- Email: [email protected]
TCT-422 6 year clinical outcomes after Absorb bioresorbable scaffold implantation in small vessel: The Maasstad Absorb Registry
B170
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
[2 – 3]). The PSP score displays a Nagelkerke’s R2 of 0.06, a HosmerLemeshow statistic of 3.65 (p ¼ 0.887), and an AUCs of 0.584 (95%CI [0.541 – 0.628]). At 1-year, a PSP score of 3 was associated with a lower rate of PoCE when compared to score of <3 (15.3% vs. 23.9%; HR 1.74, CI95% [1.27 – 2.38]; p ¼ 0.001), even after adjustment (HR 1.77, CI95% [1.22 – 2.59]; p ¼ 0.002). At 1-year, each point in the PSP score was associated with a reduction of 43% of risk of definite/probable scaffold thrombosis (HR 0.57, 95%CI [0.35 – 0.93]; p ¼ 0.025). CONCLUSION The PSP score displays a discrete overall performance, calibration, and discrimination abilities to predict adverse cardiac events. A PSP score of 3 was associated with a reduction in PoCE and definite/probable scaffold thrombosis. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-420 Incidence of side branch occlusions following bioresorbable scaffold implantation for long left anterior descending artery lesions Akihito Tanaka,1 Azeem Latib,2 Richard Jabbour,3 Hiroyoshi Kawamoto,4 Antonio Mangieri,5 Damiano Regazzoli,6 Marco Ancona,7 Francesco Giannini,8 Lorenzo Azzalini,9 Alaide Chieffo,10 Mauro Carlino,11 Matteo Montorfano,12 Antonio Colombo13 1 San Raffaele Scientific Institute, Milan, Italy; 2EMO-GVM Centro Cuore Columbus, Milan, Italy; 3NHS, Newington, United Kingdom; 4San Raffaele Scientific Institute/EMO GVM Centro Cuore Columbus, Milan, Milan, Italy; 5San Raffaele Hospital, Milan, Milan, Italy; 6San Raffaele Hospital; 7San Raffaele Scientific Insitute, milan, Milan, Italy; 8 Interventional Cardiology institute San Raffaele Hospital, Soverato, Reggio Calabria, Italy; 9San Raffaele Scientific Institute, Milano, Italy; 10 San Raffaele Scientific Institute, Milan, Italy; 11San Raffaele Hospital, Milan, Milan, Italy; 12San Raffaele Hospital, Milan, Italy; 13Columbus Hospital/San Raffaele Hospital, Milan, Milan, Italy BACKGROUND Bioresorbable vascular scaffolds (BVS) have numerous potential advantages over permanent metallic stents due to the complete resorption process. Long diffuse lesions, especially of the left anterior descending artery (LAD), may be ideal treatment targets for BVS implantation, however concerns exist regarding side branch (SB) occlusions. The purpose of this study was to investigate the incidence of SB occlusions following BVS implantation for long LAD lesions. METHODS Data were examined from patients who underwent LAD percutaneous coronary intervention with BVS between May 2012 and December 2015. Patients were included if the total scaffold length was 40mm in the LAD without concomitant use of metallic stents. One hundred and fourteen patients were analyzed, and a total of 729 LAD SBs were jailed post BVS implantation (6.42.4 per patient). SBs were divided into 3 groups according to the diameters, as determined by visual assessment: 1) small (<1mm); 2) intermediate (1-2mm); and 3) large (>2mm). Side branch occlusion (SBO) was defined as a reduction in TIMI flow to grade 0 or 1 at the end of procedure. RESULTS The total scaffold length in the LAD MB was 62.018.5mm. Out of 729 SBs jailed by BVS, 442 (59.9%) were small (<1mm), 202 (27.7%) intermediate (1-2mm), and 105 (14.4%) large (>2mm). Seventyfour SBs (74/729; 10.2%) were occluded in total. Occluded SBs were more likely to be small (82.4% vs 55.1%, p<0.001), have prexisting ostial stenoses (>50%) (66.2% vs 31.6%; p<0.001), or be SBs at overlapping scaffold sites (23.0% vs 11.6%; p¼0.010). The respective rate of SB occlusion was 14.5% in small (61/442), 5.9% intermediate (12/202), and 1.0% in large (1/105) SBs. The rate of peri-procedural MI was 15.8% in the overall cohort (18.8% of patients with 1 SB occlusion (9/48) vs 13.6% of those without any SBO (9/66) respectively, [p¼0.46]). CONCLUSION Side branch occlusion after BVS implantation in long LAD lesions were mainly of small branches, and the clinical impact may be minimal. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-421 In Vivo Serial Assessment of Coronary Vessel Geometry Restoration and Resorption Process Following the Implantation of Second-Generation Drug-Eluting Absorbable Metal Scaffold (DREAMS 2G): Insights from the BIOSOLVE-II First-In-Man Trial Hector Manel Garcia-Garcia,1 Michael Haude,2 Hüseyin Ince,3 Alexandre Abizaid,4 Ralph Toelg,5 Pedro Lemos,6 Clemens von Birgelen,7 Evald Christiansen,8 William Wijns,9 Franz-Josef Neumann,10 Christoph Kaiser,11 Eric Eeckhout,12 Soo Teik Lim,13 Javier Escaned,14 Ron Waksman15
1
MedStar Washington Hospital Center, Washington DC; Lukaskrankenhaus Neuss, Neuss, Germany; 3Vivantes Klinikum im Friedrichshain and Am Urban; 4Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil; 5Herzzentrum Segeberger Kliniken, Henstedt-Ulzburg, Germany; 6University of São Paulo Medical School, São Paulo, São Paulo, Brazil; 7Thoraxcentrum Twente, Enschede, Netherlands; 8Aarhus University Hospital, Aarhus, Denmark; 9Unknown, Aalst, Belgium; 10Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 11University Hospital Basel, Basel, Switzerland; 12Cardiology, University Hospital CHUV, 1011 Lausanne, Switzerland; 13National Heart Centre Singapore, Singapore, Singapore; 14Hospital Clínico San Carlos, Madrid, Spain; 15 Medstar Heart Institute, Washington, District of Columbia, United States 2
BACKGROUND The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile and stable performance outcomes up to 12 months. We assessed the baseline, 6month and 12-month imaging performance of this novel device which may provide a mechanistic explanation for the optimal clinical results. METHODS The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and –if subjects consented– at 12 months. Quantitative coronary angiography (QCA) - based curvature and angulation were assessed; intravascular ultrasound (IVUS) based echogenicity and radiofrequency data analysis was evaluated. RESULTS Restoration of the vessel geometry was observed as assessed by the serial changes in curvature and angulation; the differences in curvature and angulation between pre-procedure and 12 months are very small with no significant p values (0.9650 and 0.2149 respectively). Refer to Table Advance resorption process, particularly from baseline to 6 months, was detected. Hyperchogenic tissue (echogenicity) and dense calcium (radiofrequency data analysis) – both surrogates for strut size – showed significant decrease. Refer to Table Dense Calcium Curvature (cm-1)
Angulation ( )
percentage
Hyper-
volume, %
echogenic, %
Pre-procedure
0.0414 (0.0309)
31.39 (15.35)
NA
NA
Post-procedure
0.0298 (0.0235)
19.89 (11.97)
37.30 (10.37)
3.69 (2.23)
6-month [95% CI]
0.0383 (0.0307)
27.24 (14.58)
18.87 (8.67)
1.22 (0.76)
12-month [95%
0.0416 (0.0320)
28.05 (15.30)
20.86 (9.96)
1.31 (1.41)
0.0085
7.35 [3.48,11.22]
CI]
D6-month vs post [95% CI]
D12-month vs post [95% CI]
D6-month vs pre [95% CI]
D12-month vs pre [95% CI]
[0.0006,0.0164] 0.0119
8.16 [2.88,13.45]
[0.0011,0.0227] -0.0031 [-0.0110,0.0048] 0.0002 [-0.0106,0.0110]
-18.43 [-21.61,-15.25] -16.44 [-19.62,-13.26]
-4.15
-2.48 [-3.36, -1.60] -2.39 [-3.27, -1.51]
NA
NA
NA
NA
[-8.04,-0.27] -3.34 [-8.63,1.95]
CONCLUSION Restoration of the vessel geometry and fast resorption signs were observed between baseline and 6-12 months following implantation of the drug-eluting metal absorbable scaffold DREAMS 2G. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-422 6 year clinical outcomes after Absorb bioresorbable scaffold implantation in small vessel: The Maasstad Absorb Registry Valeria Paradies,1 Pieter Smits,2 Kees-Jan Royaards,3 Floris Kauer,4 Jochem Wassing,5 Martin van der Ent,6 George Vlachojannis7 1 Maastad Ziekenhuis, Rotterdam, Netherlands; 2Maasstad Ziekenhuis, Rotterdam, Netherlands; 3Unknown, Rotterdam, Netherlands; 4 Department of Cardiovascular Surgery, University of Tübingen, Germany, Rotterdam, Netherlands; 5Maasstad Hospital, Capelle a/ d IJssel, Netherlands; 6Unknown, Alphen aan den Rijn, Netherlands; 7 Factoid Team/ CRF, New York, New York, United States BACKGROUND The safety and efficacy of the Absorb (Abbott) bioresorbable scaffold (BRS) has been documented in lower-risk patient. Early experience with BRS in small vessels (SV) have shown an increased risk of adverse clinical events. Here we report the long-term clinical outcomes of BRS implantation in SV at a high-volume Dutch center. METHODS Between July 2009 and June 2015, 321 patients (363 lesions) were treated with BRS in our center. Registry data collection is
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
ongoing and gathered prospectively in-hospital, at 1 and 6 months and then yearly up to 6 years. We defined SV as vessel with a pre-procedural reference vessel diameter (RVD) 2.75 mm at quantitative coronary analysis (QCA).
TCT-424 One-Year Clinical, Angiographic and OCT Follow-up after Absorb BVS Implantation in Long Coronary Artery Lesions: mechanisms of coronary artery remodeling
RESULTS A total of 207 patients with at least one SV were included in this analysis. Mean follow-up time was 22.4 months14.9 with 85.8 % of patients having at least 1 year of follow-up. Clinical presentation of pts. (72.4% male, mean age 58.5 11.7 years, 16.4% diabetics, 25.6% with previous PCI and/or CABG) was ACS in 55.1%. Multivessel treatment was perfomed in 17,9% (37 pz). Mean lesion length by QCA was 23.7 11.0 mm and mean RVD was 2.20.3 mm with 14.5% of moderate/sever calcification lesions and 19.8 % of bifurcation treatment. Pre-dilatation was performed in 93.2% and post-dilatation in 57.9%. The mean scaffold length was 28.115.0 mm with 30.9% of cases using overlapping scaffolds. OCT or IVUS was used in 26.0%. Device success was 99.0% (failure to deliver in 2 pts). Over the entire follow-up period, death occurred in 3.4 % (7/207), myocardial infarction (MI) in 5.3% (11/207), target lesion revascularization in 7.2 % (15/207), target vessel revascularization (TVR) in 8.2% (17/207), non-target vessel revascularization in 2.9 (6/207) %. Overall MACE (death, MI, TVR) rate was 12.0% (25/207). Definite stent thrombosis (ST) occurred in 6 pts. (2.9%), of whom early ST occurred in 4 pts and late ST in 2 pts.
Nikolai Strygo,1 Oleg Polonetsky,2 Valeriy Stelmashok3 1 Institut of Cardiology, Minsk, Belarus; 2Unknown, Minsk, Belarus; 3 RSPC “Cardiology”, Minsk, Belarus
CONCLUSION This registry including patients with SV documents a relatively good safety and efficacy profile of the BRS in SV at a longterm follow-up with adverse events rate comparable with previous results in less complex subsets of patients. CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds TCT-423 Adaptable strut contour analysis in scaffold evaluation by optical coherence tomography. Validation of the FANTOM II study analysis by micro-CT, bench test and in-vivo Emil Holck,1 Jo Simonsen,2 Jouke Dijkstra,3 Jesper Thomsen,4 Annemarie Brüel,5 Jeffrey Anderson,6 Evald Christiansen,7 Niels Holm8 1 Aarhus University Hospital, Skejby, Viby J, Denmark; 2Toronto General Hospital, University Health Network, Toronto, ON, Canada; 3LUMC, Leiden, Netherlands; 4Canadian Vigour Center; 5Dept. of biomedicine, Aarhus University; 6REVA Medical, San Diego, California, United States; 7Aarhus University Hospital, Aarhus, Denmark; 8Aarhus University Hospital, Aarhus N, Denmark BACKGROUND The Tyrosine-derived polycarbonate Fantom bioresorbable scaffold (BRS) (Reva Medical, San Diego, CA) which contains covalently bound iodine has a unique appearance by optical coherence tomography (OCT). We aimed to characterize the OCT signature of the Fantom BRS by micro-CT and validate a novel, flexible method for scaffold OCT analysis applied to the Fantom BRS. METHODS Two Fantom BRS (3.0x18mm) were deployed in silicon phantoms and scanned by micro-CT and OCT for verification of a novel fixed thickness, adjustable strut box analysis in the validated OCT analysis software QCU-CMS (Medis medical imaging, the Netherlands). The method was applied to in-vivo baseline and 6-month follow-up OCT scans in the FANTOM II trial (clinical trial identifier: NCT02539966) and compared to manual strut contour analysis and to standard lumen and stent contour analysis using the OPTIS proprietary OCT software (St. Jude Medical, USA). Stent strut area was measured applying a fixed strut thickness of 125 mm and cross sectional analysis was performed every 0.5 mm. Inter-observer variability for the novel BRS OCT analysis was assessed for both bench and in-vivo scans. RESULTS Micro-CT indicated a slightly curved strut surface resulting in a mean strut-thickness of 123.616.8mm. Bench test comparison of QCUCMS and ORW analysis showed a difference in mean stent diameter of 0.030.002 mm (p<0.01) with an inter-method correlation of 0.96 and an inter-observer correlation of 0.93. Difference in stent strut area (n¼381) was 0.0008[0.0005;0.0012] mm2 (p<0.01) with an intermethod correlation of 0.95 and an inter-observer correlation of 0.95. Invivo comparison was performed in OCT scans from 5 patients. In baseline scans, a total of 196 frames were analysed by QCU-CMS and ORW with a difference in stent-strut area (n¼1579) of 0.0030.009mm2 (p<0.01) with a correlation of 0.91. Further a difference in mean stent diameter of 0.030.04 mm (p<0.01) with a correlation of 0.98 was observed. Results were consistent in the follow-up recordings. CONCLUSION Very good correlation and minimal differences below the observer variation was observed for the Fantom BRS analysis by a novel, flexible, and highly feasible OCT analysis method customizable to all known stent types. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds
B171
BACKGROUND Bioresorbable vascular scaffold (BVS) technology is the perspective option for ischemic heart disease treatment. Nevertheless, BVS application remains unstudied in some clinical cases, in particular, for long coronary lesions correction. Aim of this study was to establish the BVS Absorb effectiveness and safety for long coronary lesions correction. METHODS 60 patients with long coronary lesions (length more than 25mm) were included in the study. In accordance with the implant type all patients were randomized in 2 groups: group 1 (n¼30) BVS Absorb implantation, group 2 (n¼30) Xience V/Xience Prime implantation. Implant apposition was controlled by coronary angiography and optical coherence tomography (OCT). Extent of the lesion was 35.38 10.73mm in group 1 (BVS Absorb) and 38.08 13.98mm in group 2 (Xience), stented zone length was 44.4 14.4 mm and 48.13 16.64 mm accordingly. Post PCI follow-up included 12 month’s observation period. Elective coronary angiography and OCT control were performed after 12 months at all patients. In OCT minimal, maximal, mean diameter and area of lumen in stenting zone, amount of malapposed, protruding and uncovered struts, as well as neointima thickness and area was calculated. Measurements were done all over the stented area with 1 mm step (21365 struts were analysed). STATISTICA software version 10.0 was used for processing. RESULTS No cardiac death, recurrent MIs were observed in 12 month after the lesions correction. Three patients from Group 1 underwent elective PCI of target lesion due to BVS restenosis and one underwent target vessel revascularization. In group 2 there was two cases of target lesion revascularization due to restenosis (difference statistically nonsignificant). In 12 month 2D OCT analysis revealed significant reduction of minimal lumen diameter, maximal lumen diameter and mean lumen area in both groups (< 0.001 in all cases). CONCLUSION Both types of implants allow to obtain equivalent 12 months clinical results. Despite of achievement of greater lumen area after Xience V/Xience Prime DES implantation, BVS is associated with more smooth and thin neointima proliferation and the presence of less number of malapposed and especially uncovered struts. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-425 Bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the Italian multicenter RAI Registry Giulia Masiero,1 Giuseppe Tarantini,2 Marco Mojoli,3 Bruno Loi,4 Bernardo Cortese,5 attilio varricchio,6 Alfonso Ielasi,7 Francesco Pisano,8 Pietro Mazzarotto,9 Paolo Calabro’,10 Roberto Gistri,11 Alessandro Durante,12 Davide Piraino,13 Gabriele Tumminello,14 valerio lucci,15 Luciano Moretti,16 Leonardo Misuraca,17 Giampaolo Pasquetto,18 Alessandro Colombo,19 Maurizio Ferrario,20 Sebastian Coscarelli,21 Zoran Olivari,22 Annamaria Nicolino,23 Luigi Piatti,24 Paola Tellaroli,25 Donatella Corrado,26 Giuseppe Steffenino27 1 University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Montegaldella, Vicenza, Italy; 2Policinico Universitario, Padova, Padua, Italy; 3University of Padova, Padova, Venice, Italy; 4 Azienda Ospedaliera Brotzu, Cagliari, Cagliari, Italy; 5Fatebenefratelli Hospital, Milan, Milan, Italy; 6hospital, napoli, California, United States; 7 Unknown, Castellanza, Italy; 8Central Chest Institute of thailand; 9The Golden Cardiovascular Center; 10Second University of Naples, Napoli, Italy; 11azienda sanitaria locale 5 spezzino, la spezia, La Spezia, Italy; 12 San Raffaele Hospital, Milano, Italy; 13Interventional Cardiology Unit, University of Palermo, Palermo Italy; 14Tufts Medical Center; 15casi, avezzano, Illinois, United States; 16Division of Cardiology, Mazzoni Hospital; Ascoli Piceno, Ascoli Piceno, Italy; 17Cardiology Unit, Ospedale della Misericordia, Grosseto, Grosseto, Grosseto, Italy; 18Padua South Hospital, MONSELICE, Padua, Italy; 19“Luigi Sacco” Hospital, Milano, Milan, Italy; 20Hopital Albert Schweitzer Colmar, France; 21 Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy; 22 Ospedale Cà Foncello, Treviso, Treviso, Italy; 23Ospedale Santa Corona, Savona, Italy; 24Ospedale Manzoni, Lecco, Lecco, Italy; 25University of Padua, Padova, Padua, Italy; 26Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; 27Unknown, Cuneo, Italy
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
[2 – 3]). The PSP score displays a Nagelkerke’s R2 of 0.06, a HosmerLemeshow statistic of 3.65 (p ¼ 0.887), and an AUCs of 0.584 (95%CI [0.541 – 0.628]). At 1-year, a PSP score of 3 was associated with a lower rate of PoCE when compared to score of <3 (15.3% vs. 23.9%; HR 1.74, CI95% [1.27 – 2.38]; p ¼ 0.001), even after adjustment (HR 1.77, CI95% [1.22 – 2.59]; p ¼ 0.002). At 1-year, each point in the PSP score was associated with a reduction of 43% of risk of definite/probable scaffold thrombosis (HR 0.57, 95%CI [0.35 – 0.93]; p ¼ 0.025). CONCLUSION The PSP score displays a discrete overall performance, calibration, and discrimination abilities to predict adverse cardiac events. A PSP score of 3 was associated with a reduction in PoCE and definite/probable scaffold thrombosis. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-420 Incidence of side branch occlusions following bioresorbable scaffold implantation for long left anterior descending artery lesions Akihito Tanaka,1 Azeem Latib,2 Richard Jabbour,3 Hiroyoshi Kawamoto,4 Antonio Mangieri,5 Damiano Regazzoli,6 Marco Ancona,7 Francesco Giannini,8 Lorenzo Azzalini,9 Alaide Chieffo,10 Mauro Carlino,11 Matteo Montorfano,12 Antonio Colombo13 1 San Raffaele Scientific Institute, Milan, Italy; 2EMO-GVM Centro Cuore Columbus, Milan, Italy; 3NHS, Newington, United Kingdom; 4San Raffaele Scientific Institute/EMO GVM Centro Cuore Columbus, Milan, Milan, Italy; 5San Raffaele Hospital, Milan, Milan, Italy; 6San Raffaele Hospital; 7San Raffaele Scientific Insitute, milan, Milan, Italy; 8 Interventional Cardiology institute San Raffaele Hospital, Soverato, Reggio Calabria, Italy; 9San Raffaele Scientific Institute, Milano, Italy; 10 San Raffaele Scientific Institute, Milan, Italy; 11San Raffaele Hospital, Milan, Milan, Italy; 12San Raffaele Hospital, Milan, Italy; 13Columbus Hospital/San Raffaele Hospital, Milan, Milan, Italy BACKGROUND Bioresorbable vascular scaffolds (BVS) have numerous potential advantages over permanent metallic stents due to the complete resorption process. Long diffuse lesions, especially of the left anterior descending artery (LAD), may be ideal treatment targets for BVS implantation, however concerns exist regarding side branch (SB) occlusions. The purpose of this study was to investigate the incidence of SB occlusions following BVS implantation for long LAD lesions. METHODS Data were examined from patients who underwent LAD percutaneous coronary intervention with BVS between May 2012 and December 2015. Patients were included if the total scaffold length was 40mm in the LAD without concomitant use of metallic stents. One hundred and fourteen patients were analyzed, and a total of 729 LAD SBs were jailed post BVS implantation (6.42.4 per patient). SBs were divided into 3 groups according to the diameters, as determined by visual assessment: 1) small (<1mm); 2) intermediate (1-2mm); and 3) large (>2mm). Side branch occlusion (SBO) was defined as a reduction in TIMI flow to grade 0 or 1 at the end of procedure. RESULTS The total scaffold length in the LAD MB was 62.018.5mm. Out of 729 SBs jailed by BVS, 442 (59.9%) were small (<1mm), 202 (27.7%) intermediate (1-2mm), and 105 (14.4%) large (>2mm). Seventyfour SBs (74/729; 10.2%) were occluded in total. Occluded SBs were more likely to be small (82.4% vs 55.1%, p<0.001), have prexisting ostial stenoses (>50%) (66.2% vs 31.6%; p<0.001), or be SBs at overlapping scaffold sites (23.0% vs 11.6%; p¼0.010). The respective rate of SB occlusion was 14.5% in small (61/442), 5.9% intermediate (12/202), and 1.0% in large (1/105) SBs. The rate of peri-procedural MI was 15.8% in the overall cohort (18.8% of patients with 1 SB occlusion (9/48) vs 13.6% of those without any SBO (9/66) respectively, [p¼0.46]). CONCLUSION Side branch occlusion after BVS implantation in long LAD lesions were mainly of small branches, and the clinical impact may be minimal. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-421 In Vivo Serial Assessment of Coronary Vessel Geometry Restoration and Resorption Process Following the Implantation of Second-Generation Drug-Eluting Absorbable Metal Scaffold (DREAMS 2G): Insights from the BIOSOLVE-II First-In-Man Trial Hector Manel Garcia-Garcia,1 Michael Haude,2 Hüseyin Ince,3 Alexandre Abizaid,4 Ralph Toelg,5 Pedro Lemos,6 Clemens von Birgelen,7 Evald Christiansen,8 William Wijns,9 Franz-Josef Neumann,10 Christoph Kaiser,11 Eric Eeckhout,12 Soo Teik Lim,13 Javier Escaned,14 Ron Waksman15
1
MedStar Washington Hospital Center, Washington DC; Lukaskrankenhaus Neuss, Neuss, Germany; 3Vivantes Klinikum im Friedrichshain and Am Urban; 4Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil; 5Herzzentrum Segeberger Kliniken, Henstedt-Ulzburg, Germany; 6University of São Paulo Medical School, São Paulo, São Paulo, Brazil; 7Thoraxcentrum Twente, Enschede, Netherlands; 8Aarhus University Hospital, Aarhus, Denmark; 9Unknown, Aalst, Belgium; 10Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany; 11University Hospital Basel, Basel, Switzerland; 12Cardiology, University Hospital CHUV, 1011 Lausanne, Switzerland; 13National Heart Centre Singapore, Singapore, Singapore; 14Hospital Clínico San Carlos, Madrid, Spain; 15 Medstar Heart Institute, Washington, District of Columbia, United States 2
BACKGROUND The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile and stable performance outcomes up to 12 months. We assessed the baseline, 6month and 12-month imaging performance of this novel device which may provide a mechanistic explanation for the optimal clinical results. METHODS The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and –if subjects consented– at 12 months. Quantitative coronary angiography (QCA) - based curvature and angulation were assessed; intravascular ultrasound (IVUS) based echogenicity and radiofrequency data analysis was evaluated. RESULTS Restoration of the vessel geometry was observed as assessed by the serial changes in curvature and angulation; the differences in curvature and angulation between pre-procedure and 12 months are very small with no significant p values (0.9650 and 0.2149 respectively). Refer to Table Advance resorption process, particularly from baseline to 6 months, was detected. Hyperchogenic tissue (echogenicity) and dense calcium (radiofrequency data analysis) – both surrogates for strut size – showed significant decrease. Refer to Table Dense Calcium Curvature (cm-1)
Angulation ( )
percentage
Hyper-
volume, %
echogenic, %
Pre-procedure
0.0414 (0.0309)
31.39 (15.35)
NA
NA
Post-procedure
0.0298 (0.0235)
19.89 (11.97)
37.30 (10.37)
3.69 (2.23)
6-month [95% CI]
0.0383 (0.0307)
27.24 (14.58)
18.87 (8.67)
1.22 (0.76)
12-month [95%
0.0416 (0.0320)
28.05 (15.30)
20.86 (9.96)
1.31 (1.41)
0.0085
7.35 [3.48,11.22]
CI]
D6-month vs post [95% CI]
D12-month vs post [95% CI]
D6-month vs pre [95% CI]
D12-month vs pre [95% CI]
[0.0006,0.0164] 0.0119
8.16 [2.88,13.45]
[0.0011,0.0227] -0.0031 [-0.0110,0.0048] 0.0002 [-0.0106,0.0110]
-18.43 [-21.61,-15.25] -16.44 [-19.62,-13.26]
-4.15
-2.48 [-3.36, -1.60] -2.39 [-3.27, -1.51]
NA
NA
NA
NA
[-8.04,-0.27] -3.34 [-8.63,1.95]
CONCLUSION Restoration of the vessel geometry and fast resorption signs were observed between baseline and 6-12 months following implantation of the drug-eluting metal absorbable scaffold DREAMS 2G. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-422 6 year clinical outcomes after Absorb bioresorbable scaffold implantation in small vessel: The Maasstad Absorb Registry Valeria Paradies,1 Pieter Smits,2 Kees-Jan Royaards,3 Floris Kauer,4 Jochem Wassing,5 Martin van der Ent,6 George Vlachojannis7 1 Maastad Ziekenhuis, Rotterdam, Netherlands; 2Maasstad Ziekenhuis, Rotterdam, Netherlands; 3Unknown, Rotterdam, Netherlands; 4 Department of Cardiovascular Surgery, University of Tübingen, Germany, Rotterdam, Netherlands; 5Maasstad Hospital, Capelle a/ d IJssel, Netherlands; 6Unknown, Alphen aan den Rijn, Netherlands; 7 Factoid Team/ CRF, New York, New York, United States BACKGROUND The safety and efficacy of the Absorb (Abbott) bioresorbable scaffold (BRS) has been documented in lower-risk patient. Early experience with BRS in small vessels (SV) have shown an increased risk of adverse clinical events. Here we report the long-term clinical outcomes of BRS implantation in SV at a high-volume Dutch center. METHODS Between July 2009 and June 2015, 321 patients (363 lesions) were treated with BRS in our center. Registry data collection is
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 68, NO. 18, SUPPL B, 2016
ongoing and gathered prospectively in-hospital, at 1 and 6 months and then yearly up to 6 years. We defined SV as vessel with a pre-procedural reference vessel diameter (RVD) 2.75 mm at quantitative coronary analysis (QCA).
TCT-424 One-Year Clinical, Angiographic and OCT Follow-up after Absorb BVS Implantation in Long Coronary Artery Lesions: mechanisms of coronary artery remodeling
RESULTS A total of 207 patients with at least one SV were included in this analysis. Mean follow-up time was 22.4 months14.9 with 85.8 % of patients having at least 1 year of follow-up. Clinical presentation of pts. (72.4% male, mean age 58.5 11.7 years, 16.4% diabetics, 25.6% with previous PCI and/or CABG) was ACS in 55.1%. Multivessel treatment was perfomed in 17,9% (37 pz). Mean lesion length by QCA was 23.7 11.0 mm and mean RVD was 2.20.3 mm with 14.5% of moderate/sever calcification lesions and 19.8 % of bifurcation treatment. Pre-dilatation was performed in 93.2% and post-dilatation in 57.9%. The mean scaffold length was 28.115.0 mm with 30.9% of cases using overlapping scaffolds. OCT or IVUS was used in 26.0%. Device success was 99.0% (failure to deliver in 2 pts). Over the entire follow-up period, death occurred in 3.4 % (7/207), myocardial infarction (MI) in 5.3% (11/207), target lesion revascularization in 7.2 % (15/207), target vessel revascularization (TVR) in 8.2% (17/207), non-target vessel revascularization in 2.9 (6/207) %. Overall MACE (death, MI, TVR) rate was 12.0% (25/207). Definite stent thrombosis (ST) occurred in 6 pts. (2.9%), of whom early ST occurred in 4 pts and late ST in 2 pts.
Nikolai Strygo,1 Oleg Polonetsky,2 Valeriy Stelmashok3 1 Institut of Cardiology, Minsk, Belarus; 2Unknown, Minsk, Belarus; 3 RSPC “Cardiology”, Minsk, Belarus
CONCLUSION This registry including patients with SV documents a relatively good safety and efficacy profile of the BRS in SV at a longterm follow-up with adverse events rate comparable with previous results in less complex subsets of patients. CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds TCT-423 Adaptable strut contour analysis in scaffold evaluation by optical coherence tomography. Validation of the FANTOM II study analysis by micro-CT, bench test and in-vivo Emil Holck,1 Jo Simonsen,2 Jouke Dijkstra,3 Jesper Thomsen,4 Annemarie Brüel,5 Jeffrey Anderson,6 Evald Christiansen,7 Niels Holm8 1 Aarhus University Hospital, Skejby, Viby J, Denmark; 2Toronto General Hospital, University Health Network, Toronto, ON, Canada; 3LUMC, Leiden, Netherlands; 4Canadian Vigour Center; 5Dept. of biomedicine, Aarhus University; 6REVA Medical, San Diego, California, United States; 7Aarhus University Hospital, Aarhus, Denmark; 8Aarhus University Hospital, Aarhus N, Denmark BACKGROUND The Tyrosine-derived polycarbonate Fantom bioresorbable scaffold (BRS) (Reva Medical, San Diego, CA) which contains covalently bound iodine has a unique appearance by optical coherence tomography (OCT). We aimed to characterize the OCT signature of the Fantom BRS by micro-CT and validate a novel, flexible method for scaffold OCT analysis applied to the Fantom BRS. METHODS Two Fantom BRS (3.0x18mm) were deployed in silicon phantoms and scanned by micro-CT and OCT for verification of a novel fixed thickness, adjustable strut box analysis in the validated OCT analysis software QCU-CMS (Medis medical imaging, the Netherlands). The method was applied to in-vivo baseline and 6-month follow-up OCT scans in the FANTOM II trial (clinical trial identifier: NCT02539966) and compared to manual strut contour analysis and to standard lumen and stent contour analysis using the OPTIS proprietary OCT software (St. Jude Medical, USA). Stent strut area was measured applying a fixed strut thickness of 125 mm and cross sectional analysis was performed every 0.5 mm. Inter-observer variability for the novel BRS OCT analysis was assessed for both bench and in-vivo scans. RESULTS Micro-CT indicated a slightly curved strut surface resulting in a mean strut-thickness of 123.616.8mm. Bench test comparison of QCUCMS and ORW analysis showed a difference in mean stent diameter of 0.030.002 mm (p<0.01) with an inter-method correlation of 0.96 and an inter-observer correlation of 0.93. Difference in stent strut area (n¼381) was 0.0008[0.0005;0.0012] mm2 (p<0.01) with an intermethod correlation of 0.95 and an inter-observer correlation of 0.95. Invivo comparison was performed in OCT scans from 5 patients. In baseline scans, a total of 196 frames were analysed by QCU-CMS and ORW with a difference in stent-strut area (n¼1579) of 0.0030.009mm2 (p<0.01) with a correlation of 0.91. Further a difference in mean stent diameter of 0.030.04 mm (p<0.01) with a correlation of 0.98 was observed. Results were consistent in the follow-up recordings. CONCLUSION Very good correlation and minimal differences below the observer variation was observed for the Fantom BRS analysis by a novel, flexible, and highly feasible OCT analysis method customizable to all known stent types. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds
B171
BACKGROUND Bioresorbable vascular scaffold (BVS) technology is the perspective option for ischemic heart disease treatment. Nevertheless, BVS application remains unstudied in some clinical cases, in particular, for long coronary lesions correction. Aim of this study was to establish the BVS Absorb effectiveness and safety for long coronary lesions correction. METHODS 60 patients with long coronary lesions (length more than 25mm) were included in the study. In accordance with the implant type all patients were randomized in 2 groups: group 1 (n¼30) BVS Absorb implantation, group 2 (n¼30) Xience V/Xience Prime implantation. Implant apposition was controlled by coronary angiography and optical coherence tomography (OCT). Extent of the lesion was 35.38 10.73mm in group 1 (BVS Absorb) and 38.08 13.98mm in group 2 (Xience), stented zone length was 44.4 14.4 mm and 48.13 16.64 mm accordingly. Post PCI follow-up included 12 month’s observation period. Elective coronary angiography and OCT control were performed after 12 months at all patients. In OCT minimal, maximal, mean diameter and area of lumen in stenting zone, amount of malapposed, protruding and uncovered struts, as well as neointima thickness and area was calculated. Measurements were done all over the stented area with 1 mm step (21365 struts were analysed). STATISTICA software version 10.0 was used for processing. RESULTS No cardiac death, recurrent MIs were observed in 12 month after the lesions correction. Three patients from Group 1 underwent elective PCI of target lesion due to BVS restenosis and one underwent target vessel revascularization. In group 2 there was two cases of target lesion revascularization due to restenosis (difference statistically nonsignificant). In 12 month 2D OCT analysis revealed significant reduction of minimal lumen diameter, maximal lumen diameter and mean lumen area in both groups (< 0.001 in all cases). CONCLUSION Both types of implants allow to obtain equivalent 12 months clinical results. Despite of achievement of greater lumen area after Xience V/Xience Prime DES implantation, BVS is associated with more smooth and thin neointima proliferation and the presence of less number of malapposed and especially uncovered struts. CATEGORIES CORONARY: Bioresorbable Vascular Scaffolds TCT-425 Bioresorbable vascular scaffold technology for small vessel coronary artery disease: results from the Italian multicenter RAI Registry Giulia Masiero,1 Giuseppe Tarantini,2 Marco Mojoli,3 Bruno Loi,4 Bernardo Cortese,5 attilio varricchio,6 Alfonso Ielasi,7 Francesco Pisano,8 Pietro Mazzarotto,9 Paolo Calabro’,10 Roberto Gistri,11 Alessandro Durante,12 Davide Piraino,13 Gabriele Tumminello,14 valerio lucci,15 Luciano Moretti,16 Leonardo Misuraca,17 Giampaolo Pasquetto,18 Alessandro Colombo,19 Maurizio Ferrario,20 Sebastian Coscarelli,21 Zoran Olivari,22 Annamaria Nicolino,23 Luigi Piatti,24 Paola Tellaroli,25 Donatella Corrado,26 Giuseppe Steffenino27 1 University of Padua - Department of Cardiac, Thoracic and Vascular Sciences, Montegaldella, Vicenza, Italy; 2Policinico Universitario, Padova, Padua, Italy; 3University of Padova, Padova, Venice, Italy; 4 Azienda Ospedaliera Brotzu, Cagliari, Cagliari, Italy; 5Fatebenefratelli Hospital, Milan, Milan, Italy; 6hospital, napoli, California, United States; 7 Unknown, Castellanza, Italy; 8Central Chest Institute of thailand; 9The Golden Cardiovascular Center; 10Second University of Naples, Napoli, Italy; 11azienda sanitaria locale 5 spezzino, la spezia, La Spezia, Italy; 12 San Raffaele Hospital, Milano, Italy; 13Interventional Cardiology Unit, University of Palermo, Palermo Italy; 14Tufts Medical Center; 15casi, avezzano, Illinois, United States; 16Division of Cardiology, Mazzoni Hospital; Ascoli Piceno, Ascoli Piceno, Italy; 17Cardiology Unit, Ospedale della Misericordia, Grosseto, Grosseto, Grosseto, Italy; 18Padua South Hospital, MONSELICE, Padua, Italy; 19“Luigi Sacco” Hospital, Milano, Milan, Italy; 20Hopital Albert Schweitzer Colmar, France; 21 Cardiovascular Intervention Unit, San Martino Hospital, Belluno, Italy; 22 Ospedale Cà Foncello, Treviso, Treviso, Italy; 23Ospedale Santa Corona, Savona, Italy; 24Ospedale Manzoni, Lecco, Lecco, Italy; 25University of Padua, Padova, Padua, Italy; 26Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; 27Unknown, Cuneo, Italy