6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold

Abizaid, Alexandre; Carrié, Didier; Frey, Norbert; Lutz, Matthias; Weber‐Albers, Joachim; Dudek, Darius; Chevalier, Bernard; Weng, Shu‐Chuan; Costa, Ricardo; Anderson, Jeffrey; Stone, Gregg W.

doi:10.1016/j.jcin.2017.07.033

Cited by 49 publications

(38 citation statements)

References 17 publications

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“…The FANTOM II study aimed to investigate safety and performance of the Fantom BRS in a multicentre setting. The mid-term clinical and angiographic follow-up was reported previously and indicated an excellent safety profile 8. Here, we report the mechanical performance and healing patterns of the Fantom BRS after 6 and 9 months assessed by baseline adjusted, fully matched optical coherence tomography (OCT).…”

Section: Introductionmentioning

confidence: 64%

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

et al. 2019

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ObjectivesWe aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS).BackgroundThe Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes.Methods and resultsFANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7 mm2 and 5.7±1.4 mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6 mm2 and 5.6±1.4 mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5 mm2 at baseline to 7.2±1.4 mm2 at 6 months (p=0.12), and from 7.4±1.5 mm2 to 7.3±1.4 mm2 at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months.ConclusionsThe novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.

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Section: Introductionmentioning

confidence: 64%

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

et al. 2019

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“…Investigators and commenters find these results comparable with other BVS. More encouraging results are anticipated from Cohort B of the Fantom II study, including 240 patients and nine month follow-up [79,82].…”

Section: Real-world Bvs Performance-outcomes and Evaluationmentioning

confidence: 94%

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Jeżewski

Kubisa

Eyileten

et al. 2019

JCM

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Percutaneous coronary interventions with stent-based restorations of vessel patency have become the gold standard in the treatment of acute coronary states. Bioresorbable vascular scaffolds (BVS) have been designed to combine the efficiency of drug-eluting stents (DES) at the time of implantation and the advantages of a lack of foreign body afterwards. Complete resolution of the scaffold was intended to enable the restoration of vasomotor function and reduce the risk of device thrombosis. While early reports demonstrated superiority of BVS over DES, larger-scale application and longer observation exposed major concerns about their use, including lower radial strength and higher risk of thrombosis resulting in higher rate of major adverse cardiac events. Further focus on procedural details and research on the second generation of BVS with novel properties did not allow to unequivocally challenge position of DES. Nevertheless, BVS still have a chance to present superiority in distinctive indications. This review presents an outlook on the available first and second generation BVS and a summary of results of clinical trials on their use. It discusses explanations for unfavorable outcomes, proposed enhancement techniques and a potential niche for the use of BVS.

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“…The multicenter FANTOM II study evaluated 240 patients implanted with the Fantom scaffolds, and the 6 month clinical outcome showed no deaths, one ScT (0.9%), two MIs (1.7%) and two clinically driven TLRs (1.7%); one patient had both an MI and TLR. The risk of MACE within 6 months occurred in 2.6% of patients; by contrast, other CE-marked BRSs have higher MACE risks, ranging from 3.0 to 5.0% ( 18 ). OCT analysis revealed a favorable healing pattern of the Fantom scaffolds at 6 and 9 months, during which the mean and minimal scaffold areas maintained stability and acute malapposition was effectively resolved, with no late vessel wall detachment ( 19 ).…”

Section: Current Status Of Brssmentioning

confidence: 99%

Bioresorbable Scaffolds: Contemporary Status and Future Directions

Xiang

Jia

et al. 2020

Front. Cardiovasc. Med.

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Percutaneous coronary intervention, which is safe, effective, and timely, has become an important treatment for coronary artery diseases and has been widely used in clinical practice. However, there are still some problems that urgently need to be solved. Permanent vessel caging through metallic implants not only prevents the process of positive vessel remodeling and the restoration of vascular physiology but also makes the future revascularization of target vessels more difficult. Bioresorbable scaffolds (BRSs) have been developed as a potential solution to avoid the above adverse reactions caused by permanent metallic devices. BRSs provide temporary support to the vessel wall in the short term and then gradually degrade over time to restore the natural state of coronary arteries. Nonetheless, long-term follow-up of large-scale trials has drawn considerable attention to the safety of BRSs, and the significantly increased risk of late scaffold thrombosis (ScT) limits its clinical application. In this review, we summarize the current status and clinical experiences of BRSs to understand the application prospects and limitations of these devices. In addition, we focus on ScT after implantation, as it is currently the primary drawback of BRS. We also analyze the causes of ScT and discuss improvements required to overcome this serious drawback and to move the field forward.

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6-Month Clinical and Angiographic Outcomes of a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold

Cited by 49 publications

References 17 publications

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study

Bioresorbable Vascular Scaffolds—Dead End or Still a Rough Diamond?

Bioresorbable Scaffolds: Contemporary Status and Future Directions

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