Application Of Drug-coated Balloon Research Articles

Provisional stenting : drug-coated versus uncoated balloon for side branch in coronary bifurcation lesions: randomized study

Abstract Introduction The rePOT technique is a novel and easily applied approach for coronary bifurcations. Drug-Coated Balloon (DCB) angioplasty is increasingly being utilized in management of small vessels and coronary bifurcation lesions. Herein, we propose a new approach for treating coronary bifurcation lesions with the application of DCB to treat the side-branch in addition to the rePOT technique: the POT-sideDCB-POT technique. Materiel and Method: We described for the first time the POT-sideDCB-POT method for true bifurcation lesions (including the side-branch ostium), which is in line with the recommended management algorithm of the European Bifurcation Club8 consisting of a sequential approach to bifurcation stenting using the provisional strategy. The POT-sideDCB-POT is easy to perform and respects the geometry of all the three bifurcation segments. Results Overall, 100 patients with CBLs treated with provisional stenting using DES were included from our studie,50 with DCB side branche and 50 with UCB With a follow-up duration of 12 months, SB protection with DCB was associated with a lower degree of postoperative diameter stenosis (mean difference (MD): −10.35%, 95% confidence interval (CI): −13.17 to−8.53, p < 0.001; I2 = 0%) and less late lumen loss (MD: −0.18 mm, 95% CI:−0.28 to−0.10, p < 0.001; I2 = 69%) of SB compared to those with UCB. Moreover, SB protection with DCB was associated with reduced risks of target lesion revascularization (risk ratio [RR]: 0.45, 95% CI: 0.27 to 0.88, p = 0.02; I2 = 0%) and major adverse cardiovascular events (RR: 0.42, 95% CI: 0.27 to 0.66, p < 0.01; I2 = 0%). Subgroup analysis according to the study design showed similar results. Conclusions For patients with CBL treated with provisional stenting using DES, SB protection with DCB was associated with better angiographic and clinical outcomes than those with UCB.

Serial angiography and angioscopy of late lumen enlargement after drug-coated balloon for dysfunctional arteriovenous fistula.

The use of a drug-coated balloon (DCB) to treat dysfunctional arteriovenous fistula (AVF) has shown promising results. After percutaneous coronary intervention with DCB, late lumen enlargement (LLE) often develops in the early follow-up phase, but questions regarding the natural history of changes in lesions after DCB angioplasty have not been clearly elucidated. Here, we reported on a patient in whom angiography and angioscopy were performed immediately and 4 months after DCB angioplasty to treat cephalic vein stenosis of the dysfunctional AVF. Immediately after DCB application, angiography showed good dilatation and blood flow and mild vascular dissection that did not affect blood flow. Angioscopy showed that although the balloon had damaged the intima and the paclitaxel particles had adhered to the vessel wall. Four months after DCB treatment, follow-up angiography and angioscopy were performed. Angiography showed LLE in the cephalic vein of the AVF that had been treated by DCB angioplasty. Angioscopy showed that the intima of the vessel had almost completely healed, and the paclitaxel particles had disappeared. LLE might occur when DCB is used for AVF.

Gelatin microgel-coated balloon catheter with enhanced delivery of everolimus for long-term vascular patency

In-stent restenosis (ISR) after percutaneous coronary intervention is a major reason for limited long-term patency due to complex neointimal proliferation caused by vascular injury. Drug-coated balloon (DCB) has been developed to treat various cardiovascular diseases including ISR by providing anti-proliferative drugs into blood vessel tissues. However, a significant proportion of the drug is lost during balloon tracking, resulting in ineffective drug delivery to the target region. In this study, we report an everolimus-coated balloon (ECB) using everolimus-loaded gelatin-hydroxyphenyl propionic acid microgel (GM) with enhanced everolimus delivery to vascular walls for long-term patency. GM with high drug loading (> 97%) was simply prepared by homogenizing enzyme-mediated crosslinked hydrogels. The optimal condition to prepare GM-coated ECB (GM-ECB) was established by changing homogenization time and ethanol solvent concentration (30 ∼ 80%). In vitro sustained everolimus release for 30 d, and cellular efficacy using smooth muscle cells and vascular endothelial cells were evaluated. Additionally, an in vivo drug transfer levels of GM-ECB using rabbit femoral arteries were assessed with reduced drug loss and efficient drug delivery capability. Finally, using ISR-induced porcine models, effective in vivo vascular patency 4 weeks after treatment of ECBs was also confirmed. Thus, this study strongly demonstrates that GM can be used as a potential drug delivery platform for DCB application. Statement of significanceWe report an ECB using everolimus-loaded GM prepared by homogenization of enzymatic cross-linked hydrogel. GM showed efficient drug loading (> 97 %) and controllable size. GM-ECB exhibited potential to deliver everolimus in a sustained manner to target area with drug efficacy and viability against SMC and EC. Although GM-ECB had much lower drug content compared to controls, animal study demonstrated enhanced drug transfer and reduced drug loss of GM-ECB due to the protection of encapsulated drugs by GM, and the possible interaction between GM and endothelium. Finally, vascular patency and safety were assessed using ISR-induced porcine models. We suggest an advanced DCB strategy to alleviate rapid drug clearance by bloodstream while improving drug delivery for a long-term vascular patency.

Abstract 15381: Clinical Outcomes of Post-Drug-Coated Balloon Angioplasty Dissection in Large De-Novo Coronary Artery Disease

Introduction: Drug-coated balloon (DCB) may be an alternative to stents in the treatment of large native coronary artery disease. However, the complications of acute elastic recoil and coronary dissections confine the practical application of DCB. Little is known about the clinical outcomes of different types of dissection after DCB angioplasty with or without stenting. Aims: This study sought to investigate the clinical outcomes of post-DCB dissection in large de novo coronary artery disease. Methods: This was a retrospective observational study. A consecutive series of patients with large native coronary artery disease (reference diameter ≥ 3.0 mm) who occurred coronary dissections after the treatment of DCB angioplasty were included. These patients were divided into stented groups and non-stented groups depending on whether bail-out stents were employed. Post-angioplasty coronary artery dissections were classified into type A-F. The cumulative incidence of major adverse cardiac events (MACE) was compared between the two groups. Results: Between March 2017 and October 2022, 676 patients with large de novo coronary artery disease developed post-DCB angioplasty dissection, 554 of which treated with DCB only, 122 of which underwent bail-out stent implantation. These dissections were type A (60.5%), B (30.9%), C (6.5%), D (1.9%) and F (0.1%), respectively. During a mean follow-up of 1 year, MACE occurred in 60 patients (9 in the stented group and 51 in the non-stented group; 7.4% vs. 9.2%; p=0.522). For type B dissection, the rate of MACE was similar in the stented group than that in the non-stented group (11.1% vs. 8.2%; p=0.502). For type C dissection, the rate of MACE was numerically higher in the non-stented group than that in the stented group (9.5% vs. 0%; p=0.222). Conclusions: For post-DCB angioplasty dissection in large de-novo coronary artery disease, type B dissection requires no bail-out stent implantation and type C dissection deserves further investigation.

Low-Dose vs High-Dose Drug-Coated Balloon for Symptomatic Femoropopliteal Artery Disease: The PROSPECT MONSTER Study Outcomes

BackgroundRandomized trials have shown comparable outcomes between second-generation low-dose drug-coated balloons (LD-DCBs) and first-generation high-dose drug-coated balloons (HD-DCBs); but the trial patients had low clinical complexity, and there were no comparisons in medically complex populations. ObjectivesThe aim of this study was to compare outcomes between an LD-DCB (Ranger; 2.0 μg/mm2) and an HD-DCB (IN.PACT; 3.5 μg/mm2) in patients with symptomatic femoropopliteal artery disease. MethodsPROSPECT MONSTER (Prospective Comparison of Second-Generation Low-Dose Drug-Coated Balloon With High-Dose Drug-Coated Balloon) was a prospective, multicenter, nonrandomized trial that prospectively collected data from 581 patients who underwent endovascular therapy with the LD-DCB (n = 370) or the HD-DCB (n = 211) for symptomatic femoropopliteal artery disease (Rutherford classes 2-5). The primary outcome was the 1-year primary patency of the LD-DCB in comparison with that of the HD-DCB, as evaluated using propensity score matching. The incidence of impaired flow after drug-coated balloon application was also evaluated. ResultsPropensity score matching extracted 163 pairs (358 and 163 patients in the LD-DCB and HD-DCB groups, respectively), with no significant intergroup difference in baseline characteristics. The 1-year primary patency rates in the matched population were similar between the LD-DCB and HD-DCB groups (87.0% [95% CI: 82.5%-91.7%] vs 81.3% [95% CI: 74.8%-88.5%]; HR: 0.93; 95% CI: 0.55-1.59; P = 0.79), as was the incidence of impaired flow (13.6% vs 9.8%; OR: 1.46; 95% CI: 0.78-2.73; P = 0.24). No baseline characteristics had any significant interaction effects on the association of the LD-DCB vs the HD-DCB and 1-year restenosis risk. ConclusionsLD-DCBs demonstrate efficacy and safety comparable with HD-DCBs in patients with complex clinical backgrounds, suggesting that drug-coated balloon treatment using a lower dose may be possible.

Effectiveness of drug-coated balloon in acute myocardial infarction: A protocol for systematic review and meta-analysis.

The management of acute myocardial infarction (AMI) has improved dramatically over the past 3 decades and is evolving. Percutaneous coronary intervention is an alternative means of achieving coronary revascularization. Previous studies comparing the published literature on drug-coated balloon (DCB) and drug-eluting stents have drawn divergent conclusions. We perform a protocol for systematic review and meta-analysis to compare the efficacy and safety of DCB and drug-eluting stent in the management of AMI. This systematic review was registered in the PROSPERO network (registration number: CRD42023397266). We will follow the Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocol to accomplish the systematic review protocol. A systematic search will be conducted in PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure, Wanfang Database, and Weipu Database without any language restrictions from their inception to February 2022. The risk of bias will be assessed independently by 2 authors using parameters defined in the Cochrane Handbook for Systematic Reviews of Interventions criteria. Statistical analysis will be performed using the STATA13.0 software (IBM, USA). The results of this systematic review and meta-analysis will be publicly available and published in a peer-reviewed journal. The results of the study will provide the evidence for the application of DCB in the treatment of AMI.

Clinical Application of Drug-coated Balloon in Coronary Small Vessel Disease and Stent Restenosis

Clinical Application of Drug-coated Balloon in Coronary Small Vessel Disease and Stent Restenosis

Comparison of Clinical Outcomes With Drug Coated Balloons Versus Plain Balloon Angioplasty In Chronic Limb-Threatening Ischemia.

The use of drug coated balloon (DCB) for angioplasty has shown superior efficacy against plain balloons for treating complex infrainguinal arterial disease. We report and compare the clinical outcomes following application of DCB(Paclitaxel) and plain angioplasty (POBA) in our tertiary care centre. A retrospective, single centre analysis of 301 patients with chronic limb-threatening ischemia involving the infrainguinal segment was conducted between September 2014 and September 2018, after approval from the Institutional review board. We analyzed clinical outcomes by measuring postoperative ABI improvement, restenosis requiring reintervention procedure, minor and major amputations at the end of 18 months. . To find the association between the group variables (POBA and DCB) and other risk variables, Chi-square test/Fisher's exact test was used. Multivariable logistic regression analysis was used. Patients who underwent treatment with plain balloon (POBA) and DCB(Paclitaxel) angioplasty were 246(81.7%) and 55(18.3%) respectively. Our study group was predominantly male (Male: Female = 6.7:1), most patients were more than 50 years of age (n = 251, 83.4%). Smoking (n = 199, 66.1%) and diabetes (n = 210, 69.8%) were the most common atherosclerotic risk factors. Postoperative Ankle Brachial Pressure Index (ABI) improvement were similar in both groups (POBA = 57.7%; DCB = 69.8%; p = 0.103). Minor and major amputations following POBA were 26% and 22%; and DCB were 12.7% and 16.4% respectively. Re-stenosis requiring a re-interventional procedure within 18 months was 15%, (n = 37) following POBA; and 12.7% (n = 7) following DCB (p = 0.661). This retrospective study shows similar clinical limb related outcomes following POBA and DCB at 18 months. However, our comparative analysis between the POBA and DCB groups was totally unadjusted and not adjusted for common confounders such as age and sex. Hence, for one to draw definitive conclusions leading to changes in clinical practice; a randomized, prospective study with a larger patient cohort is needed.

Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.

Background Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) of small-vessel coronary artery disease (SVD) is related to an increased risk of in-stent restenosis (ISR) and stent thrombosis (ST). The application of the drug-coated balloon (DCB) for patients with SVD remains controversial. Objectives Assess the outcomes of DCB in the treatment of SVD compared with DES in patients with SVD. Methods A meta-analysis of randomized controlled trials (RCTs) published up to June 2020, reporting the outcomes of DCB versus DES in the treatment of SVD, was performed. Results Four RCTs with 1227 patients were included. The results indicated that DCB was associated with the decreased risk for myocardial infarction (MI) compared with the DES, but the difference showed no significance (OR 0.50, 95% CI 0.24–1.03, P=0.06). And, there was no significant difference in death (OR 0.76, 95% CI 0.17–3.43, P=0.72), cardiac death (OR 1.92, 95% CI 0.74–4.98, P=0.18), target vessel revascularization (TVR) (OR 0.81, 95% CI 0.51–1.28, P=0.36), target lesion revascularization (TLR) (OR 1.29, 95% CI 0.66–2.52, P=0.46), and major adverse cardiac events (MACE) (OR 0.92, 95% CI 0.61–1.38, P=0.69) between the DCB group and DES group. Conclusion Compared with DES, DCB was associated with a decreased risk of MI among patients with SVD, but the difference showed no significance. The application of DCB in SVD is associated with comparable outcomes of death, TVR, and MACE when compared with DES.

Drug-coated balloon treatment in coronary artery disease: Recommendations from an Asia-Pacific Consensus Group

Coronary artery disease (CAD) is currently the leading cause of death globally, and the prevalence of this disease is growing more rapidly in the Asia-Pacific region than in Western countries. Although the use of metal coronary stents has rapidly increased thanks to the advancement of safety and efficacy of newer generation drug eluting stent (DES), patients are still negatively affected by some the inherent limitations of this type of treatment, such as stent thrombosis or restenosis, including neoatherosclerosis, and the obligatory use of dual antiplatelet therapy (DAPT) with unknown optimal duration. Drug-coated balloon (DCB) treatment is based on a leave-nothing-behind concept and therefore it is not limited by stent thrombosis and long-term DAPT; it directly delivers an anti-proliferative drug which is coated on a balloon after improving coronary blood flow. At present, DCB treatment is recommended as the first-line treatment option in metal stent-related restenosis linked to DES and bare metal stent. For de novo coronary lesions, the application of DCB treatment is extended further, for conditions such as small vessel disease, bifurcation lesions, and chronic total occlusion lesions, and others. Recently, several reports have suggested that fractional flow reserve guided DCB application was safe for larger coronary artery lesions and showed good long-term outcomes. Therefore, the aim of these recommendations of the consensus group was to provide adequate guidelines for patients with CAD based on objective evidence, and to extend the application of DCB to a wider variety of coronary diseases and guide their most effective and correct use in actual clinical practice.

Leave Nothing Behind: Treatment of Intracranial Atherosclerotic Disease with Drug-Coated Balloon Angioplasty.

Intracranial atherosclerosis disease (ICAD) is an essential cause of stroke. The characteristics of effective treatment include low periprocedural risk and asustained treatment effect. Angioplasty with aconventional balloon for ICAD is safe but has adauntingly high restenosis rate. Drug-coated balloon (DCB) angioplasty might reduce the risk of restenosis while maintaining the overall safety of the procedure. This study included symptomatic ICAD patients with more than 70% stenosis. Intermediate catheters were placed distally, and the lesions were predilated with aconventional balloon, followed by aDCB (SeQuent Please, BBraun, Melsungen, Germany). The primary endpoint was any stroke or death within 30days or ipsilateral ischemic stroke thereafter. The secondary endpoint was arterial restenosis of more than 50% during follow-up. Atotal of 39sessions of DCB angioplasty were performed for 39lesions in 35patients between October 2015 and April 2018 in asingle center. All of the DCBs could be navigated to the lesions. Major periprocedural complications were noted in two patients (5.7%, 2/35), and minor periprocedural complications were also noted in two patients (5.7%, 2/35). The average percentages of stenosis of the lesions were 76.6% ± 7% before treatment, 32.4% ± 11.2% after DCB angioplasty, and 25% ± 16% at follow-up. Stenosis over 50% was present in 3lesions during the follow-up period (8.3%, 3/36). In this study, the application of DCBs to treat ICAD patients was feasible and safe. Alarger scale clinical trial is warranted to further evaluate the safety and efficacy of this treatment.

Late lumen enlargement after drug-coated balloon angioplasty for de novo coronary artery disease.

We aimed to identify predictors of late lumen enlargement (LLE) after drug-coated balloon (DCB) angioplasty for de novo coronary lesions. LLE, which is defined as an increase in the luminal diameter of the vessel from the immediate postprocedural measurement to follow-up measurements, is frequently observed after DCB angioplasty for de novo coronary artery disease. No predictors of LLE are known. This retrospective observational study analyzed 196 de novo coronary lesions in 182 patients who underwent both DCB angioplasty and follow-up angiography. Of the 196 lesions, 109 (56%) developed LLE during a mean follow-up period of 7.2 ± 2.5months. As defined by American College of Cardiology (ACC)/American Heart Association (AHA) lesion types, lesions with LLE were significantly less severe than lesions without LLE (types A, B1, B2 and C 15%, 35%, 38% and 13% vs. 7%, 24%, 45% and 24%, respectively; p = 0.036), although no significant differences in clinical or other lesion background characteristics were observed between the groups. Among type C lesions, chronic total occlusion (CTO) was more frequently observed in lesions with LLE than in lesions without LLE (79% vs 43%, p = 0.036). Lesion severity predicts LLE after DCB angioplasty for de novo coronary artery disease. Among type C lesions, CTO is expected in lesions showing LLE, and preparations should therefore be made prior to DCB application. Further research is needed.

Application of drug-coated balloon in coronary artery intervention: challenges and opportunities.

In recent decades, the outcomes of coronary heart disease (CHD) have markedly improved, which can be partly attributed to the use of novel drugs (especially statins and antiplatelet drugs) and partly to the evolution of percutaneous coronary intervention (PCI). From percutaneous transluminal coronary angioplasty to bare-metal stent and then to drug-eluting stent, every step of PCI is attractive to interventional cardiologist, great progress has been made for patients with CHD. In the past few years, some successor devices for treating CHD have emerged. Undoubtedly, drug-coated balloon (DCB), which was recommended by 2014 ESC Guidelines on myocardial revascularization, is a “shining star” among them. DCB involves a semi-compliant angioplasty balloon coated with an anti-proliferative agent that can exert antirestenotic efficacy by permeating into the vessel wall during balloon contact. This review discusses the conception and merits, preclinical data, emerging clinical indications, and results from clinical trials of this novel interventional technology. Although DCB has shown authentic efficacy in the treatment of in-stent restenosis, its use in de novo coronary lesions is still in dispute. Hence, concerns and the future direction of DCB are also covered in this paper.

Drug Coated Balloons in Acute Coronary Syndromes - Opportunities and Limitations

Currently available data on drug coated balloon (DCB) angioplasty as a clinical treatment modality for coronary and peripheral artery disease are limited but hold promise. Advantages over standard angioplasty and stent technologies include a homogeneous drug delivery to the vessel wall, an immediate drug release without the use of a polymer, the option of using balloon catheters alone or in combination with a bare metal stent, no foreign object left behind in the body, the potential of reducing anti-platelet therapy, and a lower restenosis rates in some indications. The clinical and angiographic presentation of patients with acute coronary syndrome (ACS) is heterogeneous. Therefore, different clinical scenarios of DCB application in ACS may be discussed. Frequently, thrombosis in the ACS-related lesion plays a major role. Patients in hemodynamic critical situations under catecholamine therapy may present with too small vessel diameters. Another clinically relevant scenario represents in-stent restenosis (ISR) which is frequently associated with ACS.

Paclitaxel-coated balloon in combination with bare metal stent for treatment of de novo coronary lesions: an optical coherence tomography first-in-human randomised trial, balloon first vs. stent first

To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first vs. BMS first). In a multicentre pilot trial, 26 patients with de novo coronary lesions were randomised to receive a paclitaxel-coated balloon application followed by BMS implantation (DCB first) or vice versa (BMS first). Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed post-procedure and at six months, with OCT % neointimal volume obstruction as primary endpoint. Longitudinal geographical miss was only observed in DCB first (23.1 vs. 0.0%, p=0.220). Implantation of BMS first resulted in fewer malapposed struts (p=0.013) but similar coverage at six months. No significant difference was found regarding the primary endpoint (25.5 vs. 24.9%, p=0.922), mean thickness of coverage (261 vs. 225 µm, p=0.763), late loss (0.53 vs. 0.45 mm, p=0.833), binary restenosis (27.3 vs. 16.7% in-segment, p=0.640) or clinical endpoints. Sequential application of DCB and not pre-mounted BMS for treatment of de novo coronary lesions results in efficient inhibition of neointimal hyperplasia. The sequence of application (DCB first vs. BMS first) does not seem to influence the outcome, except for better apposition in BMS first.