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Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial
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Journal of Cardiology journal homepage: www.elsevier.com/locate/jjcc
Original article
Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial Takashi Kubo (MD, PhD, FJCC)a, Toshiro Shinke (MD, PhD, FJCC)b, Takayuki Okamura (MD, PhD)c, Kiyoshi Hibi (MD, PhD, FJCC)d, Gaku Nakazawa (MD, PhD)e, Yoshihiro Morino (MD, PhD)f, Junya Shite (MD, PhD, FJCC)g, Tetsuya Fusazaki (MD, PhD)f, Hiromasa Otake (MD, PhD)b, Ken Kozuma (MD, PhD)h, Takashi Akasaka (MD, PhD, FJCC)a,* a
Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan Department of Internal Medicine, Division of Cardiovascular and Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan d Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan e Division of Cardiology, Tokai University School of Medicine, Isehara, Japan f Division of Cardiology, Iwate Medical University, Morioka, Japan g Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan h Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan b c
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 August 2015 Received in revised form 2 November 2015 Accepted 16 November 2015 Available online xxx
Background: Optical coherence tomography is becoming increasingly widespread as an adjunctive intravascular diagnostic technique in percutaneous coronary intervention (PCI), because of its ability to visualize coronary structures at high resolution. Several studies have reported that intravascular ultrasound (IVUS) guidance in PCI might be helpful to reduce subsequent stent thrombosis, restenosis, repeat revascularization, myocardial infarction, and cardiac death. The OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial is aimed at evaluating the impact of optical frequency domain imaging (OFDI) guidance in PCI on clinical outcomes compared with IVUS guidance. Methods and design: The OPINION trial is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. The eligible patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. PCI is performed using the biolimus-eluting stent in accordance with a certain criteria of OFDI and IVUS for optimal stent deployment. All patients will undergo a followup angiography at 8 months. The primary endpoint is target vessel failure composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization at 12 months. Conclusion: When completed, the OPINION trial will contribute to define the clinical value of the OFDI guidance in PCI. ß 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Keywords: Coronary artery disease Drug-eluting stent Intravascular ultrasound Optical coherence tomography Percutaneous coronary intervention
Introduction Percutaneous coronary intervention (PCI) is a common management strategy for patients with coronary artery disease. Since its introduction into clinical practice in 1977, angiography
* Corresponding author at: Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan. Tel.: +81 73 441 0621; fax: +81 73 446 0631. E-mail address: [email protected] (T. Akasaka).
has been the workhorse imaging guidance for PCI [1]. However, angiography provides little information about the vessel wall or plaque lining the vessel, and has limitations in assessing lesion morphology because it depicts the coronary artery from a planar two-dimensional silhouette of the contrast-filled vessel lumen [2]. The angiographic lesion assessment is impeded in patients with eccentric lesions, diffuse disease, tortuous vessels, and multiple branches overlapping segments. In the early 1990s, intravascular ultrasound (IVUS) was developed as an adjunctive imaging modality to overcome these
http://dx.doi.org/10.1016/j.jjcc.2015.11.007 0914-5087/ß 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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limitations of angiography. IVUS provides cross-sectional images of coronary arteries and allows assessment of arterial atherosclerotic diseases. By detecting luminal, external elastic membrane, and stent boundaries, IVUS is able to estimate vessel diameter, lumen area, plaque volume, and the results of PCI procedures such as stent underexpansion, incomplete stent apposition, and coronary artery dissection. The major role of IVUS in PCI is assessment of lesion morphology before PCI, stent optimization during PCI, and prediction of complications after PCI. Previous randomized trials, registries, and meta-analyses of IVUS-guided versus angiography-guided PCI reported that IVUS results in greater acute lumen gains with reductions in subsequent restenosis, stent thrombosis, repeat revascularization, myocardial infarction, and cardiac death [3–8]. In the mid-2000s, optical coherence tomography (OCT) emerged as a high-resolution intracoronary imaging technology that is capable of providing microscopic images of the coronary wall. OCT measures the intensity of reflected light waves and translates these optical echoes into a cross-sectional image. The spatial resolution of OCT is 10–20 mm, and it is approximately 10 times greater than that of IVUS. An excellent contrast between lumen and vessel wall in OCT allows accurate lumen measurements, which might be helpful in determining appropriate balloon or stent size [9–12]. Compared with IVUS, OCT is more sensitive in detecting suboptimal lesion morphologies after PCI, such as intrastent tissue protrusion, incomplete stent apposition, stent edge dissection, and intra-stent thrombus [9,13,14]. In addition, tissue characterization by OCT enables us to identify lipid-rich plaques and aids to predict no-reflow phenomenon after PCI and periprocedural myocardial infarction [15–17]. Furthermore, the most recently developed optical frequency domain imaging (OFDI: LUNAWAVE, Terumo Corporation, Tokyo, Japan) provides a high frame rate (158 frames/s), which enables imaging of long coronary segments (up to 150 mm) within a few seconds in combination with rapid spiral pullback (40 mm/s) and contrast injection through a guiding catheter. OFDI is becoming increasingly widespread as a clinical tool to guide PCI. Like IVUS, OFDI guidance is expected to improve procedural and clinical results [18]. Therefore, we designed the OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial powered to evaluate the non-inferiority of OFDIguided PCI compared with IVUS-guided PCI in terms of clinical outcomes.
Table 2 Exclusion criteria. 1. 2. 3. 4.
STEMI or NSTEMI in previous 3 months Cardiogenic shock Congestive heart failure Chronic kidney disease (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl) Hemodialysis or peritoneal dialysis Three-vessel disease Left main coronary artery disease Aorto-ostial lesion arising within 3 mm of the origin of a coronary artery Chronic total occlusion Small vessel disease (reference vessel diameter <2.5 mm) Coronary bypass graft In stent restenosis Planned surgery within 1 year
5. 6. 7. 8. 9. 10. 11. 12. 13.
STEMI, ST-segment elevation myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; eGFR, estimated glomerular filtration rate.
Research Informatics Data Center, Kobe, Japan (Fig. 1). Minimization, a dynamic randomization method that can balance groups with respect to both the numbers in each treatment arm and the characteristics of each group, is utilized in this trial [19]. The randomization is stratified by (1) age, (2) history of diabetes, and (3) participating cardiovascular centers. In each group, either OFDI or IVUS is used before, during, and immediately after PCI. Investigators will follow up the subjects for 12 months at participating centers and will conduct medical examinations and blood testing. Coronary angiography will be performed at 8 months follow-up time point at participating cardiovascular centers. This trial is approved by the Institutional Review Board or Independent Ethics Committee of all of the participating cardiovascular centers. The planned duration is between June 2013 and December 2015. This trial has been registered at clinicaltrials.gov (NCT01873027), according to the statement of the International Committee of Medical Journal Editors. OFDI-imaging OFDI imaging is performed using LUNAWAVETM imaging system and FastViewTM imaging catheter (Terumo corporation). A bolus intracoronary injection of nitroglycerin or isosorbide dinitrate is administered before OFDI imaging. After manual
Materials and methods
Patients scheduled for PCI using drug-eluting stent N =800 pts
Study design The OPINION is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial comparing OFDI-guided PCI with IVUS-guided PCI. Patients who satisfy all of the inclusion criteria (Table 1) and none of the exclusion criteria (Table 2) are enrolled in this trial. The eligible patients give written informed consent and are then randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI using a webbased randomization software conducted at the Translational
OFDI-guided PCI N = 400 pts
Randomization 1:1
IVUS-guided PCI N = 400 pts
Clinical follow-up Hospital discharge
Follow-up coronary angiography 8 months Table 1 Inclusion criteria.
Clinical follow-up 1. 2. 3.
Patients scheduled for PCI using drug-eluting stent to a de novo native coronary artery lesion Aged 20–85 years at the time of their consent Patients who agree to be enrolled in the trial giving signed written informed consent
PCI, percutaneous coronary intervention.
12 months Fig. 1. Flow chart of the trial timeline. Patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. Clinical or coronary angiography follow-up is performed at the time of hospital discharge, 8 months, and 12 months after PCI. OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention; IVUS, intravascular ultrasound.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Table 3 OFDI and IVUS criteria of optimal stent deployment.
Reference site Determination of stent diameter Determination of stent length Goal of stent deployment
OFDI-guided PCI
IVUS-guided PCI
Most normal looking No lipidic plaque By measuring lumen diameter at proximal and distal reference sites
Largest lumen Plaque burden < 50% By measuring vessel diameter at proximal and distal reference sites
By measuring distance from distal to proximal reference site In-stent minimal lumen area 90% of the average reference lumen area Complete apposition of the stent over its entire length against the vessel wall Symmetric stent expansion defined by minimum lumen diameter/maximum lumen diameter 0.7 No plaque protrusion, thrombus, or edge dissection with potential to provoke flow disturbances
OFDI, optical frequency domain imaging; IVUS, intravascular ultrasound.
calibration, the OFDI catheter is advanced more than 5 mm distally to the target lesion over a 0.014-inch conventional angioplasty guidewire. Following the catheter placement, preheated contrast media at 37 8C is flushed through the guiding catheter at a rate of 2–4 ml/s for approximately 3–6 s by using an injector pump. When a blood-free image is observed, the OFDI imaging core is pulled back over a longitudinal distance up to 150 mm at a rate of 20– 40 mm/s by using standalone electronic control of the pullback motor. During PCI, the obtained OFDI images are evaluated on-line in real-time in conformity with criteria of the report from the International Working Group for Intravascular OCT Standardization and Validation [20]. IVUS-imaging IVUS imaging is performed using VISIWAVETM imaging system (Terumo Corporation) and ViewITTM imaging catheter (Terumo Corporation) that consisted of a 40-MHz transducer. After intracoronary injection of nitroglycerin or isosorbide dinitrate, the IVUS catheter is advanced more than 5 mm beyond the target lesion over a guidewire and withdrawn to the aorto-ostial junction at a pullback speed of 0.5 mm/s automatically. During PCI, the obtained IVUS images are evaluated online in real-time in conformity with criteria of the American College of Cardiology clinical expert consensus document on IVUS [21]. PCI procedure PCI procedure is performed using 6 Fr to 8 Fr catheters through femoral, brachial, or radial artery. The biolimus-eluting stent (BES: NOBORI, Terumo Corporation) is used in all patients. Intravascular imaging of either OFDI or IVUS is performed before PCI. If the imaging catheter fails to pass through the target lesion before PCI, balloon dilatation is allowed prior to the imaging. Stent diameter and stent length are determined by the obtained images. In OFDI, reference site is set at a cross-section adjacent to the target lesion that is most normal looking and free of lipidic plaque (defined as signal-poor region with diffuse border). Then, stent diameter is decided by measuring lumen diameter at proximal and distal reference sites, and stent length is decided by measuring distance from distal to proximal reference site. In IVUS, reference site is set at a cross-section adjacent to the target lesion that has the largest lumen and plaque burden of <50%. Then, stent diameter is decided by measuring vessel diameter (approximated by the external elastic membrane diameter) at proximal and distal reference sites and stent length is decided by measuring distance from distal to proximal reference site. Balloon angioplasty after the intravascular imaging and before stent implantation is left to the discretion of operator. Following stent implantation with adequate inflation pressure according to the compliance chart of the stent delivery
balloon, the iterative intravascular imaging is performed to evaluate the results. If intravascular imaging criteria of optimal stent deployment (Table 3) are not met, additional procedures are performed, if deemed safe and feasible. Stent underexpansion (defined as in-stent minimal lumen area <90% of the average reference lumen area), incomplete stent apposition (defined as separation of a stent strut from vessel wall), asymmetric stent expansion (defined by minimum lumen diameter/maximum lumen diameter <0.7), and plaque or thrombus protrusion (defined as projection of tissue into the lumen between stent struts) with potential to provoke flow disturbances require further dilatation of the previously implanted stent with a balloon. Balloon size and inflation pressure is left to the discretion of operator. Stent edge dissection (defined as disruption of the arterial lumen surface in both the 5-mm distal and proximal stent edges) with potential to provoke flow disturbance requires the implantation of an additional stent at the edge of the previously implanted stent. Those additional procedures are followed by further, intravascular imaging. Antithrombotic therapy Procedural anticoagulation is achieved with unfractionated heparin according to the local site protocols. The recommended antiplatelet regimen is aspirin (81 mg daily) indefinitely and thienopyridine (75 mg clopidogrel daily) for 12 months. A 300 mg loading dose of clopidogrel before the procedure is administered if patients are not pretreated. Status of antiplatelet therapy is evaluated throughout the follow-up period. Coronary angiography Following intracoronary injection of nitroglycerin or isosorbide dinitrate, coronary angiograms of the target lesion are obtained from at least two, preferably orthogonal projections. All images are stored on a CD-ROM for off-line analysis. Baseline, post-procedure, and 8 months follow-up angiograms are assessed at 1 angiographic core laboratory (Cardiocore, Tokyo, Japan). Quantitative coronary angiography (QCA) analysis is performed with use of the QAngio XA system ver 7.1 (Medis, Leiden, the Netherlands). The target segment is defined as the entire segment involving the implanted stent and the 5-mm proximal and distal edges adjacent to the stent. A segment treated with multiple overlapping stents is regarded as a single target segment. The QCA measurements include reference vessel diameter (RVD), minimal luminal diameter (MLD), percent diameter stenosis [(RVD MLD) 100/RVD], PCI procedure success (percent diameter stenosis at postprocedure <50%), acute gain (MLD at post-procedure MLD at baseline), late loss (MLD at post-procedure MLD at follow-up), and binary restenosis (percent diameter stenosis at follow-up 50%).
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Endpoints The primary endpoint is target vessel failure (TVF) at 12 months. TVF is a composite of cardiac death, myocardial infarction (MI) attributed to the target vessel, and clinicallydriven target vessel revascularization (TVR). The secondary endpoints include cardiac death, MI, stent thrombosis, binary restenosis, clinically-driven target lesion revascularization (TLR), clinically-driven TVR, major adverse cardiovascular events (MACE), stroke, and contrast-induced nephropathy. Death is regarded as cardiac in origin unless obvious non-cardiac causes could be identified. MI is regarded as present with serum creatinine kinase (CK) MB fraction 2 times upper limit of normal or serum troponin the 99th percentile. Stent thrombosis is defined according to the Academic Research Consortium definitions [22]. TLR is defined as repeat PCI or bypass graft placement for restenosis at the lesion treated during index PCI, or occurring within 5 mm of the PCI site (edge effect) as determined clinically by the investigator at each site. TVR is defined as unplanned repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI. Both TLR and TVR are considered clinically-driven if angiography during follow-up showed a diameter stenosis 50% and if a patient had a positive history of recurrent angina pectoris or objective signs of ischemia in any diagnostic test. All the angiograms of patients with stent thrombosis, binary restenosis, TLR, or TVR, are to be analyzed by the angiographic core laboratory in an attempt to adjudicate accurately. MACE is a composite of cardiac death, MI, or clinically-driven TLR. Stroke is defined as ischemic or hemorrhagic stroke requiring hospitalization with symptoms lasting >24 h. Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 h after PCI. The endpoint events are adjudicated by the independent and blinded clinical event assessment committee. Event assessment The event assessment committee consists of three experts in cardiovascular medicine. All clinical problems are documented by investigators using a clinical event data form. The clinical event data are independently reviewed by the three experts. A clinical problem that at least one expert judged to be an endpoint event is decided as the event. A clinical problem that all experts judged not to be an endpoint event is decided as a non-event. If there are difficulties in making a judgment based on the clinical event data form, further information will be requested from the investigators and angiographic core laboratory and a decision will be made at a subsequent review on the basis of all the data provided. Safety monitoring Safety is observed throughout the study and will be evaluated by regular medical examination and laboratory tests immediately after and at 8 and 12 months after PCI. The data and safety monitoring committee evaluates MACE and any other adverse events. Sample size calculation OPINION is a trial powered to evaluate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI on the primary endpoint at 12 months. At study initiation, we did not know the estimated TVF rate in IVUS-guided PCI with BES. Therefore, we assumed that the TVF rate after IVUS-guided PCI with BES is
equivalent to that after IVUS-guided PCI with sirolimus-eluting stent (SES). In the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET), the TVF rate at 12 months after SES deployment with high prevalence (81%) of IVUS guidance was 8.8% [23]. With the assumption of 9% TVF rate at 12 months after IVUS-guided PCI with BES, a total of 774 patients would yield 80% power to detect non-inferiority with a noninferiority margin of 7% (hazard ratio = 1.85) at a one-sided significance level of 0.05. A total of 800 patients are to be enrolled considering possible dropout during follow-up. Statistical analysis The non-inferiority test for primary endpoint is analyzed with one-sided 5% significant level in per-protocol set. Other clinical outcomes are analyzed according to the intention-to-treat principle. Each end point is assessed by the Kaplan–Meier method and compared by a log-rank test. Effect of treatment is compared by the Cox proportional hazards model and is expressed by a hazard ratio with 95% confidence interval. All statistical analyses are performed by SAS version 9.3 (SAS Institute Inc, Carey, NC, USA) software. The p-values are two-sided, and p-values <0.05 are regarded as statistically significant. OFDI imaging substudy The OFDI imaging substudy (NCT01873222) is an exploratory research to assess vascular response after OFDI-guided PCI or IVUS-guided PCI. A total of 100 patients are consecutively enrolled from the subjects in the main OPINION trial at 7 cardiovascular centers of steering committee members. Sample size is not calculated statistically in this preliminary pilot substudy. Postprocedure OFDI is performed in 50 patients with IVUS-guided PCI, and post-procedure IVUS is conducted in 50 patients with OFDIguided PCI. Additional intervention is not allowed after the postprocedure OFDI or IVUS imaging. Furthermore, follow-up OFDI at 8 months after PCI is performed in the patients enrolled in the substudy. TLR or TVR are not considered OFDI-driven. The OFDI and IVUS images are assessed at 1 intravascular imaging core laboratory (Kobe University Graduate School of Medicine, Kobe, Japan). The endpoints for the imaging substudy include percentage of incomplete stent apposition at post-procedure, minimum stent area at post-procedure, frequency of coronary dissection at post-procedure, percentage of uncovered stent strut with neointima at 8 months follow-up, and minimum lumen area at 8 months follow-up.
Discussion The impact of the OCT guidance in PCI on clinical outcome remains uncertain, although recent studies have shown its potential benefit. The 2011 American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines for PCI provides no recommendation for the routine use of OCT in clinical practice, while this guideline recommends the use of IVUS for guidance of coronary stent implantation, particularly in cases of left main coronary artery stenting (Class IIb, Level of Evidence: B) [24]. The 2014 European guidelines (European Society of Cardiology) for Myocardial Revascularization also gives a lower-grade recommendation for the use of OCT (Class IIb, Level of Evidence: C) in selected patients to optimize stent implantation as compared with the use of IVUS (Class IIa, Level of Evidence: B) [25]. When completed, the OPINION trial will contribute to define the clinical value of the OCT guidance in PCI.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Conclusion We presented the rationale, design, and aim of the OPINION trial intended to evaluate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. Funding sources This work is supported by a grant from Terumo Corporation. However, the company was not involved in the design and execution of this study. Disclosure Dr Kubo has received lecture fees from Terumo Corporation. Dr Akasaka has received lecture fees from Terumo Corporation and has received research funds from Terumo Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Acknowledgments None.
Appendix. Research Group Organization Principal Investigator: Takashi Akasaka, Wakayama Medical University Steering committee: Takashi Akasaka, Wakayama Medical University Takashi Kubo, Wakayama Medical University Kiyoshi Hibi, Yokohama City University Medical Center Yoshihiro Morino, Iwate Medical University Gaku Nakazawa, Tokai University School of Medicine Takayuki Okamura, Yamaguchi University Graduate School of Medicine Toshiro Shinke, Kobe University Graduate School of Medicine Junya Shite, Osaka Saiseikai Nakatsu Hospital Tetsuya Fusazaki, Iwate Medical University QCA Core Laboratory: Ken Kozuma, Teikyo University School of Medicine IVUS and OFDI Core Laboratory: Hiromasa Otake, Kobe University Graduate School of Medicine Data Center: Koichi Yamashiro, Translational Research Informatics Data Center Takashi Yamauchi, Translational Research Informatics Data Center Ayumi Tsuji, Translational Research Informatics Data Center Masanori Fukushima, Translational Research Informatics Data Center Study Statistician: Tetsuya Ioji, Translational Research Informatics Data Center Data and Safety Monitoring Committee: Katsumi Miyauchi, Juntendo University School of Medicine Morimasa Takayama, The Sakakibara Heart Institute of Okayama Nobuhiro Tanaka, Tokyo Medical University Event Assessment Committee: Katsumi Miyauchi, Juntendo University School of Medicine Morimasa Takayama, The Sakakibara Heart Institute of Okayama Nobuhiro Tanaka, Tokyo Medical University Participating institutions and collaborators 1. Wakayama Medical University: Akasaka T, Kubo T, Ino Y
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2. Kobe University Graduate School of Medicine: Shinke T, Takahashi H 3. Seirei Hamamatsu General Hospital: Okada H 4. Urasoe General Hospital: Uehara H 5. Kanazawa Cardiovascular Hospital: Horita Y, Terai H 6. Kitasato University school of Medicine: Shimohama T, Tojo T, Kameda R 7. Tenyoukai Central Hospital: Takaoka J 8. Aichi Medical University: Amano T, Waseda K, Takashima H, Ando H 9. Kokura Memorial Hospital: Ando K, Doumei T 10. Iwate Medical University: Morino Y, Fusazaki T, Okuyama Y 11. Tokai University School of Medicine: Nakazawa G 12. Himeji Cardiovascular Center: Yasaka Y, Sawada T 13. Japan Community Health Care Organization Hokkaido Hospital: Furuya J 14. Osaka Saiseikai Nakatsu Hospital: Shite J, Nagoshi R 15. Saiseikai Fukuoka General Hospital: Serikawa T, Osaka K 16. Nara Medical University: Uemura S, Watanabe M 17. Hyogo College of Medicine: Fujii K, Saita T 18. Mitsui Memorial Hospital: Tanabe K 19. Yamaguchi University Graduate School of Medicine: Okamura T, Yamada J, Mochizuki M 20. Bellland General Hospital: Kataoka T, Iguchi T 21. Caress Sapporo Hokko Memorial Hospital: Nozaki Y 22. Akashi Medical Center: Kawata M, Matsuura A, Akita T, Kamemura K, Takada H, Uzu K, Kato Y 23. Akita Medical Center: Sato T, Makabe S 24. Yokohama City University Medical Center: Hibi K, Maejima N 25. Teikyo University School of Medicine: Isshiki T, Suzuki N 26. Miyazaki Medical Association Hospital: Kuriyama N, Koiyawa H 27. Yodogawa Christian Hospital: Matsumoto D 28. Okamura Memorial Hospital: Tarutani Y 29. Kyoto University Graduate School of Medicine: Kimura T, Shiomi H, Watanabe H 30. Tsuchiya General Hospital: Shiode N, Kagawa Y, Hatanari M 31. The Sakakibara Heart Institute of Okayama: Hirohata A 32. University of Occupational and Environmental Health: Sonoda S 33. Kawasaki Medical School Hospital: Okura H, Kume T, Neishi Y, Yamada R 34. Osaka City University: Yoshiyama M, Hasegawa T 35. Higashisumiyoshi Morimoto Hospital: Sakanoue Y, Tada Y 36. Nippon Medical School Chiba Hokusoh Hospital: Takano M, Munakata R, Ohba T, Inami T, Murakami D, Kimata N, Kurihara O, Shimura T 37. Saitama Sekishinkai Hospital: Hasegawa K 38. Fukuoka Wajiro Hospital: Otsuka Y, Kodama S, Nakamura K, Koyama T, Imoto H 39. Shingu Municipal Medical Center: Kitabata H 40. Showa University Fujigaoka Hospital: Suzuki H, Maeda A, Wakabayashi K, Sato T, Sasai M, Mori H 41. Yokosuka City Hospital: Okuda J, Saka K 42. Tokyo Medical and Dental University Hospital: Isobe M, Yoshikawa S
References [1] Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med 1979;301:61–8. [2] Topol EJ, Nissen SE. Our preoccupation with coronary luminology. The dissociation between clinical and angiographic findings in ischemic heart disease. Circulation 1995;92:2333–42. [3] Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri Jr EL, Xu K, Parise H, Mehran R, et al. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of
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G Model
JJCC-1214; No. of Pages 6 T. Kubo et al. / Journal of Cardiology xxx (2015) xxx–xxx
6
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation 2014;129:463–70. Hur SH, Kang SJ, Kim YH, Ahn JM, Park DW, Lee SW, Yun SC, Lee CW, Park SW, Park SJ. Impact of intravascular ultrasound-guided percutaneous coronary intervention on long-term clinical outcomes in a real world population. Catheter Cardiovasc Interv 2013;81:407–16. Zhang Y, Farooq V, Garcia-Garcia HM, Bourantas CV, Tian N, Dong S, Li M, Yang S, Serruys PW, Chen SL. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: a meta-analysis of one randomised trial and ten observational studies involving 19,619 patients. EuroIntervention 2012;8:855–65. Claessen BE, Mehran R, Mintz GS, Weisz G, Leon MB, Dogan O, de Ribamar Costa Jr J, Stone GW, Apostolidou I, Morales A, Chantziara V, Syros G, Sanidas E, Xu K, Tijssen JG, et al. Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with drug-eluting stents. JACC Cardiovasc Interv 2011;4:974–81. Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J 2008;29:1851–7. Parise H, Maehara A, Stone GW, Leon MB, Mintz GS. Meta-analysis of randomized studies comparing intravascular ultrasound versus angiographic guidance of percutaneous coronary intervention in pre-drug-eluting stent era. Am J Cardiol 2011;107:374–82. Kubo T, Akasaka T, Shite J, Suzuki T, Uemura S, Yu B, Kozuma K, Kitabata H, Shinke T, Habara M, Saito Y, Hou J, Suzuki N, Zhang S. OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study. JACC Cardiovasc Imaging 2013;6:1095–104. Kubo T, Yamano T, Liu Y, Ino Y, Shiono Y, Orii M, Taruya A, Nishiguchi T, Shimokado A, Teraguchi I, Tanimoto T, Kitabata H, Yamaguchi T, Hirata K, Tanaka A, et al. Feasibility of optical coronary tomography in quantitative measurement of coronary arteries with lipid-rich plaque. Circ J 2015;79: 600–6. Liu Y, Shimamura K, Kubo T, Tanaka A, Kitabata H, Ino Y, Tanimoto T, Shiono Y, Orii M, Yamano T, Yamaguchi T, Hirata K, Imanishi T, Akasaka T. Comparison of longitudinal geometric measurement in human coronary arteries between frequency-domain optical coherence tomography and intravascular ultrasound. Int J Cardiovasc Imaging 2014;30:271–7. Orii M, Kubo T, Tanaka A, Kitabata H, Ino Y, Shiono Y, Shimamura K, Aoki H, Ohta S, Ozaki Y, Ishibashi K, Yamano T, Tanimoto T, Yamaguchi T, Hirata K, et al. Interscan reproducibility of geometric coronary artery measurements using frequency-domain optical coherence tomography. Int Heart J 2013;54:64–7. Kubo T, Tanaka A, Kitabata H, Ino Y, Tanimoto T, Akasaka T. Application of optical coherence tomography in percutaneous coronary intervention. Circ J 2012;76:2076–83. Kubo T, Imanishi T, Kitabata H, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Takarada S, Tanaka A, Nakamura N, Mizukoshi M, Tomobuchi Y, Akasaka T. Comparison of vascular response after sirolimus-eluting stent implantation between patients with unstable and stable angina pectoris: a serial optical coherence tomography study. JACC Cardiovasc Imaging 2008;1:475–84. Tanaka A, Imanishi T, Kitabata H, Kubo T, Takarada S, Tanimoto T, Kuroi A, Tsujioka H, Ikejima H, Komukai K, Kataiwa H, Okouchi K, Kashiwaghi M, Ishibashi K, Matsumoto H, et al. Lipid-rich plaque and myocardial perfusion after successful stenting in patients with non-ST-segment elevation acute coronary syndrome: an optical coherence tomography study. Eur Heart J 2009;30:1348–55.
[16] Ozaki Y, Tanaka A, Tanimoto T, Kitabata H, Kashiwagi M, Kubo T, Takarada S, Ishibashi K, Komukai K, Ino Y, Hirata K, Mizukoshi M, Imanishi T, Akasaka T. Thin-cap fibroatheroma as high-risk plaque for microvascular obstruction in patients with acute coronary syndrome. Circ Cardiovasc Imaging 2011;4: 620–7. [17] Lee T, Kakuta T, Yonetsu T, Takahashi K, Yamamoto G, Iesaka Y, Fujiwara H, Isobe M. Assessment of echo-attenuated plaque by optical coherence tomography and its impact on post-procedural creatine kinase-myocardial band elevation in elective stent implantation. JACC Cardiovasc Interv 2011;4: 483–91. [18] Prati F, Di Vito L, Biondi-Zoccai G, Occhipinti M, La Manna A, Tamburino C, Burzotta F, Trani C, Porto I, Ramazzotti V, Imola F, Manzoli A, Materia L, Cremonesi A, Albertucci M. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l’Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention 2012;8:823–9. [19] Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31:103–15. [20] Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, et al. 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. J Am Coll Cardiol 2012;59: 1058–72. [21] Mintz GS, Nissen SE, Anderson WD, Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG. American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2001;37:1478–92. [22] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. [23] Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Takatsu Y, Nishikawa H, Yamamoto Y, Nakagawa Y, Hayashi Y, Iwabuchi M, et al. Comparison of everolimus-eluting and sirolimuseluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation 2012;126:1225–36. [24] Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 2011;124: e574–651. [25] Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Ju¨ni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35: 2541–619.
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Original article
Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial Takashi Kubo (MD, PhD, FJCC)a, Toshiro Shinke (MD, PhD, FJCC)b, Takayuki Okamura (MD, PhD)c, Kiyoshi Hibi (MD, PhD, FJCC)d, Gaku Nakazawa (MD, PhD)e, Yoshihiro Morino (MD, PhD)f, Junya Shite (MD, PhD, FJCC)g, Tetsuya Fusazaki (MD, PhD)f, Hiromasa Otake (MD, PhD)b, Ken Kozuma (MD, PhD)h, Takashi Akasaka (MD, PhD, FJCC)a,* a
Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan Department of Internal Medicine, Division of Cardiovascular and Respiratory Medicine, Kobe University Graduate School of Medicine, Kobe, Japan Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Ube, Japan d Division of Cardiology, Yokohama City University Medical Center, Yokohama, Japan e Division of Cardiology, Tokai University School of Medicine, Isehara, Japan f Division of Cardiology, Iwate Medical University, Morioka, Japan g Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan h Division of Cardiology, Teikyo University School of Medicine, Tokyo, Japan b c
A R T I C L E I N F O
A B S T R A C T
Article history: Received 4 August 2015 Received in revised form 2 November 2015 Accepted 16 November 2015 Available online xxx
Background: Optical coherence tomography is becoming increasingly widespread as an adjunctive intravascular diagnostic technique in percutaneous coronary intervention (PCI), because of its ability to visualize coronary structures at high resolution. Several studies have reported that intravascular ultrasound (IVUS) guidance in PCI might be helpful to reduce subsequent stent thrombosis, restenosis, repeat revascularization, myocardial infarction, and cardiac death. The OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial is aimed at evaluating the impact of optical frequency domain imaging (OFDI) guidance in PCI on clinical outcomes compared with IVUS guidance. Methods and design: The OPINION trial is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial in Japan. The eligible patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. PCI is performed using the biolimus-eluting stent in accordance with a certain criteria of OFDI and IVUS for optimal stent deployment. All patients will undergo a followup angiography at 8 months. The primary endpoint is target vessel failure composed of cardiac death, myocardial infarction attributed to the target vessel, and clinically-driven target vessel revascularization at 12 months. Conclusion: When completed, the OPINION trial will contribute to define the clinical value of the OFDI guidance in PCI. ß 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Keywords: Coronary artery disease Drug-eluting stent Intravascular ultrasound Optical coherence tomography Percutaneous coronary intervention
Introduction Percutaneous coronary intervention (PCI) is a common management strategy for patients with coronary artery disease. Since its introduction into clinical practice in 1977, angiography
* Corresponding author at: Department of Cardiovascular Medicine, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan. Tel.: +81 73 441 0621; fax: +81 73 446 0631. E-mail address: [email protected] (T. Akasaka).
has been the workhorse imaging guidance for PCI [1]. However, angiography provides little information about the vessel wall or plaque lining the vessel, and has limitations in assessing lesion morphology because it depicts the coronary artery from a planar two-dimensional silhouette of the contrast-filled vessel lumen [2]. The angiographic lesion assessment is impeded in patients with eccentric lesions, diffuse disease, tortuous vessels, and multiple branches overlapping segments. In the early 1990s, intravascular ultrasound (IVUS) was developed as an adjunctive imaging modality to overcome these
http://dx.doi.org/10.1016/j.jjcc.2015.11.007 0914-5087/ß 2015 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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limitations of angiography. IVUS provides cross-sectional images of coronary arteries and allows assessment of arterial atherosclerotic diseases. By detecting luminal, external elastic membrane, and stent boundaries, IVUS is able to estimate vessel diameter, lumen area, plaque volume, and the results of PCI procedures such as stent underexpansion, incomplete stent apposition, and coronary artery dissection. The major role of IVUS in PCI is assessment of lesion morphology before PCI, stent optimization during PCI, and prediction of complications after PCI. Previous randomized trials, registries, and meta-analyses of IVUS-guided versus angiography-guided PCI reported that IVUS results in greater acute lumen gains with reductions in subsequent restenosis, stent thrombosis, repeat revascularization, myocardial infarction, and cardiac death [3–8]. In the mid-2000s, optical coherence tomography (OCT) emerged as a high-resolution intracoronary imaging technology that is capable of providing microscopic images of the coronary wall. OCT measures the intensity of reflected light waves and translates these optical echoes into a cross-sectional image. The spatial resolution of OCT is 10–20 mm, and it is approximately 10 times greater than that of IVUS. An excellent contrast between lumen and vessel wall in OCT allows accurate lumen measurements, which might be helpful in determining appropriate balloon or stent size [9–12]. Compared with IVUS, OCT is more sensitive in detecting suboptimal lesion morphologies after PCI, such as intrastent tissue protrusion, incomplete stent apposition, stent edge dissection, and intra-stent thrombus [9,13,14]. In addition, tissue characterization by OCT enables us to identify lipid-rich plaques and aids to predict no-reflow phenomenon after PCI and periprocedural myocardial infarction [15–17]. Furthermore, the most recently developed optical frequency domain imaging (OFDI: LUNAWAVE, Terumo Corporation, Tokyo, Japan) provides a high frame rate (158 frames/s), which enables imaging of long coronary segments (up to 150 mm) within a few seconds in combination with rapid spiral pullback (40 mm/s) and contrast injection through a guiding catheter. OFDI is becoming increasingly widespread as a clinical tool to guide PCI. Like IVUS, OFDI guidance is expected to improve procedural and clinical results [18]. Therefore, we designed the OPtical frequency domain imaging vs. INtravascular ultrasound in percutaneous coronary InterventiON (OPINION) trial powered to evaluate the non-inferiority of OFDIguided PCI compared with IVUS-guided PCI in terms of clinical outcomes.
Table 2 Exclusion criteria. 1. 2. 3. 4.
STEMI or NSTEMI in previous 3 months Cardiogenic shock Congestive heart failure Chronic kidney disease (eGFR <30 ml/min/1.73 m2 or serum creatinine level >1.5 mg/dl) Hemodialysis or peritoneal dialysis Three-vessel disease Left main coronary artery disease Aorto-ostial lesion arising within 3 mm of the origin of a coronary artery Chronic total occlusion Small vessel disease (reference vessel diameter <2.5 mm) Coronary bypass graft In stent restenosis Planned surgery within 1 year
5. 6. 7. 8. 9. 10. 11. 12. 13.
STEMI, ST-segment elevation myocardial infarction; NSTEMI, non-ST-segment elevation myocardial infarction; eGFR, estimated glomerular filtration rate.
Research Informatics Data Center, Kobe, Japan (Fig. 1). Minimization, a dynamic randomization method that can balance groups with respect to both the numbers in each treatment arm and the characteristics of each group, is utilized in this trial [19]. The randomization is stratified by (1) age, (2) history of diabetes, and (3) participating cardiovascular centers. In each group, either OFDI or IVUS is used before, during, and immediately after PCI. Investigators will follow up the subjects for 12 months at participating centers and will conduct medical examinations and blood testing. Coronary angiography will be performed at 8 months follow-up time point at participating cardiovascular centers. This trial is approved by the Institutional Review Board or Independent Ethics Committee of all of the participating cardiovascular centers. The planned duration is between June 2013 and December 2015. This trial has been registered at clinicaltrials.gov (NCT01873027), according to the statement of the International Committee of Medical Journal Editors. OFDI-imaging OFDI imaging is performed using LUNAWAVETM imaging system and FastViewTM imaging catheter (Terumo corporation). A bolus intracoronary injection of nitroglycerin or isosorbide dinitrate is administered before OFDI imaging. After manual
Materials and methods
Patients scheduled for PCI using drug-eluting stent N =800 pts
Study design The OPINION is a multicenter, prospective, randomized, controlled, open-label, parallel group, non-inferiority trial comparing OFDI-guided PCI with IVUS-guided PCI. Patients who satisfy all of the inclusion criteria (Table 1) and none of the exclusion criteria (Table 2) are enrolled in this trial. The eligible patients give written informed consent and are then randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI using a webbased randomization software conducted at the Translational
OFDI-guided PCI N = 400 pts
Randomization 1:1
IVUS-guided PCI N = 400 pts
Clinical follow-up Hospital discharge
Follow-up coronary angiography 8 months Table 1 Inclusion criteria.
Clinical follow-up 1. 2. 3.
Patients scheduled for PCI using drug-eluting stent to a de novo native coronary artery lesion Aged 20–85 years at the time of their consent Patients who agree to be enrolled in the trial giving signed written informed consent
PCI, percutaneous coronary intervention.
12 months Fig. 1. Flow chart of the trial timeline. Patients are randomly assigned to receive either OFDI-guided PCI or IVUS-guided PCI. Clinical or coronary angiography follow-up is performed at the time of hospital discharge, 8 months, and 12 months after PCI. OFDI, optical frequency domain imaging; PCI, percutaneous coronary intervention; IVUS, intravascular ultrasound.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Table 3 OFDI and IVUS criteria of optimal stent deployment.
Reference site Determination of stent diameter Determination of stent length Goal of stent deployment
OFDI-guided PCI
IVUS-guided PCI
Most normal looking No lipidic plaque By measuring lumen diameter at proximal and distal reference sites
Largest lumen Plaque burden < 50% By measuring vessel diameter at proximal and distal reference sites
By measuring distance from distal to proximal reference site In-stent minimal lumen area 90% of the average reference lumen area Complete apposition of the stent over its entire length against the vessel wall Symmetric stent expansion defined by minimum lumen diameter/maximum lumen diameter 0.7 No plaque protrusion, thrombus, or edge dissection with potential to provoke flow disturbances
OFDI, optical frequency domain imaging; IVUS, intravascular ultrasound.
calibration, the OFDI catheter is advanced more than 5 mm distally to the target lesion over a 0.014-inch conventional angioplasty guidewire. Following the catheter placement, preheated contrast media at 37 8C is flushed through the guiding catheter at a rate of 2–4 ml/s for approximately 3–6 s by using an injector pump. When a blood-free image is observed, the OFDI imaging core is pulled back over a longitudinal distance up to 150 mm at a rate of 20– 40 mm/s by using standalone electronic control of the pullback motor. During PCI, the obtained OFDI images are evaluated on-line in real-time in conformity with criteria of the report from the International Working Group for Intravascular OCT Standardization and Validation [20]. IVUS-imaging IVUS imaging is performed using VISIWAVETM imaging system (Terumo Corporation) and ViewITTM imaging catheter (Terumo Corporation) that consisted of a 40-MHz transducer. After intracoronary injection of nitroglycerin or isosorbide dinitrate, the IVUS catheter is advanced more than 5 mm beyond the target lesion over a guidewire and withdrawn to the aorto-ostial junction at a pullback speed of 0.5 mm/s automatically. During PCI, the obtained IVUS images are evaluated online in real-time in conformity with criteria of the American College of Cardiology clinical expert consensus document on IVUS [21]. PCI procedure PCI procedure is performed using 6 Fr to 8 Fr catheters through femoral, brachial, or radial artery. The biolimus-eluting stent (BES: NOBORI, Terumo Corporation) is used in all patients. Intravascular imaging of either OFDI or IVUS is performed before PCI. If the imaging catheter fails to pass through the target lesion before PCI, balloon dilatation is allowed prior to the imaging. Stent diameter and stent length are determined by the obtained images. In OFDI, reference site is set at a cross-section adjacent to the target lesion that is most normal looking and free of lipidic plaque (defined as signal-poor region with diffuse border). Then, stent diameter is decided by measuring lumen diameter at proximal and distal reference sites, and stent length is decided by measuring distance from distal to proximal reference site. In IVUS, reference site is set at a cross-section adjacent to the target lesion that has the largest lumen and plaque burden of <50%. Then, stent diameter is decided by measuring vessel diameter (approximated by the external elastic membrane diameter) at proximal and distal reference sites and stent length is decided by measuring distance from distal to proximal reference site. Balloon angioplasty after the intravascular imaging and before stent implantation is left to the discretion of operator. Following stent implantation with adequate inflation pressure according to the compliance chart of the stent delivery
balloon, the iterative intravascular imaging is performed to evaluate the results. If intravascular imaging criteria of optimal stent deployment (Table 3) are not met, additional procedures are performed, if deemed safe and feasible. Stent underexpansion (defined as in-stent minimal lumen area <90% of the average reference lumen area), incomplete stent apposition (defined as separation of a stent strut from vessel wall), asymmetric stent expansion (defined by minimum lumen diameter/maximum lumen diameter <0.7), and plaque or thrombus protrusion (defined as projection of tissue into the lumen between stent struts) with potential to provoke flow disturbances require further dilatation of the previously implanted stent with a balloon. Balloon size and inflation pressure is left to the discretion of operator. Stent edge dissection (defined as disruption of the arterial lumen surface in both the 5-mm distal and proximal stent edges) with potential to provoke flow disturbance requires the implantation of an additional stent at the edge of the previously implanted stent. Those additional procedures are followed by further, intravascular imaging. Antithrombotic therapy Procedural anticoagulation is achieved with unfractionated heparin according to the local site protocols. The recommended antiplatelet regimen is aspirin (81 mg daily) indefinitely and thienopyridine (75 mg clopidogrel daily) for 12 months. A 300 mg loading dose of clopidogrel before the procedure is administered if patients are not pretreated. Status of antiplatelet therapy is evaluated throughout the follow-up period. Coronary angiography Following intracoronary injection of nitroglycerin or isosorbide dinitrate, coronary angiograms of the target lesion are obtained from at least two, preferably orthogonal projections. All images are stored on a CD-ROM for off-line analysis. Baseline, post-procedure, and 8 months follow-up angiograms are assessed at 1 angiographic core laboratory (Cardiocore, Tokyo, Japan). Quantitative coronary angiography (QCA) analysis is performed with use of the QAngio XA system ver 7.1 (Medis, Leiden, the Netherlands). The target segment is defined as the entire segment involving the implanted stent and the 5-mm proximal and distal edges adjacent to the stent. A segment treated with multiple overlapping stents is regarded as a single target segment. The QCA measurements include reference vessel diameter (RVD), minimal luminal diameter (MLD), percent diameter stenosis [(RVD MLD) 100/RVD], PCI procedure success (percent diameter stenosis at postprocedure <50%), acute gain (MLD at post-procedure MLD at baseline), late loss (MLD at post-procedure MLD at follow-up), and binary restenosis (percent diameter stenosis at follow-up 50%).
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Endpoints The primary endpoint is target vessel failure (TVF) at 12 months. TVF is a composite of cardiac death, myocardial infarction (MI) attributed to the target vessel, and clinicallydriven target vessel revascularization (TVR). The secondary endpoints include cardiac death, MI, stent thrombosis, binary restenosis, clinically-driven target lesion revascularization (TLR), clinically-driven TVR, major adverse cardiovascular events (MACE), stroke, and contrast-induced nephropathy. Death is regarded as cardiac in origin unless obvious non-cardiac causes could be identified. MI is regarded as present with serum creatinine kinase (CK) MB fraction 2 times upper limit of normal or serum troponin the 99th percentile. Stent thrombosis is defined according to the Academic Research Consortium definitions [22]. TLR is defined as repeat PCI or bypass graft placement for restenosis at the lesion treated during index PCI, or occurring within 5 mm of the PCI site (edge effect) as determined clinically by the investigator at each site. TVR is defined as unplanned repeat PCI or bypass graft placement for a stenosis in another part of the vessel treated at the index PCI. Both TLR and TVR are considered clinically-driven if angiography during follow-up showed a diameter stenosis 50% and if a patient had a positive history of recurrent angina pectoris or objective signs of ischemia in any diagnostic test. All the angiograms of patients with stent thrombosis, binary restenosis, TLR, or TVR, are to be analyzed by the angiographic core laboratory in an attempt to adjudicate accurately. MACE is a composite of cardiac death, MI, or clinically-driven TLR. Stroke is defined as ischemic or hemorrhagic stroke requiring hospitalization with symptoms lasting >24 h. Contrast-induced nephropathy is defined as either a greater than 25% increase of serum creatinine or an absolute increase in serum creatinine of 0.5 mg/dl within 72 h after PCI. The endpoint events are adjudicated by the independent and blinded clinical event assessment committee. Event assessment The event assessment committee consists of three experts in cardiovascular medicine. All clinical problems are documented by investigators using a clinical event data form. The clinical event data are independently reviewed by the three experts. A clinical problem that at least one expert judged to be an endpoint event is decided as the event. A clinical problem that all experts judged not to be an endpoint event is decided as a non-event. If there are difficulties in making a judgment based on the clinical event data form, further information will be requested from the investigators and angiographic core laboratory and a decision will be made at a subsequent review on the basis of all the data provided. Safety monitoring Safety is observed throughout the study and will be evaluated by regular medical examination and laboratory tests immediately after and at 8 and 12 months after PCI. The data and safety monitoring committee evaluates MACE and any other adverse events. Sample size calculation OPINION is a trial powered to evaluate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI on the primary endpoint at 12 months. At study initiation, we did not know the estimated TVF rate in IVUS-guided PCI with BES. Therefore, we assumed that the TVF rate after IVUS-guided PCI with BES is
equivalent to that after IVUS-guided PCI with sirolimus-eluting stent (SES). In the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET), the TVF rate at 12 months after SES deployment with high prevalence (81%) of IVUS guidance was 8.8% [23]. With the assumption of 9% TVF rate at 12 months after IVUS-guided PCI with BES, a total of 774 patients would yield 80% power to detect non-inferiority with a noninferiority margin of 7% (hazard ratio = 1.85) at a one-sided significance level of 0.05. A total of 800 patients are to be enrolled considering possible dropout during follow-up. Statistical analysis The non-inferiority test for primary endpoint is analyzed with one-sided 5% significant level in per-protocol set. Other clinical outcomes are analyzed according to the intention-to-treat principle. Each end point is assessed by the Kaplan–Meier method and compared by a log-rank test. Effect of treatment is compared by the Cox proportional hazards model and is expressed by a hazard ratio with 95% confidence interval. All statistical analyses are performed by SAS version 9.3 (SAS Institute Inc, Carey, NC, USA) software. The p-values are two-sided, and p-values <0.05 are regarded as statistically significant. OFDI imaging substudy The OFDI imaging substudy (NCT01873222) is an exploratory research to assess vascular response after OFDI-guided PCI or IVUS-guided PCI. A total of 100 patients are consecutively enrolled from the subjects in the main OPINION trial at 7 cardiovascular centers of steering committee members. Sample size is not calculated statistically in this preliminary pilot substudy. Postprocedure OFDI is performed in 50 patients with IVUS-guided PCI, and post-procedure IVUS is conducted in 50 patients with OFDIguided PCI. Additional intervention is not allowed after the postprocedure OFDI or IVUS imaging. Furthermore, follow-up OFDI at 8 months after PCI is performed in the patients enrolled in the substudy. TLR or TVR are not considered OFDI-driven. The OFDI and IVUS images are assessed at 1 intravascular imaging core laboratory (Kobe University Graduate School of Medicine, Kobe, Japan). The endpoints for the imaging substudy include percentage of incomplete stent apposition at post-procedure, minimum stent area at post-procedure, frequency of coronary dissection at post-procedure, percentage of uncovered stent strut with neointima at 8 months follow-up, and minimum lumen area at 8 months follow-up.
Discussion The impact of the OCT guidance in PCI on clinical outcome remains uncertain, although recent studies have shown its potential benefit. The 2011 American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions guidelines for PCI provides no recommendation for the routine use of OCT in clinical practice, while this guideline recommends the use of IVUS for guidance of coronary stent implantation, particularly in cases of left main coronary artery stenting (Class IIb, Level of Evidence: B) [24]. The 2014 European guidelines (European Society of Cardiology) for Myocardial Revascularization also gives a lower-grade recommendation for the use of OCT (Class IIb, Level of Evidence: C) in selected patients to optimize stent implantation as compared with the use of IVUS (Class IIa, Level of Evidence: B) [25]. When completed, the OPINION trial will contribute to define the clinical value of the OCT guidance in PCI.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
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Conclusion We presented the rationale, design, and aim of the OPINION trial intended to evaluate the non-inferiority of OFDI-guided PCI compared with IVUS-guided PCI in terms of clinical outcomes. Funding sources This work is supported by a grant from Terumo Corporation. However, the company was not involved in the design and execution of this study. Disclosure Dr Kubo has received lecture fees from Terumo Corporation. Dr Akasaka has received lecture fees from Terumo Corporation and has received research funds from Terumo Corporation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Acknowledgments None.
Appendix. Research Group Organization Principal Investigator: Takashi Akasaka, Wakayama Medical University Steering committee: Takashi Akasaka, Wakayama Medical University Takashi Kubo, Wakayama Medical University Kiyoshi Hibi, Yokohama City University Medical Center Yoshihiro Morino, Iwate Medical University Gaku Nakazawa, Tokai University School of Medicine Takayuki Okamura, Yamaguchi University Graduate School of Medicine Toshiro Shinke, Kobe University Graduate School of Medicine Junya Shite, Osaka Saiseikai Nakatsu Hospital Tetsuya Fusazaki, Iwate Medical University QCA Core Laboratory: Ken Kozuma, Teikyo University School of Medicine IVUS and OFDI Core Laboratory: Hiromasa Otake, Kobe University Graduate School of Medicine Data Center: Koichi Yamashiro, Translational Research Informatics Data Center Takashi Yamauchi, Translational Research Informatics Data Center Ayumi Tsuji, Translational Research Informatics Data Center Masanori Fukushima, Translational Research Informatics Data Center Study Statistician: Tetsuya Ioji, Translational Research Informatics Data Center Data and Safety Monitoring Committee: Katsumi Miyauchi, Juntendo University School of Medicine Morimasa Takayama, The Sakakibara Heart Institute of Okayama Nobuhiro Tanaka, Tokyo Medical University Event Assessment Committee: Katsumi Miyauchi, Juntendo University School of Medicine Morimasa Takayama, The Sakakibara Heart Institute of Okayama Nobuhiro Tanaka, Tokyo Medical University Participating institutions and collaborators 1. Wakayama Medical University: Akasaka T, Kubo T, Ino Y
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2. Kobe University Graduate School of Medicine: Shinke T, Takahashi H 3. Seirei Hamamatsu General Hospital: Okada H 4. Urasoe General Hospital: Uehara H 5. Kanazawa Cardiovascular Hospital: Horita Y, Terai H 6. Kitasato University school of Medicine: Shimohama T, Tojo T, Kameda R 7. Tenyoukai Central Hospital: Takaoka J 8. Aichi Medical University: Amano T, Waseda K, Takashima H, Ando H 9. Kokura Memorial Hospital: Ando K, Doumei T 10. Iwate Medical University: Morino Y, Fusazaki T, Okuyama Y 11. Tokai University School of Medicine: Nakazawa G 12. Himeji Cardiovascular Center: Yasaka Y, Sawada T 13. Japan Community Health Care Organization Hokkaido Hospital: Furuya J 14. Osaka Saiseikai Nakatsu Hospital: Shite J, Nagoshi R 15. Saiseikai Fukuoka General Hospital: Serikawa T, Osaka K 16. Nara Medical University: Uemura S, Watanabe M 17. Hyogo College of Medicine: Fujii K, Saita T 18. Mitsui Memorial Hospital: Tanabe K 19. Yamaguchi University Graduate School of Medicine: Okamura T, Yamada J, Mochizuki M 20. Bellland General Hospital: Kataoka T, Iguchi T 21. Caress Sapporo Hokko Memorial Hospital: Nozaki Y 22. Akashi Medical Center: Kawata M, Matsuura A, Akita T, Kamemura K, Takada H, Uzu K, Kato Y 23. Akita Medical Center: Sato T, Makabe S 24. Yokohama City University Medical Center: Hibi K, Maejima N 25. Teikyo University School of Medicine: Isshiki T, Suzuki N 26. Miyazaki Medical Association Hospital: Kuriyama N, Koiyawa H 27. Yodogawa Christian Hospital: Matsumoto D 28. Okamura Memorial Hospital: Tarutani Y 29. Kyoto University Graduate School of Medicine: Kimura T, Shiomi H, Watanabe H 30. Tsuchiya General Hospital: Shiode N, Kagawa Y, Hatanari M 31. The Sakakibara Heart Institute of Okayama: Hirohata A 32. University of Occupational and Environmental Health: Sonoda S 33. Kawasaki Medical School Hospital: Okura H, Kume T, Neishi Y, Yamada R 34. Osaka City University: Yoshiyama M, Hasegawa T 35. Higashisumiyoshi Morimoto Hospital: Sakanoue Y, Tada Y 36. Nippon Medical School Chiba Hokusoh Hospital: Takano M, Munakata R, Ohba T, Inami T, Murakami D, Kimata N, Kurihara O, Shimura T 37. Saitama Sekishinkai Hospital: Hasegawa K 38. Fukuoka Wajiro Hospital: Otsuka Y, Kodama S, Nakamura K, Koyama T, Imoto H 39. Shingu Municipal Medical Center: Kitabata H 40. Showa University Fujigaoka Hospital: Suzuki H, Maeda A, Wakabayashi K, Sato T, Sasai M, Mori H 41. Yokosuka City Hospital: Okuda J, Saka K 42. Tokyo Medical and Dental University Hospital: Isobe M, Yoshikawa S
References [1] Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med 1979;301:61–8. [2] Topol EJ, Nissen SE. Our preoccupation with coronary luminology. The dissociation between clinical and angiographic findings in ischemic heart disease. Circulation 1995;92:2333–42. [3] Witzenbichler B, Maehara A, Weisz G, Neumann FJ, Rinaldi MJ, Metzger DC, Henry TD, Cox DA, Duffy PL, Brodie BR, Stuckey TD, Mazzaferri Jr EL, Xu K, Parise H, Mehran R, et al. Relationship between intravascular ultrasound guidance and clinical outcomes after drug-eluting stents: the assessment of
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007
G Model
JJCC-1214; No. of Pages 6 T. Kubo et al. / Journal of Cardiology xxx (2015) xxx–xxx
6
[4]
[5]
[6]
[7]
[8]
[9]
[10]
[11]
[12]
[13]
[14]
[15]
dual antiplatelet therapy with drug-eluting stents (ADAPT-DES) study. Circulation 2014;129:463–70. Hur SH, Kang SJ, Kim YH, Ahn JM, Park DW, Lee SW, Yun SC, Lee CW, Park SW, Park SJ. Impact of intravascular ultrasound-guided percutaneous coronary intervention on long-term clinical outcomes in a real world population. Catheter Cardiovasc Interv 2013;81:407–16. Zhang Y, Farooq V, Garcia-Garcia HM, Bourantas CV, Tian N, Dong S, Li M, Yang S, Serruys PW, Chen SL. Comparison of intravascular ultrasound versus angiography-guided drug-eluting stent implantation: a meta-analysis of one randomised trial and ten observational studies involving 19,619 patients. EuroIntervention 2012;8:855–65. Claessen BE, Mehran R, Mintz GS, Weisz G, Leon MB, Dogan O, de Ribamar Costa Jr J, Stone GW, Apostolidou I, Morales A, Chantziara V, Syros G, Sanidas E, Xu K, Tijssen JG, et al. Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with drug-eluting stents. JACC Cardiovasc Interv 2011;4:974–81. Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J 2008;29:1851–7. Parise H, Maehara A, Stone GW, Leon MB, Mintz GS. Meta-analysis of randomized studies comparing intravascular ultrasound versus angiographic guidance of percutaneous coronary intervention in pre-drug-eluting stent era. Am J Cardiol 2011;107:374–82. Kubo T, Akasaka T, Shite J, Suzuki T, Uemura S, Yu B, Kozuma K, Kitabata H, Shinke T, Habara M, Saito Y, Hou J, Suzuki N, Zhang S. OCT compared with IVUS in a coronary lesion assessment: the OPUS-CLASS study. JACC Cardiovasc Imaging 2013;6:1095–104. Kubo T, Yamano T, Liu Y, Ino Y, Shiono Y, Orii M, Taruya A, Nishiguchi T, Shimokado A, Teraguchi I, Tanimoto T, Kitabata H, Yamaguchi T, Hirata K, Tanaka A, et al. Feasibility of optical coronary tomography in quantitative measurement of coronary arteries with lipid-rich plaque. Circ J 2015;79: 600–6. Liu Y, Shimamura K, Kubo T, Tanaka A, Kitabata H, Ino Y, Tanimoto T, Shiono Y, Orii M, Yamano T, Yamaguchi T, Hirata K, Imanishi T, Akasaka T. Comparison of longitudinal geometric measurement in human coronary arteries between frequency-domain optical coherence tomography and intravascular ultrasound. Int J Cardiovasc Imaging 2014;30:271–7. Orii M, Kubo T, Tanaka A, Kitabata H, Ino Y, Shiono Y, Shimamura K, Aoki H, Ohta S, Ozaki Y, Ishibashi K, Yamano T, Tanimoto T, Yamaguchi T, Hirata K, et al. Interscan reproducibility of geometric coronary artery measurements using frequency-domain optical coherence tomography. Int Heart J 2013;54:64–7. Kubo T, Tanaka A, Kitabata H, Ino Y, Tanimoto T, Akasaka T. Application of optical coherence tomography in percutaneous coronary intervention. Circ J 2012;76:2076–83. Kubo T, Imanishi T, Kitabata H, Kuroi A, Ueno S, Yamano T, Tanimoto T, Matsuo Y, Masho T, Takarada S, Tanaka A, Nakamura N, Mizukoshi M, Tomobuchi Y, Akasaka T. Comparison of vascular response after sirolimus-eluting stent implantation between patients with unstable and stable angina pectoris: a serial optical coherence tomography study. JACC Cardiovasc Imaging 2008;1:475–84. Tanaka A, Imanishi T, Kitabata H, Kubo T, Takarada S, Tanimoto T, Kuroi A, Tsujioka H, Ikejima H, Komukai K, Kataiwa H, Okouchi K, Kashiwaghi M, Ishibashi K, Matsumoto H, et al. Lipid-rich plaque and myocardial perfusion after successful stenting in patients with non-ST-segment elevation acute coronary syndrome: an optical coherence tomography study. Eur Heart J 2009;30:1348–55.
[16] Ozaki Y, Tanaka A, Tanimoto T, Kitabata H, Kashiwagi M, Kubo T, Takarada S, Ishibashi K, Komukai K, Ino Y, Hirata K, Mizukoshi M, Imanishi T, Akasaka T. Thin-cap fibroatheroma as high-risk plaque for microvascular obstruction in patients with acute coronary syndrome. Circ Cardiovasc Imaging 2011;4: 620–7. [17] Lee T, Kakuta T, Yonetsu T, Takahashi K, Yamamoto G, Iesaka Y, Fujiwara H, Isobe M. Assessment of echo-attenuated plaque by optical coherence tomography and its impact on post-procedural creatine kinase-myocardial band elevation in elective stent implantation. JACC Cardiovasc Interv 2011;4: 483–91. [18] Prati F, Di Vito L, Biondi-Zoccai G, Occhipinti M, La Manna A, Tamburino C, Burzotta F, Trani C, Porto I, Ramazzotti V, Imola F, Manzoli A, Materia L, Cremonesi A, Albertucci M. Angiography alone versus angiography plus optical coherence tomography to guide decision-making during percutaneous coronary intervention: the Centro per la Lotta contro l’Infarto-Optimisation of Percutaneous Coronary Intervention (CLI-OPCI) study. EuroIntervention 2012;8:823–9. [19] Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975;31:103–15. [20] Tearney GJ, Regar E, Akasaka T, Adriaenssens T, Barlis P, Bezerra HG, Bouma B, Bruining N, Cho JM, Chowdhary S, Costa MA, de Silva R, Dijkstra J, Di Mario C, Dudek D, et al. 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. J Am Coll Cardiol 2012;59: 1058–72. [21] Mintz GS, Nissen SE, Anderson WD, Mintz GS, Nissen SE, Anderson WD, Bailey SR, Erbel R, Fitzgerald PJ, Pinto FJ, Rosenfield K, Siegel RJ, Tuzcu EM, Yock PG. American College of Cardiology clinical expert consensus document on standards for acquisition, measurement and reporting of intravascular ultrasound studies (IVUS). A report of the American College of Cardiology Task Force on Clinical Expert Consensus Documents. J Am Coll Cardiol 2001;37:1478–92. [22] Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW. Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344–51. [23] Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Takatsu Y, Nishikawa H, Yamamoto Y, Nakagawa Y, Hayashi Y, Iwabuchi M, et al. Comparison of everolimus-eluting and sirolimuseluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation 2012;126:1225–36. [24] Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: a report of the American College of Cardiology Foundation/ American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 2011;124: e574–651. [25] Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Ju¨ni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J 2014;35: 2541–619.
Please cite this article in press as: Kubo T, et al. Optical frequency domain imaging vs. intravascular ultrasound in percutaneous coronary intervention (OPINION trial): Study protocol for a randomized controlled trial. J Cardiol (2016), http://dx.doi.org/10.1016/ j.jjcc.2015.11.007