Lukasz Koltowski

Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation.

OBJECTIVES The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. BACKGROUND Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ~10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. METHODS The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. RESULTS Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. CONCLUSIONS This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data.

Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): A randomised, open-label, multicentre trial

BACKGROUND Current guidelines recommend potent platelet inhibition with prasugrel or ticagrelor for 12 months after an acute coronary syndrome managed with percutaneous coronary intervention (PCI). However, the greatest anti-ischaemic benefit of potent antiplatelet drugs over the less potent clopidogrel occurs early, while most excess bleeding events arise during chronic treatment. Hence, a stage-adapted treatment with potent platelet inhibition in the acute phase and de-escalation to clopidogrel in the maintenance phase could be an alternative approach. We aimed to investigate the safety and efficacy of early de-escalation of antiplatelet treatment from prasugrel to clopidogrel guided by platelet function testing (PFT). METHODS In this investigator-initiated, randomised, open-label, assessor-blinded, multicentre trial (TROPICAL-ACS) done at 33 sites in Europe, patients were enrolled if they had biomarker-positive acute coronary syndrome with successful PCI and a planned duration of dual antiplatelet treatment of 12 months. Enrolled patients were randomly assigned (1:1) using an internet-based randomisation procedure with a computer-generated block randomisation with stratification across study sites to either standard treatment with prasugrel for 12 months (control group) or a step-down regimen (1 week prasugrel followed by 1 week clopidogrel and PFT-guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). The assessors were masked to the treatment allocation. The primary endpoint was net clinical benefit (cardiovascular death, myocardial infarction, stroke or bleeding grade 2 or higher according to Bleeding Academic Research Consortium [BARC]) criteria) 1 year after randomisation (non-inferiority hypothesis; margin of 30%). Analysis was intention to treat. This study is registered with ClinicalTrials.gov, number NCT01959451, and EudraCT, 2013-001636-22. FINDINGS Between Dec 2, 2013, and May 20, 2016, 2610 patients were assigned to study groups; 1304 to the guided de-escalation group and 1306 to the control group. The primary endpoint occurred in 95 patients (7%) in the guided de-escalation group and in 118 patients (9%) in the control group (pnon-inferiority=0·0004; hazard ratio [HR] 0·81 [95% CI 0·62-1·06], psuperiority=0·12). Despite early de-escalation, there was no increase in the combined risk of cardiovascular death, myocardial infarction, or stroke in the de-escalation group (32 patients [3%]) versus in the control group (42 patients [3%]; pnon-inferiority=0·0115). There were 64 BARC 2 or higher bleeding events (5%) in the de-escalation group versus 79 events (6%) in the control group (HR 0·82 [95% CI 0·59-1·13]; p=0·23). INTERPRETATION Guided de-escalation of antiplatelet treatment was non-inferior to standard treatment with prasugrel at 1 year after PCI in terms of net clinical benefit. Our trial shows that early de-escalation of antiplatelet treatment can be considered as an alternative approach in patients with acute coronary syndrome managed with PCI. FUNDING Klinikum der Universität München, Roche Diagnostics, Eli Lilly, and Daiichi Sankyo.

Age and outcomes following guided de-escalation of antiplatelet treatment in acute coronary syndrome patients undergoing percutaneous coronary intervention: results from the randomized TROPICAL-ACS trial

Aims Guided de-escalation of P2Y12-inhibitor treatment was recently identified as an effective alternative treatment strategy in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention. Safety and efficacy of this strategy may differ in relation to patients age. This pre-specified analysis of the TROPICAL-ACS trial aimed to assess the impact of age on clinical outcomes following guided de-escalation of antiplatelet treatment in ACS patients. Methods and results Patients were randomly assigned in a 1:1 fashion to either standard treatment with prasugrel for 12 months (control group) or to a guided de-escalation regimen (1 week prasugrel followed by 1 week clopidogrel and platelet function testing guided maintenance therapy with clopidogrel or prasugrel from day 14 after hospital discharge; guided de-escalation group). We used Cox regression models to assess the associations of age on clinical endpoints and interactions. In younger patients (age ≤70, n = 2240), the 1 year incidence of the primary endpoint (cardiovascular death, myocardial infarction, stroke, or bleeding ≥ grade 2 according to Bleeding Academic Research Consortium criteria) was significantly lower in guided de-escalation vs. control group [5.9% vs. 8.3%; hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.51-0.96; P = 0.03, number needed to treat = 42]. In elderly patients (age >70, n = 370), the absolute risk of events was higher without significant differences between guided de-escalation vs. control group (15.5% vs. 13.6%; HR 1.17, 95% CI 0.69-2.01; P = 0.56). When the impact of age, as a continuous variable, was analysed on outcomes after guided de-escalation vs. control treatment, an increasing relative risk reduction was observed in the primary endpoint by decreasing age (Pint = 0.02), due to significant reductions in bleeding. Conclusion Treatment effects of guided de-escalation for P2Y12 inhibitors depend on patients age with younger patients deriving a significant net clinical benefit. Although the safety and efficacy of guided de-escalation in the elderly was similar to uniform prasugrel therapy, this should be further investigated due to the limited sample size of this group.

Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective PCI patients: A pilot study: ONSIDE TEST pilot

BACKGROUND Dual antiplatelet therapy (DAPT) is recommended after elective percutaneous coronary intervention (PCI) in stable coronary artery disease (SCAD) patients; however, still one-third of patients do not obtain adequate platelet inhibition that may result in increased cardiovascular risk. The aim of the ONSIDE TEST study is to evaluate the clinical impact of point-of-care genotyping- and platelet function-based personalized dual antiplatelet strategies in SCAD individuals undergoing PCI. METHODS Fifty patients were randomized to one of the three study arms: 1) genotyping, 2) platelet function testing (PFT) and 3) control. Patients were tested with point-of-care Spartan RX CYP2C19 System (group 1) and VerifyNow P2Y12 assay (group 2). In cases of inadequate response to clopidogrel, a loading dose of prasugrel was administered before PCI. The main clinical endpoint is the incidence of periprocedural myocardial injury (PMI). RESULTS Five (32%) patients in the genotyping arm and two (13%) in the in the PFT arm were identi-fied as poor clopidogrel metabolizers. The periprocedural platelet reactivity was significantly lower in the genotyping (80 ± 49.0 PRU) and PFT (36.5 ± 47 PRU) arms as compared to the control arm (176 ± 67.8 PRU), p = 0.01 and p = 0.03, respectively. PMI appeared in 17 (37%) patients of the entire study population. CONCLUSIONS Personalized DAPT results in an improved platelet inhibition. Apart from genotyping and aggregometry, it is feasible to integrate into everyday clinical practice PMI rates which are relevant when comparing different strategies.

Delayed neointimal healing pattern after bioresorbable scaffold implantation

Fig. 1 a (Baseline) Optical coherence tomography (OCT) directly after implantation of the bioresorbable scaffold (BVS). Adequate BVS expansion and focally malapposed struts in the distal 3-mm scaffold segment (white arrow) into right coronary artery. b (1-year follow-up) Uncovered stent struts (blue arrows) at 12 months after the intervention. c (2-year follow-up) 24-month OCT revealed complete coverage of all struts with a homogeneous, bright neointimal layer and resolved malapposition in the distal segment

Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER)

Background Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome. Methods and design OCTOBER is a randomized, investigator‐initiated, multicenter trial aimed to show superiority of OCT‐guided stent implantation compared to standard angiographic‐guided implantation in bifurcation lesions. The primary outcome measure is a 2‐year composite end point of cardiac death, target lesion myocardial infarction, and ischemia‐driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non–ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2‐stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results. Implications A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.

TRANSCATHETER AORTIC VALVE IMPLANTATION IN PATIENTS WITH BICUSPID AORTIC VALVE STENOSIS UTILIZING THE NEXT GENERATION FULLY RETRIEVABLE AND REPOSITIONABLE VALVE SYSTEM: EARLY RESULTS FROM THE MULTICENTER POL-TAVI REGISTRY

Background: The aim of this study was to evaluate the outcomes of transcatheter aortic valve implantation (TAVI) in bicuspid aortic valve (BiAV) stenosis using a mechanically expanded Lotus™ device. The BiAV has been excluded from landmark clinical trials and is considered as relative

Implementation of mild therapeutic hypothermia for post-resuscitation care of sudden cardiac arrest survivors in cardiology units in Poland

BACKGROUND The post-cardiac arrest (CA) period is often associated with secondary damage of the brain that leads to severe neurological deficits. The current practice guidelines recommend the use of therapeutic hypothermia (TH) to prevent neurological deficit and improve survival. OBJECTIVES The aim of the study was to investigate the implementation of medical guidelines in clinical practice and to evaluate the barriers for implementation of TH in cardiology units in Poland. MATERIAL AND METHODS A telephone survey, fax and online inquiry form were used to assess the implementation of TH in cardiology units in the management of unconscious patients after cardiac arrest (CA). The questions addressed the local practice, TH protocol, reasons for not using TH and outcomes of CA patients. RESULTS We obtained information from 79 units out of 150 asked (53%). At the time of the survey, 24 units (30.8%) were using TH as part of their post-CA management. Of all CA patients, 45% underwent TH in cardiac intensive care units (CICU), 37.5% in the coronary care unit (CCU) and 12.5% in the intensive care unit (ICU). The major barrier for the implementation of TH declared by the non-cooling centers was lack of sufficient knowledge regarding the technique and protocol, as well as experience (37%); access to dedicated equipment was not perceived as an obstacle. CONCLUSIONS The number of cardiology units that provide TH for comatose CA patients is low. The main limiting factor for wider use of TH is lack of knowledge and experience. There is a clear need for urgent educational activities for cardiology units. The benefits of TH still have not reached their potential in cardiology units.

TCT-74 A Serial 3- and 9-year Optical Coherence Tomography Assessment of Vascular Healing Response to Sirolimus- and Paclitaxel-Eluting Stents

nos: 73 76 TCT-73 Serial Three-Vessel Optical Coherence Tomography and Intravascular Ultrasound Analysis of Changing Morphologies Associated of Plaque Progression in Patients With Stable Angina Pectoris Myong Hwa Yamamoto, kennosuke yamashita, Mitsuaki Matsumura, Seitarou Ebara, Toshitaka Okabe, Shigeo Saito, Koichi Hoshimoto, Kisaki Amemiya, Tadayuki Yakushiji, Naoei Isomura, Hiroshi Araki, Chiaki Obara, Masahiko Ochiai, Gary Mintz, Akiko Maehara Cardiovascular Research Foundation, New York, New York, United States; Showa University Northern Yokohama Hospital, Yokohama, Japan; Cardiovascular Research Foundation, New York, New York, United States; NorthPoint Solutions, LLC; Showa University Northern Yokohama Hospital, Tokyo, Japan; Showa University Northern Yokohama Hospital, Yokohama, Japan; CRF; Showa universty yohohama northern hospital, Yokohama, Japan; Showa University Northern Yokohama Hospital, Yokohama, Japan; Showa University Northern Yokohama Hospital, Yokohama, Japan; Showa Univ. Northern Yokohama Hospital, Yokohama, Japan; Ospedale Sacco Vialba; Showa University Northern Yokohama Hospital, Kanagawa, Japan; Cardiovascular Research Foundation, Washington, District of Columbia, United States; Cardiovascular Research Foundation, New York, New York, United States BACKGROUND OCT morphologies associated with plaque progression are not well-studied. METHODS We used baseline and 8-mo follow-up 3-vessel OCT and IVUS to assess 124 non-culprit lesions (IVUS plaque burden 40%) in 45 pts with stable angina after culprit lesion percutaneous coronary intervention. Plaque progression was defined as IVUS minimum lumen area decrease >0.5mm2. Lipid plaques by OCT were defined as signal-poor regions with diffuse borders. RESULTS Overall, 24/124 plaques progressed and were characterized by OCT as plaque rupture (n1⁄44), new layer appearance (n1⁄47), thickening of fibrous cap (n1⁄47), or no OCT morphological change with negative remodeling by IVUS (n1⁄46, vessel area at baseline 12.2 [9.9, 18.7]mm2 to follow-up; 10.2 [8.0, 18.5]mm2, p1⁄40.17) (Figure). Pts with plaque progression (n1⁄416) reported less statin use (31.3% vs. 72.4%, p1⁄40.007) and higher baseline LDL-C (110.0 vs. 87.0 mg/dL, p1⁄40.007) and hs-CRP (0.097 vs. 0.051 mg/dL, p1⁄40.004). Multivariable logistic regression analysis showed that lipid plaque by OCT was an independent predictor of plaque progression (OR: 10.2, p1⁄40.001). Progression (n[24) Non-progression (n[103) P value Baseline lumen area, mm2 (IVUS) 4.6 [3.8, 6.3] 4.8 [3.5, 6.4] 0.83 Baseline plaque burden, % (IVUS) 62.8 [55.8, 70.2] 58.7 [53.2, 67.7] 0.17 Baseline remodeling index (IVUS) 0.93 [0.90, 0.97] 0.95 [0.86, 1.02] 0.72 Follow-up lumen area, mm2 (IVUS) 3.7 [2.8, 4.5] 4.8 [3.6, 6.4] 0.007 Baseline thin-cap fibroatheroma (OCT) 6 (25.0%) 4 (3.9%) <0.001 Baseline lipid plaque (OCT) 20 (83.3%) 30 (29.1%) <0.001 Baseline cap thickness, mm 0.11 [0.06, 0.20] 0.12 [0.09, 0.20] 0.39 Baseline lipid index (mean lipid arc multiplied by lipid length) 493 [305, 906] 324 [174, 589] 0.18 D lipid index -17.0 [-84.9, 16.2] 12.4 [-12.3, 33.9] 0.02 CONCLUSION OCT lipid plaque was a predictor of plaque progression even in pts with stable angina; in turn, plaque progressions was associated with distinct OCT morphologies that changed during follow-up. CATEGORIES IMAGING: Intravascular TCT-74 A Serial 3and 9-year Optical Coherence Tomography Assessment of Vascular Healing Response to Sirolimusand Paclitaxel-Eluting Stents Mariusz Tomaniak, Janusz Kochman, Lukasz Koltowski, Arkadiusz Pietrasik, Adam Rdzanek, Jacek Jąkała, Klaudia Proniewska, Krzysztof Malinowski, Krzysztof Filipiak, Grzegorz Opolski Medical University of Warsaw, Warsaw, Poland; Medical University of Warsaw, Warsaw, Poland; Medical University of Warsaw, Warszawa, Poland; Medical University of Warsaw, Warsaw, Poland; Medical University of Warsaw, Warsaw, Poland; UC Davis; Krakow Cardiovascular Research Institute, Krakow, Poland; Rush University; Hannover Medical School; Dept. of Cardiology, Medical University of Warsaw, Warsaw, Poland BACKGROUND Early-generation drug-eluting stents (DES) have been demonstrated to delay vascular healing. Limited optical coherence tomography (OCT) data on the very long-term neointimal response after DES implantation are available. METHODS The aim of this single–centre study was to conduct a longterm OCT assessment of stent strut coverage, malapposition, protrusion and neoatherosclerosis as markers of neointimal response at 3 and 9 years after implantation of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). Consecutive patients undergoing elective PCI with SES (Cypher, Cordis) or PES (Taxus, Boston Scientific) were included. An OCT evaluation was performed after 3 and 9 years. Struts’ analyses were conducted at 1 mm longitudinal intervals in a frame-by-frame fashion by the independent core laboratory. RESULTS Between 3and 9-years following the stent implantation the lumen, neointimal and malapposition area did not increase in the assessed 22 SES and 25 PES patients. An OCT analysis confirmed similar neointimal coverage with comparable number of uncovered struts at 3and 9 years in SES and PES group (p1⁄4 0.68; 0.79). There was no significant difference in the incidence of malapposed or protruding struts between 3and 9-year follow-up in each type of stent. Likewise, no features of neoatheroslerosis progression were observed with a comparable rate of thin cap fibroatheroma (TCFA) found in 6.67% of SES patients and 8.0 % of PES patients at 9 years (p1⁄40.20). J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y , V O L . 6 8 , N O . 1 8 , S U P P L B , 2 0 1 6 B31 Parameter SES PES p value (3 vs. 9 years) 3 years 9 years 3 years 9 years p (SES); p (PES) Minimal lumen area, mm2 3.60 3.22 4.83 4.53 0.15; 0.26 Lumen area, mm2 4.95 4.76 6.78 6.39 0.46; 0.15 Neointima area, mm2 0.75 1.07 1.13 1.14 0.25; 0.95 Uncovered struts per stent, % 11.75 4.89 2.12 2.44 0.68; 0.79 Protruding struts per stent, % 4.22 0.51 1.26 0 0.25; 0.32 Mallaposed struts per stent, % 0.12 0.87 0.54 1.07 0.13; 0.23