Volume 3 – Number 1 – January 2017

20 September inIssue, Uncategorized

In this new edition, we present recent results on the COMBO and PROMUS devices, the REMEDEE FIM trial, CREDO-Kyoto AMI registry on CTOs, or a look at BRS with the ALSTER-OCT registry.

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Editorial

A panoply of milestones and achievements

17 January inEditorial, Issue, Table of content TOP

Upendra Kaul, Takeshi Kimura, Seung-Jung Park, Huay Cheem Tan and Runlin Gao

We begin 2017 having passed several milestones, among which we count this new edition of AsiaIntervention. As you, our readers, are well aware, while this is not the first edition of our fledgling journal, we are still at the early stages of establishing our reputation. Anyone who has ever been involved with a serious, peer-reviewed, scientific publication will know that the growing pains can be considerable and the remedy – at least at first – difficult to apply or find… namely, greater participation from our readership. Our journal is now picking up speed, and developing its own rhythm and personality, but the future depends on your submissions and your critical response. We are convinced both of the quality we offer here and of your active involvement in the coming years.

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Chronic total occlusion (CTO) in Japan

17 January inEditorial, Issue, Table of content TOP

Hiroki Watanabe, Takeshi Kimura

Chronic total occlusion (CTO) was once called an unexplored frontier for interventional cardiologists. The need for a high level of technical expertise, longer procedure time, a higher rate of procedure-related complications, and other available treatment options prevented general cardiologists from revascularising CTO. Also, there was a paucity of reliable data supporting the clinical benefit of CTO revascularisation.

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Functional PCI in bifurcation lesions

17 January inEditorial, Issue, Table of content TOP

Duk-Woo Park, Seung-Jung Park

In the contemporary practice of percutaneous coronary interventions (PCI), bifurcation lesions account for approximately 20-30% of all coronary lesion subsets. Bifurcation PCI remains one of the most challenging procedures with respect to procedural complexity and relatively high rates of early and long-term adverse cardiac events, as compared to non-bifurcation PCI. Although there have been marked advancements in stents, devices, techniques, and adjunctive drug therapies, the optimal management of bifurcation lesions is still the subject of considerable debate. Despite great interest in this complex lesion subset and a fast growing body of scientific evidence, over the past decade, the management of bifurcation disease has been focused mainly on technical aspects. However, given that adjunctive imaging and functional tools are widely applicable in contemporary practice, an integrated approach combining functional aspects and technical aspects might be helpful to guide treating physicians in their decision making on PCI strategies and procedural optimisation, which are ultimately linked to improvement of the outcomes of patients with such complex lesions. Herein, we highlight the most debated issues and propose our recommendations for a simple and integrated approach while emphasising the functional aspects of bifurcation PCI.

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Sightseeing: in search of the best vascular view

17 January inEditorial, Issue, Table of content TOP

Francesco Prati, Enrico Romagnoli, Laura Gatto

Intravascular imaging guidance represents an unrequited romance for most interventional cardiologists. Indeed, the full potential of the “perfect view” of plaque and vessel contours often remains unexpressed in clinical practice. Optical coherence tomography (OCT) images are very attractive for interventional cardiologists and experts in atherosclerosis. The clinical and research insight of an OCT high-resolution image should not be limited to a simple ideal case, characterised by a mild narrowing located in a proximal coronary segment. The proper identification and characterisation of atherosclerotic plaque morphology probably represents the most important attribute of FD-OCT images. Indeed, the possibility to assess lesions before any treatment (i.e., predilatation) constitutes an important advantage for the better understanding of the vulnerability of the evaluated plaque (i.e., fibrous cap thickness and macrophage infiltration) and the underlying pathophysiologic mechanism (e.g., plaque erosion or ulceration). This is also true for the evaluation of a restenotic severe lesion or stent thrombosis (e.g., acute underexpansion or late malapposition assessment). In all of these cases, balloon predilatation inevitably leads to plaque disruption with consequent loss of the above-mentioned information. Furthermore, a true understanding of luminal dimensions at lesion and reference sites is key to selecting balloon-stent diameters and lengths.

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The COMBO stent: can it deliver on its dual promise?

17 January inEditorial, Issue, Table of content TOP

Roisin Colleran, Michael Joner

By effectively suppressing neointimal hyperplasia (NIH), drugeluting stents (DES) have proven highly successful in reducing instent restenosis (ISR) compared with bare metal stents. However, after their introduction into clinical practice, concern emerged regarding a possible excess of late adverse events with DES as compared with bare metal stents. In particular, late stent failure due to stent thrombosis (ST) may occur at a higher rate over the medium term, at least with early-generation devices.

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National society presentation

Interventional Cardiovascular Society of Malaysia (ICSM)

17 January inNational society presentation

Wan Azman Wan Ahmad

ICSM was formed under the umbrella of the National Heart Association of Malaysia (NHAM) in 2003. NHAM was officially registered in 1978. Our Vision is to reduce the burden of cardiovascular disease in Malaysia. Our Mission is to promote quality cardiovascular care through education and research and to influence healthcare policies. This journey has been marked by significant developments and challenges amidst a fluidly changing social-economic landscape to become an Association that its members are proud of. NHAM now has 761 active members (including associate members) and ICSM has 156 active members. NHAM is an affiliate society of the European Society of Cardiology, the American College of Cardiology, the ASEAN Federation of Cardiology and is a member society of the World Heart Federation.

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Summary of presentations TCT

Asia-Pacific Hotlines at TCT 2016: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)

17 January inSummary of presentations TCT

Hiroki Shiomi

What was your rationale for this study and what was known before?

In several previous studies, routine follow-up coronary angiography (FUCAG) after percutaneous coronary intervention (PCI) has been reported to have increased the rate of coronary revascularisation, but not to have improved clinical outcomes. Based on these study results, the current clinical guidelines in the United States of America have already disregarded routine FUCAG, even after PCI for left main coronary artery disease. On the other hand, prior studies carried out in the drug-eluting stent (DES) era were performed in the context of pivotal randomised trials. There have been no randomised clinical trials evaluating the clinical impact of routine FUCAG post PCI in the real-world clinical practice including in patients with, for example, complex coronary artery disease and acute myocardial infarction, at high risk for cardiovascular events.

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Coronary Interventions

The COMBO dual therapy stent in patients presenting with acute ST-elevation myocardial infarction: a one-year follow-up study

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Rajiv Ananthakrishna, William Kristanto, et al

Abstract
Aims: The aim of this study was to evaluate the safety and efficacy of the COMBO dual therapy stent in patients with acute ST-elevation myocardial infarction (STEMI). We report the one-year clinical outcomes.


Methods and results:
Patients with acute STEMI who underwent primary percutaneous coronary intervention (PCI) between November 2013 and March 2015 and received the COMBO dual therapy stent were enrolled in this prospective single-centre registry. The primary outcome was target lesion failure (TLF), defined as a combination of cardiac mortality, target vessel myocardial infarction (TVMI), or clinically driven target lesion revascularisation (TLR). A total of 117 patients received 147 COMBO dual therapy stents during the study period, and 9.4% of the patients presented with cardiogenic shock. Thrombolysis In Myocardial Infarction (TIMI) 3 flow post procedure was achieved in 98.5% of lesions. At one year, the TLF rate was 7.7%. The rates of cardiac mortality, TVMI, and TLR were 4.3%, 2.6%, and 3.4%, respectively. The incidence of definite/probable stent thrombosis was 4.3% at 12 months, with four of the five cases occurring within 30 days. The all-cause mortality was 5.1% at one year.


Conclusions:
COMBO stent implantation during primary PCI for acute STEMI showed acceptable rates of TLF at one year, although the rates of early ST were not negligible. Further studies are warranted to evaluate the safety in a larger high-risk population.

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Differences in optical coherence tomography findings between an endothelial progenitor cell-capture sirolimuseluting stent and a paclitaxel-eluting stent: insights from the OCT substudy of the REMEDEE first-in-man trial

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Stephen W.L. Lee, Michael Haude, Akiko Maehara, Shun-Ling Kong, Hubertus Degen, Roxana Mehran

Abstract
Aims: First-generation DES are associated with delayed endothelial coverage and poor stent healing, increasing the risk of late stent thrombosis, late catch-up and neoatherosclerosis. This observational REMEDEE substudy aimed to examine differences in vascular healing by OCT between the EPC-capture sirolimus-eluting COMBO stent and a paclitaxel-eluting stent (TAXUS).


Methods and results:
A subset of 33 patients (COMBO=23, TAXUS=10) with de novo coronary artery lesions in the REMEDEE study had OCT examination at the nine-month angiographic follow-up. Betweenstent differences of OCT strut coverage, apposition, and neointimal morphology were compared by a core laboratory. Four thousand eight hundred and seventy-five COMBO and 2,697 TAXUS stent struts were analysed. More COMBO (98.5%) than TAXUS (97.6%) struts were well apposed and covered (p=0.3998); when overlying the ostium of a side branch, more TAXUS (0.7%) than COMBO (0.2%) struts were uncovered (p=0.0135). The COMBO stent was associated with a more homogeneous neointimal pattern (79.2% vs. 40.0% for TAXUS, p=0.04) and less layering (0.0% vs. 20.0% with TAXUS, p=0.08).


Conclusions:
OCT showed nearly complete (98.5%) coverage of the COMBO stent by nine months and significantly more homogeneous neointimal tissue than with the TAXUS. These observations suggest better healing with the COMBO stent in comparison with the TAXUS stent at nine months.

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A modified frequency domain optical coherence tomography procedure for imaging severely stenotic coronary artery lesions

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Feng Tian, Ying Zhou, Yundai Chen, Jing Wang, Shanshan Zhou, Tao Zhang

Abstract
Aims: This proof-of-concept study aimed to investigate the clinical feasibility of a modified frequency domain optical coherence tomography (FD-OCT) procedure for imaging severely stenotic coronary artery lesions.


Methods and results:
In total, 46 patients in whom clear images were unobtainable using conventional FD-OCT examination were consecutively enrolled in this study. Then, they were randomly divided into two groups: group A (FD-OCT examination using the new modified procedure, n=23), and group B (FD-OCT examination using a previously described procedure, the Yamaguchi method, n=23). The procedure success was 100% in group A and 86.96% in group B. Clear images of the proximal segment were obtained by both procedures for all patients. The percentage of clear images for the distal segment was 95.65% in group A and 85% in group B. Clear images of the maximal stenosis segment were 100% in group A and 95% in group B. However, these outcomes were not significantly different between the two groups. The amount of contrast agent used in group A was lower than that used in group B.


Conclusions:
The new modified procedure can obtain clear images of severely stenotic coronary artery lesions. The difference in contrast volume is of statistical significance but may be of minimal clinical significance.

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Optical coherence tomography analysis of neointimal tissue in drug-eluting stents with biodegradable and durable polymer coatings: the ALSTER-OCT registry

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Christian-Hendrik Heeger, Felix Lesche, Maximillian Fenski, Laura Hildebrand, Robert A. Byrne, Anne-Sophie Schedifka, Alexander Ghanem, Tomohisa Tada, Felix Meincke, Andreas Busjahn, Peter Wohlmuth, Michael Joner, Karl-Heinz Kuck, Martin W. Bergmann

Abstract
Aims: Optical coherence tomography (OCT) for follow-up after drug-eluting stent implantation permits detection of strut coverage, apposition and neointimal tissue. We aimed to compare OCT follow-up data and clinical outcome of two new-generation drug-eluting stents, Orsiro sirolimus-eluting stents (O-SES) and zotarolimus-eluting stents (ZES).


Methods and results:
Eighty patients underwent OCT following implantation of O-SES (n=34) or ZES (n=46). Imaging was performed after three (n=39), six (n=28) or nine months (n=13). OCT data were acquired (coverage, apposition, neointimal thickness) and neointimal maturation was assessed by novel greyscale signal intensity analysis. Image analysis revealed increased strut coverage, tissue maturation and neointima formation over the three time points. There were no significant differences between O-SES and ZES in terms of coverage and apposition at any time. We also found no differences for neointimal thickness, maturation and rate of major adverse cardiac events (a composite of cardiac death, myocardial infarction and ischaemia-driven target lesion revascularisation within 12 months, O-SES 9.4% vs. ZES 6.8%, p=0.69).


Conclusions:
No statistical differences were observed between O-SES and ZES concerning stent healing as well as one-year clinical outcome. Although preliminary, our findings may support the hypothesis that OCT-based analyses in small patient cohorts sensitively detect stent healing and could possibly be regarded as surrogates for DES healing and closely correlated to clinical outcome.

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Imaging outcomes of bioresorbable scaffold overlap: an optical coherence tomography analysis from the ABSORB EXTEND trial

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Yohei Sotomi, Pannipa Suwannasom, Chiung-Jen Wu, Hiroki Tateishi, Wai-Fung Cheong, Wei-Ying Zhao, Susan Veldhof, Robbert J. de Winter, Joanna J. Wykrzykowska, Vasim Farooq, Alexandre Abizaid, Patrick W Serruys, Yoshinobu Onuma

Abstract
Aims: The purpose of this study was to assess the vascular response and vessel healing of overlapped Absorb scaffolds (Abbott Vascular, Santa Clara, CA, USA) compared to non-overlapped devices in human coronary arteries as assessed by optical coherence tomography (OCT) in the same treated segment.


Methods and results:
The ABSORB EXTEND (NCT01023789) trial is a prospective, single-arm, openlabel clinical study which enrolled 800 patients. The planned overlap OCT subgroup in the ABSORB EXTEND trial was analysed and two-year OCT follow-up was performed in seven patients. In cross-section level analysis at baseline, lumen and abluminal scaffold areas were larger in overlap segments than in nonoverlap segments, whereas the endoluminal scaffold area was similar. At two-year follow-up, lumen area and endoluminal scaffold areas were similar in both segments despite the neointimal area being larger in the overlap segments. The neointimal coverage was essentially fully complete in both non-overlap (99.4±0.8%) and overlap segments (99.8±0.4%) at two-year follow-up.


Conclusions:
The imaging results of this small OCT subgroup analysis in the ABSORB EXTEND trial demonstrated substantial vessel healing and vascular response in the overlap segments of Absorb at twoyear follow-up comparable to the non-overlap segments.

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In vitro evaluation of the appropriate guidewire for performing the reversed guidewire technique to treat severely angulated bifurcated lesions

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Hidenori Komiyama, Masamichi Takano, Yusaku Shibata, Masato Matsushita, Osamu Kurihara, Katsuhito Kato, Ryo Munakata, Daisuke Murakami, Yasushi Miyauchi, Yoshihiko Seino, Kyoichi Mizuno, Wataru Shimizu

Abstract
Aims: The aim of this study was to determine which guidewire is best for crossing through severely angulated bifurcation lesions.


Methods and results:
Bench test 1 determined which wire could access the orifice of the side branch. A composite coil wire (SION blue), a polymer-coated wire (Fielder FC), a polymer-coated tapered wire (Fielder XT-R), and a polymer-coated composite core wire (SION black) were evaluated. We manipulated all the guidewires with 90° and 45° angles at 3 cm and 1 mm, respectively, from the guidewire tip. The tip of the SION blue and Fielder XT-R wires detached from the main branch and did not turn to the orifice of the side branch. The Fielder FC and SION black wires reached the ostium along the main branch. Bench test 2 measured the wires’ crossability with pull force using a double lumen catheter. The Fielder FC and SION black were chosen based on the bench test 1 results. The pullback force was significantly smaller for the SION black than for the Fielder FC (8.14±0.90 cN vs. 12.00±1.29 cN, p=0.0016). The SION black’s shape changed, whereas the composite core wire retained its original shape.


Conclusions:
When treating severely angulated bifurcated lesions, a polymer-coated composite core guidewire is optimal.

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A prospective, multicentre registry to assess an everolimuseluting coronary stent system (PROMUS Element™) for coronary revascularisation in an unrestricted Indian population: the PROMUS Element™ India all-comers registry

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Ajit S. Mullasari, Suma M. Victor, Vijayakumar Subban, Latchumanadhas Kalidoss, Sanjay Shah, Shireesh Sathe, Selvamani Sethuraman, Devang Desai, Atul Abhyankar, Shirish Hiremath, Upendra Kaul, Samuel Mathew

Abstract
Aims: This registry aims to evaluate the safety and effectiveness of an everolimus-eluting, platinum chromium- based coronary stent system, PROMUS Element™, in an all-comers Indian population.


Methods and results:
This prospective, open-label, single-arm study recruited 1,000 patients. The primary endpoint was target vessel failure (TVF) at 12 months post procedure, defined as ischaemia-driven revascularisation of the target vessel (TVR), target vessel myocardial infarction (MI) or cardiac death. Patients were followed up to two years. Mean age was 58.2 (±11.2) years; 83.5% were males. Diabetes mellitus and hypertension were prevalent at 41.1% and 56.5%, respectively. The majority of the patients presented with acute coronary syndrome, of whom 28% had prior STEMI. The primary endpoint occurred in 2.4% at one year. The device-oriented composite endpoint (DoCE), defined as cardiac death, target vessel MI and ischaemia-driven target lesion revascularisation (TLR), was 2.2% at one year and 3.0% at two years. Major adverse cardiac events (MACE), a composite of death, Q-wave MI and TLR, were 2.6% at one year and 3.5% at two years. Cardiac death and all MI were 2.3% and 10.3%, respectively. The definite/ probable stent thrombosis rate was low (0.6%). At two years, 91.7% continued to be on dual antiplatelet therapy and the patient follow-up rate was 95.8%.


Conclusions:
The primary endpoint and follow-up data up to two years demonstrate the safety and efficacy of the PROMUS Element coronary stent system in an Indian patient population.

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On-label vs. off-label use of vascular closure devices in Japanese patients undergoing percutaneous coronary intervention

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Toshiki Kuno, Shun Kohsaka, Hiroaki Miyata, Mitsuaki Sawano, Shunsuke Takagi, Shigetaka Noma, Koji Negishi, Yuichiro Maekawa, Yohei Numasawa, Keiichi Fukuda

Abstract
Aims: Vascular closure devices (VCD) provide immediate haemostasis and enable early mobilisation for patients undergoing percutaneous coronary intervention (PCI). At present, the use of VCD in Japan is only approved for elective PCI patients who are expected to be discharged within 48 hrs. The aim of this study was to clarify the safety of VCD use in on- and off-label cases.


Methods and results:
We analysed 7,901 consecutive patients undergoing a femoral-approach PCI between 2008 and 2014 at 13 hospitals in Japan. We compared in-hospital outcomes of VCD users to VCD non-users (control). In addition, propensity score matching analyses were performed for on- and off-label VCD users, subsequently generating two matched data sets consisting of 2,626 patients (with on-label), and 626 patients (with off-label), respectively. The patients’ average age was 67.7±11.1 and 54.5% presented with ACS. Overall, 20.8% used VCD for haemostasis, and the crude in-hospital vascular complication rates were not different between the VCD users and the controls (2.0% vs. 2.1%, p=0.741). Female gender was the only variable associated with a risk of vascular complication among VCD users (OR 3.12, 95% CI: 1.45-6.71, p=0.004). Even after propensity score matching, the incidence of vascular complications did not differ among VCD users and the control group for either the on-label (2.0 vs. 2.1%, p=0.783) or off-label data set (2.2 vs. 1.6%, p=0.560).


Conclusions:
VCD users had a similar bleeding complication rate to the controls, including in patients with off-label use. Further studies are necessary to confirm the safety of VCD in different scenarios.

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Clinical impact of revascularisation of chronic total occlusion in a non-infarct-related artery in patients with ST-segment elevation acute myocardial infarction undergoing primary percutaneous coronary intervention (from the CREDO-Kyoto AMI registry)

17 January inCoronary Interventions, Issue, Table of content BOTTOM

Hiroki Watanabe, Takeshi Morimoto, Hiroki Shiomi, Erika Yamamoto, Naritatsu Saito, Yutaka Furukawa, Yoshihisa Nakagawa, Kenji Ando, Kazushige Kadota, Takeshi Kimura

Abstract
Aims: This study aimed to investigate the clinical effect of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) in a non-infarct-related artery (IRA) on long-term cardiovascular outcomes in ST-elevation myocardial infarction (STEMI) patients.


Methods and results:
The study population consisted of 134 STEMI patients undergoing primary PCI who received PCI for CTO in a non-IRA in the CREDO-Kyoto AMI registry. The patients were divided into two groups: 83 patients who underwent successful CTO-PCI (success group) and 51 patients who underwent failed CTO-PCI (failure group). We performed a landmark analysis set at 90 days to compare clinical outcomes in the groups. The cumulative five-year incidence of all-cause death was not significantly lower in the success group than in the failure group (19.8% vs. 15.4%, log-rank p=0.65). Similarly, the adjusted risk for all-cause death was not statistically different between the groups (adjusted hazard ratio: 1.64, 95% confidence interval: 0.63-5.05, p=0.32). No significant difference was observed between the groups in the cumulative incidence of cardiac death, non-cardiac death, myocardial infarction, heart failure hospitalisation, and any coronary revascularisation.


Conclusions:
Successful PCI of CTO in non-IRA was not associated with improved five-year mortality in STEMI patients. Further larger studies are warranted to confirm the present findings.

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Interventions for vascular disease and heart failure

Buddy wire technique for successful transfemoral transcatheter aortic valve implantation through an extremely tortuous abdominal aorta: a basic technique in Asian patients?

17 January inInterventions for vascular disease and heart failure, Issue

Toru Naganuma, Satoru Mitomo, Hiroto Yabushita, Tatsuya Nakao, Aleksandar Lazarevic, Sunao Nakamura

Recent papers have reported better outcomes in transfemoral (TF) transcatheter aortic valve implantation (TAVI) than with transapical and direct aortic approaches. However, TF TAVI is challenging in a case with an extremely tortuous access route. Our case highlights the feasibility of TF TAVI in the presence of extreme tortuosity in the abdominal aorta if the “buddy wire technique” is appropriately utilised. Asian operators should become familiar with this technique, as the angle of the abdominal aorta may be more acute in Asians than in Caucasians.

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