/39 (71.8%) in the BA group (p<0.001). Target lesion revascularization for symptomatic recurrent restenosis was performed in 6/44 (13.6%) patients in the DEB vs.13/42 (31.0%) in the BA group (p=0.045). Using DEB for treating femoropopliteal ISR led to a significant reduction in recurrent restenosis and repeat angioplasty at 1-year follow-up as compared to historical controls.

Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK)

Background— The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. Methods and Results— The Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion &gt;40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy &gt;1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drug-eluting balloon group compared with 131±79 mm in the PTA group ( P =0.7). Binary restenosis, assessed by angiography in &gt;90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group ( P &lt;0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P =0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P &lt;0.001). Only 1 major amputation occurred, in the PTA group ( P =0.9). Conclusions— Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia. Clinical Trial Registration— URL: http://ClinicalTrials.gov . Unique identifier: NCT01558505.

A randomized multicentre study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: The BELLO (Balloon Elution and Late Loss Optimization) study

Objectives: The aim of this study was to evaluate the efficacy of drug-eluting balloons (DEB) compared with paclitaxel eluting stents (PES) for the reduction of restenosis in small vessels. Background: DEB have been shown to be effective in the treatment of coronary in-stent restenosis, but data are limited regarding their efficacy in de-novo disease. Methods: BELLO (Balloon Elution and Late Loss Optimization) is a prospective, multicentre trial that randomized 182 patients with lesions located in small vessels (reference diameter <2.8 mm) to treatment with paclitaxel DEB and provisional bare-metal stenting (n = 90) or PES implantation (n = 92). The primary endpoint was noninferiority of angiographic in-stent (in-balloon) late loss with a delta of 0.25 mm. Secondary end-points were angiographic restenosis, target lesion revascularization, and major adverse cardiac events (MACE; death, myocardial infarction, target vessel revascularization) at 6 months. Results: Baseline characteristics were well matched, except for a smaller vessel size in the DEB group (2.15 ± 0.27 mm vs. 2.25 ± 0.24 mm; p = 0.003). The majority (89%) of lesions involved vessels with a diameter<2.5 mm. Bailout stenting was required in 20% of lesions in the DEB group. The primary endpoint of in-stent (in-balloon) late loss was significantly less with DEB compared with PES (0.08 ± 0.38 mm vs. 0.29 ± 0.44 mm; difference −0.21; 95% CI: −0.34 to −0.09; p noninferiority < 0.001; p superiority = 0.001). At 6 months, DEB and PES were associated with similar rates of angiographic restenosis (8.9% vs. 14.1%; p = 0.25), target lesion revascularization (4.4% vs. 7.6%; p = 0.37), and MACE (7.8% vs. 13.2%; p = 0.77). Conclusions: Treatment of small-vessel disease with a paclitaxel DEB was associated with less angiographic late loss and similar rates of restenosis and revascularization as a PES.