Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study

Zandvoort, Laurens J.C. van; Dudek, Dariusz; Weber‐Albers, Joachim; Abizaid, Alexandre; Christiansen, Evald Høj; Müller, D.; Kochman, Janusz; Kołtowski, Łukasz; Lassen, Jens Flensted; Wojdyla, Roman; Wykrzykowska, Joanna J.; Onuma, Yoshinobu; Daemen, Joost

doi:10.4244/eij-d-18-00491

Cited by 6 publications

(5 citation statements)

References 18 publications

(14 reference statements)

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“…The present data set included IVUS pullbacks of patients enrolled in the FANTOM II trial that underwent IVUS‐guided PCI at the index procedure 18 . In brief, this trial evaluated the long‐term safety and the efficacy of the Fantom bioresorbable scaffold (REVA Medical), a desaminotyrosine‐derived polycarbonate sirolimus‐eluting bioresorbable scaffold with a strut thickness of around 125 µm.…”

Section: Methodsmentioning

confidence: 99%

“…The present data set included IVUS pullbacks of patients enrolled in the FANTOM II trial that underwent IVUS‐guided PCI at the index procedure. 18 In brief, this trial evaluated the long‐term safety and the efficacy of the Fantom bioresorbable scaffold (REVA Medical), a desaminotyrosine‐derived polycarbonate sirolimus‐eluting bioresorbable scaffold with a strut thickness of around 125 µm. Inclusion criteria included the presence of stable or unstable coronary artery disease with evidence of myocardial ischemia or a positive functional study, single de novo coronary artery lesions with an average reference diameter ranging between 2.5 and 3.5 mm, and an estimated lesion length <20 mm.…”

Section: Methodsmentioning

confidence: 99%

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Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries

Neleman

Khachabi

Jonker

et al. 2022

Cathet Cardio Intervent

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Objectives: To validate a simplified core laboratory intravascular ultrasound (IVUS) analysis method based on frames with visually determined minimal lumen areas (MLAs) as compared with a comprehensive (per frame) analysis method.Background: IVUS-guided percutaneous coronary intervention has proven to be superior to angiography-guided stenting. In clinical practice, cross-sections with visually determined MLA are measured to determine lesion severity or minimal stent area (MSA), however, its accuracy has not been compared with a comprehensive per frame analysis method.Methods: A total of 50 stented coronary segments of anonymized core lab datasets were analyzed using a comprehensive analysis method and reanalyzed by two core lab analysts using the simplified method including a maximum of seven frames to be analyzed (the visually determined MSA, the first and last frame, and the MLA of each reference segment). The main parameters of interest were MSA, MLA in the reference segments, and plaque burden.Results: The simplified method showed moderate agreement for measurement of the proximal MLA (7.51 ± 2.52 vs. 6.32 ± 1.88 mm 2 , intraclass correlation coefficient[ICC] = 0.73), good agreement for the distal MLA (5.41 ± 1.85 vs. 5.11 ± 1.38 mm 2 , ICC = 0.84) and plaque burden proximal (0.49 ± 0.12 vs. 0.50 ± 0.11, ICC = 0.88), and excellent agreement for the MSA (5.35 ± 1.05 vs. 5.32 ± 0.99 mm 2 , ICC = 0.94) and plaque burden distal (0.47 ± 0.14 vs. 0.47 ± 0.12, ICC = 0.92), when compared with the comprehensive analysis method. Inter-and intraobserver analysis revealed good-to-excellent agreement for all parameters. Conclusions: Measuring poststenting IVUS cross-sections with visually determinedMLAs by experienced core lab analysts is an accurate and reproducible method to identify MLAs.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries

Neleman

Khachabi

Jonker

et al. 2022

Cathet Cardio Intervent

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“…A total of 240 patients were enrolled in two cohorts (cohort A with 6‐ and 24‐month angiographic follow‐up, and cohort B with 9‐ and 48‐month angiographic follow‐up) (Figure 1). Only selected patient underwent 24‐month follow‐up angiography in cohort A. Intravascular ultrasound and optical coherence tomography sub‐studies were embedded in the study in selected patients 10 …”

Section: Methodsmentioning

confidence: 99%

“…The Fantom BRS is a desaminotyrosine‐derived polycarbonate sirolimus‐eluting scaffold, designed to have radiopacity, excellent radial strength and favorable expansion properties 8 . The clinical and angiographic outcomes of the Fantom BRS were evaluated and reported in the FANTOM I pilot and subsequent FANTOM II study 8–10 …”

Section: Introductionmentioning

confidence: 99%

Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold

Saito

Cristea

Bouras

et al. 2020

Cathet Cardio Intervent

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Background Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire‐based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus‐eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS. Methods The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post‐percutaneous coronary intervention (PCI), and at 6‐ or 9‐month and 24‐month follow‐up, using a QFR threshold ≤0.80 to define functional ischemia. Results QFR was analyzable in 178 patients at baseline, 185 post‐PCI, 178 at 6‐ or 9‐month follow‐up, and 30 at 24‐month follow‐up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post‐PCI, 13 (7.3%) at 6‐ or 9‐month follow‐up, and 3 (10.0%) at 24‐month follow‐up had a QFR ≤0.80. QFR improved from baseline to post‐PCI, and decreased from post‐PCI up to 24‐month follow‐up. During follow‐up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization. Conclusions Off‐line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

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“…During the follow-up period of 6 to 9 months, over 250 patients had BRS implants. The long-term quantitative flow ratio (QFR) analysis that followed demonstrated the stent’s improvement in ischemia [ 117 , 118 ]. Then, the same material was used for sirolimus-eluting MOTIV stents for BTK vascular patency.…”

Section: Bioabsorbable Scaffolds In Padmentioning

confidence: 99%

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease: A Literature Review of New Developments

Cui,

2024

Rev. Cardiovasc. Med.

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This review aimed to explore the therapeutic effect of bioabsorbable stents in the inferior genicular artery, from the emergence of absorbable bare metal stents to the latest technology in polymer and anti-proliferative eluting drugs mixed with coated bioresorbable vascular stents (BVSs). Currently, there are conflicting data regarding the safety and effectiveness of BVSs in infrapopliteal artery interventions, especially compared to the current generation of drug-eluting stents (DESs). This review will cover the existing data on BVSs in reconstructing the infrapopliteal arterial blood flow and active clinical trials for future iterations of BVSs. In terms of primary patency rate and target lesion revascularization rate, the available research on the effectiveness of BVSs in reconstructing the infrapopliteal arterial blood flow suggests that a BVS is compatible with current DESs within 3–12 months; long-term data have not yet been reported. The ABSORB BVS is the most studied BVS in cardiovascular disease (CAD). Initially, the ABSORB BVS showed promising results. Managing intricate regions in peripheral artery disorders, such as branching or lengthy lesions, continues to be a formidable undertaking. In contrast to the advanced narrowing of arteries seen in standard permanent stent procedures, bioabsorbable stents have the potential to promote the expansion and beneficial merging of blood channels in the latter stages. Furthermore, incorporating stents and re-establishing the endothelial function can diminish the probability of restenosis or thrombosis. Nevertheless, the extent to which bioabsorbable stents may simultaneously preserve arterial patency and guarantee their structural integrity remains uncertain. The powerful and intricate mechanical stresses exerted by the blood in the superficial femoral artery and popliteal artery can cause negative consequences on any implant inserted into the vessel, regardless of its composition, even metal. Furthermore, incorporating stents is advantageous for treating persistent occlusive lesions since it does not impact later treatments, including corrective bypass operations. Evidence is scarce about the use of bioabsorbable stents in treating infrapopliteal lesions. Utilizing bioabsorbable stents in minor infrapopliteal lesions can successfully maintain the patency of the blood vessel lumen, whereas balloon angioplasty cannot offer this benefit. The primary focus of testing these materials is determining whether bioabsorbable scaffolds can provide adequate radial force in highly calcified elongated lesions. Indeed, using “-limus” medication elution technology in conjunction with bioabsorbable stents has previously offered clinical benefits in treating the popliteal artery, as evidenced by limited trials.BVSs for peripheral arterial disease (PAD) show promise and have the potential to offer a less inflammatory and more vessel-friendly option compared to permanent metallic stents. However, current evidence does not yet allow for a ...

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Intravascular ultrasound findings of the Fantom sirolimus-eluting bioresorbable scaffold at six- and nine-month follow-up: the FANTOM II study

Abstract: The use of the Fantom BRS in stable coronary artery disease was associated with low rates of neointimal hyperplasia volume and in-scaffold volume obstruction at both six and nine months.

Cited by 6 publications

References 18 publications

Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries

Validation of a simplified intravascular ultrasound core lab analysis method in stented coronary arteries

Long‐term serial functional evaluation after implantation of the Fantom sirolimus‐eluting bioresorbable coronary scaffold

Bioresorbable Scaffolds for Below-the-Knee Arterial Disease: A Literature Review of New Developments

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