- Email: [email protected]
TCT-409 Optical coherence tomography surveillance of tissue coverage at six months after stenting for acute myocardial infarction with bioabsorbable vascular scaffolds in the ISAR-Absorb MI trial
B168
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
CONCLUSION These results from a large, real-world registry show that this challenging subgroup of high-risk patients with ACS can be effectively treated with a new generation DES with bioresorbable polymer. The low rates of stent thrombosis supports the safe use of the Ultimaster DES. CATEGORIES CORONARY: Acute Coronary Syndromes TCT-408 Three-year clinical outcome of Everolimus-eluting bioresorbable scaffold vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction - TROFI II trial Patrick Serruys,1 Taku Asano,2 Salvatore Brugaletta,3 Lorenz Raber,4 Yoshinobu Onuma,5 Stephan Windecker,4 Manel Sabate6 1 Imperial College, London, United Kingdom; 2Academic Medical Center, Amsterdam, Netherlands; 3Hospital Clinic Barcelona, Barcelona, Spain; 4University Hospital Bern, Bern, Switzerland; 5 Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands; 6 Hospital Clínic; University of Barcelona, Barcelona, Spain
CONCLUSION Intervention to EIA CTOs is associated with increased intraprocedural complexity but with similar long-term outcomes including high patency and low rates of TLR out to five years. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention
USE OF BRS DURING TREATMENT OF PATIENTS WITH ACS
Abstract nos: 407 - 411 TCT-407 Treatment of acute coronary syndrome patients with a sirolimus-eluting bioresorbable polymer-coated stent: 1-year clinical outcomes from the e-Ultimaster registry (on behalf of the e-Ultimaster investigators) Orazbek Sakhov,1 Murat Kuzhukeyev,2 Almat Kodasbayev,1 Aizhan Kulanbayeva,1 Saule Dairbekova1 1 City Heart Center, Almaty, Kazakhstan; 2Kazakh National Medical University, Almaty, Kazakhstan BACKGROUND The e-Ultimaster all-comer registry enrolls patients treated with the Ultimaster drug-eluting stent (DES) to further validate its safety and efficacy in every day clinical practice. We investigated 1-year clinical outcomes in a predefined subset of high-risk patients with acute coronary syndrome (ACS). METHODS e-Ultimaster recruitment started in 2014 and is still ongoing. To date, 5468 patient have been treated with the Ultimaster sirolimus eluting, thin strut (80um) cobalt chromium, stent coated with a bioresorbable polymer, who either reached 1 year follow-up, or died. RESULTS A total of 3205 high-risk patients with unstable angina (18.9%), non-ST segment elevation myocardial infarction (NSTEMI; 43.6%) or ST segment elevation myocardial infarction (STEMI; 37.5%) were included. Mean SD age was 64.5 11.4 years and 76% were men, with a mean BMI of 27.9 kg/m 2, 31% smokers, 24% with diabetes and 59% had hypertension. Radial access was used in 85.9%. 48.3 % of patients had multi-vessel disease and the mean number of lesion per patient was 1.4 0.7. Chronic total occlusion was present in 2% of patients and bifurcation lesions in 13%, while 42% had long lesions. At 1 year follow-up, rates of cardiac death, MI and target vessel MI were 1.8%, 1.1% and 0.97%, respectively. Clinically driven (CD) target vessel revascularization (TVR) was performed in 2.8% of patients and CD target lesion revascularization (TLR) in 1.6%. Target lesion failure (TLF), a composite of cardiac death, TV-related MI and CD-TLR, was 3.7% and TVR, a composite of cardiac death, TV-related MI and CDTVR was 4.7%. Definite and probable stent thrombosis at 1 year occurred in 1% of the patients. Bleeding rate was 2.9%. At 3 months follow-up, 95% of patients were on dual antiplatelet therapy (DAPT), while 69% of patients were on DAPT at 1 year. 90% of patients were free of angina at 1 year follow-up.
BACKGROUND In the TROFI II randomized trial, stenting of culprit lesions with bioresorbable vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in an arterial healing pattern that was comparable with that of metallic Everolimus-eluting stent (EES) as assessed by optical frequency domain imaging at 6 months and associated with a low incidence of clinical adverse events . However, there is still limited data of the long-term outcome after implantation of Absorb with patients presenting with STEMI in the context of a randomized control trial. We sought to investigate the 3year device-oriented composite endpoint (DOCE: a composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization) rate of the patients treated with Absorb scaffolds and EES in this challenging setting. METHODS A total of 191 patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES (Absorb [n ¼ 95] or EES [n ¼ 96]; mean age 58.6 years old; 17.8% females) in the TROFI II trial. The patients were clinically followed up yearly up to 3 years. The 3-year follow up data is being collected and will be analyzed according to the device type. RESULTS 6-month optical frequency domain imaging healing score (HS) of Absorb, which was based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects, was 1.74 (2.39) compared to HS of EES (2.80 4.44, difference [90% Cl] 21.06 [21.96, 20.16]; Pnon-inferioiity < 0.001). DOCE was comparably low between groups (3.2 % Absorb vs. 3.2% EES; p¼ns) whereas device thrombosis rate was also comparable (2.1% Absorb vs 1.0% EES; p¼ns) at 2-years follow-up. CONCLUSION In September 2017, 191 patients will have completed their 3-year clinical follow-up. The complete data of 3-year follow-up will be presented at the time of congress. CATEGORIES CORONARY: Acute Myocardial Infarction
TCT-409 Optical coherence tomography surveillance of tissue coverage at six months after stenting for acute myocardial infarction with bioabsorbable vascular scaffolds in the ISAR-Absorb MI trial Himanshu Rai,1 Fernando Alfonso,2 Michael Maeng,3 Jens Wiebe,4 Javier Cuesta Cuesta,5 Evald Christiansen,3 Petra Hoppmann,6 Sebastian Kufner,4 Simon Schneider,6 Karl-Ludwig Laugwitz,7 Adnan Kastrati,8 Robert Byrne4 1 ISAResearch Centre, Deutsches Herzzentrum München (German Heart Centre Munich), Munich, Germany; 2Hospital Universitario de la Princesa, Madrid, Spain; 3Aarhus University Hospital, Aarhus, Denmark; 4Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 5Hospital La Princesa, Madrid, Spain; 6 Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 7Klinikum rechts der Isar TUM, Munich, Germany; 8Deutsches Herzzentrum München, Munich, Germany BACKGROUND Bioresorbable stents (BRS) are novel devices designed to overcome the long-term limitations of permanent stent implantation. Optical coherence tomography (OCT) surveillance can provide
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
B169
important insights on the process of vessel wall healing after BRS implantation. We sought to evaluate OCT-assessed healing at 6 months after implantation of everolimus eluting BRS in patients treated for acute myocardial infarction (AMI).
TCT-411 Initial experience with sirolimus-eluting magnesium-based bioresorbable vascular scaffold implantation in patients with ST-elevation myocardial infarction.
METHODS ISAR-Absorb MI is a multicentre, assessor-blind randomized trial comparing outcomes of patients with AMI undergoing treatment with everolimus eluting BRS or conventional everolimuseluting stents with angiographic surveillance planned for all patients at 6-8 months follow-up. Selected patients who had OCT surveillance (with commercially-available frequency domain OCT imaging) performed at the time of angiographic follow-up were included for the present analysis. Raw data of OCT image acquisitions were collected at four recruiting centres and analysed at a centralized core laboratory. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment using QIvus 3.0.30.0 software.
Quentin de Hemptinne,1 Briki Rachid,2 Paul-Gaël Silance,3 Philippe Unger,3 Nadia Debbas4 1 CHU Saint-Pierre, Université Libre de Bruxelles, Belgium, Brussels, Belgium; 2CHU Saint-Pierre, brussels, Belgium; 3CHU Saint-Pierre, Brussels, Belgium; 4CHU St Pierre, Brussels, Belgium
RESULTS OCT imaging data at post stenting follow-up on a total of 45 patients / stented target lesions at a median of 212 days was available for analysis. Morphometric analysis revealed mean stented length to be 18.856.09 mm. Mean minimum lumen area was 5.431.98 mm2, while the minimum stent area was 6.021.82 mm2. Average lumen area was 6.992.16 mm2, while the average stent area was 7.362.07 mm2. The total number of frames assessed was 915, with a total of 8,556 visible struts. Overall strut coverage was 98.60%; 0.41% of struts were found to be malapposed. Mean thickness of neointimal coverage was 94.9331.43 mm, while mean neointimal area was 0.350.46 mm2 and mean percentage stenosis was 5.396.56%. Four (8.89 %) patients required target lesion revascularization at follow-up. CONCLUSION In selected patients undergoing OCT imaging at 6-8 months after implantation of everolimus eluting BRS stents for AMI, we observed generally favourable healing characteristics with high rates of strut coverage and low rates of strut malapposition. CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds TCT-410 Reendothelialization after SYNERGY stent and Bioresorbable Vascular Scaffold ABSORB implantation in Acute Myocardial Infarction : COVER-AMI Study
BACKGROUND Recent studies have demonstrated favorable clinical outcomes for the sirolimus-eluting magnesium-based bioresorbable vascular scaffold (BVS) MAGMARIS Ò (Biotronik, Berlin, Germany) in patients with stable coronary artery disease. There are currently no data on its use in patients with ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess safety and efficacy of magnesium-based BVS implantation in the setting of primary percutaneous coronary intervention (PCI) in patients presenting with STEMI to our institution. METHODS We are conducting a single-center feasibility study of MagmarisÒ implantation in STEMI patients. Primary endpoints are procedural success and device-oriented composite endpoint including cardiac death, target vessel myocardial infarction and target lesion revascularization as defined by the Academic Research Consortium criteria. This study is intended to obtain data from 25 consecutive STEMI patients undergoing primary PCI with magnesium-based BVS implantation, according to pre-specified inclusion/exclusion criteria. RESULTS Median age of the first 10 patients included is 42 years [3849]. Mean number of implanted device is 1.2 0.4, with a mean length of 25 8 mm and mean diameter of 3.35 0.2. So far procedural success is 100% with one case of distal edge dissection requiring a second scaffold implantation, and in-hospital DOCE rate is 0%. CONCLUSION This is the first reported initial clinical experience of magnesium-based BVS (MagmarisÒ ) implantation in STEMI patients. Preliminary results of this single-center feasibility study seem reassuring with excellent procedural success rates, low complication rates and excellent short-term clinical outcomes. We will report further results of additional included patients, mid-term clinical outcomes, and intra-coronary imaging results.
Thibault Lhermusier,1 Paul Ohayon,2 Nicolas Boudou,1 Francisco Campelo Parada,3 Frédéric Bouisset,4 Meyer Elbaz,5 Didier Carrié6 1 CHU Rangueil, Toulouse, France; 2Chu Rangueil, Toulouse, France; 3 Rangueil Hospital, Toulouse, France; 4Toulouse University Hospital, Toulouse, France; 5Rangueil Hospital, Toulouse, France; 6Hôpital Rangueil, Toulouse, France
CATEGORIES CORONARY: Acute Coronary Syndromes
BACKGROUND Incomplete reendothelialization after a stent implantation is strongly associated with stent thrombosis. Non-randomized preclinical studies have shown a particularly rapid endothelialization after a SYNERGYÒ EES implantation, which is now widely used. Moreover, vascular response after ABSORB Ò BVS implantation seems similar to that observed with XIENCEÒ EES at 1 year but data concerning early reendothelialization remain scarce.
Abstract nos: 412 - 416
METHODS We designed a randomized, controlled, prospective trial to assess 3 months strut coverage and neointimal response in STEMI patients treated with SYNERGYÒ EES or ABSORBÒ BVS. RESULTS Twenty-two patients were included between July 2016 and February 2017. At 3 months, no significant differences in the angiographic lumen loss were seen in the Absorb and in the Synergy arm (0,20 [ 0,23 mm] vs. 0,10 [ 0,14 mm, p ¼ 0,286] and there were no binary restenosis in both groups. Strut coverage analyzed by OCT showed high reendothelialization rates, with no significant difference regarding uncovered struts rate: 2,9 [ 2,5 %] in the Absorb arm and 5,2 [ 4,9 %] in the Synergy arm (p ¼ 0,203). In stent/scaffold area obstruction was significantly higher in the Absorb group (9,6 [ 4,8 %] vs. 7.0 [ 2,5 %], p < 0,001]). Malapposed area and intraluminal masses area were similar in both groups. CONCLUSION Primary PCI for culprit lesions in STEMI patients with an ABSORBÒ BVS or a SYNERGYÒ stent leaded to a nearly complete healing in both groups but we noticed an higher in stent/scaffold area obstruction with the ABSORBÒ BVS. However, OCT is better to assess coverage than healing. It will be important in the future to differentiate mature from immature tissue coverage after stent implantation. Finally, ongoing clinical follow-up is waiting at twelve months. CATEGORIES CORONARY: Stents: Drug-Eluting
DILEMMAS IN CORONARY PHYSIOLOGY - III
TCT-412 Prognostic implications of pressure-bounded coronary flow reserve versus flow-derived coronary flow reserve. Gilbert Wijntjens,1 Martijn van Lavieren,2 Tim van de Hoef,3 Mauro Echavarria Pinto,4 Martijn Meuwissen,5 Valérie Stegehuis,6 Karel Koch,3 Steven Chamuleau,7 Michiel Voskuil,8 Robbert de Winter,3 Jan Tijssen,9 Javier Escaned,10 Jan Piek11 1 Academisch Medisch Centrum, Amsterdam, Netherlands; 2Academic Medical Center- University of Amster, Amsterdam, Netherlands; 3 Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands; 4Hospital General ISSSTE, Queretaro, Querétaro, Mexico; 5 Breda Amphia Ziekenhuis, Breda, Netherlands; 6Academic Medical Center, Amsterdam, Netherlands; 7UMCU, Utrecht, Netherlands; 8 University Medical Center Utrecht, Utrecht, Netherlands; 9AMC, Naarden, Netherlands; 10Hospital Clínico San Carlos, Madrid, Spain; 11 Academic Medical Center, University of Amsterdam, Amsterdam, Netherland BACKGROUND Pressure-bounded coronary flow reserve (Pb-CFR) is a novel technique that estimates the bounds of CFR from routine pressure measurements, but has not been compared with flowderived CFR (CFR) regarding clinical outcome. We compared the longterm prognostic value of Pb-CFR versus CFR. METHODS We evaluated 453 intermediate coronary lesions with intracoronary pressure and flow sensors (298 lesions by Doppler flow velocity and 155 lesions by the thermodilution method). The lower and higher bound of Pb-CFR were defined as O[(1-FFR)/(1-Pd/Pa)] and (1-FFR)/(1-Pd/Pa), respectively. Long-term follow-up (median: 11.8
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
CONCLUSION These results from a large, real-world registry show that this challenging subgroup of high-risk patients with ACS can be effectively treated with a new generation DES with bioresorbable polymer. The low rates of stent thrombosis supports the safe use of the Ultimaster DES. CATEGORIES CORONARY: Acute Coronary Syndromes TCT-408 Three-year clinical outcome of Everolimus-eluting bioresorbable scaffold vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction - TROFI II trial Patrick Serruys,1 Taku Asano,2 Salvatore Brugaletta,3 Lorenz Raber,4 Yoshinobu Onuma,5 Stephan Windecker,4 Manel Sabate6 1 Imperial College, London, United Kingdom; 2Academic Medical Center, Amsterdam, Netherlands; 3Hospital Clinic Barcelona, Barcelona, Spain; 4University Hospital Bern, Bern, Switzerland; 5 Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands; 6 Hospital Clínic; University of Barcelona, Barcelona, Spain
CONCLUSION Intervention to EIA CTOs is associated with increased intraprocedural complexity but with similar long-term outcomes including high patency and low rates of TLR out to five years. CATEGORIES ENDOVASCULAR: Peripheral Vascular Disease and Intervention
USE OF BRS DURING TREATMENT OF PATIENTS WITH ACS
Abstract nos: 407 - 411 TCT-407 Treatment of acute coronary syndrome patients with a sirolimus-eluting bioresorbable polymer-coated stent: 1-year clinical outcomes from the e-Ultimaster registry (on behalf of the e-Ultimaster investigators) Orazbek Sakhov,1 Murat Kuzhukeyev,2 Almat Kodasbayev,1 Aizhan Kulanbayeva,1 Saule Dairbekova1 1 City Heart Center, Almaty, Kazakhstan; 2Kazakh National Medical University, Almaty, Kazakhstan BACKGROUND The e-Ultimaster all-comer registry enrolls patients treated with the Ultimaster drug-eluting stent (DES) to further validate its safety and efficacy in every day clinical practice. We investigated 1-year clinical outcomes in a predefined subset of high-risk patients with acute coronary syndrome (ACS). METHODS e-Ultimaster recruitment started in 2014 and is still ongoing. To date, 5468 patient have been treated with the Ultimaster sirolimus eluting, thin strut (80um) cobalt chromium, stent coated with a bioresorbable polymer, who either reached 1 year follow-up, or died. RESULTS A total of 3205 high-risk patients with unstable angina (18.9%), non-ST segment elevation myocardial infarction (NSTEMI; 43.6%) or ST segment elevation myocardial infarction (STEMI; 37.5%) were included. Mean SD age was 64.5 11.4 years and 76% were men, with a mean BMI of 27.9 kg/m 2, 31% smokers, 24% with diabetes and 59% had hypertension. Radial access was used in 85.9%. 48.3 % of patients had multi-vessel disease and the mean number of lesion per patient was 1.4 0.7. Chronic total occlusion was present in 2% of patients and bifurcation lesions in 13%, while 42% had long lesions. At 1 year follow-up, rates of cardiac death, MI and target vessel MI were 1.8%, 1.1% and 0.97%, respectively. Clinically driven (CD) target vessel revascularization (TVR) was performed in 2.8% of patients and CD target lesion revascularization (TLR) in 1.6%. Target lesion failure (TLF), a composite of cardiac death, TV-related MI and CD-TLR, was 3.7% and TVR, a composite of cardiac death, TV-related MI and CDTVR was 4.7%. Definite and probable stent thrombosis at 1 year occurred in 1% of the patients. Bleeding rate was 2.9%. At 3 months follow-up, 95% of patients were on dual antiplatelet therapy (DAPT), while 69% of patients were on DAPT at 1 year. 90% of patients were free of angina at 1 year follow-up.
BACKGROUND In the TROFI II randomized trial, stenting of culprit lesions with bioresorbable vascular scaffolds (Absorb [Abbott Vascular, Santa Clara, CA, USA]) in the setting of ST-segment elevation myocardial infarction (STEMI) resulted in an arterial healing pattern that was comparable with that of metallic Everolimus-eluting stent (EES) as assessed by optical frequency domain imaging at 6 months and associated with a low incidence of clinical adverse events . However, there is still limited data of the long-term outcome after implantation of Absorb with patients presenting with STEMI in the context of a randomized control trial. We sought to investigate the 3year device-oriented composite endpoint (DOCE: a composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization) rate of the patients treated with Absorb scaffolds and EES in this challenging setting. METHODS A total of 191 patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES (Absorb [n ¼ 95] or EES [n ¼ 96]; mean age 58.6 years old; 17.8% females) in the TROFI II trial. The patients were clinically followed up yearly up to 3 years. The 3-year follow up data is being collected and will be analyzed according to the device type. RESULTS 6-month optical frequency domain imaging healing score (HS) of Absorb, which was based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects, was 1.74 (2.39) compared to HS of EES (2.80 4.44, difference [90% Cl] 21.06 [21.96, 20.16]; Pnon-inferioiity < 0.001). DOCE was comparably low between groups (3.2 % Absorb vs. 3.2% EES; p¼ns) whereas device thrombosis rate was also comparable (2.1% Absorb vs 1.0% EES; p¼ns) at 2-years follow-up. CONCLUSION In September 2017, 191 patients will have completed their 3-year clinical follow-up. The complete data of 3-year follow-up will be presented at the time of congress. CATEGORIES CORONARY: Acute Myocardial Infarction
TCT-409 Optical coherence tomography surveillance of tissue coverage at six months after stenting for acute myocardial infarction with bioabsorbable vascular scaffolds in the ISAR-Absorb MI trial Himanshu Rai,1 Fernando Alfonso,2 Michael Maeng,3 Jens Wiebe,4 Javier Cuesta Cuesta,5 Evald Christiansen,3 Petra Hoppmann,6 Sebastian Kufner,4 Simon Schneider,6 Karl-Ludwig Laugwitz,7 Adnan Kastrati,8 Robert Byrne4 1 ISAResearch Centre, Deutsches Herzzentrum München (German Heart Centre Munich), Munich, Germany; 2Hospital Universitario de la Princesa, Madrid, Spain; 3Aarhus University Hospital, Aarhus, Denmark; 4Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 5Hospital La Princesa, Madrid, Spain; 6 Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München, Munich, Germany; 7Klinikum rechts der Isar TUM, Munich, Germany; 8Deutsches Herzzentrum München, Munich, Germany BACKGROUND Bioresorbable stents (BRS) are novel devices designed to overcome the long-term limitations of permanent stent implantation. Optical coherence tomography (OCT) surveillance can provide
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, VOL. 70, NO. 18, SUPPL B, 2017
B169
important insights on the process of vessel wall healing after BRS implantation. We sought to evaluate OCT-assessed healing at 6 months after implantation of everolimus eluting BRS in patients treated for acute myocardial infarction (AMI).
TCT-411 Initial experience with sirolimus-eluting magnesium-based bioresorbable vascular scaffold implantation in patients with ST-elevation myocardial infarction.
METHODS ISAR-Absorb MI is a multicentre, assessor-blind randomized trial comparing outcomes of patients with AMI undergoing treatment with everolimus eluting BRS or conventional everolimuseluting stents with angiographic surveillance planned for all patients at 6-8 months follow-up. Selected patients who had OCT surveillance (with commercially-available frequency domain OCT imaging) performed at the time of angiographic follow-up were included for the present analysis. Raw data of OCT image acquisitions were collected at four recruiting centres and analysed at a centralized core laboratory. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment using QIvus 3.0.30.0 software.
Quentin de Hemptinne,1 Briki Rachid,2 Paul-Gaël Silance,3 Philippe Unger,3 Nadia Debbas4 1 CHU Saint-Pierre, Université Libre de Bruxelles, Belgium, Brussels, Belgium; 2CHU Saint-Pierre, brussels, Belgium; 3CHU Saint-Pierre, Brussels, Belgium; 4CHU St Pierre, Brussels, Belgium
RESULTS OCT imaging data at post stenting follow-up on a total of 45 patients / stented target lesions at a median of 212 days was available for analysis. Morphometric analysis revealed mean stented length to be 18.856.09 mm. Mean minimum lumen area was 5.431.98 mm2, while the minimum stent area was 6.021.82 mm2. Average lumen area was 6.992.16 mm2, while the average stent area was 7.362.07 mm2. The total number of frames assessed was 915, with a total of 8,556 visible struts. Overall strut coverage was 98.60%; 0.41% of struts were found to be malapposed. Mean thickness of neointimal coverage was 94.9331.43 mm, while mean neointimal area was 0.350.46 mm2 and mean percentage stenosis was 5.396.56%. Four (8.89 %) patients required target lesion revascularization at follow-up. CONCLUSION In selected patients undergoing OCT imaging at 6-8 months after implantation of everolimus eluting BRS stents for AMI, we observed generally favourable healing characteristics with high rates of strut coverage and low rates of strut malapposition. CATEGORIES CORONARY: Stents: Bioresorbable Vascular Scaffolds TCT-410 Reendothelialization after SYNERGY stent and Bioresorbable Vascular Scaffold ABSORB implantation in Acute Myocardial Infarction : COVER-AMI Study
BACKGROUND Recent studies have demonstrated favorable clinical outcomes for the sirolimus-eluting magnesium-based bioresorbable vascular scaffold (BVS) MAGMARIS Ò (Biotronik, Berlin, Germany) in patients with stable coronary artery disease. There are currently no data on its use in patients with ST-elevation myocardial infarction (STEMI). Therefore, we sought to assess safety and efficacy of magnesium-based BVS implantation in the setting of primary percutaneous coronary intervention (PCI) in patients presenting with STEMI to our institution. METHODS We are conducting a single-center feasibility study of MagmarisÒ implantation in STEMI patients. Primary endpoints are procedural success and device-oriented composite endpoint including cardiac death, target vessel myocardial infarction and target lesion revascularization as defined by the Academic Research Consortium criteria. This study is intended to obtain data from 25 consecutive STEMI patients undergoing primary PCI with magnesium-based BVS implantation, according to pre-specified inclusion/exclusion criteria. RESULTS Median age of the first 10 patients included is 42 years [3849]. Mean number of implanted device is 1.2 0.4, with a mean length of 25 8 mm and mean diameter of 3.35 0.2. So far procedural success is 100% with one case of distal edge dissection requiring a second scaffold implantation, and in-hospital DOCE rate is 0%. CONCLUSION This is the first reported initial clinical experience of magnesium-based BVS (MagmarisÒ ) implantation in STEMI patients. Preliminary results of this single-center feasibility study seem reassuring with excellent procedural success rates, low complication rates and excellent short-term clinical outcomes. We will report further results of additional included patients, mid-term clinical outcomes, and intra-coronary imaging results.
Thibault Lhermusier,1 Paul Ohayon,2 Nicolas Boudou,1 Francisco Campelo Parada,3 Frédéric Bouisset,4 Meyer Elbaz,5 Didier Carrié6 1 CHU Rangueil, Toulouse, France; 2Chu Rangueil, Toulouse, France; 3 Rangueil Hospital, Toulouse, France; 4Toulouse University Hospital, Toulouse, France; 5Rangueil Hospital, Toulouse, France; 6Hôpital Rangueil, Toulouse, France
CATEGORIES CORONARY: Acute Coronary Syndromes
BACKGROUND Incomplete reendothelialization after a stent implantation is strongly associated with stent thrombosis. Non-randomized preclinical studies have shown a particularly rapid endothelialization after a SYNERGYÒ EES implantation, which is now widely used. Moreover, vascular response after ABSORB Ò BVS implantation seems similar to that observed with XIENCEÒ EES at 1 year but data concerning early reendothelialization remain scarce.
Abstract nos: 412 - 416
METHODS We designed a randomized, controlled, prospective trial to assess 3 months strut coverage and neointimal response in STEMI patients treated with SYNERGYÒ EES or ABSORBÒ BVS. RESULTS Twenty-two patients were included between July 2016 and February 2017. At 3 months, no significant differences in the angiographic lumen loss were seen in the Absorb and in the Synergy arm (0,20 [ 0,23 mm] vs. 0,10 [ 0,14 mm, p ¼ 0,286] and there were no binary restenosis in both groups. Strut coverage analyzed by OCT showed high reendothelialization rates, with no significant difference regarding uncovered struts rate: 2,9 [ 2,5 %] in the Absorb arm and 5,2 [ 4,9 %] in the Synergy arm (p ¼ 0,203). In stent/scaffold area obstruction was significantly higher in the Absorb group (9,6 [ 4,8 %] vs. 7.0 [ 2,5 %], p < 0,001]). Malapposed area and intraluminal masses area were similar in both groups. CONCLUSION Primary PCI for culprit lesions in STEMI patients with an ABSORBÒ BVS or a SYNERGYÒ stent leaded to a nearly complete healing in both groups but we noticed an higher in stent/scaffold area obstruction with the ABSORBÒ BVS. However, OCT is better to assess coverage than healing. It will be important in the future to differentiate mature from immature tissue coverage after stent implantation. Finally, ongoing clinical follow-up is waiting at twelve months. CATEGORIES CORONARY: Stents: Drug-Eluting
DILEMMAS IN CORONARY PHYSIOLOGY - III
TCT-412 Prognostic implications of pressure-bounded coronary flow reserve versus flow-derived coronary flow reserve. Gilbert Wijntjens,1 Martijn van Lavieren,2 Tim van de Hoef,3 Mauro Echavarria Pinto,4 Martijn Meuwissen,5 Valérie Stegehuis,6 Karel Koch,3 Steven Chamuleau,7 Michiel Voskuil,8 Robbert de Winter,3 Jan Tijssen,9 Javier Escaned,10 Jan Piek11 1 Academisch Medisch Centrum, Amsterdam, Netherlands; 2Academic Medical Center- University of Amster, Amsterdam, Netherlands; 3 Academic Medical Center - University of Amsterdam, Amsterdam, Netherlands; 4Hospital General ISSSTE, Queretaro, Querétaro, Mexico; 5 Breda Amphia Ziekenhuis, Breda, Netherlands; 6Academic Medical Center, Amsterdam, Netherlands; 7UMCU, Utrecht, Netherlands; 8 University Medical Center Utrecht, Utrecht, Netherlands; 9AMC, Naarden, Netherlands; 10Hospital Clínico San Carlos, Madrid, Spain; 11 Academic Medical Center, University of Amsterdam, Amsterdam, Netherland BACKGROUND Pressure-bounded coronary flow reserve (Pb-CFR) is a novel technique that estimates the bounds of CFR from routine pressure measurements, but has not been compared with flowderived CFR (CFR) regarding clinical outcome. We compared the longterm prognostic value of Pb-CFR versus CFR. METHODS We evaluated 453 intermediate coronary lesions with intracoronary pressure and flow sensors (298 lesions by Doppler flow velocity and 155 lesions by the thermodilution method). The lower and higher bound of Pb-CFR were defined as O[(1-FFR)/(1-Pd/Pa)] and (1-FFR)/(1-Pd/Pa), respectively. Long-term follow-up (median: 11.8