Bioresorbable vascular scaffold treatment induces the formation of neointimal cap that seals the underlying plaque without compromising the luminal dimensions: a concept based on serial optical coherence tomography data

Bourantas, Christos V.; Serruys, Patrick W.; Nakatani, Shimpei; Zhang, Yaojun; Farooq, Vasim; Diletti, Roberto; Ligthart, Jurgen; Sheehy, Alexander; Geuns, Robert‐Jan M. van; McClean, Dougal; Chevalier, Bernard; Windecker, Stephan; Koolen, Jacques; Ormiston, John A.; Whitbourn, Robert; Rapoza, Richard; Veldhof, Susan; Onuma, Yoshinobu; García‐García, Héctor M.

doi:10.4244/eijy14m10_06

Cited by 46 publications

(23 citation statements)

References 36 publications

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“…Thus, DCB angioplasty as a stand-alone procedure might be a promising trade-off between POBA, DES, and BVS. On the other hand, it has been shown that BVS has the capacity to “seal” underlying coronary plaques [39, 42]. Whether or not this translates into a favorable long-term course remains nevertheless unclear.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2016

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BackgroundPercutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please® balloon without stenting for elective PCI of de novo lesions.Methods and resultsIn 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: −0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment.ConclusionsFFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months.Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT02120859Electronic supplementary materialThe online version of this article (doi:10.1007/s00392-016-1019-4) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2016

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“…Bioresorbable vascular scaffolds (BVS) have recently been introduced as a novel approach for treatment of coronary artery disease, providing transient vascular support and drug delivery, potentially restoring the vascular physiology after device bioresorption [1][2][3][4] . The theoretical advantages of this novel technology, such as late lumen enlargement, restoration of coronary vasomotion and plaque sealing, make this device appealing for patients with ruptured thincapped lipid-rich soft plaques in general [5][6][7] and thrombotic lesions in acute coronary syndromes and STEMI in particular [8][9][10] . Due to vasoconstriction and presence of thrombus, the treatment of acute lesions is often associated with device undersizing and the occurrence of malapposition after thrombus resolution.…”

Section: Abstract • Bioresorbable Vascular Scaffolds (Bvs) • Percutanmentioning

confidence: 99%

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study

Fam

Felix²,

Geuns³

et al. 2016

EuroIntervention

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STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes.

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“…The neointimal response in the BMS causes a higher reduction of luminal dimensions compared with the Absorb stent with documented late lumen enlargement. Thus, the Absorb stent may have a value in the invasive re-capping of high-risk plaques [89,90]. One OCT study demonstrated that after an Absorb stent implantation neointimal tissue develops that covers almost the whole circumference of the vessel wall.…”

Section: Hot Topics In 2015mentioning

confidence: 99%

Absorb bioresorbable stents for the treatment of coronary artery disease

Kočka

Toušek²,

Widimský

2015

Expert Review of Medical Devices

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Bioresorbable stents are considered to be the 'fourth revolution' in percutaneous coronary intervention. The first clinically available Absorb(®) bioresorbable device is made of poly-l-lactic acid polymer and elutes everolimus. The process of bioresorption is completed in 3 years. The introduction of this device into clinical practice went through several logical phases: first-in-man studies, randomized Absorb II study with moderately complex patients and lesions, registries of real life patient population and reports of challenging cases. The procedural results are excellent; many insights have been gained by intracoronary imaging. Intermediate-term outcomes are very encouraging both from imaging and from clinical perspectives. The issue of increased stent thrombosis rate was raised in one study, but other studies have been reassuring. Excellent lesion preparation, sizing and complete expansion of the Absorb device are crucial for optimal procedural and clinical results. Results of ongoing large randomized studies will determine the future role of this technology.

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Bioresorbable vascular scaffold treatment induces the formation of neointimal cap that seals the underlying plaque without compromising the luminal dimensions: a concept based on serial optical coherence tomography data

Cited by 46 publications

References 36 publications

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

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

Initial experience with everolimus-eluting bioresorbable vascular scaffolds for treatment of patients presenting with acute myocardial infarction: a propensity-matched comparison to metallic drug eluting stents 18-month follow-up of the BVS STEMI first study

Absorb bioresorbable stents for the treatment of coronary artery disease

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