Bioresorbable Coronary Scaffold Thrombosis

Puricel, Serban; Cuculi, Florim; Weissner, Melissa; Schmermund, Axel; Jamshidi, Peiman; Nyffenegger, Tobias; Binder, Harald; Eggebrecht, Holger; Münzel, Thomas; Cook, Stéphane; Gori, Tommaso

doi:10.1016/j.jacc.2015.12.019

Cited by 299 publications

(102 citation statements)

References 25 publications

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“…In fact, concerns about ST of BRS have recently been raised [14,15]. A retrospective study of not only ACS but also stable angina patients showed stent thrombosis can be reduced when guideline-based implantation protocol with appropriate BRS size and pre-and postdilatation was employed [13]. However, in ACS patients of the present study, ST rates still remained higher in both the BRS groups than in EES group.…”

Section: Discussioncontrasting

confidence: 48%

“…Recently, bioresorbable vascular scaffolds (BRS) were introduced, which provide temporary vessel scaffolding with drug delivery capacity but do not carry the limitations of a permanent metallic stent in the long term [8,9]. Prospective studies demonstrated BRS safety and efficacy on selected patients [10][11][12], but some studies have reported increased ST rates [13][14][15][16][17][18][19]. However, data on a large sample of ACS patients are still lacking [15,17,[20][21][22][23][24], and only few studies have evaluated the impact of lesion preparation and postdilatation of BRS [25][26][27].…”

Section: Introductionmentioning

confidence: 99%

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Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

et al. 2016

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Background: Safety and efficacy of bioresorbable vascular scaffolds (BRS) and the role of postdilatation on outcome in acute coronary syndrome (ACS) patients compared with those of everolimus-eluting stents (EES) remain unknown. The aim of the study is to compare the safety and efficacy of BRS with EES in ACS and without, comparable to EES patients (6.0% vs. 12.6% vs. 4.7%, p < 0.001). The same trend was observed for TLR (3.4% vs. 8.4% vs. 1.9%, p < 0.001 (Cardiol J 2016; 23, 4: 374-383)

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Section: Discussioncontrasting

confidence: 48%

Section: Introductionmentioning

confidence: 99%

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

et al. 2016

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“…In this early period, the more aggressive vessel preparation required for BVS implantation, particularly in complex lesions, 21 and the larger footprint of BVS, leading to occlusion of small side branches, may increase the risk for periprocedural MI. 22,23 The thicker, wider scaffold struts may also result in nonlaminar flow and altered shear stress before the scaffold is covered by neointima, 24 activating platelets and increasing the risk for …”

Section: Discussionmentioning

confidence: 99%

Three-Year Outcomes With the Absorb Bioresorbable Scaffold

et al. 2018

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Background: The Absorb bioresorbable vascular scaffold (BVS) completely resorbs within 3 years after coronary artery implantation. The safety and effectiveness of BVS through this critical 3-year period have not been characterized. Methods: We performed an individual-patient-data pooled meta-analysis of the 4 randomized ABSORB trials in which 3389 patients with coronary artery disease were randomly assigned to everolimus-eluting Absorb BVS (n=2164) or cobalt-chromium everolimus-eluting stents (n=1225). The primary efficacy outcome measure was target lesion failure (cardiac mortality, target vessel myocardial infarction, or ischemia-driven target lesion revascularization), and the primary safety outcome measure was device thrombosis. Results: BVS compared with cobalt-chromium everolimus-eluting stents resulted in higher 3-year rates of target lesion failure (11.7% versus 8.1%; risk ratio [RR], 1.38; 95% confidence interval [CI], 1.10–1.73; P =0.006), driven by greater target vessel myocardial infarction (7.8% versus 4.2%; RR, 1.72; 95% CI, 1.26–2.35; P =0.0006) and ischemia-driven target lesion revascularization (6.6% versus 4.4%; RR, 1.44; 95% CI, 1.05–1.98; P =0.02), with comparable cardiac mortality (1.1% versus 1.1%; RR, 0.93; 95% CI, 0.47–1.88; P =0.85). Device thrombosis rates through 3 years were also higher with BVS (2.4% versus 0.6%; RR, 3.71; 95% CI, 1.70–8.11; P =0.001). Between 1 and 3 years, target lesion failure rates (6.1% versus 3.9%; P =0.02) and device thrombosis rates (1.1% versus 0.0%; P <0.0001) were higher with BVS than cobalt-chromium everolimus-eluting stents. Conclusions: In the present individual-patient-data pooled meta-analysis of the ABSORB trials, BVS was associated with increased rates of target lesion failure and device thrombosis between 1 and 3 years and cumulatively through 3 years of follow-up compared with everolimus-eluting stents. Clinical Trial Registration: URL: https://clinicaltrials.gov . Unique identifiers: NCT01751906, NCT01844284, NCT01923740, and NCT01425281.

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“…Optimized implantation strategy with OCT and longer dual antiplatelet therapy would likely reduce acute and subacute scaffold thrombosis19; however, timing of the termination of dual antiplatelet therapy is important to determine as scaffold has been shown to persist even at 5 years after implantation 20. To overcome the adverse end points, second‐generation bioresorbable scaffolds should be thinner and have a faster degradation profile, but radial strength must be comparable to a metallic drug‐eluting stent.…”

Section: Discussionmentioning

confidence: 99%

Comparison of a Drug‐Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3‐Year Follow‐Up

Yahagi

Yang

Torii

et al. 2017

JAHA

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BackgroundArterial Remodeling Technologies bioresorbable scaffold (ART‐BRS), composed of l‐ and d‐lactyl units without drug, has shown its safety in a porcine coronary model at 6 months. However, long‐term performance remains unknown. The aim of this study was to evaluate the ART‐BRS compared to a bare metal stent (BMS) in a healthy porcine coronary model for up to 3 years.Methods and ResultsEighty‐two ART‐BRS and 66 BMS were implanted in 64 Yucatan swine, and animals were euthanatized at intervals of 1, 3, 6, 9, 12, 18, 24, and 36 months to determine the vascular response using quantitative coronary angiography, optical coherence tomography, light and scanning electron microscopy, and molecular weight analysis. Lumen enlargement was observed in ART‐BRS as early as 3 months, which progressively increased up to 18 months, whereas BMS showed no significant difference over time. Percentage area stenosis by optical coherence tomography was greater in ART‐BRS than in BMS at 1 and 3 months, but this relationship reversed beyond 3 months. Inflammation peaked at 6 months and thereafter continued to decrease up to 36 months. Complete re‐endothelialization was observed at 1 month following implantation in both ART‐BRS and BMS. Scaffold dismantling started at 3 months, which allowed early vessel enlargement, and bioresorption was complete by 24 months.Conclusions ART‐BRS has the unique quality of early programmed dismantling accompanied by vessel lumen enlargement with mild to moderate inflammation. The main distinguishing feature of the ART‐BRS from other scaffolds made from poly‐l‐lactic acid may result in early and long‐term vascular restoration.

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Bioresorbable Coronary Scaffold Thrombosis

Abstract: The 12-month incidence of ScT reached 3% and could be significantly reduced when an optimized implantation strategy was employed. (retrospective multicentric registry and Mainz Intracoronary Database. The Coronary Slow-flow and Microvascular Diseases Registry [MICAT]; NCT02180178).

Cited by 299 publications

References 25 publications

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

Impact of postdilatation on performance of bioresorbable vascular scaffolds in patients with acute coronary syndrome compared with everolimus-eluting stents: A propensity score-matched analysis from a multicenter “real-world” registry

Three-Year Outcomes With the Absorb Bioresorbable Scaffold

Comparison of a Drug‐Free Early Programmed Dismantling PDLLA Bioresorbable Scaffold and a Metallic Stent in a Porcine Coronary Artery Model at 3‐Year Follow‐Up

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