Head-to-Head Comparison of the Neointimal Response Between Metallic and Bioresorbable Everolimus-Eluting Scaffolds Using Optical Coherence Tomography

Gomez‐Lara, Josep; Brugaletta, Salvatore; Farooq, Vasim; Onuma, Yoshinobu; Diletti, Roberto; Windecker, Stephan; Thuesen, Leif; McClean, Dougal; Koolen, Jacques; Whitbourn, Robert; Dudek, Dariusz; Smits, Pieter C.; Chevalier, Bernard; Regar, Evelyn; Veldhof, Susan; Rapoza, Richard; Ormiston, John A.; García‐García, Héctor M.; Serruys, Patrick W.

doi:10.1016/j.jcin.2011.08.016

Cited by 63 publications

(27 citation statements)

References 30 publications

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“…A parallel increment in neointimal growth as assessed by OCT was found at 6 to 12 months (neointimal area: 5,22,24 at the same time points. Taken together, neointimal proliferation with a magnesium-based, paclitaxeleluting, bioabsorbable scaffold remains excessive.…”

Section: Vascular Healing Responsementioning

confidence: 65%

Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Waksman

Prati

Bruining

et al. 2013

Circ: Cardiovascular Interventions

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1,2 stent thrombosis, especially at the late phase, remains a major concern, probably related to delayed healing, chronic inflammation, and impaired endothelialization.3 Furthermore, metallic stents are associated with artifacts in noninvasive imaging of MRI or multislice computed tomography, impairment of vessel geometry, and often jailing of side branches. Because of their permanent nature, metallic stents can also induce neoatherosclerosis during long-term follow-up. 4 Polymeric bioabsorbable temporary scaffolds have been developed to resolve these limitations. Second-generation bioabsorbable everolimus-eluting scaffold systems (BVS 1.1, ABSORB; Abbott Vascular, Santa Clara, CA) have shown a late lumen loss at 12 months similar to that seen with permanent everolimus-eluting stents (EES), along with a major adverse cardiac event rate of 7.1%. 5 In addition, unlike permanent metallic stents, interesting observations of the bioresorbable vascular scaffold technology are vessel lumen enlargement during follow-up and the ability of the vessel to Background-The drug-eluting absorbable metal scaffold has demonstrated feasibility, safety, and promising clinical and angiographic outcomes at 12 months in human coronary arteries. This study aimed to evaluate the degradation rate and long-term vascular responses to drug-eluting absorbable metal scaffold. Methods and Results-BIOSOLVE-I was a multicenter, single-arm, first-in-man trial assessing the safety and performance of drug-eluting absorbable metal scaffold in 46 patients with coronary artery disease. Patients who underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography, at 6 and 12 months were included in this study. From postimplantation to follow-up, arterial curvature and angulation were significantly increased by the degradation process. The greatest increase was seen from postimplantation to 6 months. The systolic-diastolic changes of the curvature and angulation gradually improved throughout the follow-up period. At the site of implantation, vasoconstriction (−10% mean reduction) was observed during the acetylcholine test at 6 months. The average percent hyperechogenicity of the scaffolded segments showed a continuous decrease over time, with the most pronounced changes within the first 6 months (from 22.1±7.0% to 15.8±3.7%; P<0.001). Struts discernible on optical coherence tomography at 6 and 12 months showed full neointimal coverage, with stabilization of the mean scaffold area from 6 to 12 months. Furthermore, the mean neointimal area (1.55±0.51 versus 1.58±0.34 mm 2 ; P=0.794) remained unchanged from 6 to 12 months. Conclusions-This

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Section: Vascular Healing Responsementioning

confidence: 65%

Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Waksman

Prati

Bruining

et al. 2013

Circ: Cardiovascular Interventions

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“…12 Therefore, research in this fi eld has been redirected toward biodegradable polymer-based metallic DES, polymer-free DES, or completely bioresorbable scaff olds. [28][29][30] Although these pathological fi ndings were noted after implantation of fi rst-generation DES, the use of EES has provided reassuring data in imaging studies in animals and people [31][32][33] that have been confi rmed in a network meta-analysis of ST-elevation myocardial infarction. 34 However, this meta-analysis was limited by the availability of only two trials specifi cally designed for patients with ST-elevation myocardial infarction (the EXAMINATION trial 21 and the XAMI trial 35 of the comparison of EES vs fi rst-generation sirolimus-eluting stents) and by the shorter follow-up (1 year and 2 years).…”

Section: Discussionmentioning

confidence: 98%

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

et al. 2016

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SummaryBackground Data for the safety and effi cacy of new-generation drug-eluting stents at long-term follow-up, and specifi cally in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial.

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“…Whereas compared with DEB it may achieve greater acute gain, prevent acute recoil, and stabilize dissections. Furthermore, BVS allows a more prolonged drug-delivery, which is comparable with that obtained after DES implantation, 22 and it delivers everolimus, which is known to be a superior antiproliferative drug compared with paclitaxel. 23 However, the BVS struts thickness (150 μm) associated with a higher BVS/vessel ratio compared with what observed for conventional metallic DES (26% versus 12%) 24 may represent an important limitation to its use particularly in small restenotic vessels (RVD ≤2.8 mm).…”

Section: Downloaded From Bioresorbable Scaffold For In-stent Restenosmentioning

confidence: 96%

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis

Moscarella

Ielasi

Granata

et al. 2016

Circ: Cardiovascular Interventions

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T reatment of in-stent restenosis (ISR) is still a technical challenge for interventional cardiologists. Several studies have demonstrated that treating drug-eluting stent (DES) ISR is even more challenging because of the unfavorable substrate of DES ISR because of the presence of resistant stent underexpansion or neoatherosclerosis that have been shown to be associated with poorer clinical and angiographic outcomes than treating bare-metal stent (BMS) ISR.1-4 Despite this, current recommended options for ISR treatment are DES or drug-eluting balloon (DEB), regardless of the type of ISR lesion (within BMS or DES).5 However, both these technologies present some drawbacks and recently the bioresorbable vascular scaffold (BVS, ABSORB; Abbott Vascular, Santa Clara, CA) has emerged as an attractive alternative strategy for ISR. No in-hospital death, myocardial infarction, or revascularization occurred. At 15 months of follow-up, the incidence of the device-oriented composite end point estimated with the Kaplan-Meier method was 9.1%. No significant differences were reported between drug-eluting stent and bare-metal stent ISR groups in terms of device-oriented composite end point (10.9% versus 6.4%; hazard ratio, 1.7; 95% confidence interval, 0.5-6.5; P=0.425) and its singular components (cardiac death: 2.8% versus 2.0%, hazard ratio, 1.3; 95% confidence interval, 0.1-14.1, P=0.843; target vessel myocardial infarction: 1.5% versus 0%, P=0.421; ischemia-driven target lesion revascularization: 9.6% versus 4.4%, hazard ratio, 2.3; 95% confidence interval, 0.5-10.8, P=0.309). Conclusions-Our registry suggests that the use of BVS implantation for the treatment of complex drug-eluting stent and bare-metal stent ISR lesions might be associated with acceptable long-term clinical outcomes.(Circ Cardiovasc Interv. 2016;9:e003148.

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Head-to-Head Comparison of the Neointimal Response Between Metallic and Bioresorbable Everolimus-Eluting Scaffolds Using Optical Coherence Tomography

Abstract: The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

Cited by 63 publications

References 30 publications

Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Serial Observation of Drug-Eluting Absorbable Metal Scaffold

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

Long-Term Clinical Outcomes After Bioresorbable Vascular Scaffold Implantation for the Treatment of Coronary In-Stent Restenosis

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