Drug-eluting Balloon Treatment Research Articles

Long-Term Follow-up and Mortality Rate of Patients of the Randomized Freeway Stent Study

PurposeThis follow-up study was designed as a reopen of the completed Freeway Stent Study and collected mortality and clinical outcome data for at least 5 years after enrollment to evaluate long-term patient safety and treatment efficacy. The primary study enrolled 204 patients with stenosis or occlusion in the superficial femoral artery and proximal popliteal artery. Patients were randomized to primary nitinol stenting followed by standard PTA or primary nitinol stenting followed by FREEWAY™ paclitaxel-eluting balloon PTA.MethodsPrevious patients were recontacted by phone or during a routine hospital visit, and medical records were reviewed. Vital and clinical status information was collected.ResultsNo increased late mortality was observed at 5 years, with an all-cause mortality rate of 12.0% in the FREEWAY drug-eluting balloon group versus 15.0% in the non-paclitaxel PTA group. No accumulation of any cause of death was observed in either group, nor was there any correlation with the dose of paclitaxel used. Freedom from clinically driven target lesion revascularization at 5 years was significantly higher in the FREEWAY drug eluting balloon group (85.3%) compared to standard PTA group (72.7%) Log-rank p = 0.032.ConclusionThe safety results presented support the recent conclusions that the use of paclitaxel technology does not lead to an increase in mortality. At the same time, the efficacy results clearly demonstrate that the potential benefits of drug-eluting balloon treatment are maintained over a 5-year period.Graphical

TCT-408 First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: The DEBuT-LRP Study

TCT-408 First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: The DEBuT-LRP Study

First-in-Human Drug-Eluting Balloon Treatment of Vulnerable Lipid-Rich Plaques: Rationale and Design of the DEBuT-LRP Study.

Patients with non-obstructive lipid-rich plaques (LRPs) on combined intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) are at high risk for future events. Local pre-emptive percutaneous treatment of LRPs with a paclitaxel-eluting drug-coated balloon (PE-DCB) may be a novel therapeutic strategy to prevent future adverse coronary events without leaving behind permanent coronary implants. In this pilot study, we aim to investigate the safety and feasibility of pre-emptive treatment with a PE-DCB of non-culprit non-obstructive LRPs by evaluating the change in maximum lipid core burden in a 4 mm segment (maxLCBImm4) after 9 months of follow up. Therefore, patients with non-ST-segment elevation acute coronary syndrome underwent 3-vessel IVUS-NIRS after treatment of the culprit lesion to identify additional non-obstructive non-culprit LRPs, which were subsequently treated with PE-DCB sized 1:1 to the lumen. We enrolled 45 patients of whom 20 patients (44%) with a non-culprit LRP were treated with PE-DCB. After 9 months, repeat coronary angiography with IVUS-NIRS will be performed. The primary endpoint at 9 months is the change in maxLCBImm4 in PE-DCB-treated LRPs. Secondary endpoints include clinical adverse events and IVUS-derived parameters such as plaque burden and luminal area. Clinical follow-up will continue until 1 year after enrollment. In conclusion, this first-in-human study will investigate the safety and feasibility of targeted pre-emptive PE-DCB treatment of LRPs to promote stabilization of vulnerable coronary plaque at risk for developing future adverse events.

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

In this study, we present one-year results of drugeluting balloon treatment of femoropopliteal in-stent restenosis. A total of 62 patients (48 males, 14 females; mean age 64.2±9.1 years; range, 54 to 81 years) who underwent drugeluting 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. 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. 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.

Safety Issues Associated with Paclitaxel-Eluting Balloons and Progress of Sirolimus-Eluting Balloons

Drug eluting balloons (DEBs) are semi-compliant angioplasty balloons covered with an antiproliferative drug which is rapidly released locally into the vessel wall during balloon contact. Their advantages include a broader area of drug contact, more homogenous drug-tissue transfer for stent-based local drug delivery, no implant leaving as well as shortened dual antiplatelet therapy. DEBs application was first recommended by the European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the treatment of in-stent restenosis (ISR) after prior bare-metal stent (BMS) (Class IIA, Level B) in 2010. Since then, rapid progress has been made in the use of DEBs for treatment of in-stent restenosis, bifurcation, small vessel diseases, and other de novo occlusive coronary artery diseases even the symptomatic peripheral arterial disease. However, a meta-analysis of 28 randomized controlled trials (RCTs) with 4663 patients investigating paclitaxel-coated devices (DEBs & drug-eluting stent) in the femoral and/or popliteal arteries showed a highly significant association between risk of death and paclitaxel exposure in a dose-time-dependent manner. Safety issues associated with clinical application of paclitaxel DEBs in femoropopliteal artery was widely discussed. This study reviewed the issues, different molecular mechanisms of paclitaxel and sirolimus in antiproliferative effects, and progress of sirolimus-eluting balloons.

Recurrent stenosis following carotid artery stenting treated with a drug-eluting balloon: a single-center retrospective analysis.

Early in-stent restenosis after stent-protected angioplasty of the carotid artery (SPAC) is an infrequent, but potentially harmful condition for patients with carotid artery disease. In our retrospective single-center analysis of 176 patients with carotid artery stenting between 2009 and 2015, using duplex ultrasound, we detected 9 patients with high-grade carotid artery in-stent restenosis. All restenosis patients were treated with a drug-eluting balloon (DEB) to prevent recurrent neointimal hyperplasia. One patient had bilateral carotid artery disease with bilateral in-stent restenosis, and 1 patient needed repeated DEB treatment 19months after the first DEB intervention, so 11 DEB procedures, in total, were performed. The median time-interval between primary carotid artery stenting and first DEB-treatment was 9months. In 3 of the 11 interventions, the DEB treatment was assisted by an additional stent. One repeat DEB treatment was necessary, and three DEB treatments were followed by a secondary stent. No peri-interventional complications (TIA, stroke, or death) were observed during or after DEB intervention. Therefore, in the entire group, the 1y event-free survival (EFS) was 100%, and the 2y/3y/5y EFS was 83%. DEB intervention seems to be an effective and safe treatment for patients with high-grade in-stent restenosis after SPAC.

Safety and performance of the DRug-Eluting Absorbable Metal Scaffold (DREAMS) in patients with de novo coronary lesions: 3-year results of the prospective, multicentre, first-in-man BIOSOLVE-I trial

Bioresorbable scaffolds were designed to overcome the limitations of permanent stents. In the BIOSOLVE-I study we aimed to assess the long-term safety and performance of a drug-eluting absorbable metal scaffold (DREAMS) at three years. In this prospective, multicentre first-in-man study, 46 patients with 47 de novo lesions were enrolled. We report the final results at three-year follow-up. Mean age was 65.3±9.7 years, lesions were 2.73±0.48 mm in diameter and 10.99±4.59 mm long. Follow-up at three years was available for 44 patients (one patient died of a non-cardiac cause and one patient withdrew consent). Three target lesion failures (TLF) occurred (6.6%), consisting of two clinically driven target lesion revascularisations at scheduled six-month angiography (4.3%) and one myocardial infarction after drug-eluting balloon treatment in a non-target lesion but target vessel at 12-month angiography (2.2%). No cardiac death or scaffold thrombosis occurred. Seven patients had additional angiographic follow-up at 28±4 months: in-scaffold late lumen loss had improved from 0.51±0.46 mm (median 0.28 mm) at 12 months to 0.32±0.32 mm (median 0.20 mm). The BIOSOLVE-I study showed excellent long-term outcomes at three years with a low TLF rate and no cardiac death or scaffold thrombosis. No TLF event was observed beyond 377 days.

TCTAP A-029 Clinical Results of DEB Treatment for De-Novo Coronary Artery Disease in a Registry Study in China

Randomized trials have demonstrated that drug eluting balloon (DEB) angioplasty plus bare-metal stenting is non-inferior to drug eluting stenting in dealing with de-novo lesions. The efficacy and safety of the DEB for treatment of de-novo coronary artery disease in a large-scale registry has been

Evaluation of the Biodegradable Igaki-Tamai Scaffold After Drug-Eluting Balloon Treatment of De Novo Superficial Femoral Artery Lesions

Purpose: To evaluate the safety and efficacy of the Igaki-Tamai biodegradable scaffold after drug-eluting balloon (DEB) angioplasty in patients with occlusive superficial femoral artery (SFA) disease. Methods: A prospective, single-center, nonrandomized study enrolled 20 patients (mean age 66.7±11.6 years; 14 men) with symptomatic de novo SFA lesions undergoing angioplasty with the In.Pact Admiral paclitaxel-coated balloon and subsequent implantation of the Igaki-Tamai bioresorbable scaffold. All patients were claudicants. The average diameter stenosis was 89.7%, and the mean length was 43.6 mm. Clinical examinations with duplex sonography were performed after 1, 6, 9, and 12 months. The main study outcomes were technical success, restenosis, target lesion revascularization (TLR), ankle-brachial index (ABI) improvement, and changes in quality of life evaluated with the walking impairment questionnaire. Safety was assessed by monitoring the occurrence of adverse events. Results: Angioplasty with a paclitaxel-coated balloon was performed in all patients, resulting in an average diameter stenosis of 24%. Subsequent implantation of the Igaki-Tamai scaffold reduced the average diameter stenosis to 3.5%. In the first 6 months, 2 cases of restenosis were reported, with no TLRs within that period. However, by the 12-month follow-up in 19 patients, 11 patients had lost in-stent patency. Among these patients, 8 had TLRs, which were the only adverse events recorded that were referable to the procedure. Quality-of-life assessments showed improvement in the majority of patients. Conclusion: The GAIA-DEB study shows that DEB treatment of the femoral artery prior to the implantation of the biodegradable Igaki-Tamai scaffold is safe. However, the antiproliferative actions of paclitaxel in the vessel wall were not effective in preventing restenosis. In-stent restenosis occurred predominantly after 6 months.

Efficacy of Drug-Eluting Balloons for Patients With In-Stent Restenosis

The optimal treatment for in-stent restenosis (ISR) of both bare-metal stent (BMS) and drug-eluting stent (DES) is currently unclear. The aim of this meta-analysis was to assess the role of drug-eluting balloon (DEB) as an optional treatment for ISR. We searched PubMed, MEDLINE, EMBASE, BIOS, and Web of Science from 2005 to July 2014. Eight studies, enrolling 1413 patients were included. Main end points were late lumen loss (LLL), binary in-segment restenosis (BR), major adverse cardiac events (MACEs), target lesion revascularization (TLR), death, myocardial infarction (MI), and stent thrombosis (ST). When compared to plain old balloon angioplasty (POBA), DEB treatment significantly reduced the risk of MACE (risk rato [RR] 0.37, P < .01), death (RR 0.44, P = .04), TLR (RR 0.27, P < .01), BR (RR [95% CI]: 0.23[0.12 to 0.43], P < .01) and associated with better outcomes of LLL ( 0.50 [ 0.65 to 0.35] mm, P < .01). However, the differences were not significant between DEB treatment and DES treatment in all primary and secondary end points. The DEB was a better option to treat ISR when compared to POBA. However, it had similar effects as DES.

Drug-Eluting Balloon Therapy for Femoropopliteal Occlusive Disease

Purpose: To assess the association of patient, lesion, and procedure variables, including calcification, with late lumen loss (LLL) after use of drug-eluting balloon (DEB) therapy in patients with femoropopliteal arterial disease. Methods: In this retrospective study, 91 patients (mean age 72.0±8.62 years; 50 men) were analyzed at 6 months after DEB treatment. Lesions were located in the superficial femoral artery (SFA, n=68) and popliteal artery (n=23). Lesion calcification was graded by a core laboratory using 2 published scoring indices: the peripheral artery calcification scoring system and a grading system based on circumference (arc) and length of calcium. Results: The median LLL after 6 months was 0.2 mm (interquartile range −0.5, 1.14) overall and varied significantly across lesions with differing severity of calcification (p=0.042). However, LLL did not differ based on calcium location (intimal, medial, or mixed) or calcium length (p=0.351 and p=0.258, respectively). Additional predictors of LLL after DEB treatment included diabetes (p=0.034), coronary artery disease (p=0.024), and prior intervention (p=0.013). Interestingly, the severity of residual stenosis after the intervention did not have any impact on the LLL during follow-up (Spearman r = −0.238). Conclusion: Severity of lesion calcification is associated with LLL after treatment with DEB. One possible approach to overcome this limitation might be plaque modification or removal prior to DEB usage. Nevertheless, clinical data that support this hypothesis are currently lacking.

Provisional main branch stenting with drug-eluting stents after drug-eluting balloon treatment of the side branch: A simple and durable technique for treating bifurcation lesions

Provisional main branch stenting with drug-eluting stents after drug-eluting balloon treatment of the side branch: A simple and durable technique for treating bifurcation lesions

Mechanisms of Postintervention and Nine-Month Luminal Enlargement After Treatment of Drug-Eluting In-Stent Restenosis With a Drug-Eluting Balloon

Using optical coherence tomography (OCT), the mechanisms of postintervention and 9-month luminal enlargement in drug-eluting stent in-stent restenosis (ISR) lesions treated with a drug-eluting balloon (DEB) were evaluated. A total of 42 patients with DEB-treated drug-eluting stent ISR lesions underwent serial OCT examination before intervention, after intervention, and at 9-month follow-up. Preintervention OCT-derived neointima was classified as either a homogeneous or nonhomogeneous pattern. Ten ISR lesions with homogeneous neointima were identified and compared with 32 ISR lesions with nonhomogeneous neointima. When comparing pre- and postintervention evaluations, changes in luminal cross-sectional area (CSA) were 3.4mm(2) in ISR lesions with homogeneous neointima and 3.7mm(2) in those with nonhomogeneous neointima, respectively (p= 0.529); changes in stent CSA were 2.5mm(2) and 1.4mm(2), respectively, p= 0.004; and changes in neointimal CSA were-0.9mm(2) and-2.3mm(2), respectively, p= 0.001. At 9-month follow-up, changes in luminal CSA were-2.0mm(2) and-0.9mm(2) in ISR lesions with homogeneous and nonhomogeneous neointima, respectively (p= 0.021); in stent CSA changed by-0.2mm(2) in both groups (p= 0.851) and changes in neointimal CSA was 1.8mm(2) and 0.7mm(2), respectively (p= 0.003). At the 9-month follow-up, >50% neointimal CSA stenosis was observed in 60% and 19% of the ISR lesions with homogeneous and nonhomogeneous neointima, respectively (p= 0.020). In conclusion, the mechanism of postintervention luminal enlargement by DEB varied with the preintervention OCT-based neointimal characteristics. ISR lesions with homogeneous neointima determined by OCT were associated with greater subsequent regrowth of neointima after DEB treatment.

Vascular imaging balloon with local drug delivery for the treatment of renal artery recurrent in-stent restenosis

Renal artery stenosis is a common finding among patients with atherosclerotic disease and its percutaneous treatment with stent implantation is frequently performed by interventional cardiologists and vascular radiologists. However, renal artery in-stent restenosis is not a rare complication and its management is not straightforward. We describe and report angiographic follow-up of an innovative approach to renal artery in-stent restenosis based on combined intravascular ultrasound and drug-eluting balloon treatment.

TCT-533 Drug-Eluting Balloon for treatment of superficial femoral artery in-stent restenosis. Two years results from an Italian registry.

TCT-533 Drug-Eluting Balloon for treatment of superficial femoral artery in-stent restenosis. Two years results from an Italian registry.

TCT-580: Clinical Evaluation of the IN.PACT Drug-eluting Balloon for Treatment of Femoro-popliteal Arterial Disease: Twelve Month Results from a Multicenter Italian Registry

TCT-580: Clinical Evaluation of the IN.PACT Drug-eluting Balloon for Treatment of Femoro-popliteal Arterial Disease: Twelve Month Results from a Multicenter Italian Registry

Clinical Evaluation of the IN.PACT Drug-eluting Balloon for Treatment of Femoro-popliteal Arterial Disease: Twelve Month Results from a Multicenter Italian Registry

Clinical Evaluation of the IN.PACT Drug-eluting Balloon for Treatment of Femoro-popliteal Arterial Disease: Twelve Month Results from a Multicenter Italian Registry

Analysis of Potential Cost-Savings After Introduction of Drug-Eluting Balloon Angioplasty for In-Stent Restenosis or Small Vessel Disease

Background and ObjectivesThe drug-eluting balloon (DEB) catheter system was developed to treat restenosis. Furthermore, DEB angioplasty has been shown to reduce restenosis risk when compared to drug-eluting stents (DES) in patients with in-stent restenosis (ISR) or small vessel disease (SVD). In addition, DEB angioplasty reduces costs due to fewer revascularizations and reduced clopidogrel treatment length. The objective of this study was to predict the expected cost-savings when DEB is substituted for DES in patients with ISR or SVD.Subjects and MethodsThe subjects included were patients treated by DES at Seoul National University Hospital from January 2006 to June 2009, with clinical data after percutaneous coronary intervention, were. A model was developed to allow the costs of DES and the calculated costs of DEB incurred by patients with ISR or SVD to be compared. The overall cost of DEB was calculated to be 1,256,150 won and the overall cost of DES was 2,102,500 won, and the cost of clopidogrel was 2,168 won. Expected repeat revascularizations within 12 months of DEB were calculated based on information provided by the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery (PEPCAD) I and II trials.ResultsBy substituting DEB for DES, total cost (including the cost of initial DEB treatment, the cost of repeat revascularization after DEB treatment, and the cost of clopidogrel treatment) was found to be 34% lower in ISR patients and 48% lower in SVD patients.ConclusionDEB angioplasty will significantly reduce costs as compared to DES in ISR and in SVD patients.