Coated Balloon Angioplasty Research Articles

Statement of Clarification: Drug Coated Balloon Angioplasty in Failing AV Fistulas.

Statement of Clarification: Drug Coated Balloon Angioplasty in Failing AV Fistulas.

VSICON 2018 Prize Paper Abstracts

VSICON 2018 Prize Paper Abstracts

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis

The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either predilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included postinterventional lumen gain and late lumen loss (LLL) at 6 months. The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs. 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs. NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs. 0.40 ± 0.46 mm, P = 0.468). Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

TCT-774 Duration of dual antiplatelet therapy in elective drug coated balloon angioplasty

The duration of dual antiplatelet therapy (DAPT) for drug coated balloon (DCB) angioplasty in elective percutaneous coronary angioplasty (PCI) guidelines have been reviewed in 2017. Previous German Consensus Group guidelines (2011) advised 1 month only of DAPT for patients with stable coronary

Rotational Atherectomy Combined with Drug Coated-Balloons for in-Stent Restenosis

Refractory coronary in-stent restenosis remains a clinically relevant problem in interventional cardiology despite the use of drug coated balloon angioplasty and further drug eluting stent deployment. In this study, we investigated whether the novel approach of lesion debulking with rotational atherectomy prior to drug coated balloon angioplasty for challenging coronary in-stent restenosis is safe and effective. Procedural and registry data was retrospectively analysed for 26 patients who underwent rotational atherectomy immediately followed by drug coated balloon angioplasty to 43 coronary in-stent restenosis lesions with mean follow up of 19 months. Lesion success was achieved in all cases with no major procedural complications. There were no instances of death or myocardial infarction in the follow up period. Target lesion revascularisation occurred in six patients and target vessel revascularisation occurred in eight patients. All target lesion revascularisation occurred in lesions that had already failed drug coated balloon angioplasty without debulking previously while four such lesions were free of lesion failure in the follow up period. Lesion debulking with rotational atherectomy followed by drug coated balloon angioplasty is a feasible treatment option for selected cases of in-stent restenosis. Further study is needed to fully assess its efficacy in comparison to conventional treatment.

P4569Duration of dual anti platelet therapy in elective drug coated balloon angioplasty

P4569Duration of dual anti platelet therapy in elective drug coated balloon angioplasty

Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial.

Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas. This randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (≤30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers' usual protocols; reintervention was clinically driven. The primary efficacy outcome assessment was done at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end points included assessment of postintervention target lesion primary patency and access circuit primary patency at 6 months. The 180-day end point was not met with target lesion primary patency (71%±4% for the drug-coated balloon and 63%±4% for control; P=0.06), representing a difference of 8%±6% (95% confidence interval, -3% to 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary safety noninferiority end point was met and did not differ between groups (P=0.002). Paclitaxel-coated balloon-assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov number NCT02440022).

Abstract 103: Local Mir-29b Inhibition Using Drug-eluting Balloons Blocks Abdominal Aortic Aneurysm Expansion in Atherosclerotic Ldlr-/- Mini-pigs

Introduction: Abdominal aortic aneurysm (AAA) is a major challenge in vascular surgery practice due to high morbidity and mortality, especially in case of rupture. Despite open surgery or endovascular stent implantation, no therapeutic option remains to clinicians. Micro-RNAs (miR) have emerged as novel therapeutic targets in the cardiovascular field. For translational research, animal models mimicking human disease are crucial, however, most often a compromise between size, cost and features similar to human disease limits the translational value. Material and Methods: We used the homozygote low-density lipoprotein receptor (LDLR) knockout (KO) Yucatan mini-pig to create a human-relevant animal model for AAA. Local application of porcine pancreatic elastase was applied to the infrarenal aorta for aneurysm inductions. Vascular ultrasound and CT was used for follow-up examination. 8 days after induction, catheter-guided anti-miR-29b coated balloon angioplasty was performed. Animals were sacrificed after 30 days. PCR and immunohistochemistry were used for further characterization of the model. Results: The LDLR KO is hypercholesterolemic and shows severe atherosclerosis in the infrarenal aorta. Aneurysms can be induced by local elastase application for 10 minutes and the aortic diameter increases by 60% over the course of four weeks. Despite atherosclerosis, the aneurysmatic vessel wall shows many features of human disease such as inflammation, extracellular matrix remodeling, angiogenesis and vascular smooth muscle cell phenotype switch. Targeted delivery by balloon angioplasty is feasible and anti-miR-29b penetrates through all layers of the aortic wall, eventually inducing local matrix remodeling. Anti-miR-29b treated animals had significantly smaller AAAs, while not showing any signs of off-target effects. Conclusion: Elastase perfusion in atherosclerosis-prone pigs is a feasible pre-clinical AAA model with many features similar to human disease. Locally balloon-delivered anti-miR-29b induces a pro-fibrotic response, halting aneurysm growth.

TCTAP A-071 Sirolimus Coated Balloon Angioplasty for In-stent Restenosis in Small Coronary Arteries

TCTAP A-071 Sirolimus Coated Balloon Angioplasty for In-stent Restenosis in Small Coronary Arteries

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in-stent restenosis.

The objective of this study was to assess the 12-month clinical outcomes in patients with drug-eluting stent in-stent restenosis (DES-ISR) who were either pre-dilated with non-compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty. This monocentric, retrospective study included patients with DES-ISR who were routinely treated over a 2-year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES-ISR lesion were analyzed. The primary endpoint was the clinically driven target-lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post-interventional lumen gain and late lumen loss (LLL) at 6 months. The 12-month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468). Scoring Balloon Angioplasty can safely and effectively prepare DES-ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

SeQuent Please vs. Pantera Lux drug coated balloon angioplasty in real life: Results from the Düsseldorf DCB registry

BackgroundIn-stent restenosis (ISR) is still a major concern in interventional cardiology. Drug coated balloon (DCB) angioplasty has been shown to be a promising option in treatment of ISR. However heterogeneity of different DCBs in suppression of neointimal growth has been described in a porcine model of coronary ISR. Therefore, in this registry analysis, we compared two frequently used paclitaxel eluting DCBs, the SeQuent Please and the Pantera Lux DCB. Methods571 patients were treated with DCB angioplasty at the Heinrich-Heine University Düsseldorf between 2009 and 2012. Follow-up was conducted during ambulatory care at our department. Major adverse cardiac events (death, myocardial infarction [MI] and target lesion revascularization) were registered during hospitalization and follow-up. ResultsPatient characteristics, prior diseases, clinical presentation, ejection fraction, procedural success and lost-for-follow-up did not differ between patients treated with the SeQuent Please and. The Pantera Lux DCB. MACE during hospital course were similar as well (Pantera Lux: 6 patients [1.6%] vs. SeQuent®Please: 3 patients [1.5%], relative risk 1.06, 95% confidence interval 0.3–4.2, P=0.93). Event free survival was significantly longer in patients treated with the Pantera Lux DCB as compared to SeQuent Please DCB (Hazard ratio: 0.65, 95% confidence interval 0.43–0.98; P value of log-rank test: 0.0405). ConclusionMACE free survival was longer in Pantera Lux DCB treated patients as compared to SeQuent Please treated patients. This finding has to be confirmed in future clinical trials.

3:09 PMAbstract No. 149 - Drug coated balloon angioplasty in femoropopliteal lesions: a single centre real world experience

median value. There was no significant difference in either stratum for longitudinal systolic blood pressure by treatment group. The correlation between baseline UACR and eGFR was weak (r1⁄4.23). Conclusions: The absence of renal microvascular disease, marked by UACR o1⁄422.5 mg/g, indicates a potential large subgroup with renal artery stenosis that may experience improved event-free and overall-survival after renal artery stent placement.

Healing after coronary artery dissection: The effect of a drug coated balloon angioplasty in a bifurcation lesion. A lesson from intravascular ultrasound analysis

Healing after coronary artery dissection: The effect of a drug coated balloon angioplasty in a bifurcation lesion. A lesson from intravascular ultrasound analysis

Drug coated balloon angioplasty in elderly patients with small vessel coronary disease.

Coronary angioplasty in advanced age is associated with higher rate of comorbidities and complications. Drug coated balloon only angioplasty (DCBA) has emerged as an alternative to treat small vessel coronary disease (SVCD), of reference vessel diameters <2.8 mm, with shorter duration of dual antiplatelet (DAPT). This is the first study to assess the DCBA efficacy in an elderly population with SVCD. We performed a prospective study of 447 patients (334 patients aged <75 and 113 patients aged ⩾75 years old) acquired from the SeQuent Please Small Vessel 'Paclitaxel-Coated Balloon Only' registry. In the older age group, more patients have hypertension (89% versus 77%; p = 0.006), renal insufficiency (21% versus 6%; p < 0.001), atrial fibrillation (17% versus 7%; p = 0.001), and calcified lesions (33% versus 20%; p = 0.006). At 30 days, there was one myocardial infarction requiring target lesion revascularization (TLR) in the younger group. No major adverse cardiac event (MACE) was observed in the older group. At 9 months, the MACE rate in the younger group was 4.2% and 6.1% in the older group (p = 0.453), with TLR rates at 3.9% and 3.0% (p = 0.704) respectively. There was no cardiac death observed. DBCA in the elderly with SVCD is as safe and effective compared with younger patients despite more complex anatomy and comorbidities.

CRT-146 In-Drug Eluting Stent Restenosis Treated By Paclitaxel Coated Balloon Angioplasty: Results From The French Prospective Garo Registry

The clinical benefits of paxlitaxel-coated balloon angioplasty (PCB) have been extensively studied in bare metal stent in-stent restenosis (BMS-ISR) and in drug eluting stent in-stent restenosis (DES-ISR). The GARO Registry is a dedicated ‘all comers’ study in an unselected patient population

CRT-146 In-Drug Eluting Stent Restenosis Treated By Paclitaxel Coated Balloon Angioplasty: Results From The French Prospective GARO Registry

CRT-146 In-Drug Eluting Stent Restenosis Treated By Paclitaxel Coated Balloon Angioplasty: Results From The French Prospective GARO Registry

TCT-266 PEPCAD-DES: A randomized, multicenter, single blinded trial comparing paclitaxel coated balloon angioplasty with plain balloon angioplasty in drug-eluting-stent restenosis – 3 year results

TCT-266 PEPCAD-DES: A randomized, multicenter, single blinded trial comparing paclitaxel coated balloon angioplasty with plain balloon angioplasty in drug-eluting-stent restenosis – 3 year results

Monitoring of Gadolinium-BOPTA Uptake into the Vessel Wall during Magnetic Resonance (MR)-Guided Angioplasty of the Peripheral Arteries with a Paclitaxel/Gadolinium-BOPTA-Coated Balloon: An Experimental Study at 3 Tesla

The success of paclitaxel distribution within the vessel wall during paclitaxel-coated balloon angioplasty to prevent restenosis cannot be monitored under X-ray guidance. The aim of this pilot study was to demonstrate the feasibility of monitoring Gadolinium-BOPTA delivery within the vessel wall during magnetic resonance (MR)-guided paclitaxel/Gadolinium-BOPTA-coated balloon angioplasty of the peripheral arteries. 6 pigs (47 ± 2 kg) were investigated. All experiments were performed using a 3 Tesla MR scanner. MR-guided bilateral angioplasty of the iliac arteries was performed using a paclitaxel/MR contrast agent-coated balloon catheter. The feasibility of monitoring the delivery of Gadolinium-BOPTA to the vessel wall was assessed in 4 animals. In two additional animals, bilateral stenosis was surgically induced in the iliac arteries. Delivery of paclitaxel to the vessel wall was monitored using a 3 D T1-weighted gradient echo (GE) sequence for delineation of the vessel wall. Normalized signal intensity (SI) of the vessel wall was measured before and repeatedly after the intervention for 45 min. in all animals. Paclitaxel/gadolinium-BOPTA-coated balloon angioplasty was successfully accomplished in all iliac arteries (n = 12). In animals with stenosis MR-angiography demonstrated successful dilatation (n = 4). The normalized SI of the vessel wall on T1-weighted GE images significantly increased after the intervention in all animals with and without stenosis for more than 45 min. (p < 0.001). Monitoring of Gadolinium-BOPTA into the vessel wall during MR-guided coated balloon angioplasty is feasible. This is a first step towards providing a tool for the online control of homogenous drug delivery after paclitaxel-coated balloon angioplasty. • Monitoring of gadolinium-BOPTA uptake into the vessel wall during MR-guided coated balloon angioplasty is feasible.• Endovascular MR-guided interventions on a 3 Tesla MR scanner are feasible.• This is a first step towards providing a tool for online control of homogenous drug delivery after paclitaxel-coated balloon angioplasty.

Angiographic and clinical outcomes of paclitaxel coated balloon angioplasty versus uncoated balloon angioplasty in drug eluting stent restenosis: subgroup analysis from the PEPCAD-DES study

Angiographic and clinical outcomes of paclitaxel coated balloon angioplasty versus uncoated balloon angioplasty in drug eluting stent restenosis: subgroup analysis from the PEPCAD-DES study

TCT-69 PEPCAD-DES: A randomized, multicenter, single blinded trial comparing paclitaxel coated balloon angioplasty with plain balloon angioplasty in drug-eluting-stent restenosis – 12 months results

TCT-69 PEPCAD-DES: A randomized, multicenter, single blinded trial comparing paclitaxel coated balloon angioplasty with plain balloon angioplasty in drug-eluting-stent restenosis – 12 months results