Drug-Coated Balloon Angioplasty and Debulking for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis

Tong, Zhu; Guo, Lianrui; Qi, Lixing; Cui, Shijun; Gao, Xixiang; Li, Yang; Guo, Jianming; Gu, Yongquan

doi:10.1155/2020/3076346

Cited by 10 publications

(9 citation statements)

References 24 publications

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“…There is a focus on more complex and combined techniques for the treatment of ISRs which are producing more encouraging results such as DES, again with major limitations such as a stent length which excludes treating long stenosis. DCB shows superior results compared to traditional re-PTA with a stent and is becoming the technique of choice for ISRs [ 12 , 13 , 14 , 15 , 62 ]. Combined techniques such as laser atherectomy and DCB are also being developed and appear to be candidates to become the reference technique, but adequate studies are warranted [ 1 , 11 , 18 , 19 ].…”

Section: Discussionmentioning

confidence: 99%

“…DCB has been shown to yield excellent results in the setting of PAD. Angiographic and clinical data highlight the superiority of this technique, and the European clinical practice guidelines endorsed its use in the treatment of ISR (class I, Evidence A) [ 11 , 12 , 13 ]. The DCB is a traditional drug-coated balloon, mainly with Paclitaxel, which significantly improves the short- and medium-term patency of angioplasty by minimizing neo-intimal hyperplasia [ 14 , 15 , 16 , 17 ].…”

Section: Introductionmentioning

confidence: 99%

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The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

et al. 2022

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Peripheral arterial disease (PAD) is an increasingly pathological condition that commonly affects the femoropopliteal arteries. The current fashionable treatment is percutaneous transluminal angioplasty (PTA), often with stenting. However, the in-stent restenosis (ISR) rate after the stenting of the femoropopliteal (FP) district remains high. Many techniques have been proposed for the treatment of femoropopliteal ISR, such as intravascular brachytherapy, laser atherectomy, second stenting and drug-coated balloons angioplasty (DCB). DCB showed a significantly lower rate of restenosis and target lesions revascularization (TLR) compared to conventional PTA. However, further studies and multi-center RCTs with dedicated long-term follow-up are needed to verify the true efficiency of this approach. Nowadays, the correlation between PAD and inflammation biomarkers is well known. Multiple studies have shown that proinflammatory markers (such as C-reactive proteins) and the high plasma levels of microRNA could predict the outcomes after stent placement. In particular, circulating microRNA-320a, microRNA-3937, microRNA-642a-3p and microRNA-572 appear to hold promise in diagnosing ISR in patients with PAD, but also as predictors of stent patency. This narrative review intends to summarize the current knowledge on the value of circulating biomarkers as predictors of ISR and to foster the scientific debate on the advantages of using DCB in the treatment of ISR in the FP district.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

et al. 2022

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“…The results showed that DCB (patency: relative risk (RR) 2.38, 95% CI 1.71, 3.30, p < 0.01; freedom from TLR: RR 1.56, 95% CI 1.33, 1.82, p < 0.01) and ELA (patency: RR 2.25, 95% CI 1.14, 4.44, p < 0.05; freedom from TLR: RR 1.59, 95% CI 1.12, 2.25, p = 0.01) were superior in terms of primary patency rates and freedom from TLR compared to SBA at the 12-month follow-up. 30 ELA and DCB are performed without the need for an additional stent layer. Therefore, ELA and DCB should be superior to other percutaneous strategies and may provide…”

Section: Discussionmentioning

confidence: 99%

The safety and efficacy of different endovascular treatments for in-stent restenosis of the femoropopliteal artery: A network meta-analysis

Wang

Lin

et al. 2022

Vasc Med

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Purpose: Femoropopliteal artery in-stent restenosis (ISR) remains a challenging treatment. We performed a network meta-analysis (NWM) for femoropopliteal artery ISR to explore the safety and efficacy of endovascular therapeutic strategies. Methods: The MEDLINE, Embase, Web of Science, and Cochrane databases were used as data sources. The network meta-analysis (NWM) approach used random-effects models based on the frequentist framework. We compared technical success rate, primary patency, target lesion revascularization (TLR), and major amputation at the 12-month follow-up for femoropopliteal artery ISR. Results: In total, 14 eligible studies (10 prospective and four retrospective; 1348 patients; and eight treatment modalities – standard balloon angioplasty (SBA), drug-coated balloon (DCB), peripheral cutting balloon angioplasty (PCBA), Viabahn endoprosthesis (VBE), directional atherectomy (DA), excimer laser atherectomy (ELA), and combinations – were included. The primary patency rates (at 6 months) were significantly higher for DCB and ELA+DCB than for SBA and ELA+SBA. ELA+DCB had higher primary patency rates (at 12 months) than ELA+SBA and SBA. The technical success rates were significantly lower for DCB and SBA than for VBE. The major amputation rates were significantly lower for ELA+DCB than for DCB. Based on the surface values under the cumulative ranking curve (SUCRA), ELA+DCB was considered the best treatment in terms of primary patency at 6 months (SUCRA = 91.1), primary patency at 12 months (SUCRA = 82.3), and TLR (SUCRA = 83.4). Conclusion: ELA+DCB showed positive encouraging results in primary patency (6, 12 months), TLR, and major amputation in femoropopliteal ISR. The efficacy and safety of ELA+DCB are worthy of further investigation. (PROSPERO Registration No.: CRD42021246674)

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“…The results showed ( 18 ) that at 6 months, compared with PTA, the laser atherectomy method had a higher rate of patency (71.1 vs. 56.4%, P = 0.004) and a lower rate of TLR (20.2 vs. 36.3%, P = 0.003). However, similar to DCBs, atherectomy did not increase the ABI significantly or improve the ischemic condition ( 19 ). Although atherectomy has advantages over other treatments in terms of major amputation and all-cause mortality, a meta-analysis has shown that atherectomy alone seems to be less effective for FP-ISR ( 20 ).…”

Section: Discussionmentioning

confidence: 99%

“…Although reports of DCB angioplasty or MATH offer alternative approaches to established ISR treatment ( 13 , 19 , 23 ), clinical evidence of the combination of these two modalities is scarce. DEFINITIVE AR was the first prospective, multicenter study designed to estimate the effect of treating FP-ISR with the combination of the directional atherectomy (DA) and DCB ( 4 ).…”

Section: Discussionmentioning

confidence: 99%

Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

Liu

Guo

et al. 2021

Front. Surg.

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Background: Studies investigating debulking devices with drug-coated balloons (DCBs) in the treatment of femoropopliteal (FP) artery in-stent restenosis (ISR) are limited. We aimed to evaluate the safety and midterm outcome of percutaneous mechanical atherectomy plus thrombectomy (MATH) using the Rotarex®S (Straub Medical, Wangs, Switzerland) catheter followed by a DCB in the treatment of FP-ISR.Methods: This study was a single-center single-arm trial. Patients with symptomatic (Rutherford category 2–5) de novo restenosis lesions of FP-ISR were treated with MATH and subsequent DCB. From June 2016 to May 2018, 59 patients with FP-ISR were enrolled. The primary endpoint was target lesion revascularization (TLR) and changes in the Rutherford category of the target limb at 12 months. Secondary endpoints included primary and secondary patency at 12 months, technical success rate, major adverse events, and ankle-brachial index (ABI). Risk factors for TLR were analyzed using Cox proportional hazard model.Results: The average follow-up time was 33 ± 8 months. The rate of technical success was 88.1% (52/59). Nine patients received bailout stenting. The rate of freedom from TLR was 84.7% (50/59) at 1 year, the Rutherford category changed at 12 months were significantly improved from baseline (p < 0.01). The primary patency rates and the secondary patency at the 12-month follow-ups were 82.5 and 92.5%, respectively. The ABI changed at 12 months were significantly improved from baseline (p < 0.01). Global limb anatomic staging system (GLASS) classification III [hazard ratio (HR) 18.44, 95% CI (1.57–215.99), p = 0.020] and postoperative Rutherford classification ≥4 [HR 8.28, 95% CI (1.85–37.06), p = 0.006] were identified as independent predictors of TLR.Conclusion: Our preliminary data suggested that MATH using a Rotarex®S catheter combined with DCB angioplasty is a safe, minimally invasive, and effective treatment for FP-ISR with favorable, immediate, and midterm outcomes.Clinical Trial Registration:http://www.chictr.org.cn, identifier [ChiCTR2000041380].

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Drug-Coated Balloon Angioplasty and Debulking for the Treatment of Femoropopliteal In-Stent Restenosis: A Systematic Review and Meta-Analysis

Cited by 10 publications

References 24 publications

The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

The Diagnostic Value of Circulating Biomarkers and Role of Drug-Coated Balloons for In-Stent Restenosis in Patients with Peripheral Arterial Disease

The safety and efficacy of different endovascular treatments for in-stent restenosis of the femoropopliteal artery: A network meta-analysis

Percutaneous Mechanical Atherectomy Plus Thrombectomy Using the Rotarex®S Device Followed by a Drug-Coated Balloon for the Treatment of Femoropopliteal Artery In-stent Restenosis: A Prospective Single-Center, Single-Arm Efficacy Trial (PERMIT-ISR Trial)

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