Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography

Poerner, Tudor C.; Duderstadt, Corinna; Goebel, Björn; Kretzschmar, Daniel; Figulla, Hans R.; Otto, Sylvia

doi:10.1007/s00392-016-1019-4

Cited by 40 publications

(24 citation statements)

References 43 publications

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“…Moreover, without a mechanical scaffold, using a DCB removes the technical burden of treating ISR and allows patients to receive non-invasive magnetic resonance examination. In our study, as for coronary artery disease,8 the DCB seems to play a significant role in vascular remodeling and patency improvement for intracranial arteries. As shown in figure 3, residual stenosis of approximately 50% of the basilar artery was found after DCB dilatation.…”

Section: Discussionsupporting

confidence: 50%

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

Han

Zhang

Xiao

et al. 2018

J NeuroIntervent Surg

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BackgroundThe optimal treatment for patients with symptomatic severe intracranial atherosclerotic disease is not well established. Angioplasty and stenting have been attempted, with controversial results, mainly attributed to perioperative complications and a high incidence of restenosis or in-stent restenosis. Drug-coated balloons (DCBs) have shown encouraging results for coronary and peripheral artery disease, without convincing data for intracranial vasculature.ObjectivesTo assess the feasibility, clinical and angiographic outcomes of DCBs for patients with intracranial de novo atherosclerotic disease.MethodsBetween September 2016 and September 2017, details of 30 patients with 31 arteries treated with DCBs for symptomatic severe intracranial atherosclerotic disease (≥70% stenosis or chronic total occlusion) were retrospectively collected in our centre. All lesions were predilated with conventional balloons. Periprocedural complications and clinical and vascular imaging follow-up outcomes were analysed.ResultsAll arteries were successfully dilated with DCBs and 29 (93.5%) arteries achieved good antegrade perfusion, with remedial stenting for two arteries. Two patients presented with new ischemic stroke after the procedure. Over a mean follow-up of 9.8±2.6 months, no patient had recurrent ischemic symptoms. Repeat vascular imaging was performed at 7.0±1.1 months, with cerebral angiography in 24 patients (25 arteries) and MR angiography in six patients (six arteries). Only one (3.2%) artery presented with angiographic asymptomatic restenosis.ConclusionsThis study suggests that DCB dilatation may be a safe and effective alternative for intracranial de novo atherosclerotic disease.

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Section: Discussionsupporting

confidence: 50%

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

Han

Zhang

Xiao

et al. 2018

J NeuroIntervent Surg

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“…Additionally, when the same criteria of lesion preparation using FFR were ap-plied, DCB treatment showed persistent anatomical and physiological patency with plaque redistribution and vessel remodeling without chronic elastic recoil or plaque compositional change during follow-up [38]. Similarly, recent European data showed that if it was determined that there was sufficient lesion preparation with residual stenosis < 40%, FFR > 0.80 and no severe dissection, DCB treatment was feasible and safe with a trend toward positive vessel remodeling without lumen loss at 6 months [40].…”

Section: Optimal Lesion Preparationmentioning

confidence: 88%

“…In addition, using intravascular ultrasound (IVUS) and optical coherence tomography (OCT), the investigators suggested that DCB restores coronary blood flow by means of plaque modification, causing an increment in the minimal lumen area [38,39]. Recent European data also showed that the FFR-guided DCB-only approach of de novo lesions (cutoff value of FFR: 0.80) was feasible and safe in stable CAD, showing positive remodeling without lumen loss by OCT at 6 months [40]. Another study showed that the safety and efficacy of DCB was comparable with DES when the cut-off value of FFR was 0.75 after balloon angioplasty [41].…”

Section: De Novo Lesionmentioning

confidence: 99%

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

Her

Shin²,

Bang

et al. 2021

Cardiol J.

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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.

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“…OCT showed an increased mean luminal diameter and volume at follow-up in addition to the sealing of 66% of dissections. The OCTOPUS II study again through an FFR-guided approach with OCT analysis also showed positive luminal gain, healing of dissections and a lack of thin-cap fibroatheromas [ 34 ].…”

Section: Patient Characteristicsmentioning

confidence: 99%

Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review

et al. 2018

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Percutaneous coronary intervention (PCI) with a drug coated balloon (DCB) is a novel treatment which seeks to acutely dilate a coronary stenosis and deliver an anti-proliferative drug to the vessel wall (reducing the risk of re-stenosis), without implanting a drug eluting stent (DES). In this study, we performed a systematic review of stentless DCB-only angioplasty in de novo coronary artery disease. We identified 41 studies examining the effects of DCB-only PCI in a variety of clinical scenarios including small vessels, bifurcations, calcified lesions, and primary PCI. DCB-only PCI appears to be associated with comparable clinical outcomes to DESs and superior angiographic outcomes to plain-old balloon angioplasty. Although current data are promising, there is still a need for further long-term randomized control trial data comparing a DCB-only approach specifically against a second- or third-generation DES. A 4-week period of dual antiplatelet therapy provides a real advantage for the DCB-only PCI approach, which is not possible with most DESs. Since rates of adverse clinical outcomes are very low for all PCI procedures attention should be turned to the development of robust endpoints with which to compare DCB-only PCI approaches to the standard treatment with a DES.Electronic supplementary materialThe online version of this article (10.1007/s40119-018-0121-2) contains supplementary material, which is available to authorized users.

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Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography

Cited by 40 publications

References 43 publications

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

Drug-coated balloons for the treatment of symptomatic intracranial atherosclerosis: initial experience and follow-up outcome

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

Drug-Coated Balloon-Only Percutaneous Coronary Intervention for the Treatment of De Novo Coronary Artery Disease: A Systematic Review

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