Comparison of Drug-Coated Balloon Angioplasty vs. Drug-Eluting Stent Implantation for Drug-Eluting Stent Restenosis in the Routine Clinical Practice: A Meta-Analysis of Randomized Controlled Trials

Zhu, Yong; Liu, Kesen; Kong, Xiangyun; Jiang, Nan; Gao, Ang; Liu, Yan; Han, Hongya; Li, Hong; Zhu, Hao; Zhang, Jianwei; Zhao, Yingxin

doi:10.3389/fcvm.2021.766088

Cited by 5 publications

(3 citation statements)

References 30 publications

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“…In addition, DCB therapy has been shown to have further beneficial effects, such as plaque regression, healing responses, and positive vessel remodeling [ 23 , 24 ]. These effects can offset negative remodeling; however, treatment with DCB is reported to be less effective for ISR of DES than that for bare metal stenting [ 17 , 25 , 26 ]. In the study, patients after DES implantation consisted of 81.3% and 84.7% of the DCB and DES groups, respectively.…”

Section: Discussionmentioning

confidence: 99%

Drug-coated balloons for the treatment of stent edge restenosis

Nagasaka

Amanai

Ishibashi

et al. 2023

Coronary Artery Disease

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Background Drug-coated balloon (DCB) is a device for treating patients with in-stent restenosis; however, there are scant data on its efficacy for stent edge restenosis (SER). This study aimed to investigate the clinical outcomes of DCB use for treating SER compared with new-generation drug-eluting stent (DES) implantation. Method From December 2013 to January 2019, patients who underwent DES implantation or DCB for SER were enrolled. Clinical outcomes were analyzed, and propensity score with matching was conducted. The primary outcome was target-vessel revascularization (TVR). The secondary outcomes were the incidence of all-cause mortality, major adverse cardiovascular events (MACE), and target lesion revascularization (TLR). Result A total of 291 patients with SER were included: 160 were treated with DCB, and 131 with new-generation DES. DCB treatment for SER treatment was associated with a lower risk of TVR than DES [hazard ratio, 0.549; 95% confidence interval (CI), 0.339–0.891] at a median follow-up of 1080 days (interquartile range; 729–1080 days). Propensity score matching (PSM) was performed to adjust for baseline clinical and lesion characteristics. After PSM, no significant difference in the risk of TVR was observed (hazard ratio, 0.965; 95% CI, 0.523–1.781). Similarly, the risk for all-cause death (hazard ratio, 0.507; 95% CI, 0.093–2.770), MACE (hazard ratio: 0.812; 95% CI, 0.451–1.462), and TLR (hazard ratio: 0.962; 95% CI, 0.505–1.833) were comparable between the two groups. Conclusion DCB treatment efficacy for SER was similar to that of new-generation DES after PSM. DCB is a significant alternative to obtain comparable results with new-generation DES for the treatment of SER.

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Section: Discussionmentioning

confidence: 99%

Drug-coated balloons for the treatment of stent edge restenosis

Nagasaka

Amanai

Ishibashi

et al. 2023

Coronary Artery Disease

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“…In an ISR study, authors reported low LLL rates (0.12±0.45 mm) at 6 months, as well as low rates of the need for revascularisation and of safety events at 12 months 26 . Some recent studies have reported DCB treatment to be moderately less effective than repeat everolimuseluting stent (EES) implantation in reducing TLR for patients with coronary DES-ISR at long-term follow-up 27,28 . Still, a "leave nothing behind" strategy remains of great interest, as it has been suggested to be potentially safer regarding the risk of very late stent-associated events, including lower bleeding risk, because of its shorter DAPT regimen compared with DES 29 .…”

Section: Dcb Use In In-stent Restenosismentioning

confidence: 99%

A 2024 scientific update on the clinical performance of drug-coated balloons

Lazar,

Onea,

Olinic

et al. 2024

AsiaIntervention

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Continuous advances in the field of interventional cardiology have led to the development of drug-coated balloons (DCB). These represent a promising device for overcoming the well-known limitations of traditional metallic stents, which are associated with a persistent yearly increased risk of adverse events. This technology has the ability to homogeneously transfer the drug into the vessel wall in the absence of a permanent prosthesis implanted in the coronary vessel.Robust data support the use of DCB for the treatment of in-stent restenosis, but there is also currently growing evidence from long-term follow-up of large randomised clinical trials regarding the use of these devices in other scenarios, such as de novo small and large vessel disease, complex bifurcations, and diffuse coronary disease. Other critical clinical settings such as diabetes mellitus, high bleeding risk patients and acute coronary syndromes could be approached in the upcoming future by using DCB, alone or as part of a blended strategy in combination with drug-eluting stents.There have been important scientific and technical advances in the DCB field in recent years. The purpose of this paper is to review the most current data regarding the use of DCB, including the mid-and long-term follow-up reports on the safety and efficacy of this novel strategy in different clinical and angiographic scenarios.

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“…In recent years, the rise of drug-coated balloons (DCBs) has revolutionized care, with multiple clinical trials showing superiority over BA in maintaining primary patency and freedom from target lesion revascularization (TLR) [ 1 - 12 ]. Some procedures with longer or multiple target lesions require multiple DCBs for treatment [ 1 - 5 ]. The increasing use of DCBs has gone hand in hand with an increasing body of positive clinical data and has also been supported by favorable reimbursement [ 1 , 2 ].…”

Section: Introductionmentioning

confidence: 99%

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

Samia¹,

Adams²

2022

Cureus

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Introduction: Balloon angioplasty (BA) and stenting have long been the mainstays of endovascular therapy in peripheral arterial disease (PAD). However, the rise of drug-coated balloons (DCBs) has revolutionized care in recent years, with multiple clinical trials showing superiority over BA in maintaining primary patency and freedom from target lesion revascularization (TLR). With the recent drop of the add-on payment for DCBs, a barrier for their use and consequently reduced therapy adoption in PAD might arise. We assessed if this affected physicians' behavior and hospital administration towards stocking and using DCBs. Methods: This single-center, retrospective study evaluated DCB utilization in 2017 versus 2018. Data were collected in two groups: 1) July 1, 2017, to December 31, 2017 - with pass-through code (PTC) - prior medical billing reimbursement - and 2) January 1, 2018, to June 30, 2018 - without PTC - markedly reduced reimbursement. Patients treated for superficial femoral artery (SFA) or popliteal artery (POP) disease were included. The study aimed to determine changes in DCB utilization between the years with and without PTC, and we investigated the treatments that have replaced DCBs. Additionally, we aimed to collect data on readmissions and procedure costs compared to national data. Results: From July through December 2017, 350 DCBs were used in 209 patients (1.675 DCBs per patient), while from January through June 2018, 256 DCBs were used in 180 patients (1.422 DCBs per patient) - a 15.07% reduction in DCBs per patient. The detailed numbers of DCB-treated patients were presented as fractions of total interventions in the groups with and without PTC. Conclusion: The findings of this study show a statistically significant reduction in DCB usage following PTC withdrawal. There are several ethical implications to these findings, primarily highlighting patient beneficence and justice. Moving forward, it will be important to determine if this shift in treatment is owed to other treatment strategies such as BA, BA and atherectomy, BA and bare-metal stents (BMS), or BA and drug-eluting-stents (DES). The next steps should also include determining procedure costs and comparing readmission rates.

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Comparison of Drug-Coated Balloon Angioplasty vs. Drug-Eluting Stent Implantation for Drug-Eluting Stent Restenosis in the Routine Clinical Practice: A Meta-Analysis of Randomized Controlled Trials

Cited by 5 publications

References 30 publications

Drug-coated balloons for the treatment of stent edge restenosis

Drug-coated balloons for the treatment of stent edge restenosis

A 2024 scientific update on the clinical performance of drug-coated balloons

Changes to Drug-Coated Balloon Reimbursement Affect Peripheral Arterial Disease Patient Care: A Single-Center Experience

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