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Patrick W Serruys - One of the best experts on this subject based on the ideXlab platform.

  • acute and long term relocation of minimal lumen area after Bioresorbable Scaffold or metallic stent implantation
    Eurointervention, 2019
    Co-Authors: Yuki Katagiri, Patrick W Serruys, Joanna J. Wykrzykowska, Carlos Collet, Erhan Tenekecioglu, Jan J Piek, Taku Asano, Yosuke Miyazaki, Athanasios Katsikis, Bernard Chevalier
    Abstract:

    Aims: The aim of this study was to investigate relocation of minimal lumen area (MLA) after implantation of a Bioresorbable Scaffold (BRS). Methods and results: In the ABSORB II randomised trial (BRS vs everolimus-eluting stent [EES]), lesions were investigated by serial intravascular ultrasound pre procedure, post procedure, and at three years. MLA relocation was defined as an axial MLA shift of more than 2.4 mm. MLA relocation from post procedure to three years was observed in 163/237 (68.8%) and 75/129 (58.1%) of lesions treated by BRS and EES, respectively (p=0.041). When matching preprocedural MLA site with the same topographical sites post procedure and at three years, BRS showed significant late lumen enlargement and expansive remodelling compensating for significant plaque increase, whereas EES showed significant late lumen narrowing with significant plaque growth not compensated for by expansive remodelling from post procedure to three years. In the multivariate analysis, female gender, previous PCI, BRS implantation, total device length, and maximal pressure (either at device implantation or post-dilatation) were independently associated with MLA relocation from post procedure to three years. Conclusions: MLA relocation from post procedure to three years was more frequent in BRS than EES. Late lumen enlargement and expansive vessel remodelling at the preprocedural MLA site was observed in BRS, but not in EES.

  • 500 02 clinical outcomes at 2 years of the absorb Bioresorbable vascular Scaffold versus the xience drug eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease aida trial sub study
    Jacc-cardiovascular Interventions, 2019
    Co-Authors: Ruben Tijssen, Patrick W Serruys, Laura S.m. Kerkmeijer, Robin P. Kraak, Sjoerd H. Hofma, René J. Van Der Schaaf, Karin Arkenbout, Auke P.j.d. Weevers, Maarten A Vink, Yoshinobu Onuma
    Abstract:

    Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which Bioresorbable Scaffold implantation in percutaneous coronary intervention (PCI) might lead to better outcomes when compared to conventional treatment with metallic drug-eluting stents. ACS patients (STE-ACS

  • TCTAP A-063 Endothelial Shear Stress and Vascular Remodeling in Bioresorbable Scaffold and Metallic Stent in the ABSORB II Trial
    Journal of the American College of Cardiology, 2019
    Co-Authors: Erhan Tenekecioglu, Yoshinobu Onuma, Yuki Katagiri, Ryo Torii, Christos V. Bourantas, Frank J. H. Gijsen, Patrick W Serruys
    Abstract:

    The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with a Bioresorbable Scaffold (BRS) as compared to the metallic drug-eluting stent (DES) remains elusive. To determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen

  • Bioresorbable Scaffold: The Emerging Reality and Future Directions.
    Circulation research, 2017
    Co-Authors: Yohei Sotomi, Renu Virmani, Yoshinobu Onuma, Carlos Collet, Erhan Tenekecioglu, Neal S. Kleiman, Patrick W Serruys
    Abstract:

    In the era of drug-eluting stents, large-scale randomized trials and all-comer registries have shown excellent clinical results. However, even the latest-generation drug-eluting stent has not managed to address all the limitations of permanent metallic coronary stents, such as the risks of target lesion revascularization, neoatherosclerosis, preclusion of late lumen enlargement, and the lack of reactive vasomotion. Furthermore, the risk of very late stent, although substantially reduced with newer-generation drug-eluting stent, still remains. These problems were anticipated to be solved with the advent of fully biodegradable devices. Fully Bioresorbable coronary Scaffolds have been designed to function transiently to prevent acute recoil, but have retained the capability to inhibit neointimal proliferation by eluting immunosuppressive drugs. Nevertheless, long-term follow-up data of the leading Bioresorbable Scaffold (Absorb) are becoming available and have raised a concern about the relatively higher incidence of Scaffold thrombosis. To reduce the rate of clinical events, improvements in the device, as well as implantation procedure, are being evaluated. This review will focus on the current CE-mark approved Bioresorbable Scaffolds, their basic characteristics, and clinical results. In addition, we summarize the current limitations of Bioresorbable Scaffold and their possible solutions.

  • comparison of an everolimus eluting Bioresorbable Scaffold with an everolimus eluting metallic stent for the treatment of coronary artery stenosis absorb ii a 3 year randomised controlled single blind multicentre clinical trial
    The Lancet, 2016
    Co-Authors: Patrick W Serruys, Didier Carrié, Bernard Chevalier, Yohei Sotomi, Dariusz Dudek, Angel Cequier, Jan J Piek, Ad J Van Boven, Marcello Dominici, Dougal Mcclean
    Abstract:

    Summary Background No medium-term data are available on the random comparison between everolimus-eluting Bioresorbable vascular Scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the Bioresorbable Scaffold: increase in luminal dimensions as a result of recovered vasomotion of the Scaffolded vessel. Methods The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18–85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting Bioresorbable Scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb Bioresorbable Scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. Findings Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; p superiority =0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; p non-inferiority =0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm 2 [SD 1·48] vs 5·38 mm 2 [1·51]; p vs 5%, hazard ratio 2·17 [95% CI 1·01–4·70]; log-rank test p=0·0425), mainly driven by target vessel myocardial infarction (6% vs 1%; p=0·0108), including peri-procedural myocardial infarction (4% vs 1%; p=0·16). Interpretation The trial did not meet its co-primary endpoints of superior vasomotor reactivity and non-inferior late luminal loss for the Absorb Bioresorbable Scaffold with respect to the metallic stent, which was found to have significantly lower late luminal loss than the Absorb Scaffold. A higher rate of device-oriented composite endpoint due to target vessel myocardial infarction, including peri-procedural myocardial infarction, was observed in the Absorb group. The patient-oriented composite endpoint, anginal status, and exercise testing, were not statistically different between both devices at 3 years. Future studies should investigate the clinical impact of accurate intravascular imaging in sizing the device and in optimising the Scaffold implantation. The benefit and need for prolonged dual antiplatelet therapy after Bioresorbable Scaffold implantation could also become a topic for future clinical research. Funding Abbott Vascular.

Yoshinobu Onuma - One of the best experts on this subject based on the ideXlab platform.

  • the 2010s in clinical drug eluting stent and Bioresorbable Scaffold research a dutch perspective
    Netherlands Heart Journal, 2020
    Co-Authors: Yoshinobu Onuma, Joanna J. Wykrzykowska, Pieter C Smits, Hideyuki Kawashima, Paolo Zocca, Rosaly A Buiten, R J De Winter, C Von Birgelen
    Abstract:

    Dutch researchers were among the first to perform clinical studies in bare metal coronary stents, the use of which was initially limited by a high incidence of in-stent restenosis. This problem was greatly solved by the introduction of drug-eluting stents (DES). Nevertheless, enthusiasm about first-generation DES was subdued by discussions about a higher risk of very-late stent thrombosis and mortality, which stimulated the development, refinement, and rapid adoption of new DES with more biocompatible durable polymer coatings, biodegradable polymer coatings, or no coating at all. In terms of clinical DES research, the 2010s were characterised by numerous large-scale randomised trials in all-comers and patients with minimal exclusion criteria. Bioresorbable Scaffolds (BRS) were developed and investigated. The Igaki-Tamai Scaffold without drug elution was clinically tested in the Netherlands in 1999, followed by an everolimus-eluting BRS (Absorb) which showed favourable imaging and clinical results. Afterwards, multiple clinical trials comparing Absorb and its metallic counterpart were performed, revealing an increased rate of Scaffold thrombosis during follow-up. Based on these studies, the commercialisation of the device was subsequently halted. Novel technologies are being developed to overcome shortcomings of first-generation BRS. In this narrative review, we look back on numerous devices and on the DES and BRS trials reported by Dutch researchers.

  • 500 02 clinical outcomes at 2 years of the absorb Bioresorbable vascular Scaffold versus the xience drug eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease aida trial sub study
    Jacc-cardiovascular Interventions, 2019
    Co-Authors: Ruben Tijssen, Patrick W Serruys, Laura S.m. Kerkmeijer, Robin P. Kraak, Sjoerd H. Hofma, René J. Van Der Schaaf, Karin Arkenbout, Auke P.j.d. Weevers, Maarten A Vink, Yoshinobu Onuma
    Abstract:

    Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which Bioresorbable Scaffold implantation in percutaneous coronary intervention (PCI) might lead to better outcomes when compared to conventional treatment with metallic drug-eluting stents. ACS patients (STE-ACS

  • TCTAP A-063 Endothelial Shear Stress and Vascular Remodeling in Bioresorbable Scaffold and Metallic Stent in the ABSORB II Trial
    Journal of the American College of Cardiology, 2019
    Co-Authors: Erhan Tenekecioglu, Yoshinobu Onuma, Yuki Katagiri, Ryo Torii, Christos V. Bourantas, Frank J. H. Gijsen, Patrick W Serruys
    Abstract:

    The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with a Bioresorbable Scaffold (BRS) as compared to the metallic drug-eluting stent (DES) remains elusive. To determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen

  • three year follow up of the randomised comparison between an everolimus eluting Bioresorbable Scaffold and a durable polymer everolimus eluting metallic stent in patients with st segment elevation myocardial infarction trofi ii trial
    Eurointervention, 2018
    Co-Authors: Yuki Katagiri, Yoshinobu Onuma, Evald Høj Christiansen, Sjoerd H. Hofma, Angel Cequier, Taku Asano, Andres Iniguez, Lisette Okkels Jensen, Maarten J Suttorp, Salvatore Brugaletta
    Abstract:

    Introduction Previous midterm follow-up reports after implantation of the Absorb™ everolimus-eluting Bioresorbable Scaffold (BRS; Abbott Vascular, Santa Clara, CA, USA) in stable coronary artery disease and acute coronary syndrome have shown an increase of Scaffold thrombosis leading to an excess of the device-oriented composite endpoint (DOCE: a composite of cardiac death, target vessel myocardial infarction [TVMI], and clinically driven target lesion revascularisation [CD-TLR])1. In contrast, in the six-month primary report of ABSORB STEMI: the TROFI II Study (NCT01986803)2, which randomised patients with ST-elevation myocardial infarction (STEMI) to receive either the Absorb BRS or the XIENCE metallic everolimus-eluting stent (EES; Abbott Vascular), optical frequency domain imaging (OFDI)-derived healing score was comparable between the BRS arm and the EES arm. The aim of this report was to present the three-year clinical outcome results of the BRS and the metallic EES at the time when full resorption of the Scaffold device can be expected. Methods The trial design and methods, as well as the study population, have been described in previous reports2. Follow-up information at three years was available in 100% of the study population (Figure 1). All clinical events were adjudicated by an independent clinical events adjudication committee. Time-to-event variables were compared by log-rank test. Results Clinical outcomes at three years are tabulated in Table 1. At three years, the rates of DOCE were 5.3% (5/95) in the BRS arm and 3.1% (3/96) in the EES arm without a statistically significant difference (p=0.465). There were two cardiac deaths (2.1%) in the BRS arm: one was adjudicated as cardiac death on day 280 since no information was available as the patient died overseas. The autopsy of the second patient who died on day 999 revealed no evidence of Scaffold thrombosis. There were no cardiac deaths in the EES arm. Discussion Three years after implantation of BRS or EES, in the setting of primary PCI, the rates of DOCE and ST were low and not significantly different between both arms. It is of note that there were no cases of ST after two years, while most of the patients in both arms discontinued dual antiplatelet therapy between one and two years (Supplementary Table 1). The three-year clinical results are in line with the comparable OFDI-derived healing scores2 and neointimal quality3 at six months. In addition, the recent report in the subpopulation of the current cohort showed a better vasomotion in BRS than in EES and similar microcirculatory function as well as healing score at three years4. Although routine thrombectomy is not recommended in the recent guidelines, in treating STEMI patients with BRS, thrombectomy could facilitate better Scaffold sizing to achieve better long-term outcome. In the substudy of the present trial4, intraluminal dismantling was observed by OCT in 26.3%. However, the fact that the substudy only included event-free patients precludes the understanding of the clinical implication of intraluminal dismantling. Limitations The trial was not powered to evaluate clinical endpoints. The implantation technique reflects the state of the art at the time of enrolment in 2014 and did not take into account the more recent findings on BRS usage in terms of size selection, lesion preparation and deployment technique. It remains to be elucidated whether the comparative clinical outcomes in this study performed in STEMI patients will be maintained after three years. Conclusions Three years after implantation of BRS or EES, in the setting of primary PCI, the rates of DOCE and ST were low and not significantly different between both arms. The three-year clinical results are in line with the comparable healing scores observed at six months. However, the study was not powered to assess clinical endpoints.

  • Bioresorbable Scaffold: The Emerging Reality and Future Directions.
    Circulation research, 2017
    Co-Authors: Yohei Sotomi, Renu Virmani, Yoshinobu Onuma, Carlos Collet, Erhan Tenekecioglu, Neal S. Kleiman, Patrick W Serruys
    Abstract:

    In the era of drug-eluting stents, large-scale randomized trials and all-comer registries have shown excellent clinical results. However, even the latest-generation drug-eluting stent has not managed to address all the limitations of permanent metallic coronary stents, such as the risks of target lesion revascularization, neoatherosclerosis, preclusion of late lumen enlargement, and the lack of reactive vasomotion. Furthermore, the risk of very late stent, although substantially reduced with newer-generation drug-eluting stent, still remains. These problems were anticipated to be solved with the advent of fully biodegradable devices. Fully Bioresorbable coronary Scaffolds have been designed to function transiently to prevent acute recoil, but have retained the capability to inhibit neointimal proliferation by eluting immunosuppressive drugs. Nevertheless, long-term follow-up data of the leading Bioresorbable Scaffold (Absorb) are becoming available and have raised a concern about the relatively higher incidence of Scaffold thrombosis. To reduce the rate of clinical events, improvements in the device, as well as implantation procedure, are being evaluated. This review will focus on the current CE-mark approved Bioresorbable Scaffolds, their basic characteristics, and clinical results. In addition, we summarize the current limitations of Bioresorbable Scaffold and their possible solutions.

Juan F. Granada - One of the best experts on this subject based on the ideXlab platform.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS: A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS: At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION: At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Chang Lee, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • TCT-160 A Novel Thin Strut (100 μm) Sirolimus-Eluting Bioresorbable Scaffold With Hybrid Cell Design: Preclinical Evaluation In Porcine Coronary Arteries
    Journal of the American College of Cardiology, 2015
    Co-Authors: Pawel Gasior, Renu Virmani, Yanping Cheng, Jenn Mcgregor, Gerard Conditt, Juan F. Granada, Lijie Wang, Gaoke Feng, Frank D. Kolodgie, Greg L. Kaluza
    Abstract:

    The first-in-class and most widely commercially available Bioresorbable Scaffold (BRS) Absorb has strut thickness of 150 microns, far exceeding those of contemporary drug-eluting stents. As such, it has potential for delivery challenges and higher thrombogenicity. As such, decreasing the BRS strut

  • DRUG RELEASE PROFILE OF A NOVEL SIROLIMUS ELUTING Bioresorbable Scaffold: IMPLICATION ON NEOINTIMAL FORMATION AND HEALING
    Journal of the American College of Cardiology, 2015
    Co-Authors: Masahiko Shibuya, Yanping Cheng, Alex Estrada, Kamal Ramzipoor, Chang Lee, Greg L. Kaluza, Jennifer Mcgregor, Serge Rousselle, Juan F. Granada
    Abstract:

    The first-in-class Absorb (Abbott Vascular, Santa Clara, CA) Bioresorbable Scaffold (BRS) is eluting everolimus, but a number of other Scaffolds are in development with sirolimus as the antirestenotic agent. In this study, we set out to correlate the pharmacokinetic data with antirestenotic efficacy

Antonio Colombo - One of the best experts on this subject based on the ideXlab platform.

  • Latest generation stents: is it time to revive the Bioresorbable Scaffold?
    Minerva cardioangiologica, 2020
    Co-Authors: Andrea Buono, Alfonso Ielasi, Antonio Colombo
    Abstract:

    Bioresorbable Scaffolds (BRS) have been introduced in the last decade in percutaneous coronary interventions. Despite several advantages being postulated, the negative results from the mid-term follow-up of the Absorb trials have tempered enthusiasm for these innovative devices. The Absorb Scaffold was associated with higher rates of target-lesion failure and Scaffold thrombosis when compared to current metallic stents, and for this reason was withdrawn from the market. This failure has to be considered multifactorial, involving technical and technological aspects. Continuous engineering refinements in BRS technology, means newer-generation devices are available in clinical practice, and several more are under preclinical and clinical assessment. Thinner and smaller struts, associated with a faster resorption and reendothelialization process, are at the basis of promising preclinical results for new BRS. In this review we summarize the Absorb Scaffold experience and focus on the latest evidence concerning emerging new BRS, to explore if a "BRS revival" is conceivable.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS: A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS: At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION: At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Chang Lee, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • New generation Bioresorbable Scaffold technologies: an update on novel devices and clinical results.
    Journal of Thoracic Disease, 2017
    Co-Authors: Damiano Regazzoli, Antonio Colombo, Pier Pasquale Leone, Azeem Latib
    Abstract:

    Bioresorbable Scaffolds (BRS) represent a novel horizon in interventional cardiology and may lead to some potential long-term advantages including the restoration of vasomotion, positive remodeling and a reduced incidence of late and very-late Scaffold thrombosis (ScT). This technology, introduced to overcome limitations of current metallic drug-eluting stents (DES), is constantly and rapidly evolving with many companies working on Bioresorbable devices. The aim of this review is to present an update on the most promising Scaffolds that are under development.

  • Bioresorbable Scaffolds for treatment of coronary bifurcation lesions: Critical appraisal and future perspectives.
    Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2016
    Co-Authors: Roberto Diletti, Azeem Latib, Antonio Colombo, Robert Jan Van Geuns, Didier Tchetche, Emanuele Barbato, Bruno Farah, Jean Fajadet, Nicolas M Van Mieghem
    Abstract:

    Bioresorbable vascular Scaffolds have been recently introduced as a novel paradigm for coronary artery disease treatment allowing temporary vessel support and drug delivery without indefinite coronary caging, potentially reducing the long-term limitation of metallic stents. The scientific community has rapidly embraced this concept and Bioresorbable devices have been introduced in clinical practice. However, despite the fact that bifurcation lesions represent a large and challenging subset in the field of interventional cardiology, this subgroup of lesions have been avoided in the initial experience with Bioresorbable Scaffolds and clear recommendations on methodological approaches are lacking. In the present report, we describe the various techniques for bifurcation treatment with Bioresorbable Scaffolds and the theoretical advantages and disadvantages of this technology in different scenarios, with a glimpse to challenging subsets and possible complications. Therefore, we aim to provide experience based insights and practical guidance for Bioresorbable Scaffold implantation in bifurcation lesions. © 2016 Wiley Periodicals, Inc.

Pawel Gasior - One of the best experts on this subject based on the ideXlab platform.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES: In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND: The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS: A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS: At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION: At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • first in human evaluation of the vascular biocompatibility and biomechanical performance of a novel ultra high molecular weight amorphous plla Bioresorbable Scaffold in the absence of anti proliferative drugs two year imaging results in humans
    Catheterization and Cardiovascular Interventions, 2018
    Co-Authors: Miguel Moncada, Pawel Gasior, Alex Estrada, Kamal Ramzipoor, Chang Lee, Antonio Colombo, Juan A Delgado, Danny Dokko, Juan F. Granada
    Abstract:

    OBJECTIVES In this first-in-human study, we prospectively studied the vascular compatibility and mechanical performance of a novel bare ultra-high molecular weight amorphous PLLA Bioresorbable Scaffold (BRS, FORTITUDE®, Amaranth Medical, Mountain View, California) up to two years after implantation using multimodality imaging techniques. BACKGROUND The vascular biocompatibility of polymers used in BRS has not been fully characterized in the absence of anti-proliferative drugs. METHODS A total of 10 patients undergoing single Scaffold implantation were included in the final analysis and were followed up using optical coherence tomography (OCT) at 2-years. All devices were implanted under angiographic and intravascular ultrasound (IVUS) guidance. Angiographic and IVUS follow up was performed at 6 months. Additionally, angiography and OCT imaging were performed at 2-years. RESULTS At 6 months, mean intra-Scaffold angiographic MLD slightly decreased from baseline procedural values. However, at 2 years, mean angiographic MLD increased (post procedure; 2.9 [2.7, 3.1] mm vs. 6 months; 2.1 [1.6, 2.5] vs. 2 years; 2.4 [2.1, 2.6], P = .001). Also, angiographic percent diameter stenosis decreased and late lumen gain increased between 6 months and 2 years follow up. Mean neointimal hyperplasia volume assessed by IVUS at 6 months was 26% [15.2, 29.3]. At 2 years OCT follow up neointimal hyperplasia volume was 24.2% [19.4, 28.9]. No presence of neoatherosclerosis was identified in any of the analyzed cases. CONCLUSION At 2 years, this novel PLLA-based BRS induced expansive vascular remodeling from 6 to 24 months, a biological phenomenon that appears to be independent of the presence of anti-proliferative drugs.

  • TCT-31 Impact of Strut Thickness on Short-Term Healing Response after Bioresorbable Scaffold Implantation: Serial OCT Evaluation of Novel Thin Strut Sirolimus Eluting BRS Versus Thick Strut Everolimus Eluting BRS in Porcine Coronary Arteries.
    Journal of the American College of Cardiology, 2016
    Co-Authors: Pawel Gasior, Yanping Cheng, Jinggang Xia, Andres Valencia, Alex Estrada, Jenn Mcgregor, Kamal Ramzipoor, Chang Lee, Gerard Conditt, Greg L. Kaluza
    Abstract:

    The most widely commercially available Bioresorbable Scaffold (BRS) Absorb has strut thickness of 165 microns. Therefore, it has potential for higher thrombogenicity, especially in the early phase of vessel healing. As such, decreasing the BRS strut thickness with no adverse effect on its

  • TCT-160 A Novel Thin Strut (100 μm) Sirolimus-Eluting Bioresorbable Scaffold With Hybrid Cell Design: Preclinical Evaluation In Porcine Coronary Arteries
    Journal of the American College of Cardiology, 2015
    Co-Authors: Pawel Gasior, Renu Virmani, Yanping Cheng, Jenn Mcgregor, Gerard Conditt, Juan F. Granada, Lijie Wang, Gaoke Feng, Frank D. Kolodgie, Greg L. Kaluza
    Abstract:

    The first-in-class and most widely commercially available Bioresorbable Scaffold (BRS) Absorb has strut thickness of 150 microns, far exceeding those of contemporary drug-eluting stents. As such, it has potential for delivery challenges and higher thrombogenicity. As such, decreasing the BRS strut