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Different generations of drug-coated balloons (DCBs). The 1 st and 2 nd generation of DCB employed paclitaxel as the anti-proliferative drug and the crystallinity of the coating played a role in the extent of particulate generation. The 3 rd generation is moving towards the use of Sirolimus as it is less cytotoxic but the efficacy and safety of the newer DCB coating require further evaluation. BTHC = Butyryl Trihexyl Citrate; PTX = Paclitaxel SIR = Sirolimus. P e r s o n a l U s e O n l y N o t f o r D i s t r i b u t i o n
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The progress and development of drug-coated balloons (DCBs) represents an emerging alternative treatment in peripheral and coronary artery diseases, particularly when a non-stent approach is necessary. Several studies and meta-analyses have evaluated the clinical outcomes of DCBs in different lesions and this review aims to compile the progress and...
Contexts in source publication
Context 1
... Magic Touch DCB (Concept Medical) are examples of such DCB with microcrystalline and nano-sphere coatings, respectively, which reportedly have higher drug transfer and tissue levels, but also a higher amount of particulate loss [28]. A comparison between the three DCB generations and their potential benefits and drawbacks is shown in Fig. ...
Context 2
... third generation DCB are moving into the use of encapsula- tion carriers in their coating. Encapsulating the drug improves its stability and solubility while achieving targeted delivery of the drug to tissue. Support C DCB (eucatech AG) and the Sirolimus-based Magic Touch DCB (Concept Medical) are examples of such DCB with microcrystalline and nano-sphere coatings, respectively, which reportedly have higher drug transfer and tissue levels, but also a higher amount of particulate loss [28]. A comparison between the three DCB generations and their potential benefits and drawbacks is shown in Fig. ...
Citations
... The results of this study underscore the generally comparable efficacy of drug-coated balloons (DCB) and drug-eluting stents (DES) for primary percutaneous coronary intervention in patients with multivessel coronary artery disease. The incidence rates of target vessel revascularization (TVR) and major adverse cardiac events (MACE) did not significantly differ between the DCB and DES groups, aligning with the outcomes reported in other notable studies such as the DEBATE-BTK and ZILVER-PTX trials (10,11). Such findings suggest that DCB could be an effective alternative to DES, particularly in patient populations with less complex lesions or where the risks associated with permanent implants are a concern. ...
Background: Patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary percutaneous coronary intervention (PCI) frequently face multivessel coronary artery disease (CAD). The optimal interventional approach remains debated. Objective: To systematically review and analyze the effectiveness and safety of drug-coated balloons (DCB) versus drug-eluting stents (DES) in multiculprit primary PCI through a randomized controlled trial. Methods: This prospective, single-center, randomized controlled trial included 100 patients with STEMI and multivessel CAD at Lady Reading Hospital Peshawar from April 2023 to March 2024. Patients aged 18 years or older requiring revascularization of two or more culprit lesions were randomized into two groups: one received DCBs and the other DES. Exclusions were based on contraindications to dual antiplatelet therapy, allergies to study drugs, bleeding disorders, or life expectancy under one year. Results: Each group comprised 50 patients. The prevalence of hypertension (56% in DCB vs. 60% in DES, p=0.68) and diabetes (36% in DCB vs. 40% in DES, p=0.72) was similar. TVR rates were 10% for DCB and 8% for DES (p=0.45). MACE rates were 14% for DCB and 12% for DES (p=0.37). Conclusion: The study supports the use of DCB as an alternative to DES in specific clinical scenarios, emphasizing the need for tailored treatment decisions based on individual patient and lesion characteristics.
... As a result of this pathophysiological difference, the pharmacological effects of drugs may be different in the SVG and native coronary vessels (15). For the coronary artery, DCB retains the possibility of vascular remodeling, ensures a shorter time for dual antiplatelet therapy, and reduces the vascular inflammatory response and risk of late stent thrombosis (16,17). Therefore, DCB may be a good alternative to DES under specific clinical or anatomical conditions (18). ...
Background
As a device for percutaneous coronary intervention, drug-coated balloon (DCB) is widely used to treat in-stent restenosis. However, data regarding the use of DCB in treating de novo saphenous vein graft (SVG) lesions are limited. This study aimed to explore the outcomes of using the DCB in the treatment of de novo SVG lesions of coronary heart disease (CHD).Methods
This retrospective and observational study analyzed CHD patients with de novo SVG lesions treated with DCB or the new-generation drug-eluting stent (DES) between January 2018 and December 2020. Restenosis was the primary endpoint, whereas target lesion revascularization (TLR), major adverse cardiac events, restenosis, cardiac death, target vessel revascularization, and myocardial infarction were the secondary outcomes.ResultsWe enrolled 31 and 23 patients treated with DCB and DES, respectively. The baseline clinical data, lesion characteristics, and procedural characteristics were similar between the two groups. Twenty-eight (90.3%) patients in the DCB group and 21 (91.3%) in the DES group completed follow-up angiography after 1 year. The quantitative coronary angiography measurements at angiographic follow-up showing late lumen loss were −0.07 ± 0.95 mm for the DCB group and 0.86 ± 0.71 mm for the DES group (P = 0.039), and the rates of restenosis were 13.3% and 21.7% for the DCB and DES groups, respectively (P = 0.470). No significant differences were observed in the rates of MACE (16.7% vs. 26.1%, P = 0.402) and TLR (13.3% vs. 4.3%, P = 0.374) during clinical follow-up.Conclusion
Our findings suggest that when pre-dilatation was successful, DCB might be safe and effective in treating de novo SVG lesions.
... It appears that drug-coating balloons avail a more efficient influence in wound healing. H. Ang et al. [16] described that the progress and the development of drug-coating balloons represents an emerging alternative treatment in peripheral and coronary artery; the authors have highlighted four key-elements of these balloons: the drug, the excipients, the platform and the coating process. The acute drug transfer occurs almost immediately after positioning and inflating of the balloon and it deliver the antiproliferative drug https://doi.org ...
Atherosclerosis can affect the blood vessels in any region of the body and the stenosis (narrowing) can be located on an artery that vascularize important organs, such as the brain, abdominal organs or limbs. The endovascular surgery is a modern approach to vascular pathology through minimally invasive techniques (puncture, minimally vascular approach) and it represents an enrichment of the arsenal of surgical techniques and brings considerable improvements in post-operative and long-term outcomes The use of polymer drug-coating balloons is an attractive alternative because they can offer the promise of an improved patency compared to the simple balloons and a reduction in the need for stents. The aims of this study were to describe the polymer materials and to compare the medical endpoints obtained in angiosome-targeted infrapopliteal angioplasty using a simple balloon with two layers, based on polyethylene, and respectively a drug-coated balloon that contains a multiblock copolymer from polyethylene, poly(cylohexylethylene), polyisoprene and poly(1,3-butadiene) covered by Paclitaxel. The balloons were characterized by differential scanning calorimetry, stress-strain and puncture tests in order to describe their physical and mechanical characteristics. On the other hand, 51 patients with critical limb ischemia were treated with different balloon angioplasty and they were monitored for 12 months after the intervention; the following parameters have been evaluated: diabetes, hypertension, renal insufficiency, hemodialysis, stroke, dyslipidemia, heart disease, heart failure, body mass index, number of angiosomes, creatinine, and wound healing, leg salvage and amputation-free survival at 1, 2, 3, 6, 9, 12 months. Significant associations were found in the case of anterior-tibial-artery and posterior-tibial-artery angioplasy and the age, hypertension and renal insufficiency. On the other hand, the results indicate that the drug deposition on the surface of the balloons lead to improved values for the observed medical endpoints. In conclusion, this study reveals that angiosome-based infrapopliteal angioplasty with drug-coated balloons can be associated with better wound healing and leg salvage.
... However, few studies have been reported in de novo bifurcation lesion, especially lack of evidence for SB intervention based on the patients with true bifurcation lesions. Previous evidences showed that paclitaxel-coated balloons (PCB) significantly reduced ISR risk [8,9]. Here, we hypothesize that PCB angioplasty may also decrease SB-LLL and the incidence of adverse cardiovascular events in the single-stent intervention strategy for bifurcation lesions. ...
PurposeTo compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions.Methods
In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis, and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction, and unstable angina requiring admission.ResultsThere were no differences in diameter, minimum lumen diameter (MLD), and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244–0.941, P = 0.033).ConclusionPCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.
... However, few studies have been reported in de novo bifurcation lesion, especially lack of evidence for SB intervention based on the patients with true bifurcation lesions. Previous evidences showed that paclitaxel-coated balloons (PCB) signi cantly reduced ISR risk [8,9]. Here, we hypothesize that PCB angioplasty may also decrease SB-LLL and the incidence of adverse cardiovascular events in the singlestent intervention strategy for bifurcation lesions. ...
Purpose
To compare the effects of paclitaxal-coated balloon (PCB) versus conventional balloon (CB) on side branch (SB) lesion and cardiovascular outcomes in patients with de novo true bifurcation lesions.
Methods
In total, 219 patients with de novo true bifurcation lesions were enrolled and divided into PCB group (102 cases) and CB group (117 cases) according to angioplasty strategy in SB. Drug-eluting stent (DES) was implanted in main vessel (MV) for each subject. All subjects underwent a 12-month follow-up for late lumen loss (LLL), restenosis and major adverse cardiovascular events (MACE) after percutaneous coronary intervention (PCI). MACEs included cardiac death, nonfatal myocardial infarction and angina pectoris.
Results
There were no differences in diameter, minimum lumen diameter (MLD) and stenosis for bifurcation lesions between the two groups before and immediately after PCI (P > 0.05). After 12-month follow-up, no differences occurred in MV-MLD and MV-LLL between the two groups (P > 0.05); SB-MLD in PCB group was higher than that in CB group (1.97 ± 0.36 mm vs. 1.80 ± 0.43 mm, P = 0.007); SB-LLL in PCB group was lower than that in CB group (0.11 ± 0.18 mm vs. 0.19 ± 0.25 mm, P = 0.024). Multivariate COX analyses indicated that PCB group had lower MACE risk than CB group (HR = 0.480, 95%CI 0.244–0.941, P = 0.033).
Conclusion
PCB could decrease SB-LLL and MACE risk in patients with de novo true coronary bifurcation lesion 12 months after single-DES intervention.
... These limitations resulted in the development of drug-coated balloons (DCBs). The rationale of DCB technology is that a combination of balloons and drugs is used for the treatment of coronary lesions to achieve lower rates of restenosis ( Fig. 1) (15,16). DCBs have emerged as a novel application in PCI, and a DCB strategy has already exhibited successful therapeutic potential for ISR (17)(18)(19)(20) and small vessel disease (21)(22)(23). ...
... The concept of DCBs has been extensively studied (15,24,25). DCBs are semi-compliant balloons covered with an antiproliferative drug, which is in direct contact with the vessel wall and inhibits the proliferation of smooth muscle cells (26). ...
Drug-eluting stents are the standard revascularization strategy for the treatment of symptomatic coronary artery disease. However, in-stent restenosis (ISR), stent thrombosis and reinfarction of target lesions following stent implantation present challenges. Drug-coated balloons (DCBs), which deliver antiproliferative drugs into the vessel wall without stent implantation, are a novel treatment option for percutaneous coronary intervention and have been proven to act as a promising strategy in the treatment of ISR and coronary small vessel disease. However, their role in acute myocardial infarction (AMI) remains unclear. The present review discusses current evidence for the treatment of AMI with DCBs.
... Moreover, DCBs were demonstrated to be a safe and effective alternative to DESs in patients with CAD (7). DCBs could improve the immediate and long-term outcomes for ISR and de novo lesions (8)(9)(10)(11)(12). However, only a few studies have reported DCB only treatment strategy for OCLs, especially for de novo OCLs. ...
Background:
The effects of ostial coronary lesion (OCL) treatment with a drug-coated balloon (DCB) alone remain controversial. This retrospective study assessed the effectiveness and safety with DCB only strategy for OCL and the factors associated with target lesion revascularization (TLR) in these patients.
Methods:
The study retrospectively included patients whom had OCLs treated with a paclitaxel-eluting DCB only strategy from 1 May 2014 to 1 May 2017. Patients were divided into in-stent restenosis (ISR) and de novo (primary) groups. And all patients came back to hospital, and underwent clinical and also angiographic follow-up.
Results:
Among the 44 patients with 55 OCLs, 12 (27.3%) were assigned to the ISR group and 32 (72.7%) to the de novo group. The outcomes included TLR, post-interventional lumen gain, and late lumen loss (LLL). Only 8 TLRs (7 ISR and 1 de novo) were observed after a mean follow-up of 16 months. The TLR rate in the de novo group was significantly lower than the ISR group (2.4% vs. 50%, P<0.001). The LLL was 0.07±0.63 mm. Logistic regression analysis showed that the TLR incidence was independently associated with the type of stenosis (ISR vs. de novo) after adjusting for sex [odds ratio (OR), 58.72; 95% confidence interval (CI): 4.42-779.94, P=0.002].
Conclusions:
Treatment with DCB alone was beneficial to patients with OCLs, particularly those with de novo lesions.
... Additionally, DESs are associated with late or very late stent thrombosis. This is due to the polymeric excipients, that are often used with DESs, serving as an inflammatory nidus resulting in the delay in vessel healing [4,5]. This has incentivized the use of drug-coated balloon (DCB) therapy which, due to the lack of long-term exposure to polymeric excipients, could potentially ameliorate the delayed vessel healing and the associated late or very late thrombosis. ...
... This has incentivized the use of drug-coated balloon (DCB) therapy which, due to the lack of long-term exposure to polymeric excipients, could potentially ameliorate the delayed vessel healing and the associated late or very late thrombosis. Moreover, DCBs have a smaller therapeutic footprint and can be utilized in scenarios where DESs have proven to be undesirable or ineffective: in-stent restenosis, bifurcation carinas and diffused atherosclerotic segments [4,5]. Several clinical trials have found DCBs to be superior to balloon angioplasty (BA) in the treatment of de novo and instent restenotic lesions in both femoropopliteal and below-the-knee occlusive diseases [6,7]. ...
... Therefore, in this study, the drug release and simultaneous uptake into the vessels was described by a nonlinear diffusion-advection-reaction model [23,24], as illustrated by the coupled system of Eqs. (3)- (5). ...
Interventional therapies such as drug-eluting stents (DES) and drug-coated balloons (DCB) have significantly improved the clinical outcomes of patients with coronary occlusions in recent years. Despite this marked improvement, ischemic cardiovascular disease remains the most common cause of death worldwide. To address this, research efforts are focused on improving the safety and efficacy of the next generation of these devices. However, current experimental methods are unable to account for the influence of atherosclerotic lesions on drug uptake and retention. Therefore, in this study, we used an integrated approach utilizing both in-vitro and in-silico methods to assess the performance of DCB therapy. This approach was validated against existing in-vivo results before being used to numerically estimate the effect of the atheroma. A bolus release of sirolimus was observed with our coating matrix. This, coupled with the rapid saturation of specific and non-specific binding sites observed in our study, indicated that increasing the therapeutic dose coated onto the balloons might not necessarily result in greater uptake and/or retention. Additionally, our findings alluded to an optimal exposure time, dependent on the coating matrix, for the DCBs to be expanded against the vessel. Moreover, our findings suggest that a biphasic drug release profile might be beneficial for establishing and maintaining the saturation of bindings sites within severely occluded vessels. Ultimately, we have demonstrated that computational methods may be capable of assessing the efficacy of DCB therapy as well as predict the influence of atherosclerotic lesions on said efficacy.
... 5,6 Although these procedures are effective, they damage the artery and can lead to restenosis or re-occlusion due to induction of SMC proliferation and migration. Drug-eluting stents and drug-coated balloons have been used to reduce restenosis, 7,8 but better treatment options are needed as size of the affected artery is still a major problem for intervention and prevention of restenosis. [9][10][11] Focal adhesion kinase (FAK) is a protein tyrosine kinase that mediates integrin and growth factor signaling pathways associated with cell proliferation and migration. ...
Rationale:
Neointimal hyperplasia is characterized by excessive accumulation of vascular smooth muscle cells (SMCs) leading to occlusive disorders such as atherosclerosis and stenosis. Blood vessel injury increases growth factor secretion and matrix synthesis, which promotes SMC proliferation and neointimal hyperplasia via focal adhesion kinase (FAK).
Objective:
To understand the mechanism of FAK action in SMC proliferation and neointimal hyperplasia.
Methods and results:
Using combined pharmacological FAK catalytic inhibition (VS-4718) and SMC-specific FAK kinase-dead (KD, Myh11-Cre-ERT2) mouse models, we report that FAK regulates SMC proliferation and neointimal hyperplasia in part by governing GATA4-cyclin D1 signaling. Inhibition of FAK catalytic activity facilitates FAK nuclear localization, which is required for proteasome-mediated GATA4 degradation in the cytoplasm. Chromatin immunoprecipitation identified GATA4 binding to the mouse cyclin D1 promoter and loss of GATA4-mediated cyclin D1 transcription diminished SMC proliferation. Stimulation with platelet-derived growth factor or serum activated FAK and redistributed FAK from the nucleus to cytoplasm, leading to concomitantly increased GATA4 protein and cyclin D1 expression. In a femoral artery wire injury model, increased neointimal hyperplasia was observed in parallel with elevated FAK activity, GATA4 and cyclin D1 expression following injury in control, but not in VS-4718-treated and SMC-specific FAK-KD mice. Finally, lentiviral shGATA4 knockdown in the femoral artery wire injury significantly reduced cyclin D1 expression, SMC proliferation, and neointimal hyperplasia compared to control mice.
Conclusions:
Nuclear enrichment of FAK by inhibition of FAK catalytic activity during vessel injury blocks SMC proliferation and neointimal hyperplasia through regulation of GATA4-mediated cyclin D1 transcription.
... During the last few years, drug-coated Balloons (DCB) has represented an emerging alternative to DES in specific clinical scenarios. Without the basis of stent, this local drug system consists of four components: balloon platform, anti-proliferative drugs, excipient and balloon coating process [10]. The primary goal of the system is to transfer the anti-proliferative drugs into coronary lesions to reduce the subsequent neo-intima hyperplasia and to restore normal morphology and function of vessels. ...
