Drug-coated Balloon Treatment Research Articles

Drug-Coated Balloons Versus Second-Generation Drug-Eluting Stents for the Management of Recurrent Multimetal-Layered In-Stent Restenosis

This study aimed to investigate the clinical outcomes of patients presenting with recurrent drug-eluting stent (DES) in-stent restenosis (ISR) treated with a second-generation DES or with a drug-coated balloon (DCB). To date, there are no reports of DCB treatment and limited data with regard to the efficacy of further DES implantation for recurrent ISR. Between January 2008 and December 2013, 171 lesions were assessed for eligibility (82 lesions in the second-generation DES group and 89 lesions in the DCB group). Acute gain was greater in the second-generation DES group (second-generation DES, 2.09 ± 0.53 mm vs. DCBs, 1.60 ± 0.62 mm, p< 0.001). The rates of major adverse cardiac events were comparable (at 1 year, DES 14.0% vs. DCBs 12.3%; at 2 years, DES 28.8% vs. DCBs 43.5%, p= 0.21). Major adverse cardiac event rates were mainly driven by target lesion revascularization (at 1 year, DES 12.5% vs. DCBs 10.9%; at 2 years, DES 27.7% vs. DCBs 38.3%; p= 0.40). Definite scaffold thrombosis occurred in 2 patients (1 patient in each group). Multivariable analysis revealed ISR recurrence within 1 year (hazard ratio: 2.43, 95% confidence interval: 1.14 to 5.18, p= 0.02) and lesion length (per 10-mm increase) (hazard ratio: 1.15, 95% confidence interval: 1.00 to 1.32, p= 0.049) to be independent predictors of TLR. The results after both treatments were equivalent. ISR recurrence within 1 year of the first reintervention and lesion length were independent predictors of future target lesion revascularization. Larger studies are required to confirm the late (>1 year) differences with regard to clinical outcomes.

Direct Pulmonary Vein Ablation With Stenosis Prevention Therapy.

The dominant location of electrical triggers for initiating atrial fibrillation (AF) originates from the muscle sleeves inside pulmonary veins (PVs). Currently, radiofrequency ablation (RFA) is performed outside of the PVs to isolate, rather than directly ablate these tissues, due to the risk of intraluminal PV stenosis. In 4 chronic canine experiments, we performed direct PV muscle sleeve RFA ± postablation drug-coated balloon (DCB) treatment with paclitaxel/everolimus. Of the 4 PVs, 2 PVs were ablated and treated with DCB, 1 PV was ablated without DCB treatment (positive control), and 1 PV was left as a negative control. Local electrograms were assessed in PVs for near-field signals and were targeted for ablation. After 12-14 weeks survival, PVs were interrogated for absence of near-field PV potentials, and each PV was assessed for stenosis. All canines survived the study period without cardiorespiratory complications, and remained ambulatory. In all canines, PVs that were ablated and treated with DCB remained without any significant intraluminal stenosis. In contrast, PVs that were ablated and not treated with DCB showed near or complete intraluminal stenosis. At terminal study, PV potentials remained undetectable. A blinded, histologic analysis demonstrated that ablated PVs without DCB treatment had extensive thrombus, fibrin, mineralization, and elastin disruption. Our chronic canine data suggest that direct PV tissue ablation without subsequent stenosis is feasible with the use of postablation DCBs.

Drug-coated balloon treatment for lower extremity vascular disease intervention: an international positioning document.

The advent of drug-coated balloons (DCBs) provides a novel means to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. The widespread use of these devices in the clinical arena is contemporary with the introduction and adoption of paclitaxel eluting stents for peripheral vascular intervention. However, DCB remain highly attractive approach as the long-term consequences of permanent metallic implants in peripheral applications are still unknown. Notably, the clinical value of DCB is supported by robust pre-clinical evidence regarding safety and efficacy. Likewise, the clinical value of DCB in patients has also been demonstrated by multiple randomized clinical trials in the superficial femoral artery (SFA) and proximal popliteal artery territory. However, the widespread clinical adoption of DCB into routine clinical practice remains elusive. The evidence on the value of DCB has been summarized in consensus documents and in clinical practice guidelines. In the coronary field, currently available information has been summarized in two comprehensive Experts' Consensus Documents and the European Society of Cardiology (ESC) guidelines on coronary revascularization.1–3 These documents emphasized that not all DCB are created equal and that a ‘class effect’ cannot be anticipated as the results obtained with different DCB are not uniform. This remains a major challenge since many CE marked devices are currently available yet many of these have not been supported by robust clinical results. In the peripheral territory, the information regarding the clinical use of DCB is scarce. Moreover, no previous consensus document exists describing the clinical applications and indications for the use of this technology …

New Insights from Real-World Femoral-Popliteal Drug-Coated Balloon Treatment: 1-Year Results from IN.PACT Global Study, Including Long Lesions

Purpose Randomized trial data have demonstrated superior safety and efficacy of IN.PACT Admiral Drug-coated Balloon (DCB; Medtronic, Santa Rosa, California) vs. PTA for the revascularization of mostly TransAtlantic InterSociety Consensus (TASC) A-B femoro-popliteal lesions in patients with claudication and rest pain. A prospective, single-arm study, the IN.PACT global study, was conceived to expand the appraisal of DCB towards the real-world treatment of patients with the same peripheral artery disease symptoms, including those patients with lesions > 15 cm in length. Material and Methods The IN.PACT global study is a rigorous, independently adjudicated and monitored multicenter, international, 1500 patient, single-arm study of DCB revascularization of femoro-popliteal stenosis and occlusions with a minimum length of 2 cm. One-year results from the first 655 patients enrolled are presented. The majority had severe (58.2%) or moderate (27.3%) claudication or ischemic rest pain (10.9%) at baseline, and 41.2% were diabetic. The mean lesion length was 12.23 cm, 35.8% of lesions were total occlusions, and 21.4% of lesions represented in-stent restenosis. The primary endpoint was clinically driven target lesion revascularization at 12 months. Results At 12 months, the rate of clinically driven target lesion revascularization was 8.7%. An analysis by lesion length on the subset of subjects (N=514) with unilateral limb treatment of single lesions was also performed. The clinically driven target lesion revascularization rate in lesion lengths greater than 15 cm was 11.5% (22/191), confirming the performance of the IN.PACT Admiral DCB in long lesions. Conclusions Preliminary results from the IN.PACT Global Study indicate that the IN.PACT Admiral DCB is safe and efficacious in the treatment of real-world femoro-popliteal lesions, and continues to perform well in long lesions.

CRT-1 Paclitaxel Drug-coated Balloon For The Treatment Of Drug-eluting Stent In-stent Restenosis: Subanalysis Results Of The Valentines I Trial

In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® paclitaxel drug-coated balloon (DCB). We analyzed the effect of DCB treatment on patients with drug-eluting stent (DES) restenosis. Valentines I trial prospectively enrolled

Drug-coated balloons in treatment of in-stent restenosis: a meta-analysis of randomised controlled trials

BackgroundDrug-coated balloons (DCBs) have been developed for the percutaneous treatment of coronary artery disease. An initial focus has been the management of in-stent restenosis (ISR) but randomised controlled trials (RCTs) have been small and powered only for angiographic endpoints.ObjectiveThe aim of the work was to assess the clinical and angiographic outcomes of patients treated for ISR with DCB versus control (balloon angioplasty or drug-eluting stents) by a meta-analysis of RCTs.MethodsA comprehensive search was performed of RCTs where patients with ISR were randomly assigned to either DCB or alternative coronary intervention. Outcome measurements were death, myocardial infarction (MI), target lesion revascularisation (TLR), binary definition of restenosis and in-lesion late luminal loss (LLL).ResultsFour studies were identified that fulfilled the inclusion criteria. Pooled odds ratios (ORs) were calculated for patients treated for ISR (n = 399). Mean follow-up duration was 14.5 months. DCBs were associated with lower rates of TLR [8.8 vs. 29.7 % OR (95 % confidence interval, CI) 0.20 (0.11–0.36), p < 0.0001], binary restenosis [10.3 vs. 41.3 % OR (95 % CI) 0.13 (0.07–0.24), p < 0.00001] and MI [0.5 vs. 3.8 %, OR (95 % CI) 0.21 (0.04–1.00), p = 0.05]. No significant heterogeneity was identified.ConclusionDrug-coated balloons appear to be effective versus control in reducing TLR and possibly MI versus balloon angioplasty or drug-eluting stents in the management of ISR.

Paclitaxel-iopromide coated balloon followed by “bail-out” bare metal stent in porcine iliofemoral arteries: first report on biological effects in peripheral circulation

Despite recent abundance of data on drug-coated balloon technology, the biological effects of paclitaxel coated balloon (PCB) treatment followed by bare metal stent (BMS) implantation in peripheral arteries (simulating bail-out stenting, a common clinical scenario), have not been published. PCB technology containing a paclitaxel-iopromide coating and identical iopromide-coated controls (without paclitaxel) were used in 16 porcine ilio-femoral arteries. The biological effects of inflating one (PCBx1) or two sequential (PCBx2) paclitaxel coated balloons before BMS implantation were compared to the single application of a control balloon (CCBx1; contrast coated balloons). At 30 days PCBx2 displayed significantly reduced late lumen loss by angiography (58% reduction vs. CCBx1; p=0.04) and neointimal area by histomorphometry (35% reduction vs. CCBx1 and 30% vs. PCBx1; p=0.02). Similarly, percent area stenosis in the PCBx2 group was reduced by 45% as compared to CCBx1 and PCBx1 (p=0.04). At this time, all parameters of vessel wall healing (including injury score, inflammation, and endothelialisation) following drug coated balloon treatment were comparable to the control group. Paclitaxel delivery to porcine ilio-femorals using PCB followed by BMS implantation effectively decreased neointimal proliferation. More extensive and prolonged proliferative response of the vessel after stenting (necessitating higher drug dose) could potentially explain the undetectable effect of PEBx1 relative to CCBx1 in this pilot study. Histological analysis confirmed the safety and biocompatibility of PCB technology.