Vasomotor Function Comparative Assessment at 1 and 2 Years Following Implantation of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold and the Xience V Everolimus-Eluting Metallic Stent in Porcine Coronary Arteries

Gogas, Bill D.; Benham, James J.; Hsu, Steve; Sheehy, Alexander; Lefer, David J.; Goodchild, Traci; Polhemus, David J.; Bouchi, Yasir; Hung, Olivia Y.; Yoo, Sang-Yong; Joshi, Udit; Giddens, Don P.; Veneziani, Alessandro; Quyyumi, Arshed A.; Rapoza, Richard; King, Spencer B.; Samady, Habib

doi:10.1016/j.jcin.2015.12.018

Cited by 26 publications

(13 citation statements)

References 28 publications

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“…Introduction of the Absorb BRS was a milestone in treatment of obstructive coronary artery disease. The positive initial safety reports,9 the restoration of the vasomotor function,10 the late lumen enlargement11 and the full resorption documented after 5 years12 were encouraging for the technology. However, recent reports on early luminal scaffold dismantling,4 increased rates of scaffold thrombosis1 2 and a late increase in target lesion failures in comparison with permanent DES2 3 indicates that limitations of first generation BRS affect outcomes negatively.…”

Section: Discussionmentioning

confidence: 84%

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: Discussionmentioning

confidence: 84%

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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“…The vasomotion of the scaffolded/stented vessels between the BVS and Xience DES ( Figure 4A,B) was examined in a preclinical porcine model. The results showed that vessels with the BVS demonstrated significantly restored in-scaffold vasomotor function at 1 and 2 years followup (34). Similarly, Elixir's DESolve BRS reported an increase in the scaffold area between 3 and 6 months.…”

Section: Vasomotion After Brs Implantationmentioning

confidence: 79%

Mechanical behavior of polymer-based vs. metallic-based bioresorbable stents

et al. 2017

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Bioresorbable scaffolds (BRS) were developed to overcome the drawbacks of current metallic drug-eluting stents (DES), such as late in-stent restenosis and caging of the vessel permanently. The concept of the BRS is to provide transient support to the vessel during healing before being degraded and resorbed by the body, freeing the vessel and restoring vasomotion. The mechanical properties of the BRS are influenced by the choice of the material and processing methods. Due to insufficient radial strength of the bioresorbable material, BRS often required large strut profile as compared to conventional metallic DES. Having thick struts will in turn affect the deliverability of the device and may cause flow disturbance, thereby increasing the incidence of acute thrombotic events. Currently, the bioresorbable poly-l-lactic acid (PLLA) polymer and magnesium (Mg) alloys are being investigated as materials in BRS technologies. The bioresorption process, mechanical properties, observations and clinical outcomes of PLLA-based and Mg-based BRS will be examined in this review.

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“…Plain-balloon injury, bare-metal stents (BMS) and drug-eluting stents (DES) all result in acute endothelial and VSMC dysfunction [25,61]. In addition to the directly stented section, proximal and distal segments may experience impaired vascular responses [62][63][64].…”

Section: Functional Changesmentioning

confidence: 99%

Effects of Catheterization on Artery Function and Health: When Should Patients Start Exercising Following Their Coronary Intervention?

2019

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Coronary artery disease (CAD) is a leading cause of death worldwide, and percutaneous transluminal coronary angiography (PTCA) and/or percutaneous coronary intervention (PCI; angioplasty) are commonly used to diagnose and/or treat the obstructed coronaries. Exercise-based rehabilitation is recommended for all CAD patients; however, most guidelines do not specify when exercise training should commence following PTCA and/or PCI. Catheterization can result in arterial dysfunction and acute injury, and given that fact that exercise, particularly at higher intensities, is associated with elevated inflammatory and oxidative stress, endothelial dysfunction and a pro-thrombotic milieu, performing exercise post-PTCA/PCI may transiently elevate the risk of cardiac events. This review aims to summarize extant literature relating to the impacts of coronary interventions on arterial function, including the time-course of recovery and the potential deleterious and/or beneficial impacts of acute versus long-term exercise. The current literature suggests that arterial dysfunction induced by catheterization recovers 4-12 weeks following catheterization. This review proposes that a period of relative arterial vulnerability may exist and exercise during this period may contribute to elevated event susceptibility. We therefore suggest that CAD patients start an exercise-training program between 2 and 4 weeks post-PCI, recognizing that the literature suggest there is a "grey area" for functional recovery between 2-12 weeks post catheterization. The timing of exercise onset should take into consideration the individual characteristics of patients (age, severity of disease, comorbidities) and the intensity, frequency and duration of the exercise prescription.

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Vasomotor Function Comparative Assessment at 1 and 2 Years Following Implantation of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold and the Xience V Everolimus-Eluting Metallic Stent in Porcine Coronary Arteries

Abstract: Absorb BVS-implanted coronary arteries demonstrate early functional restoration of the scaffolded and adjacent segments at 1 year, which is preserved up to 2 years.

Cited by 26 publications

References 28 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

Mechanical behavior of polymer-based vs. metallic-based bioresorbable stents

Effects of Catheterization on Artery Function and Health: When Should Patients Start Exercising Following Their Coronary Intervention?

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