Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis

Varetto, Gianfranco; Gibello, Lorenzo; Boero, Michele; Frola, Edoardo; Peretti, Tania; Spalla, Flavia; Verzini, Fabio; Rispoli, Pietro

doi:10.23736/s0021-9509.19.11115-9

Cited by 10 publications

(8 citation statements)

References 36 publications

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“…Thus, the mix of PES and paclitaxel-coated balloon studies is a main bias since many differences exist between the devices in terms of platform, excipient, polymer, drug concentration, and formulation (RR 1.66). 2 Numbers of deaths were similar between the PES and control arms at 1 year, but there was an increased risk of death following application of PES at 2 years. However, only 2 RCTs testing PES were available at 2 years [515 patients (22.2%) of 2316 subjects].…”

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confidence: 84%

Fragility of the Signal

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Leclère³

2020

J Endovasc Ther

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Katsanos et al 1 investigated the risk of drug-eluting technology, showing evidence that the application of paclitaxel-coated devices in the femoropopliteal segment was related to a significantly increased risk of death [relative risk (RR) 1.68, 95% confidence interval (CI) 1.15 to 2.47]. 1 Out of the 28 studies, 790 patients were from 4 RCTs testing a paclitaxel-eluting stent (PES). These PES studies represented a minority of patients (17.82% at 1 year). Thus, the mix of PES and paclitaxel-coated balloon studies is a main bias since many differences exist between the devices in terms of platform, excipient, polymer, drug concentration, and formulation (RR 1.66). 2 Numbers of deaths were similar between the PES and control arms at 1 year, but there was an increased risk of death following application of PES at 2 years. However, only 2 RCTs testing PES were available at 2 years [515 patients (22.2%) of 2316 subjects]. They found 20 deaths among 320 patients in the paclitaxel group (6.25%) and 7 deaths (3.58%) of 195 patients in the control group. Overall, Katsanos et al 1 reported a significant increase of death in the PES subgroup (RR 1.87, 95% CI 1.11 to 3.15). Recently, the prospective BATTLE RCT (Bare Metal Stent vs Paclitaxel Eluting Stent in the Setting of Primary Stenting of Intermediate-Length Femoropopliteal Lesions) was published comparing bare nitinol stents (Misago; Terumo, Tokyo, Japan) and PES (Zilver PTX; Cook Medical, Bloomington, IN, USA) for de novo femoropopliteal occlusive disease. 3 In the BATTLE trial, no difference was found between the groups in terms of in-stent restenosis at 1 and 2 years. After 2 years of follow-up, 7 deaths were noted in the Misago group and 1 in the Zilver PTX group (hazard ratio 7.3, 95% CI 0.9 to 59, p=0.06). Causes of death were pulmonary cancer (n=3), sepsis (n=2), trauma (n=1), and multisystem organ failure (n=1) in the Misago group and hemorrhagic shock (n=1) in the Zilver PTX group. The deaths did not appear to be linked to the devices or the procedures. Interestingly, BATTLE was included in the Katsanos et al 1 meta-analysis, but at that time only 1-year follow-up

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confidence: 84%

Fragility of the Signal

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2020

J Endovasc Ther

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“…This has been associated with improved amputation-free survival rates (AFS) compared to traditional open surgical bypass (Lin et al 2019 ). However, a major drawback of performing standard PTA, otherwise known as plain old balloon angioplasty (POBA), is the quick time to restenosis and loss of luminal patency (Varetto et al 2019 ). This is related to the barotrauma created during the POBA process, causing inflammation and ultimately neointimal hyperplasia (NIH) (Biondi-Zoccai et al 2009 ), resulting in higher re-intervention rates, albeit with no differences in mortality outcomes (Norgren et al 2007 ).…”

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confidence: 99%

Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

et al. 2022

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Sirolimus-coated balloons (SCB) have demonstrated much promise as an alternative drug eluting device to the existing paclitaxel coated balloon platforms for the treatment of peripheral arterial disease (PAD). They have been well tested pre-clinically and have demonstrated anti-restenotic effects as well as clinical safety in its use for treatment of coronary artery disease. The existing approved SCBs have thus far demonstrated good short-term patency (12-months) and did not exhibit any major adverse events or device related shortcomings in its use for treatment of PAD. There are several studies ongoing which aim to further investigate the efficacy of existing SCBs and establish a direct comparison of its outcomes compared with plain balloon angioplasty. Also, SCB utility to salvage failing arteriovenous fistulas for haemodialysis patients has also been explored. We review the current progress made in the establishment of SCB in the treatment of PAD as well as highlight ongoing studies investigating the role of SCB in various settings.

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“…2 This was mostly performed with standard balloon angioplasty, otherwise also referred to as plain old balloon angioplasty (POBA). However, its efficacy was found to be limited by poor long-term patency, 4 leading to the development of drug-coated balloon (DCB) technology, which relies on the anti-proliferative effects of certain drugs such as paclitaxel to inhibit the neointimal hyperplasia process and hence restenosis, improving patency outcomes. 5 At present, the use of DCB is considered first-line treatment for femoropopliteal lesions, 6 although evidence for below-the-knee (BTK) lesions has been controversial.…”

Section: Introductionmentioning

confidence: 99%

Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population – 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III

et al. 2022

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Background Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. Methods A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). Results AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months. Conclusion Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.

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Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis

Cited by 10 publications

References 36 publications

Fragility of the Signal

Fragility of the Signal

Utility of sirolimus coated balloons in the peripheral vasculature – a review of the current literature

Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population – 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III

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