Drug-eluting Balloon Research Articles

Drug-eluting balloons with provisional bail-out or adjunctive stenting in de novo coronary artery lesions-a systematic review and meta-analysis.

Efficacy of drug-eluting balloons (DEB) for treatment of de novo coronary lesions remains controversial. The present systematic review and meta-analysis of randomised controlled trials assessed DEB with bare-metal stents (BMS) and also DEB with provisional bail-out stents ('DEB-only' strategy), to other conventional options: plain-old balloon angioplasty (POBA), BMS and drug-eluting stents (DES). A systematic literature search from January 2000 until May 2017 was conducted. Primary outcome measure, late lumen loss (LLL); and secondary outcomes; binary restenosis, major adverse cardiac events (MACE), target lesion revascularization (TLR), myocardial infarction (MI), cardiovascular death and stent thrombosis were analysed. Seventeen RCTs were included with 2,616 patients. Several comparative groups showed significant differences. DEB with BMS were inferior to DES for LLL [mean difference (MD) =0.12 mm; 95% confidence interval (CI), 0.03 to 0.22; P=0.01]; and binary restenosis [risk ratio (RR) =1.89; (CI, 1.13 to 3.18); P=0.02]. DEB with BMS was superior to BMS for LLL [MD =-0.27 mm; (-0.45 to -0.10); P=0.002]; and MACE [RR =0.64; (0.46 to 0.90); P=0.010]. Finally, DEB alone was superior to POBA for LLL [MD =-0.39 mm; (-0.67 to -0.11); P=0.006] and binary restenosis [RR =0.20; (0.05 to 0.85); P=0.03] in bifurcation lesions. The results of this meta-analysis showed that whilst DEB with BMS is superior to BMS alone, the combination is inferior to DES for treatment of de novo coronary lesions. Thus, DEB + BMS should not be applied in de novo lesions unless in patients who have absolute contraindications to DES. DEB alone, however, should be considered for relative contraindications to DES such as small vessel disease and bifurcation lesions.

TCTAP A-014 Comparison of Clinical Outcomes After Drug-eluting Balloon and Drug-eluting Stent Use for In-stent Restenosis Related Acute Myocardial Infarction

TCTAP A-014 Comparison of Clinical Outcomes After Drug-eluting Balloon and Drug-eluting Stent Use for In-stent Restenosis Related Acute Myocardial Infarction

TCTAP A-031 Clinical Outcome of the Drug Eluting Balloon: A Single Center Retrospective Registry

TCTAP A-031 Clinical Outcome of the Drug Eluting Balloon: A Single Center Retrospective Registry

Angioplasty to promote arteriovenous fistula maturation and maintenance.

The arteriovenous fistula is currently the best permanent access for the hemodialysis patient. Unfortunately, stenosis impairs maturation, long-term survival, and function of the arteriovenous fistula. Angioplasty currently is the best procedure for the treatment of immature and dysfunctional arteriovenous fistulas. In this review, the authors discuss the optimum time to evaluate arteriovenous fistulas for maturity, methods of evaluation for maturity, and the role of angioplasty in salvaging immature arteriovenous fistulas. The review also discusses the effect of stenosis on dysfunction in mature arteriovenous fistulas and the role of angioplasty to treat this complication. Finally, the impact of cutting balloons and drug-eluting balloons in the treatment of resistant and recurrent stenosis, respectively, is also discussed.

Drug-Eluting Balloon versus New-Generation Drug-Eluting Stent for the Treatment of In-Stent Restenosis: An Updated Systematic Review and Meta-Analysis.

Background:Currently, drug-eluting balloon (DEB) appears to be an attractive alternative option for the treatment of in-stent restenosis (ISR). Nevertheless, the clinical outcomes of DEB have seldom been compared to those of new-generation drug-eluting stent (DES). Thus, this meta-analysis aimed to evaluate the safety and efficacy of DEB compared to those of new-generation DES in the treatment of ISR.Methods:A comprehensive search of electronic databases including PubMed, EMBASE, and Cochrane Library up to November 2, 2017 was performed to identify pertinent articles comparing DEB to new-generation DES for the treatment of ISR. In addition, conference proceedings for the scientific sessions of the American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and EuroPCR were also searched. The primary endpoint was target lesion revascularization (TLR) at the longest follow-up. Dichotomous variables were presented as risk ratios (RR s) with 95% confidence intervals (CIs), while the overall RRs were estimated using the Mantel-Haenszel random-effects model.Results:Five randomized controlled trials (RCTs) and eight observational studies involving 2743 patients were included in the present meta-analysis. Overall, DEB was comparable to new-generation DES in terms of TLR (RR = 1.24, 95% CI: 0.89–1.72, P = 0.21), cardiac death (RR = 1.55, 95% CI: 0.89–2.71, P = 0.12), major adverse cardiovascular event (RR = 1.21, 95% CI: 0.98–1.48, P = 0.07), myocardial infarction (RR = 1.12, 95% CI: 0.72–1.76, P = 0.62), and stent thrombosis (RR = 0.95, 95% CI: 0.38–2.42, P = 0.92). However, DEB was associated with higher risk of all-cause mortality than new-generation DES (RR = 1.65, 95% CI: 1.09–2.50, P = 0.02). This was especially true in the real-world observational studies (RR = 1.79, 95% CI: 1.12–2.88, P = 0.02). In RCTs, however, no significant difference was found between the two treatment strategies in the risk of all-cause mortality.Conclusions:The current meta-analysis showed that DEB and new-generation DES had comparable safety and efficacy for the treatment of ISR in RCTs. However, treatment with DEB was associated with higher risk of all-cause mortality in the real-world nonrandomized studies.

Linear Micro-patterned Drug Eluting Balloon (LMDEB) for Enhanced Endovascular Drug Delivery

In-stent restenosis (ISR) often occurs after applying drug eluting stents to the blood vessels suffering from atherosclerosis or thrombosis. For treatment of ISR, drug eluting balloons (DEB) have been developed to deliver anti-proliferative drugs to the lesions with ISR. However, there are still limitations of DEB such as low drug delivery efficiency and drug loss to blood flow. Although most researches have focused on alteration of drug formulation for more efficient drug delivery, there are few studies that have attempted to understand and utilize the contact modality of DEB drug delivery. Here, we developed a linear micro-patterned DEB (LMDEB) that applied higher contact pressure to enhance drug stamping to vascular tissue. Ex vivo and in vivo studies confirmed that higher contact pressure from micro-patterns increased the amount of drug delivered to the deeper regions of vessel. Finite element method simulation also showed significant increase of contact pressure between endothelium and micro-patterns. Quantitative analysis by high performance liquid chromatography indicated that LMDEBs delivered 2.3 times higher amount of drug to vascular tissue in vivo than conventional DEBs. Finally, efficacy studies using both atherosclerotic and ISR models demonstrated superior patency of diseased vessels treated with LMDEB compared to those treated with DEB.

Comparison of drug-eluting balloon versus drug-eluting stent for treatment of coronary artery disease: a meta-analysis of randomized controlled trials

BackgroundDrug-eluting balloons (DEB) have significant value for treating coronary artery disease (CAD). However, the merits of using DEB versus drug-eluting stents (DES) to treat CAD remain controversial. Herein, we conducted a meta-analysis to compare the safety and efficacy of DEB and DES for treatment of CAD.MethodsWe searched MEDLINE, EMBASE, and CENTRAL databases for eligible trials comparing DEB with DES for treatment of CAD. The primary endpoint was major adverse cardiac events (MACE); the secondary endpoints included in-lesion late lumen loss (LLL), binary restenosis (BR), myocardial infarction (MI), target lesion revascularization (TLR) and mortality.ResultsTwenty-three trials with a total of 2712 patients were included. There were no significant differences in the primary endpoint of MACE between the DEB and DES groups (Risk Ratio (RR) 1.19; 95% confidence interval (CI) (0.87, 1.63); P = 0.27), or in the clinical outcomes of each of MACE’s components, including TLR, MI and mortality. However, efficacy was significantly different between the DEB and DES groups, especially when we compared DEB to second-generation DES: in-lesion LLL (Mean Difference (MD) 0.11; (0.01, 0.22); P = 0.03); binary restenosis (RR 1.46; (1.00, 2.13); P = 0.05).ConclusionsDEB is equivalent to DES in terms of safety for managing CAD, and DEB may be considered as an alternative choice for treatment of CAD.

Abstract No. 597 Successful use of drug-eluting balloons for the management of a recalcitrant hepatic vein stenosis following extended right hepatectomy in a child with hepatoblastoma

Angioplasty with drug-eluting balloons is a treatment option in peripheral arterial occlusive disease and coronary artery stenosis. It has shown benefits in terms of patency, re-stenosis and distal flow of the treated vessel. It also shows promising results in the treatment of dysfunctional AV fistulas. Mechanical and biological response due to local injury during angioplasty leads to restenosis. The antineoplastic drug delivered in the vessel wall inhibits the cell proliferation improving the long-term results. We present a case in which drug-eluting balloons were used to treat a recalcitrant hepatic vein stenosis following venous surgical reconstruction after hepatoblastoma resection. 3-year, 6-month-old boy, history of hepatoblastoma at 15 months. Treated with chemotherapy + right hepatectomy + hepatic vein/inferior vena cava reconstruction. Presented with acute stenosis due to thrombosis. Treated 5 times with conventional angioplasty with recurrence of the stenosis. Stent appeared not an optimal option. It was decided to use a Paclitaxel coated balloon to alleviate symptoms and provide a long-term therapeutic alternative. Informed consent was obtained. A 6mm-4cm Paclitaxel drug coated balloon was utilized. Control venography was performed at 8 and 24 weeks after the initial intervention. Treatment was repeated at controls. Results were compared to standard angioplasty done before. The patient showed a significant clinical improvement, without any signs or symptoms of hepatic vein hypertension. The 8 and 24 weeks follow-up venography showed superior patency of the hepatic vein and post-surgical area in comparison with the previous standard angioplasty procedures. No complications were observed. 32 weeks clinical follow-up is satisfactory. No new interventions are planned. In the case presented, drug-eluting balloons showed superior 8 and 24 weeks patency and clinical outcome in a child with post-surgical hepatic vein stenosis in comparison to conventional balloons. Its use in similar cases of hepatic vein stenosis due to other etiologies may be considered in the future.

Abstract No. 635 Drug-eluting balloon angioplasty in the treatment of renal dialysis arteriovenous fistula stenosis

Stenosis is a common complication of renal dialysis arteriovenous (AV) fistulas, leading to poor maturation, thrombosis, and loss of haemodialysis access. [1] Recent studies propose the use of drug-eluting balloon (DEB) over standard balloon angioplasty (POBA) for AV fistula stenosis. [2] We report our experience in terms of safety and efficacy of using DEB angioplasty for the treatment of AV fistula stenosis. A retrospective study was conducted of 23 patients (14 male; mean age 72.3 ± 14.0) with 26 AV fistula stenoses that were treated with a Paclitaxel-eluting balloon. Four stenotic lesions were de novo, whereas the majority were re-stenosis following POBA. Immediate post-angioplasty technical success and complications are reported. A crossover design analysis was used to assess the intervention-free period following DEB angioplasty compared to POBA in patients with re-stenosis. Technical success was 100% in DEB treated stenoses. No immediate complications occurred. Thirteen (50%) DEB treated stenoses were intervention-free at analysis (mean follow-up 11.1 ± 5.1 months). Remaining DEB treated lesions were intervention-free for a mean duration of 6.1 ± 3.1 months. The proportion of DEB treated stenoses free from intervention was comparable to POBA at three months (95% vs. 91%; p-value = n.s). A significantly greater proportion of DEB treated lesions was intervention-free at six months (50% vs. 18%; p-value = 0.039) and nine months (53%vs.18%; p-value = 0.031). A higher proportion of DEB treated lesions was intervention-free at 12 months (22% vs. 9%; p-value = n.s.). Drug-eluting balloon angioplasty appears feasible and safe for the treatment of AV fistula stenosis and seems to be associated with a longer intervention-free period compared to standard angioplasty. Further prospective randomised trials are warranted.

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

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

Comparison of the safety and efficacy of two types of drug-eluting balloons (RESTORE DEB and SeQuent® Please) in the treatment of coronary in-stent restenosis: study protocol for a randomized controlled trial (RESTORE ISR China).

In-stent restenosis (ISR), characterized by neointimal proliferation and/or neoatherosclerosis in the vessel of the stent, can cause a reduction in lumen diameter after stent implantation, which can directly induce the recurrence of angina symptoms or an acute coronary syndrome in patients and is usually life-threatening.[1]–[3] ISR has also been considered as formidable clinical problem for the interventional cardiologists. In recent years, many remarkable improvements in medical technology of percutaneous coronary intervention (PCI), such as first-generation bare metal stents (BMS) and newer-generation drug-eluting stents (DES) have been achieved, which significantly reduce ISR occurrence in patients with PCI.[4],[5] For example, growing evidence has suggested that the safety and efficacy of revascularization procedures of newer-generation DES was greatly superior to those of first generation DES and BMS.[6]–[10] However, ISR rate remains as high as 5% to 10% for patients treated with newer-generation DES at two years.[11] More recently, a newly developed drug-eluting balloon (DEB) coated with paclitaxel, an antiproliferative drug that could inhibit neointimal hyperplasia, had emerged as an alternative therapeutic tool for ISR disease.[12],[13] DEB plays the anti-restenosis efficacy through a high-concentration, rapid local delivery of paclitaxel without the use of polymers on a stent. To date, there are numerous randomized trials performed to compare the safety and efficacy among plain old balloon angioplasty (POBA), DES and DEB for the treatment of ISR.[14] One recent meta-analysis enrolled eight randomized controlled trials and indicated that DEB was a better option for treatment of ISR when compared to POBA.[15] Another meta-analysis showed that DEB and DES have similar efficacy and safety for the treatment of ISR.[16] SeQuent® Please DEB is the only approved product utilized for ISR treatment in China.[17] Currently, a novel paclitaxel-coated balloon (RESTORE DEB) has been invented for the treatment of ISR. However, clinical information on the two different types of DEB in treatment of ISR is limited. This trial aims to compare the safety and efficacy of the RESTOREDEB versus SeQuent® Please DEB for the treatment of coronary ISR in Chinese patients.

Treatment of coronary in-stent restenosis: a systematic review.

Coronary stent implantation has significantly improved percutaneous coronary intervention and enabled the management of early complications of plain balloon angioplasty. However, a new complication has accompanied these improvements: in-stent restenosis (ISR) arising from neointimal hyperplasia. ISR after coronary angioplasty is currently one of the main limitations of this method, leading to the recurrence of exertional angina pectoris or acute coronary syndromes. The clinical incidence of ISR after bare-metal stent (BMS) implantation is approximately 20%–35%. The use of drug-eluting stents (DES) has led to a further decrease in the occurrence of ISR to 5%–10%. Evidence resulting from controlled clinical studies suggests that DES and drug-eluting balloon catheters (DEB) provide the best clinical and angiographic results in the treatment of ISR. We undertook a systematic review of the pathophysiology, diagnostics and treatment options for BMS- and DES-ISR. We discuss recent randomised studies, comparing different DES or DEB used for BMS or DES-ISR treatment, as well as the use of new biovascular scafolds and the topic of scafold restenosis.

Preliminary Results with Drug-Eluting Balloon for the Treatment of Venous Outflow Stenosis of Arteriovenous Fistulas and Grafts

Preliminary Results with Drug-Eluting Balloon for the Treatment of Venous Outflow Stenosis of Arteriovenous Fistulas and Grafts

A Review of Percutaneous Transluminal Angioplasty in Hemodialysis Fistula.

The number of patients in dialysis increases every year. In this review, we will evaluate the role of percutaneous transluminal angioplasty (PTA) according to patency of arteriovenous fistula and grafts. The main indication of PΤΑ is stenosis > 50% or obstruction of the vascular lumen of an arteriovenous fistula and graft. It is usually performed under local anesthesia. The infection rate is as low as the number of complications. Fistula can be used in dialysis in the same day without the need for a central venous catheter. Primary patency is >50% in the first year while primary assisted patency is 80–90% in the same time period. Repeated PTA is as durable as the primary PTA. An early PTA carries a risk of new interventions. Cutting balloon can be used as a second-line method. Stents and covered stents are kept for the management of complications and central outflow venous stenosis. PTA is the treatment of choice for stenosis or obstruction of dialysis fistulas. Repeated PTA may be needed for better patency. Drug eluting balloon may become the future in PTA of dialysis fistula, but more trials are needed.

Cardiology update 2018: The first quarter

Trials addressing the PCSK9 inhibitors, wearable cardioverter defibrillator, genotype-guided antiplatelet therapy, his bundle pacing, and therapies for HFpEF were discussed in American College of Cardiology 2018. TASMINH4 evaluated the need for self-monitoring and telemonitoring of blood pressure in the management of patients with poorly controlled blood pressure. In heart failure, issues regarding temporal trends and patterns of incidence, NT-proBNP, HeartMate pump, immunosuppression (sirolimus versus calcineurin) in heart transplant recipients, and aspirin use were evaluated in various trials. Drug-eluting balloon, MiStent, Resolute Onyx 2.0 drug-eluting stent, Omega-3 fatty acids, safety of drugs used in the treatment of gout (febuxostat versus allopurinol), and preventive strategies for those at risk for renal complications were tested in patients with coronary artery disease. Smokers were compared with nonsmokers presenting with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention in terms of clinical, angiographic, and outcomes. Association of influenza infection with acute myocardial infarction was also tested. A good number of trials tested different antiplatelets in different manners.

Clinical outcomes in patients treated for coronary in-stent restenosis with drug-eluting balloons: Impact of high platelet reactivity.

BackgroundThe impact of high platelet reactivity (HPR) on clinical outcomes after elective percutaneous coronary interventions (PCI) with drug-eluting balloons (DEB) due to in-stent restenosis (ISR) is unknown.ObjectiveWe sought to evaluate the prognostic importance of HPR together with conventional risk factors in patients treated with DEB.MethodsPatients treated with DEB due to ISR were enrolled in a single-centre, prospective registry between October 2009 and March 2015. Only patients with recent myocardial infarction (MI) received prasugrel, others were treated with clopidogrel. HPR was defined as an ADP-test >46U with the Multiplate assay and no adjustments were done based on results. The primary endpoint of the study was a composite of cardiovascular mortality, MI, any revascularization or stroke during one-year follow-up.Results194 stable angina patients were recruited of whom 90% were treated with clopidogrel. Clinical characteristics and procedural data were available for all patients; while platelet function testing was performed in 152 subjects of whom 32 (21%) had HPR. Patients with HPR had a higher risk for the primary endpoint (HR: 2.45; CI: 1.01–5.92; p = 0.03). The difference was primarily driven by a higher risk for revascularization and MI. According to the multivariate analysis, HPR remained a significant, independent predictor of the primary endpoint (HR: 2.88; CI: 1.02–8.14; p = 0.04), while total DEB length and statin treatment were other independent correlates of the primary outcome.ConclusionHPR was found to be an independent predictor of repeat revascularization and MI among elective patients with ISR undergoing PCI with DEB.

Manejo de la reestenosis intrastent

Intrastent restenosis is the reaccumulation of tissue within the lumen of a coronary vessel at the site of prior interventionism with a balloon or stent, as a result of the normal healing response of the vascular wall to mechanical damage. It is the result of two histopathological processes: neointimal hyperplasia due to smooth muscle migration and proliferation and extracellular matrix deposition; and vascular remodeling. It manifests clinically with symptoms of ischemia and angiographic findings showing at least a 50% reduction in the lumen of a vessel previously treated with a stent. Second generation medicated stents or drug eluting balloons are recommended for treatment, depending on the type of restenosis being treated. The use of conventional stents or balloons is not recommended as the sole treatment of intrastent restenosis.

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.

Treatment of femoropopliteal lesions with the AngioSculpt scoring balloon - results from the Heidelberg PANTHER registry.

Treatment of calcified femoropopliteal lesions remains challenging, even in the era of drug-eluting balloon angioplasty. Lesion recoil and dissections after standard balloon angioplasty in calcific lesions often require subsequent stent implantation. Additionally, poor patency rates in calcified lesions despite the use of drug-eluting balloons may be due to the limited penetration depth of the antiproliferative drug in the presence of vascular calcium deposits. Therefore, preparation of calcified lesions with the AngioSculpt™ scoring balloon might be a valuable option either as a stand-alone treatment, followed by drug-eluting balloon angioplasty or prior to subsequent stent deployment. In this retrospective, single centre registry, 124 calcified femoropopliteal lesions were treated in 101 subsequent patients. All patients were treated with scoring balloon angioplasty, either alone, in combination with drug-eluting balloons, or prior to stent deployment. The primary outcome was safety and technical success during the index procedure as well as patency at six and 12 months, as evaluated by duplex sonography. Successful scoring was safely performed in all 124 lesions with the AngioSculpt™ balloon. Overall primary patency after 12 months was 81.2 %. Patency rates did not differ significantly between the three treatment strategies. Degree of calcification did not predict patency. Improved clinical outcomes (Rutherford-Becker class and ankle-brachial index) were also observed in the study cohort. Preparation with the AngioSculpt™ scoring balloon offers a safe and valuable treatment option for calcified femoropopliteal lesions.

A Randomized Comparison of Paclitaxel-Eluting Balloon Versus Everolimus-Eluting Stent for the Treatment of Any In-Stent Restenosis: The DARE Trial

ObjectivesThe authors sought to evaluate the relative performance of a drug-eluting balloon (DEB) and a drug-eluting stent (DES) in patients with any (bare-metal or drug-eluting stent) in-stent restenosis (ISR). BackgroundThe treatment of ISR remains challenging in contemporary clinical practice. MethodsIn a multicenter randomized noninferiority trial, patients with any ISR were randomly allocated in a 1:1 fashion to treatment with a DEB (SeQuent Please paclitaxel-eluting balloon, B. Braun Melsungen, Melsungen, Germany), or a DES (XIENCE everolimus-eluting stent, Abbott Vascular, Santa Clara, California). The primary endpoint was noninferiority in terms of in-segment minimal lumen diameter (MLD) at 6-month angiographic follow-up. Secondary endpoints included angiographic parameters at 6 months and clinical follow-up up to 12 months. ResultsA total of 278 patients, of whom 56% had DES-ISR, were randomized at 8 sites to treatment with DEB (n = 141) or DES (n = 137). As compared with DEB, DES was associated with larger MLD and lower % stenosis immediately post-procedure (1.84 ± 0.46 vs. 1.72 ± 0.35; p = 0.018; and 26 ± 10% vs. 30 ± 10%; p = 0.03). Angiographic follow up was completed at 196 ± 53 days in 79% of patients. With respect to the primary endpoint of in-segment MLD at 6 months, DEB was noninferior to DES (DEB 1.71 ± 0.51 mm vs. DES 1.74 ± 0.61 mm; p for noninferiority <0.0001). Target vessel revascularization at 12-month follow-up was similar in both groups (DES 7.1% vs. DEB 8.8%; p = 0.65). ConclusionsIn patients with ISR, treatment with DEB was noninferior compared with DES in terms of 6-month MLD. There were no differences in clinical endpoints, including target vessel revascularization up to 12 months. Therefore, use of a DEB is an attractive treatment option for in-stent restenosis, withholding the need for additional stent implantation.