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TCT-290 Long-Term Integration of Bioresorbable Vascular Scaffold in the Porcine Coronary Model of Spontaneous Untreated Atherosclerosis: a 4-year QCA, IVUS, OCT and Histology Study
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
TCT-290 Long-Term Integration of Bioresorbable Vascular Scaffold in the Porcine Coronary Model of Spontaneous Untreated Atherosclerosis: a 4-year QCA, IVUS, OCT and Histology Study Yanping Cheng,1 Qing Wang,2 Laura Perkins,3 Richard Rapoza,3 Jenn McGregor,1 Gerard Conditt,1 Aloke Finn,4 Greg Kaluza,1 Juan Granada1 1 CRF Skirball Center for Innovation, Orangeburg, New York, United States; 2Abbott vascular, Santa Clara, California, United States; 3Abbott Vascular, Santa Clara, California, United States; 4CVPath Institute Inc. and University of Maryland, Baltimore, Gaithersburg, Maryland, United States BACKGROUND The integration of the Absorb bioresorbable vascular scaffold (BVS) has never been tested in in-vivo models of atherosclerosis after the resorption process has been completed. We compared the long-term vascular healing of BVS to everolimuseluting metallic stent (EES) in a familial hypercholesterolemic swine (FHS) model of spontaneous untreated atherosclerosis. METHODS The FHS model displays a human-like vascular response to coronary stents. In this study, 20 weeks following initial balloon injury, BVS and EES were implanted in coronary segments of 11 FHS and investigated with imaging and histology at 2 (4 pigs: BVS¼8, EES¼5), 3 (4 pigs: BVS¼8, EES¼4) and 4 years (3 pigs: BVS¼5, EES¼3). RESULTS Compared to 1 year, BVS showed slower late lumen loss than EES (BVS 1.140.37 vs. EES 2.090.12, p¼0.003) by angiography at 4 years. By OCT, there was no significant change in the lumen area in BVS (4.960.74mm vs. 4 year 5.040.97mm, p¼0.97) while the lumen area was significantly decreased in EES (8.111.18mm vs. 4 year 5.300.38 mm, p¼0.03). BVS struts were not visible in OCT or IVUS and barely discerned as regions of dense fibrous tissue in histology at 4 years. There was no difference in % diameter stenosis by QCA or total plaque area stenosis by IVUS (2 years: BVS 53.88.3% vs. EES 53.011.6%, p¼0.90; 3 years: BVS 61.219.0% vs. EES 56.322.0%, p¼0.72; 4 years: 62.718.0% vs. EES 67.71.2%, p¼0.57) between two devices at all time points. Consistent with imaging findings, histomorphometry showed no increase in area stenosis in BVS from 2 to 4 years (2 years: 69.07.9% vs. 3 years: 73.015.7%, p¼0.53; BVS 3 years vs. 4 years: 70.625.0%, p¼0.83) and in EES from 2 to 3 years (2 years: 57.211.4 vs. 3 years: 50.15.3%, p¼0.36). However, there was a significant increase in EES area stenosis from 3 to 4 years (4 years: 70.75.9%, p¼0.01) consistent with the increased late lumen loss in EES implanted vessels. CONCLUSION In presence of untreated atherosclerosis, BVS demonstrates comparable long-term vascular healing and antirestenotic efficacy to EES, with lower late lumen loss at 4 years thanks to favorable remodeling not attainable in the EES-caged segments. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-291 3-Year Results of Patients Undergoing Everolimus-eluting Bioresorbable Scaffolds Implantation During Daily Clinical Routine Jens Wiebe,1 Petra Hoppmann,2 Felix Voll,3 Tobias Rheude,3 Roisin Colleran,1 Sebastian Kufner,1 Salvatore Cassese,1 Michael Joner,3 Adnan Kastrati,3 Robert Byrne1 1 Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 21. med. Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 3Deutsches Herzzentrum München, Munich, Germany BACKGROUND Concern exists regarding the long-term clinical outcomes of patients undergoing drug-eluting bioresorbable scaffolds (BRS) implantation based on analysis of data from randomized trials. However, patients treated in routine practice may differ from those enrolled in randomized trials and late follow-up data from clinical practice is scarce. METHODS Consecutive patients undergoing implantation of everolimus-eluting BRS during clinical routine at two centres in Munich, Germany were included. Core lab quantitative coronary angiography was performed at baseline and at a routine angiographic surveillance, which was scheduled 6-8 months after the index procedure. Clinical follow-up was performed up to 36. The primary endpoint of interest was the composite of death, myocardial infarction or target
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lesion revascularization. The individual components of the composite endpoint, and definite scaffold thrombosis were also assessed. RESULTS A total of 419 patients with a mean age of 66.610.9 years were enrolled in this registry, of which 31.5% suffered from diabetes mellitus. Thirty-nine percent of the patients underwent BRS implantation due to acute coronary syndrome. The mean reference vessel diameter was 2.890.46 mm, 49.0% of lesions were considered to be complex according to the AHA/ACC classification and 13.1% were bifurcation lesions. The quantitative coronary angiography analysis after 6-8 months revealed a late luminal loss of 0.27 0.51 mm. After 24 months of follow-up, the composite endpoint occurred in 21.6%, target lesion revascularization in 16.0% and definite scaffold thrombosis in 3.8%. The 3 year follow-up is currently ongoing and results will be presented at the TCT conference. CONCLUSION Implantation of everolimus-eluting BRS in routine clinical practice is associated with reasonable antirestenotic performance. However rates of clinical events during late follow-up to 2 years were higher than expected. The findings from 3-year follow-up will provide further insight into the late clinical course of patients treated with these devices. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-292 Everolimus eluting biorresorbable vascular scaffold: impact of lesions complexity on clinical outcome and predictors of adverse cardiac events at long term follow up Javier Suarez De Lezo,1 Pedro Martin,2 Jorge Chavarria,3 Soledad Ojeda,3 José Segura,3 Damaso Valeron,4 Jose Novoa,5 Francisco Hidalgo,1 Miguel Romero,3 Manuel Pan3 1 Reina Sofia Hospital, Cordoba, Spain; 2Hospital Universitario Dr. NegrIn, Las Palmas de Gran Canaria, Spain; 3Reina Sofia Hospital, Córdoba, Spain; 4Doctor Negrin Hospital, Las Palmas, Spain; 5Servicio canario de salud, Las palmas de gc, Spain BACKGROUND The aim of this study is to evaluate the long term follow up of a cohort of patients treated with biorresorbable vascular scaffold (BVS), and to look for predictors of mayor adverse cardiac events. METHODS From January 2012 to July 2016, 869 patients with 1056 coronary lesions were treated with BVS in our centres. Pre-dilatation was done according to operator discretion. The scaffold diameter was selected according to the proximal angiographic reference. Post-dilation was performed if under-expansion of the platform was observed or if incomplete scaffold apposition was detected by OCT. Clinical follow up was achieved by medical outpatient visits or telephone calls. RESULTS Most of the patient were male (85%), with hypertension (54%) and hyperlipidaemia (59%) and almost one third of them (26%) were diabetic. The main clinical condition was an acute coronary syndrome (75%). According to AHA classification, 647 lesions (61%) were complex (Type B2 or C). There were 381 bifurcation lesions, (174 of them (45%) true bifurcations), 85 chronic total occlusion lesions, 359 diffuse lesions (> 20 mm) and 65 in stent restenosis lesions. In 208 instances the lesion combined at least 2 types of complexity. Predilation was performed in 482 (45.6%) lesions, and postdilation in 484 (45.8%). OCT or intracoronary ultrasound study was performed in 526 lesions (49%) to assess final result. After a follow up of 2913 months there were 16 deaths -8 cardiac- (1.8%) , 12 myocardial infarction (1.1%), 54 TLR (5.2 % per lesion and 6.1 per patient) with a global MACE of 9.4%. There were 15 thrombosis (1.4% per lesion and 1.7 per patient). According to AHA classification, there were not significant differences in terms of TLR (type A lesions 4.2%, in B1 3.6%, in B2 5.6% and in C type 6% ,p: 0.5) or thrombosis (type A lesions 1.6%, in B1 0.9%, in B2 2.4% and in C type 1% ,p: 0.7). A smaller size of the vessel (2.90.4 vs. 3.10.4, p<0.05), and of the BVS diameter (30.37 vs. 3.160.34), together with a smaller MLD post (2.580.45 vs. 2.810.49, p<0.05) was associated to TLR at follow up. Regarding predictors of thrombosis, it was more frequent in lesions of diabetic patients (3% vs 0.8%, p<0.01), with lower ejection fraction (5413 vs. 6312, p<0.05) and in patients under treatment with clopidogrel, instead of ticagrerol or prasugrel (2.8% vs 0.8%, p<0.01) increased the risk of thrombosis. CONCLUSION Treatment of complex lesions with biorresorbable vascular scaffold is feasible, with a low rate of MACE after 29 months
TCT-290 Long-Term Integration of Bioresorbable Vascular Scaffold in the Porcine Coronary Model of Spontaneous Untreated Atherosclerosis: a 4-year QCA, IVUS, OCT and Histology Study Yanping Cheng,1 Qing Wang,2 Laura Perkins,3 Richard Rapoza,3 Jenn McGregor,1 Gerard Conditt,1 Aloke Finn,4 Greg Kaluza,1 Juan Granada1 1 CRF Skirball Center for Innovation, Orangeburg, New York, United States; 2Abbott vascular, Santa Clara, California, United States; 3Abbott Vascular, Santa Clara, California, United States; 4CVPath Institute Inc. and University of Maryland, Baltimore, Gaithersburg, Maryland, United States BACKGROUND The integration of the Absorb bioresorbable vascular scaffold (BVS) has never been tested in in-vivo models of atherosclerosis after the resorption process has been completed. We compared the long-term vascular healing of BVS to everolimuseluting metallic stent (EES) in a familial hypercholesterolemic swine (FHS) model of spontaneous untreated atherosclerosis. METHODS The FHS model displays a human-like vascular response to coronary stents. In this study, 20 weeks following initial balloon injury, BVS and EES were implanted in coronary segments of 11 FHS and investigated with imaging and histology at 2 (4 pigs: BVS¼8, EES¼5), 3 (4 pigs: BVS¼8, EES¼4) and 4 years (3 pigs: BVS¼5, EES¼3). RESULTS Compared to 1 year, BVS showed slower late lumen loss than EES (BVS 1.140.37 vs. EES 2.090.12, p¼0.003) by angiography at 4 years. By OCT, there was no significant change in the lumen area in BVS (4.960.74mm vs. 4 year 5.040.97mm, p¼0.97) while the lumen area was significantly decreased in EES (8.111.18mm vs. 4 year 5.300.38 mm, p¼0.03). BVS struts were not visible in OCT or IVUS and barely discerned as regions of dense fibrous tissue in histology at 4 years. There was no difference in % diameter stenosis by QCA or total plaque area stenosis by IVUS (2 years: BVS 53.88.3% vs. EES 53.011.6%, p¼0.90; 3 years: BVS 61.219.0% vs. EES 56.322.0%, p¼0.72; 4 years: 62.718.0% vs. EES 67.71.2%, p¼0.57) between two devices at all time points. Consistent with imaging findings, histomorphometry showed no increase in area stenosis in BVS from 2 to 4 years (2 years: 69.07.9% vs. 3 years: 73.015.7%, p¼0.53; BVS 3 years vs. 4 years: 70.625.0%, p¼0.83) and in EES from 2 to 3 years (2 years: 57.211.4 vs. 3 years: 50.15.3%, p¼0.36). However, there was a significant increase in EES area stenosis from 3 to 4 years (4 years: 70.75.9%, p¼0.01) consistent with the increased late lumen loss in EES implanted vessels. CONCLUSION In presence of untreated atherosclerosis, BVS demonstrates comparable long-term vascular healing and antirestenotic efficacy to EES, with lower late lumen loss at 4 years thanks to favorable remodeling not attainable in the EES-caged segments. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-291 3-Year Results of Patients Undergoing Everolimus-eluting Bioresorbable Scaffolds Implantation During Daily Clinical Routine Jens Wiebe,1 Petra Hoppmann,2 Felix Voll,3 Tobias Rheude,3 Roisin Colleran,1 Sebastian Kufner,1 Salvatore Cassese,1 Michael Joner,3 Adnan Kastrati,3 Robert Byrne1 1 Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 21. med. Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 3Deutsches Herzzentrum München, Munich, Germany BACKGROUND Concern exists regarding the long-term clinical outcomes of patients undergoing drug-eluting bioresorbable scaffolds (BRS) implantation based on analysis of data from randomized trials. However, patients treated in routine practice may differ from those enrolled in randomized trials and late follow-up data from clinical practice is scarce. METHODS Consecutive patients undergoing implantation of everolimus-eluting BRS during clinical routine at two centres in Munich, Germany were included. Core lab quantitative coronary angiography was performed at baseline and at a routine angiographic surveillance, which was scheduled 6-8 months after the index procedure. Clinical follow-up was performed up to 36. The primary endpoint of interest was the composite of death, myocardial infarction or target
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lesion revascularization. The individual components of the composite endpoint, and definite scaffold thrombosis were also assessed. RESULTS A total of 419 patients with a mean age of 66.610.9 years were enrolled in this registry, of which 31.5% suffered from diabetes mellitus. Thirty-nine percent of the patients underwent BRS implantation due to acute coronary syndrome. The mean reference vessel diameter was 2.890.46 mm, 49.0% of lesions were considered to be complex according to the AHA/ACC classification and 13.1% were bifurcation lesions. The quantitative coronary angiography analysis after 6-8 months revealed a late luminal loss of 0.27 0.51 mm. After 24 months of follow-up, the composite endpoint occurred in 21.6%, target lesion revascularization in 16.0% and definite scaffold thrombosis in 3.8%. The 3 year follow-up is currently ongoing and results will be presented at the TCT conference. CONCLUSION Implantation of everolimus-eluting BRS in routine clinical practice is associated with reasonable antirestenotic performance. However rates of clinical events during late follow-up to 2 years were higher than expected. The findings from 3-year follow-up will provide further insight into the late clinical course of patients treated with these devices. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-292 Everolimus eluting biorresorbable vascular scaffold: impact of lesions complexity on clinical outcome and predictors of adverse cardiac events at long term follow up Javier Suarez De Lezo,1 Pedro Martin,2 Jorge Chavarria,3 Soledad Ojeda,3 José Segura,3 Damaso Valeron,4 Jose Novoa,5 Francisco Hidalgo,1 Miguel Romero,3 Manuel Pan3 1 Reina Sofia Hospital, Cordoba, Spain; 2Hospital Universitario Dr. NegrIn, Las Palmas de Gran Canaria, Spain; 3Reina Sofia Hospital, Córdoba, Spain; 4Doctor Negrin Hospital, Las Palmas, Spain; 5Servicio canario de salud, Las palmas de gc, Spain BACKGROUND The aim of this study is to evaluate the long term follow up of a cohort of patients treated with biorresorbable vascular scaffold (BVS), and to look for predictors of mayor adverse cardiac events. METHODS From January 2012 to July 2016, 869 patients with 1056 coronary lesions were treated with BVS in our centres. Pre-dilatation was done according to operator discretion. The scaffold diameter was selected according to the proximal angiographic reference. Post-dilation was performed if under-expansion of the platform was observed or if incomplete scaffold apposition was detected by OCT. Clinical follow up was achieved by medical outpatient visits or telephone calls. RESULTS Most of the patient were male (85%), with hypertension (54%) and hyperlipidaemia (59%) and almost one third of them (26%) were diabetic. The main clinical condition was an acute coronary syndrome (75%). According to AHA classification, 647 lesions (61%) were complex (Type B2 or C). There were 381 bifurcation lesions, (174 of them (45%) true bifurcations), 85 chronic total occlusion lesions, 359 diffuse lesions (> 20 mm) and 65 in stent restenosis lesions. In 208 instances the lesion combined at least 2 types of complexity. Predilation was performed in 482 (45.6%) lesions, and postdilation in 484 (45.8%). OCT or intracoronary ultrasound study was performed in 526 lesions (49%) to assess final result. After a follow up of 2913 months there were 16 deaths -8 cardiac- (1.8%) , 12 myocardial infarction (1.1%), 54 TLR (5.2 % per lesion and 6.1 per patient) with a global MACE of 9.4%. There were 15 thrombosis (1.4% per lesion and 1.7 per patient). According to AHA classification, there were not significant differences in terms of TLR (type A lesions 4.2%, in B1 3.6%, in B2 5.6% and in C type 6% ,p: 0.5) or thrombosis (type A lesions 1.6%, in B1 0.9%, in B2 2.4% and in C type 1% ,p: 0.7). A smaller size of the vessel (2.90.4 vs. 3.10.4, p<0.05), and of the BVS diameter (30.37 vs. 3.160.34), together with a smaller MLD post (2.580.45 vs. 2.810.49, p<0.05) was associated to TLR at follow up. Regarding predictors of thrombosis, it was more frequent in lesions of diabetic patients (3% vs 0.8%, p<0.01), with lower ejection fraction (5413 vs. 6312, p<0.05) and in patients under treatment with clopidogrel, instead of ticagrerol or prasugrel (2.8% vs 0.8%, p<0.01) increased the risk of thrombosis. CONCLUSION Treatment of complex lesions with biorresorbable vascular scaffold is feasible, with a low rate of MACE after 29 months