Pick Topic
Review Topic
List Experts
Examine Expert
Save Expert
  Site Guide ··   
Coronary Artery Disease: HELP
Articles by Martin B. Leon
Based on 88 articles published since 2008
||||

Between 2008 and 2019, Martin Leon wrote the following 88 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
1 Review Coronary Revascularization in Patients Undergoing Transcatheter Aortic Valve Replacement. 2017

Finn, Matthew T / Nazif, Tamim M / Fried, Justin / Labbé, Benoit M / Mohammadi, Siamak / Leon, Martin B / Kodali, Susheel K / Rodés-Cabau, Josep / Paradis, Jean-Michel. ·Columbia University Medical Center, New-York Presbyterian Hospital, New-York, New York, USA. · Columbia University Medical Center, New-York Presbyterian Hospital, New-York, New York, USA; Cardiovascular Research Foundation, New York, New York, USA. · Quebec Heart and Lung Institute, Laval University, Ville de Québec, Quebec, Canada. · Quebec Heart and Lung Institute, Laval University, Ville de Québec, Quebec, Canada. Electronic address: jm.paradis@criucpq.ulaval.ca. ·Can J Cardiol · Pubmed #28669699.

ABSTRACT: Concomitant coronary artery disease (CAD) is highly prevalent among patients with severe aortic stenosis (AS). Historically, surgical aortic valve replacement with coronary artery bypass grafting was the only treatment option for patients with severe AS and significant CAD. The rapid expansion of transcatheter aortic valve replacement has led to significant paradigm shifts in the treatment of severe AS and has raised new questions regarding the optimal management of CAD in these patients. We review the evidence regarding management of concomitant CAD in severe AS patients, specifically focusing on issues surrounding transcatheter aortic valve replacement. In the absence of robust evidence supporting specific treatment strategies, decisions regarding coronary revascularization in severe AS should be individualized and made within the context of a multidisciplinary heart team.

2 Review Open issues in transcatheter aortic valve implantation. Part 1: patient selection and treatment strategy for transcatheter aortic valve implantation. 2014

Bax, Jeroen J / Delgado, Victoria / Bapat, Vinayak / Baumgartner, Helmut / Collet, Jean P / Erbel, Raimund / Hamm, Christian / Kappetein, Arie P / Leipsic, Jonathon / Leon, Martin B / MacCarthy, Philip / Piazza, Nicolo / Pibarot, Philippe / Roberts, William C / Rodés-Cabau, Josep / Serruys, Patrick W / Thomas, Martyn / Vahanian, Alec / Webb, John / Zamorano, Jose Luis / Windecker, Stephan. ·Department of Cardiology, Leiden University Medical Center, Albinusdreef 2 2300 RC, Leiden, The Netherlands j.j.bax@lumc.nl. · Department of Cardiology, Leiden University Medical Center, Albinusdreef 2 2300 RC, Leiden, The Netherlands. · Department of Cardiology and Cardiothoracic Surgery, St Thomas' Hospital, London, UK. · Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Muenster, Muenster, Germany. · Institut de Cardiologie, Groupe Hospitalier Pitié-Salpêtrière, Paris, France. · Department of Cardiology, West-German Heart Center Essen, University Duisburg Essen, Essen, Germany. · Department of Cardiology, Kerckhoff-Klinik, Bad Nauheim, Germany. · Erasmus Medical Center, Rotterdam, The Netherlands. · St Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada. · Columbia University Medical Center, Center for Interventional Vascular Therapy, New York Presbyterian Hospital, New York, USA. · Cardiovascular Department, King's College Hospital, London, UK. · Interventional Cardiology, McGill University Health Center, Montreal, Canada Cardiovascular Surgery, German Heart Center Munich, Bavaria, Germany. · Quebec Heart and Lung Institute, Québec, Canada. · Baylor Heart and Vascular Institute and the Departments of Internal Medicine (Division of Cardiology) and Pathology, Baylor University Medical Center, Dallas, TX, USA. · Department of Cardiology, Laval University, Quebec, Canada. · Bichat Hospital, University Paris VII, Paris, France. · Cardiac Imaging Department, University Hospital Ramon y Cajal, Madrid, Spain. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. ·Eur Heart J · Pubmed #25062952.

ABSTRACT: An exponential increase in the use of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis has been witnessed over the recent years. The current article reviews different areas of uncertainty related to patient selection. The use and limitations of risk scores are addressed, followed by an extensive discussion on the value of three-dimensional imaging for prosthesis sizing and the assessment of complex valve anatomy such as degenerated bicuspid valves. The uncertainty about valvular stenosis severity in patients with a mismatch between the transvalvular gradient and the aortic valve area, and how integrated use of echocardiography and computed tomographic imaging may help, is also addressed. Finally, patients referred for TAVI may have concomitant mitral regurgitation and/or coronary artery disease and the management of these patients is discussed.

3 Review Aortic stenosis and coronary artery disease: what do we know? What don't we know? A comprehensive review of the literature with proposed treatment algorithms. 2014

Paradis, Jean-Michel / Fried, Justin / Nazif, Tamim / Kirtane, Ajay / Harjai, Kishore / Khalique, Omar / Grubb, Kendra / George, Isaac / Hahn, Rebecca / Williams, Mathew / Leon, Martin B / Kodali, Susheel. ·Columbia University Medical Center, New York, NY, USA Cardiovascular Research Foundation, New York, NY, USA Quebec Heart and Lung Institute, Quebec, Canada jm.paradis@criucpq.ulaval.ca. · Columbia University Medical Center, New York, NY, USA. · Columbia University Medical Center, New York, NY, USA Cardiovascular Research Foundation, New York, NY, USA. ·Eur Heart J · Pubmed #24970334.

ABSTRACT: Aortic valve stenosis is the most common form of valvular heart disease in the elderly population and occurs frequently in conjunction with coronary artery disease. The standard treatment option for patients with these two conditions has been surgical aortic valve replacement and coronary artery bypass grafting. The arrival of transcatheter aortic valve replacement has considerably shifted the treatment paradigms. Nevertheless, a lot of questions remain unanswered regarding the management of coronary artery disease in the setting of the transcatheter options for severe aortic stenosis. This article includes a comprehensive review of the literature and seeks to describe the actual knowledge on the topic of aortic stenosis and concomitant coronary artery disease.

4 Review The rationale for Heart Team decision-making for patients with stable, complex coronary artery disease. 2013

Head, Stuart J / Kaul, Sanjay / Mack, Michael J / Serruys, Patrick W / Taggart, David P / Holmes, David R / Leon, Martin B / Marco, Jean / Bogers, Ad J J C / Kappetein, A Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands. ·Eur Heart J · Pubmed #23425523.

ABSTRACT: Stable complex coronary artery disease can be treated with coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or medical therapy. Multidisciplinary decision-making has gained more emphasis over the recent years to select the most optimal treatment strategy for individual patients with stable complex coronary artery disease. However, the so-called 'Heart Team' concept has not been widely implemented. Yet, decision-making has shown to remain suboptimal; there is large variability in PCI-to-CABG ratios, which may predominantly be the consequence of physician-related factors that have raised concerns regarding overuse, underuse, and inappropriate selection of revascularization. In this review, we summarize these and additional data to support the statement that a multidisciplinary Heart Team consisting of at least a clinical/non-invasive cardiologist, interventional cardiologist, and cardiac surgeon, can together better analyse and interpret the available diagnostic evidence, put into context the clinical condition of the patient as well as consider individual preference and local expertise, and through shared decision-making with the patient can arrive at a most optimal joint treatment strategy recommendation for patients with stable complex coronary artery disease. In addition, other aspects of Heart Team decision-making are discussed: the organization and logistics, involvement of physicians, patients, and assisting personnel, the need for validation, and its limitations.

5 Guideline 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. 2012

Tearney, Guillermo J / Regar, Evelyn / Akasaka, Takashi / Adriaenssens, Tom / Barlis, Peter / Bezerra, Hiram G / Bouma, Brett / Bruining, Nico / Cho, Jin-man / Chowdhary, Saqib / Costa, Marco A / de Silva, Ranil / Dijkstra, Jouke / Di Mario, Carlo / Dudek, Darius / Falk, Erling / Feldman, Marc D / Fitzgerald, Peter / Garcia-Garcia, Hector M / Gonzalo, Nieves / Granada, Juan F / Guagliumi, Giulio / Holm, Niels R / Honda, Yasuhiro / Ikeno, Fumiaki / Kawasaki, Masanori / Kochman, Janusz / Koltowski, Lukasz / Kubo, Takashi / Kume, Teruyoshi / Kyono, Hiroyuki / Lam, Cheung Chi Simon / Lamouche, Guy / Lee, David P / Leon, Martin B / Maehara, Akiko / Manfrini, Olivia / Mintz, Gary S / Mizuno, Kyiouchi / Morel, Marie-angéle / Nadkarni, Seemantini / Okura, Hiroyuki / Otake, Hiromasa / Pietrasik, Arkadiusz / Prati, Francesco / Räber, Lorenz / Radu, Maria D / Rieber, Johannes / Riga, Maria / Rollins, Andrew / Rosenberg, Mireille / Sirbu, Vasile / Serruys, Patrick W J C / Shimada, Kenei / Shinke, Toshiro / Shite, Junya / Siegel, Eliot / Sonoda, Shinjo / Suter, Melissa / Takarada, Shigeho / Tanaka, Atsushi / Terashima, Mitsuyasu / Thim, Troels / Uemura, Shiro / Ughi, Giovanni J / van Beusekom, Heleen M M / van der Steen, Antonius F W / van Es, Gerrit-Anne / van Soest, Gijs / Virmani, Renu / Waxman, Sergio / Weissman, Neil J / Weisz, Giora / Anonymous6690720. ·The Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, Massachusetts 02114, USA. gtearney@partners.org ·J Am Coll Cardiol · Pubmed #22421299.

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

6 Clinical Trial Dedicated Bifurcation Stent for the Treatment of Bifurcation Lesions Involving Large Side Branches: Outcomes From the Tryton Confirmatory Study. 2016

Généreux, Philippe / Kumsars, Indulis / Schneider, Joel E / Lesiak, Maciej / Redfors, Björn / Cornelis, Kristoff / Selmon, Matthew R / Dens, Jo / Hoye, Angela / Metzger, D Christopher / Muyldermans, Luc / Slagboom, Ton / Francese, Dominic P / Ayele, Girma Minalu / Laak, Linda L / Bartorelli, Antonio L / Cutlip, Donald E / Kaplan, Aaron V / Leon, Martin B. ·Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. · Latvian Centre of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia. · North Carolina Heart and Vascular, Raleigh, North Carolina. · Karol Marcinkowski University of Medical Sciences, Pozan, Poland. · Cardiovascular Research Foundation, New York, New York. · AZ Maria Middelares, Gent, Belgium. · Austin Heart PLLC, Austin, Texas. · Ziekenhuis Oost-Limburg, Genk, Belgium. · Castle Hill Hospital, East Yorkshire, United Kingdom. · Wellmont CVA Heart Institute, Kingsport, Tennessee. · AZ Sint Jan, Bruges, Belgium. · Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. · Tryton Medical, Inc., Durham, North Carolina. · Monzino Hospital, Milan, Italy. · Harvard Clinical Research Institute, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Tryton Medical, Inc., Durham, North Carolina; Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. · Cardiovascular Research Foundation, New York, New York; NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: ml2398@columbia.edu. ·JACC Cardiovasc Interv · Pubmed #27388820.

ABSTRACT: OBJECTIVES: The aim of this study was to prospectively study and confirm the safety and efficacy of the Tryton Side Branch Stent in the treatment of coronary artery bifurcations involving large side branches (SBs). BACKGROUND: The TRYTON Pivotal randomized controlled trial (RCT) was designed to compare the Tryton stent with standard provisional SB stenting in large vessels. The trial inadvertently enrolled patients with too small SBs (<2.25 mm). The overall trial did not meet its primary endpoint, because of an increased rate of periprocedural myocardial infarction in the Tryton stent arm. A post hoc analysis restricted to the intended population showed that the trial would have met its endpoint if only patients with SBs ≥2.25 mm in diameter (by core laboratory quantitative coronary angiography) had been enrolled. METHODS: The Tryton Confirmatory Study was a prospective, single-arm extension of the TRYTON Pivotal RCT that enrolled an additional 133 patients treated with the Tryton Side Branch Stent. It was designed to confirm the results of the post hoc analysis and emphasized the inclusion of appropriately sized SBs. The primary endpoint was noninferiority with regard to periprocedural myocardial infarction (creatine kinase myocardial band 3 times the upper limit of normal) compared with a performance goal based on the TRYTON Pivotal RCT. RESULTS: Among the 133 enrolled patients, 132 (99.2%) had SBs ≥2.25 mm. Baseline clinical and angiographic parameters were similar in this study and the RCT. Periprocedural myocardial infarction occurred in 10.5% of patients, which was numerically lower than the provisional group in the TRYTON Pivotal RCT (11.9%). The 95% confidence bounds did not extend beyond the pre-defined performance goal of 17.9%, meeting the noninferiority primary endpoint. CONCLUSIONS: The Tryton Confirmatory Study, in conjunction with the post hoc analysis of the intended population in the TRYTON Pivotal RCT, supports the safety and efficacy of the Tryton Side Branch Stent for treatment of bifurcation lesions involving large SBs.

7 Clinical Trial Performance of the resolute zotarolimus-eluting stent in small vessels. 2014

Caputo, Ronald / Leon, Martin / Serruys, Patrick / Neumann, Franz-Josef / Yeung, Alan / Windecker, Stephan / Belardi, Jorge A / Silber, Sigmund / Meredith, Ian / Widimský, Petr / Saito, Shigeru / Mauri, Laura. ·St. Joseph's Hospital Cardiology, Liverpool, New York, New York. ·Catheter Cardiovasc Interv · Pubmed #24659581.

ABSTRACT: BACKGROUND: Drug eluting stents for the treatment of small vessel coronary artery disease have traditionally yielded inferior clinical outcomes compared to the use of DES in large vessels. The benefit of the second-generation Resolute zotarolimus-eluting stent (R-ZES) in small vessels was examined. METHODS: Two-year clinical outcomes from five combined R-ZES studies were compared between patients with small (reference vessel diameter [RVD] ≤2.5 mm; n = 1,956) and large (RVD >2.5 mm; n = 3174) vessels. RESULTS: Despite a higher incidence of comorbidities in the small vessel group, there was no significant difference in target lesion failure (TLF) (10.1% vs. 8.7%; P = 0.54) at 2 years. When the subgroup of patients with diabetes was examined (n = 1,553) there was no significant difference in 2-year TLF in small compared to large vessels (11.2% vs. 11.1%; P = 0.17). Similarly, within the small vessel cohort, no significant difference was seen regarding TLF at 2 years between people with and without diabetes (11.2% vs 9.6%; P = 0.28). CONCLUSION: When used for the treatment of small vessels, the R-ZES appears to provide acceptable clinical results at 2 years when compared to its performance in large vessels.

8 Clinical Trial First report of a novel abluminal groove filled biodegradable polymer rapamycin-eluting stent in de novo coronary artery disease: results of the first in man FIREHAWK trial. 2012

Qian, Jie / Xu, Bo / Lansky, Alexandra J / Yang, Yue-jin / Qiao, Shu-bin / Wu, Yong-jian / Chen, Jue / Hu, Feng-huan / Yang, Wei-xian / Mintz, Gary S / Leon, Martin B / Gao, Run-lin. ·Department of Cardiology, Cardiovascular Institute and Fu Wai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100037, China. ·Chin Med J (Engl) · Pubmed #22613516.

ABSTRACT: BACKGROUND: Durable polymers used for first-generation drug-eluting stents (DES) potentially contribute to persistent inflammation and late DES thrombosis. We report the first in human experience with the rapamycin-eluting biodegradable polymer coated cobalt-chromium FIREHAWK stent with abluminal groove. METHODS: A total of 21 patients with stable or unstable angina, or prior myocardial infarction, with single de novo native coronary stenoses < 30 mm in length in vessel sizes ranging from 2.25 to 4.0 mm were enrolled. The primary endpoint was major adverse cardiac events (MACE) at 30 days defined as the composite of cardiac death, myocardial infarction (Q and non-Q), or ischemia-driven target lesion revascularization. Secondary endpoints include device, lesion, and clinical success rates, 4-month in-stent late lumen loss by quantitative coronary angiography (QCA), proportion of uncovered or malapposed stent struts by optical coherence tomograpphy (OCT) at 4 months, and MACE at 4, 12, 24 and 36-month follow-up. RESULTS: Device success was 95.7%, lesion and clinical success was 100.0%. There were no MACE events at 30 days. One patient died of non-cardiac hemorrhagic stroke 5 days after index procedure. At 4 months, in-stent late loss was (0.13 ± 0.18) mm, and complete strut coverage was 96.2% by OCT with 0.1% strut malapposition. At 4-month follow-up there was no additional MACE events, and a single target vessel (non-target lesion) revascularization. CONCLUSIONS: The FIREHAWK abluminal groove biodegradable polymer rapamycin-eluting stent demonstrated feasibility, safety and efficacy in this first in human experience. OCT findings indicated excellent stent strut coverage 4 months after implantation. Larger studies are required to confirm whether the early FIREHAWK stent results translate into longer term restenosis and thrombosis benefits.

9 Clinical Trial An intravascular ultrasound appraisal of atherosclerotic plaque distribution in diseased coronary arteries. 2012

Golinvaux, Nicholas / Maehara, Akiko / Mintz, Gary S / Lansky, Alexandra J / McPherson, John / Farhat, Naim / Marso, Steven / de Bruyne, Bernard / Serruys, Patrick W / Templin, Barry / Cheong, Wai-Fung / Aaskar, Rasha / Fahy, Martin / Mehran, Roxana / Leon, Martin / Stone, Gregg W. ·Cardiovascular Research Foundation and Columbia University Medical Center, New York, NY 10022, USA. ·Am Heart J · Pubmed #22520529.

ABSTRACT: BACKGROUND: The assumption that atherosclerosis accumulates in the proximal coronary arteries and that distal segments are spared has yet to be systematically shown in vivo. METHODS: We used intravascular ultrasound to analyze complete proximal, mid, and distal segments from 75 diseased left anterior descending arteries (LADs) and 61 diseased right coronary arteries (RCAs) (including either the posterolateral [PLA; n = 38] or posterior descending artery [PDA; n = 23]) to document that distal coronary arteries are more often free of disease vs proximal vessels. External elastic membrane, lumen, and plaque and media areas were measured every 0.4 mm (median), and plaque burden (plaque and media/external elastic membrane) and percentage of normal (plaque and media thickness <0.3 mm) cross sections/segment were determined. RESULTS: Left anterior descending artery plaque was heaviest in proximal and mid segments, diminishing significantly in distal segments; plaque burden was 46% ± 9% in proximal, 39% ± 8% in mid, and 31% ± 9% in distal LAD (P < .0001), with 93% (median) of distal LAD cross sections being normal compared with 21% of mid and 0% of proximal cross sections (P < .0001). Right coronary artery plaque gradient was less pronounced vs the LAD; plaque burden was 37% ± 13% in proximal, 40% ± 10% in mid, and 36% ± 10% in distal RCA, followed by 31% ± 11% in PDA and 33% ± 10% in PLA. This was supported by the median percentage of normal cross sections/segment: 0% proximal, 0% mid, and 23% distal RCA sections plus 100% PDA and 48% PLA sections. CONCLUSIONS: Intravascular ultrasound data indicated a proximal-to-distal LAD plaque gradient; significant disease was uncommon in the distal LAD. Conversely, the proximal-to-distal RCA plaque gradient was less distinct than the LAD, although disease in the PDA was still reduced compared with proximal segments.

10 Clinical Trial Rationale and design of the clinical evaluation of the Resolute Zotarolimus-Eluting Coronary Stent System in the treatment of de novo lesions in native coronary arteries (the RESOLUTE US clinical trial). 2011

Mauri, Laura / Leon, Martin B / Yeung, Alan C / Negoita, Manuela / Keyes, Michelle J / Massaro, Joseph M. ·Brigham and Women's Hospital, Boston, MA 02115, USA. lmauri1@partners.org ·Am Heart J · Pubmed #21570508.

ABSTRACT: BACKGROUND: Drug-eluting stents (DES) are commonly used to treat obstructive coronary disease and avoid restenosis. Newer DES have been developed to improve effectiveness and safety. We describe a clinical trial to evaluate a DES with a novel polymer that may improve the antirestenosis effectiveness while maintaining the safety standards of currently Food and Drug Administration-approved DES. METHODS: The RESOLUTE US Trial is a multicenter, nonrandomized trial prospectively designed to compare the Resolute zotarolimus-eluting stent (R-ZES) to the Food and Drug Administration-approved Endeavor ZES using patient-level historical control data, adjusting for baseline covariates through propensity score. The stents differ primarily in the polymer, which, in the R-ZES, is designed to elute zotarolimus over a longer period. The study will enroll up to 1,574 patients with ischemic heart disease due to de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. The primary end point is target lesion failure at 12 months postprocedure, defined as the composite of cardiac death, target-vessel myocardial infarction (MI), and clinically driven target lesion revascularization by percutaneous or surgical methods. Secondary end points include device, lesion and procedural success, death, MI, cardiac death and MI, composites of these clinical events, and stent thrombosis at each follow-up assessment up to 5 years postprocedure. CONCLUSIONS: The RESOLUTE US Trial (ClinicalTrials.gov #NCT00726453) is a prospective, multicenter, observational study with a patient-level historical control designed to assess the safety and efficacy of the R-ZES for the treatment of de novo lesions in native coronary arteries.

11 Clinical Trial Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. 2011

Yeung, Alan C / Leon, Martin B / Jain, Ash / Tolleson, Thaddeus R / Spriggs, Douglas J / Mc Laurin, Brent T / Popma, Jeffrey J / Fitzgerald, Peter J / Cutlip, Donald E / Massaro, Joseph M / Mauri, Laura / Anonymous2980691. ·Stanford University School of Medicine, Palo Alto, California, USA. ·J Am Coll Cardiol · Pubmed #21470813.

ABSTRACT: OBJECTIVES: The RESOLUTE US (R-US) trial is a prospective, observational study designed to evaluate the clinical effectiveness of the Resolute zotarolimus-eluting stent (R-ZES) in a U.S. population. BACKGROUND: The R-ZES releases zotarolimus over a 6-month period in order to achieve optimal clinical effectiveness and safety. METHODS: The R-US trial recruited patients with de novo native coronary lesions suitable for 1- or 2-vessel treatment with stents from 2.25 to 4.0 mm in diameter. In the main analysis cohort (2.5- to 3.5-mm stents and single-lesion treatment), the primary endpoint was 12-month target lesion failure (TLF) defined as the composite of cardiac death, myocardial infarction (MI), and clinically-driven target lesion revascularization (TLR), compared with data from Endeavor zotarolimus-eluting stent (E-ZES) trials, adjusting for baseline covariates through propensity scores. RESULTS: Overall, 1,402 patients were enrolled with a mean reference vessel diameter of 2.59 ± 0.47 mm and diabetes prevalence of 34.4%. In the main analysis cohort, TLF was 3.7% at 12 months compared with historical E-ZES results (TLF = 6.5%). The R-ZES met the 3.3% margin of noninferiority (rate difference = -2.8%, upper 1-sided 95% confidence interval: -1.3%, p < 0.001). The overall TLF rate was 4.7%, and rates of cardiac death, MI, and TLR were 0.7%, 1.4%, and 2.8%, respectively. The 12-month rate of stent thrombosis was 0.1%. CONCLUSIONS: The R-ZES achieved a very low rate of clinical restenosis while maintaining low rates of important clinical safety events such as death, MI, and stent thrombosis at 1-year follow-up. (The Medtronic RESOLUTE US Clinical Trial [R-US]; NCT00726453).

12 Clinical Trial Two-year safety and effectiveness of sirolimus-eluting stents (from a prospective registry). 2011

Claessen, Bimmer E / Mehran, Roxana / Leon, Martin B / Heller, Eric A / Weisz, Giora / Syros, George / Mintz, Gary S / Franklin-Bond, Theresa / Apostolidou, Irene / Henriques, Jose P S / Stone, Gregg W / Moses, Jeffrey W / Dangas, George D. ·Cardiovascular Research Foundation, New York, New York, USA. ·Am J Cardiol · Pubmed #21195378.

ABSTRACT: Uncertainty exists about the long-term safety and efficacy outcomes of sirolimus-eluting stents (SESs) in unselected patients. The present study was performed to evaluate the safety and efficacy of the SES in treatment of patients with coronary artery disease in an unselected population. Over a 2-year period, 1,504 consecutive patients undergoing percutaneous coronary intervention with ≥1 SES were enrolled. The primary end point was the occurrence of target vessel failure (TVF; a composite of cardiac death, myocardial infarction, or clinically driven target vessel revascularization). An independent clinical event committee adjudicated all adverse events up to 2-year follow-up. Dual antiplatelet therapy was recommended for ≥1 year throughout the study period. Mean age was 65 ± 11 years; 75% were men, and 34% were diabetics. SESs were implanted for off-label indications in 86% of cases. TVF rates were 3.3%, 6.9%, 11.5%, and 15.5% at 30-day, 6-month, 1-year, and 2-year follow-ups, respectively. The 2-year cumulative rate of definite/probable stent thrombosis was 0.9%; 0.2% was very late thrombosis, occurring from 1 year to 2 years. Patients off dual antiplatelet therapy at 6 months had a significantly increased rate of subsequent death from noncardiac causes. Patients off dual antiplatelet therapy at 1 year had a significantly decreased rate of subsequent clinically driven target lesion revascularization. In conclusion, use of SESs in unselected patients with coronary artery disease was associated with a low TVF rate at 2 years with an acceptable incidence of stent thrombosis.

13 Clinical Trial The dynamic nature of coronary artery lesion morphology assessed by serial virtual histology intravascular ultrasound tissue characterization. 2010

Kubo, Takashi / Maehara, Akiko / Mintz, Gary S / Doi, Hiroshi / Tsujita, Kenichi / Choi, So-Yeon / Katoh, Osamu / Nasu, Kenya / Koenig, Andreas / Pieper, Michael / Rogers, Jason H / Wijns, William / Böse, Dirk / Margolis, M Pauliina / Moses, Jeffrey W / Stone, Gregg W / Leon, Martin B. ·Cardiovascular Research Foundation, New York, New York 10022, USA. ·J Am Coll Cardiol · Pubmed #20378076.

ABSTRACT: OBJECTIVES: We used virtual histology intravascular ultrasound (VH-IVUS) to investigate the natural history of coronary artery lesion morphology. BACKGROUND: Plaque stability is related to its histological composition. METHODS: We performed serial (baseline and 12-month follow-up) VH-IVUS studies and examined 216 nonculprit lesions (plaque burden >or=40%) in 99 patients. Lesions were classified into pathological intimal thickening (PIT), VH-IVUS-derived thin-capped fibroatheroma (VH-TCFA), thick-capped fibroatheroma (ThCFA), fibrotic plaque, and fibrocalcific plaque. RESULTS: At baseline, 20 lesions were VH-TCFAs; during follow-up, 15 (75%) VH-TCFAs "healed," 13 became ThCFAs, 2 became fibrotic plaque, and 5 (25%) VH-TCFAs remained unchanged. Compared with VH-TCFAs that healed, VH-TCFAs that remained VH-TCFAs located more proximally (values are median [interquartile range]) (16 mm [15 to 18 mm] vs. 31 mm [22 to 47 mm], p = 0.013) and had larger lumen (9.1 mm(2) [8.2 to 10.7 mm(2)] vs. 6.9 mm(2) [6.0 to 8.2 mm(2)], p = 0.021), vessel (18.7 mm(2) [17.3 to 28.6 mm(2)] vs. 15.5 mm(2) [13.3 to 16.6 mm(2)]; p = 0.010), and plaque (9.7 mm(2) [9.6 to 15.7 mm(2)] vs. 8.4 mm(2) [7 to 9.7 mm(2)], p = 0.027) areas; however, baseline VH-IVUS plaque composition did not differ between VH-TCFAs that healed and VH-TCFAs that remained VH-TCFAs. Conversely, 12 new VH-TCFAs developed; 6 late-developing VH-TCFAs were PITs, and 6 were ThCFAs at baseline. In addition, plaque area at minimum lumen sites increased significantly in PITs (7.8 mm(2) [6.2 to 10.0 mm(2)] to 9.0 mm(2) [6.5 to 12.0 mm(2)], p < 0.001), VH-TCFAs (8.6 mm(2) [7.3 to 9.9 mm(2)] to 9.5 mm(2) [7.8 to 10.8 mm(2)], p = 0.024), and ThCFAs (8.6 mm(2) [6.8 to 10.2 mm(2)] to 8.8 mm(2) [7.1 to 11.4 mm(2)], p < 0.001) with a corresponding decrease lumen areas, but not in fibrous or fibrocalcific plaque. CONCLUSIONS: Most VH-TCFAs healed during 12-month follow-up, whereas new VH-TCFAs also developed. PITs, VH-TCFAs, and ThCFAs showed significant plaque progression compared with fibrous and fibrocalcific plaque.

14 Article Effect of Increasing Stent Length on 3-Year Clinical Outcomes in Women Undergoing Percutaneous Coronary Intervention With New-Generation Drug-Eluting Stents: Patient-Level Pooled Analysis of Randomized Trials From the WIN-DES Initiative. 2018

Chandrasekhar, Jaya / Baber, Usman / Sartori, Samantha / Stefanini, Giulio G / Sarin, Michele / Vogel, Birgit / Farhan, Serdar / Camenzind, Edoardo / Leon, Martin B / Stone, Gregg W / Serruys, Patrick W / Wijns, William / Steg, Philippe G / Weisz, Giora / Chieffo, Alaide / Kastrati, Adnan / Windecker, Stephan / Morice, Marie-Claude / Smits, Pieter C / von Birgelen, Clemens / Mikhail, Ghada W / Itchhaporia, Dipti / Mehta, Laxmi / Kim, Hyo-Soo / Valgimigli, Marco / Jeger, Raban V / Kimura, Takeshi / Galatius, Søren / Kandzari, David / Dangas, George / Mehran, Roxana. ·The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. · Humanitas Research Hospital, Rozzano, Milan, Italy. · Institut Lorrain du Coeur et des Vaisseaux, Vandoeuvre-lès-Nancy, France. · Columbia University Medical Center, New York, New York. · Imperial College Healthcare NHS Trust, London, United Kingdom. · Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium. · Département Hospitalo Universitaire, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France. · Columbia University Medical Center, New York, New York; Shaare Zedek Medical Center, Jerusalem, Israel. · San Raffaele Scientific Institute, Milan, Italy. · Deutsches Herzentrum Munchen, Technische Universitat Munich, Germany. · Bern University Hospital, Bern, Switzerland. · Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France. · Maasstad Hospital, Rotterdam, the Netherlands. · Thoraxcentrum Twente, Enschede, the Netherlands. · Hoag Memorial Hospital Presbyterian, Newport Beach, California. · Ohio State University Medical Center, Columbus, Ohio. · Seoul National University Hospital, Seoul, Korea. · University of Ferrara, Ferrara, Italy. · University Hospital Basel, Basel, Switzerland. · Kyoto University Graduate School of Medicine, Kyoto, Japan. · Bispebjerg University Hospital, Copenhagen, Denmark. · Piedmont Heart Institute, Atlanta, Georgia. · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org. ·JACC Cardiovasc Interv · Pubmed #29301648.

ABSTRACT: OBJECTIVES: The aim of this study was to examine whether stent length per patient and stent length per lesion are negative markers for 3-year outcomes in women following percutaneous coronary intervention (PCI) with new-generation drug-eluting stents (DES). BACKGROUND: In the era of advanced stent technologies, whether stent length remains a correlate of adverse outcomes is unclear. METHODS: Women treated with new-generation DES in 14 randomized trials from the WIN-DES (Women in Innovation and Drug-Eluting Stents) pooled database were evaluated. Total stent length per patient, which was available in 5,403 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 24 mm; quartile 3, 24 to 36 mm; quartile 4, ≥36 mm), and stent length per lesion, which was available in 5,232 women (quartile 1, 8 to 18 mm; quartile 2, 18 to 20 mm; quartile 3, 20 to 27 mm; quartile 4, ≥27 mm) were analyzed in quartiles. The primary endpoint was 3-year major adverse cardiovascular events (MACE), defined as a composite of all-cause death, myocardial infarction, or target lesion revascularization. RESULTS: In the per-patient analysis, a stepwise increase was observed with increasing stent length in the adjusted risk for 3-year MACE (p for trend <0.0001), myocardial infarction (p for trend <0.001), cardiac death (p for trend = 0.038), and target lesion revascularization (p for trend = 0.011) but not definite or probable stent thrombosis (p for trend = 0.673). In the per-lesion analysis, an increase was observed in the adjusted risk for 3-year MACE (p for trend = 0.002) and myocardial infarction (p for trend <0.0001) but not other individual endpoints. On landmark analysis for late event rates between 1 and 3 years, stent length per patient demonstrated weak associations with target lesion revascularization (p = 0.0131) and MACE (p = 0.0499), whereas stent length per lesion was not associated with higher risk for any late events, suggesting that risk was established early within the first year after PCI. CONCLUSIONS: In this pooled analysis of women undergoing PCI with new-generation DES, increasing stent length per patient and per lesion were independent predictors of 3-year MACE but were not associated with definite or probable stent thrombosis.

15 Article Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions. 2018

Grundeken, Maik J / Collet, Carlos / Ishibashi, Yuki / Généreux, Philippe / Muramatsu, Takashi / LaSalle, Laura / Kaplan, Aaron V / Wykrzykowska, Joanna J / Morel, Marie-Angèle / Tijssen, Jan G / de Winter, Robbert J / Onuma, Yoshinobu / Leon, Martin B / Serruys, Patrick W. ·Amsterdam Heart Center, Academic Medical Center, Amsterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Cardiovascular Research Foundation, New York. · Columbia University Medical Center, New York. · Morristown Medical Center, Morristown, New Jersey. · Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada. · Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. · Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, New Hampshire, Lebanon. · Cardialysis B.V, Rotterdam, The Netherlands. · International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #28836339.

ABSTRACT: OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.

16 Article Double Kissing Crush Versus Provisional Stenting for Left Main Distal Bifurcation Lesions: DKCRUSH-V Randomized Trial. 2017

Chen, Shao-Liang / Zhang, Jue-Jie / Han, Yaling / Kan, Jing / Chen, Lianglong / Qiu, Chunguang / Jiang, Tiemin / Tao, Ling / Zeng, Hesong / Li, Li / Xia, Yong / Gao, Chuanyu / Santoso, Teguh / Paiboon, Chootopol / Wang, Yan / Kwan, Tak W / Ye, Fei / Tian, Nailiang / Liu, Zhizhong / Lin, Song / Lu, Chengzhi / Wen, Shangyu / Hong, Lang / Zhang, Qi / Sheiban, Imad / Xu, Yawei / Wang, Lefeng / Rab, Tanveer S / Li, Zhanquan / Cheng, Guanchang / Cui, Lianqun / Leon, Martin B / Stone, Gregg W. ·Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China. Electronic address: chmengx@126.com. · Division of Cardiology, Nanjing First Hospital and Key Laboratory of Targeted Intervention of Cardiovascular Disease, Collaboratory Innovation Center for Cardiovascular Disease Translational Medicine, Nanjing Medical University, Nanjing, China. · Division of Cardiology, Shenyang Northern Hospital, Shenyang, China. · Division of Cardiology, United Hospital, Fujian Medical University, Fuzhou, China. · Division of Cardiology, Zhengzhou University First Hospital, Zhengzhou, China. · Division of Cardiology, Armed Police Medical University, Tianjin, China. · Division of Cardiology, Xijin Hospital, 4th Military Medical University, Xi'an, China. · Division of Cardiology, Wuhan Tongji Hospital, United Medical University, Wuhan, China. · Division of Cardiology, Guangzhou Red Cross Hospital, Guangzhou, Guangdong, China. · Division of Cardiology, Xuzhou Medical University Affiliated Hospital, Xuzhou, China. · Division of Cardiology, Henan Provincial People's Hospital, Zhengzhou, China. · Division of Cardiology, Medistra Hospital, University of Indonesia Medical School, Jakarda, Indonesia. · Division of Cardiology, Bankok General Hospital, Bankok, Thailand. · Division of Cardiology, Zhongshan Hospital, Xiamen University, Xiamen, China. · Division of Cardiology, Beth Israel Hospital, New York, New York. · Division of Cardiology, Nanjing Heart Center, Nanjing, China. · Division of Cardiology, Tianjin 1(st) Central Hospital, Tianjin, China. · Division of Cardiology, Daqin Oil General Hospital, Daqin, China. · Division of Cardiology, Jiangxi Provincial People's Hospital, Nanchang, China. · Division of Cardiology, Shanghai East Hospital, Shanghai, China. · Division of Cardiology, Pederzoli Hospital-Peschiera del Garda, Verona, Italy. · Division of Cardiology, Shanghai 10th People's Hospital, Shanghai, China. · Division of Cardiology, Beijing Chaoyang Hospital, Beijing, China. · Division of Cardiology, Emory University Hospital, Atlanta, Georgia. · Division of Cardiology, Liaoning Provincial People's Hospital, Shenyang, China. · Division of Cardiology, Huaihe Hospital, Henan University, Kaifeng, China. · Division of Cardiology, Shandong Provincial Hospital, Shandong University, Jinan, China. · Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. · Division of Cardiology, Columbia University Medical Center and the Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. ·J Am Coll Cardiol · Pubmed #29096915.

ABSTRACT: BACKGROUND: Provisional stenting (PS) is the most common technique used to treat distal left main (LM) bifurcation lesions in patients with unprotected LM coronary artery disease undergoing percutaneous coronary intervention. The double kissing (DK) crush planned 2-stent technique has been shown to improve clinical outcomes in non-LM bifurcations compared with PS, and in LM bifurcations compared with culotte stenting, but has never been compared with PS in LM bifurcation lesions. OBJECTIVES: The authors sought to determine whether a planned DK crush 2-stent technique is superior to PS for patients with true distal LM bifurcation lesions. METHODS: The authors randomized 482 patients from 26 centers in 5 countries with true distal LM bifurcation lesions (Medina 1,1,1 or 0,1,1) to PS (n = 242) or DK crush stenting (n = 240). The primary endpoint was the 1-year composite rate of target lesion failure (TLF): cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Routine 13-month angiographic follow-up was scheduled after ascertainment of the primary endpoint. RESULTS: TLF within 1 year occurred in 26 patients (10.7%) assigned to PS, and in 12 patients (5.0%) assigned to DK crush (hazard ratio: 0.42; 95% confidence interval: 0.21 to 0.85; p = 0.02). Compared with PS, DK crush also resulted in lower rates of target vessel myocardial infarction I (2.9% vs. 0.4%; p = 0.03) and definite or probable stent thrombosis (3.3% vs. 0.4%; p = 0.02). Clinically driven target lesion revascularization (7.9% vs. 3.8%; p = 0.06) and angiographic restenosis within the LM complex (14.6% vs. 7.1%; p = 0.10) also tended to be less frequent with DK crush compared with PS. There was no significant difference in cardiac death between the groups. CONCLUSIONS: In the present multicenter randomized trial, percutaneous coronary intervention of true distal LM bifurcation lesions using a planned DK crush 2-stent strategy resulted in a lower rate of TLF at 1 year than a PS strategy. (Double Kissing and Double Crush Versus Provisional T Stenting Technique for the Treatment of Unprotected Distal Left Main True Bifurcation Lesions: A Randomized, International, Multi-Center Clinical Trial [DKCRUSH-V]; ChiCTR-TRC-11001213).

17 Article Validation Study of Image-Based Fractional Flow Reserve During Coronary Angiography. 2017

Pellicano, Mariano / Lavi, Ifat / De Bruyne, Bernard / Vaknin-Assa, Hana / Assali, Abid / Valtzer, Orna / Lotringer, Yonit / Weisz, Giora / Almagor, Yaron / Xaplanteris, Panagiotis / Kirtane, Ajay J / Codner, Pablo / Leon, Martin B / Kornowski, Ran. ·From the Cardiovascular Center Aalst, OLV Hospital, Belgium (M.P., B.D.B., P.X.) · Rabin Medical Center, Petach Tikva, Israel (I.L., H.V.-A., A.A., O.V., P.C., R.K.) · Department of Advanced Biomedical Sciences, Federico II University of Naples, Italy (M.P.) · CathWorks Ltd, Ra'anana, Israel (I.L., O.V., Y.L.) · Columbia University Medical Center, New York-Presbyterian Hospital (A.J.K., P.C., M.B.L.) · and Shaare Zedek Medical Center, Jerusalem, Israel (G.W., Y.A.). ·Circ Cardiovasc Interv · Pubmed #28916602.

ABSTRACT: BACKGROUND: Fractional flow reserve (FFR), an index of the hemodynamic severity of coronary stenoses, is derived from invasive measurements and requires a pressure-monitoring guidewire and hyperemic stimulus. Angiography-derived FFR measurements (FFR METHODS AND RESULTS: FFR CONCLUSIONS: There is a high concordance between FFR CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03005028.

18 Article Classification for Assessing the Quality of Diagnostic Coronary Angiography. 2017

Généreux, Philippe / Mehran, Roxana / Leon, Martin B / Bettinger, Nicolas / Stone, Gregg W. ·Cardiovascular Research Foundation, 1700 Broadway, 9th Floor, New York, NY 10019 USA. pgenereux@crf.org. ·J Invasive Cardiol · Pubmed #28809722.

ABSTRACT: Coronary angiography remains the gold standard for diagnosing obstructive coronary artery disease. However, no standardized, objective, and quantitative classification to assess the quality of coronary angiography exists. In the present report, we sought to establish a novel standardized quantitative classification for the quality of coronary angiography, taking into consideration two main parameters: coronary contrast filling and coronary sinus contrast reflux. Intraobserver and interobserver reproducibility performed among 70 angiograms and 9 readers demonstrated excellent and substantial reproducibility, respectively. The proposed classification may be useful in daily practice, clinician training, and clinical trials.

19 Article Randomized Comparison of Ridaforolimus- and Zotarolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: Primary Results From the BIONICS Trial (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis). 2017

Kandzari, David E / Smits, Pieter C / Love, Michael P / Ben-Yehuda, Ori / Banai, Shmuel / Robinson, Simon D / Jonas, Michael / Kornowski, Ran / Bagur, Rodrigo / Iniguez, Andres / Danenberg, Haim / Feldman, Robert / Jauhar, Rajiv / Chandna, Harish / Parikh, Manish / Perlman, Gidon Y / Balcells, Mercedes / Markham, Peter / Ozan, Melek Ozgu / Genereux, Philippe / Edelman, Elazer R / Leon, Martin B / Stone, Gregg W. ·From Piedmont Heart Institute, Atlanta, GA (D.E.K.) · Maasstad Hospital, Rotterdam, The Netherlands (P.C.S.) · Queen Elizabeth II Health Sciences Center, Halifax, Nova Scotia (M.P.L.) · Columbia University Medical Center and the Cardiovascular Research Foundation, New York (O.B.-Y., M.P., M.O.O., P.G., M.B.L., G.W.S.) · Tel Aviv Medical Center, Israel (S.B.) · Victoria Heart Institute Foundation, British Columbia, Canada (S.D.R.) · Kaplan Medical Center, Rehovot, Israel (M.J.) · Rabin Medical Center, Petach Tikva, Israel (R.K.) · Centre Hospitalier Universitaire de Quebec, Canada (R.B.) · Hospital Meixoeiro, Vigo, Spain (A.I.) · Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D., G.Y.P.) · MediQuest Research Group, Ocala, FL (R.F.) · North Shore University Hospital, New York (R.J.) · Victoria Heart and Vascular Center, TX (H.C.) · Medinol Ltd, Tel Aviv, Israel (G.Y.P.) · Massachusetts Institute of Technology, Cambridge (M.B., E.R.E.) · and CBSET Inc, Lexington, MA (P.M.). ·Circulation · Pubmed #28794001.

ABSTRACT: BACKGROUND: The safety and efficacy of a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting the antiproliferative agent ridaforolimus for treatment of patients with coronary artery disease is undetermined. METHODS: A prospective, international 1:1 randomized trial was conducted to evaluate in a noninferiority design the relative safety and efficacy of ridaforolimus-eluting stents (RESs) and slow-release zotarolimus-eluting stents among 1919 patients undergoing percutaneous coronary intervention at 76 centers. Inclusion criteria allowed enrollment of patients with recent myocardial infarction, total occlusions, bifurcations lesions, and other complex conditions. RESULTS: Baseline clinical and angiographic characteristics were similar between the groups. Overall, mean age was 63.4 years, 32.5% had diabetes mellitus, and 39.7% presented with acute coronary syndromes. At 12 months, the primary end point of target lesion failure (composite of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization) was 5.4% for both devices (upper bound of 1-sided 95% confidence interval 1.8%, CONCLUSIONS: In the present trial, which allowed broad inclusion criteria, the novel RESs met the prespecified criteria for noninferiority compared with zotarolimus-eluting stents for the primary end point of target lesion failure at 12 months and had similar measures of late lumen loss. These findings support the safety and efficacy of RESs in patients who are representative of clinical practice. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01995487.

20 Article Impact of Coronary Artery Disease Severity Assessed With the SYNTAX Score on Outcomes Following Transcatheter Aortic Valve Replacement. 2017

Paradis, Jean-Michel / White, Jonathon M / Généreux, Philippe / Urena, Marina / Doshi, Darshan / Nazif, Tamim / Hahn, Rebecca / George, Isaac / Khalique, Omar / Harjai, Kishore / Lasalle, Laura / Labbé, Benoit M / DeLarochellière, Robert / Doyle, Daniel / Dumont, Éric / Mohammadi, Siamak / Leon, Martin B / Rodés-Cabau, Josep / Kodali, Susheel. ·Quebec Heart and Lung Institute, Quebec, Canada. · Cardiovascular Research Foundation, New-York, NY. · Columbia University Medical Center, New-York, NY. · Hopital du Sacre-Coeur de Montreal, Montreal, Quebec Canada. · Gagnon Cardiovascular Institute Morristown Medical Center, Morristown, New Jersey. · Cardiovascular Research Foundation, New-York, NY sk2427@cumc.columbia.edu. ·J Am Heart Assoc · Pubmed #28219920.

ABSTRACT: BACKGROUND: The influence of coronary artery disease (CAD) on clinical and echocardiographic outcomes after transcatheter aortic valve replacement (TAVR) is still controversial. We sought to evaluate the impact of CAD severity as measured by the SYNTAX score (SS) on patients undergoing TAVR. METHODS AND RESULTS: A total of 377 patients who underwent TAVR in 2 high-volume centers in North America were included in our retrospective analysis. A blinded angiographic core laboratory calculated the SS on all available coronary angiograms with the use of quantitative coronary analysis. Patients were stratified into 4 groups: (1) no CAD (SS=0); (2) low SS (SS between 1 and 22); (3) intermediate SS (SS between 23 and 32); and (4) high SS (SS ≥33). Patients who had undergone percutaneous coronary intervention within 6 months prior to TAVR were separated into 2 categories based on their residual SS (<8 and ≥8). Patients with previous coronary artery bypass grafting (CABG) were divided into 2 groups: (1) low CABG SS and (2) high CABG SS. The primary end point was a composite of all-cause mortality, myocardial infarction, and stroke. At 30 days and 1 year, both the presence and the severity of CAD had no impact on the rate of the combined primary end point and on all-cause mortality, cardiovascular mortality, and myocardial infarction. Patients with less complete revascularization (residual SS ≥8 versus residual SS <8 and low CABG SS versus high CABG SS, had similar rates of the combined primary end point, all-cause mortality, cardiovascular mortality, MI, and stroke, at both 30 days and 1 year. CONCLUSIONS: In our core laboratory-validated study, neither the severity of CAD nor completeness of revascularization after percutaneous coronary intervention or CABG were associated with clinical outcomes after TAVR, at both 30 days and 1 year.

21 Article Percutaneous Coronary Intervention With Bioresorbable Scaffolds in a Young Child. 2017

Nazif, Tamim M / Kalra, Sanjog / Ali, Ziad A / Karmpaliotis, Dimitrios / Turner, Mariel E / Starc, Thomas J / Cao, Yang / Marboe, Charles C / Collins, Michael B / Leon, Martin B / Kirtane, Ajay J. ·Division of Cardiology, Columbia University Medical Center, New York, New York2Cardiovascular Research Foundation, New York, New York. · Division of Cardiology, Columbia University Medical Center, New York, New York. · Division of Pediatric Cardiology, Columbia University Medical Center, New York, New York. · Cardiovascular Research Foundation, New York, New York. · Department of Pathology, Columbia University Medical Center, New York, New York. · Division of Cardiology, Columbia University Medical Center, New York, New York2Cardiovascular Research Foundation, New York, New York5Associate Editor, JAMA Cardiology. ·JAMA Cardiol · Pubmed #28030655.

ABSTRACT: Importance: Although much less frequent than in adults, coronary artery disease requiring revascularization may develop in children because of homozygous familial hypercholesterolemia or other underlying conditions. Percutaneous coronary intervention (PCI) with a bioresorbable scaffold (BRS) may have advantages over metallic coronary stents in this population. Objective: To present a case of the successful treatment of unstable, multivessel coronary artery disease in a child with PCI with BRS implantation. This case highlights the limitations of conventional metal stents and the potential benefits of using BRSs in children. Design, Setting, and Participants: This is a case report from an academic tertiary care institution of a 3-year-old boy with homozygous familial hypercholesterolemia and unstable coronary artery disease requiring revascularization. We also briefly review the related literature. Interventions/Exposures: Intravascular imaging-guided PCI of the proximal right coronary artery and the left main and proximal left circumflex arteries was performed with BRSs. Main Outcomes and Measures: The primary outcomes were acute procedural success and survival to liver transplant (3 months after PCI). Results: Following BRS implantation, the patient recovered and remained free of cardiovascular symptoms 3 months after PCI. He subsequently underwent an orthotopic liver transplant for definitive treatment of homozygous familial hypercholesterolemia but died of noncardiac complications. A postmortem examination, including a histological assessment, revealed both BRSs to be patent with nonobstructive neointimal hyperplasia. Conclusions and Relevance: To our knowledge, this is the first report of PCI with BRSs in a child. This represents an application of a BRS with potentially important implications for the future treatment of coronary artery disease in children and warrants further study.

22 Article Utility of near-infrared spectroscopy for detection of thin-cap neoatherosclerosis. 2017

Roleder, Tomasz / Karimi Galougahi, Keyvan / Chin, Chee Yang / Bhatti, Navdeep K / Brilakis, Emmanouil / Nazif, Tamim M / Kirtane, Ajay J / Karmpaliotis, Dimitri / Wojakowski, Wojciech / Leon, Martin B / Mintz, Gary S / Maehara, Akiko / Stone, Gregg W / Ali, Ziad A. ·Center for Interventional Vascular Therapy, Division of Cardiology, New York Presbyterian Hospital and Columbia University, New York, NY, USA. · Cardiovascular Research Foundation, New York, NY, USA. · Third Division of Cardiology, Medical University of Silesia, Katowice, Poland. · Dallas VA Medical Center, Dallas, TX, USA. ·Eur Heart J Cardiovasc Imaging · Pubmed #27679596.

ABSTRACT: Aims: Near-infrared spectroscopy (NIRS) has been employed to assess the composition of the atherosclerotic plaques in native coronary arteries. However, little is known about the detection of neoatherosclerosis by NIRS in in-stent restenosis (ISR). The aim of the study was to assess the relationship between the distribution of lipid determined by NIRS and morphology of ISR on optical coherence tomography (OCT). Methods and results: We performed both NIRS and OCT in 39 drug-eluting stents with ISR. Values of lipid-core burden index (LCBI) derived by NIRS were compared with the OCT-derived thickness of the fibrous cap covering neoatherosclerotic lesions. A total of 22 (49%) in-stent neointimas were identified as lipid rich by both NIRS and OCT. There was good agreement between OCT and NIRS in identifying lipid within in-stent neointima (kappa = 0.60, 95% CI: 0.34-0.86). OCT identified thin-cap neoatheromas (TCNA) (<65 µm) in 12 stents (23%). The minimal cap thickness of in-stent neoatherosclerotic plaque measured by OCT correlated with the maxLCBI4mm (maximal LCBI per 4 mm) within the stent (r = -0.77, P< 0.01). Moreover, maxLCBI4mm was able to accurately predict TCNA with a cut-off value of >144. Conclusion: NIRS correlates with OCT identification of lipids in stented vessels and is able to predict the presence of thin fibrous cap neoatheroma.

23 Article Anatomical and functional assessment of Tryton bifurcation stent before and after final kissing balloon dilatation: Evaluations by three-dimensional coronary angiography, optical coherence tomography imaging and fractional flow reserve. 2017

Pyxaras, Stylianos A / Toth, Gabor G / Di Gioia, Giuseppe / Ughi, Giovanni J / Tu, Shengxian / Rusinaru, Dan / Adriaenssens, Tom / Reiber, Johan H C / Leon, Martin B / Bax, Jeroen J / Wijns, William. ·Cardiovascular Research Center Aalst, OLV Clinic, Aalst, Belgium. · II. Medizinische Klinik, Klinikum Coburg, Coburg, Germany. · Department of Cardiology, University Heart Centre, Graz, Austria. · Department of Cardiovascular Medicine, University Hospitals Leuven, KU Leuven, Leuven, Belgium. · School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China. · Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. · Center for Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York, New York. · Department of Cardiology, Heart & Lung Centrum, Leiden University Medical Center, Leiden, The Netherlands. · The Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway and Saolta University Healthcare Group, Galway, Ireland. ·Catheter Cardiovasc Interv · Pubmed #27567002.

ABSTRACT: OBJECTIVES: To assess the anatomical and functional impact of final kissing balloon inflation (FKBI) after implantation of a dedicated bifurcation stent system. BACKGROUND: Current evidence suggests clinical benefit of FKBI in patients undergoing bifurcation dilatation using the Tryton side branch stent (Tryton-SBS). We hypothesized that FKBI improves anatomical reconstruction and functional results of bifurcation treated by Tryton-SBS. METHODS: An unselected group of patients with complex bifurcation coronary lesions undergoing percutaneous coronary intervention (PCI) with Tryton-SBS underwent paired anatomical assessment with two- and three-dimensional quantitative coronary analysis (2D- and 3D-QCA), and optical coherence tomography (OCT), including 3D reconstruction before and after FKBI. Functional assessment by fractional flow reserve (FFR) was performed in the main branch (MB) and side branch (SB) before and after FKBI. RESULTS: Paired pre- and post-FKBI data were obtained in 10 patients. By OCT imaging, FKBI increased both the SB ostial area (4.93 ± 2.81 vs. 7.43 ± 2.87 mm CONCLUSIONS: In patients with complex bifurcation stenosis undergoing PCI with a dedicated bifurcation system, FKBI is associated with improved anatomical and functional results at the SB level, without compromising the result at the MB. © 2016 Wiley Periodicals, Inc.

24 Article Segmental comparison between a dedicated bifurcation stent and balloon angioplasty using intravascular ultrasound and three-dimensional quantitative coronary angiography: A subgroup analysis of the Tryton IDE randomized trial. 2017

Grundeken, Maik J / Garcia-Garcia, Hector M / Kumsars, Indulis / Lesiak, Maciej / Kayaert, Peter / Dens, Jo / Stella, Pieter R / de Winter, Robbert J / Laak, Linda L / Généreux, Philippe / Kaplan, Aaron V / Leon, Martin B / Wykrzykowska, Joanna J / Onuma, Yoshinobu / Serruys, Patrick W. ·The Heartcenter, Academic Medical Center - University of Amsterdam, Amsterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Cardialysis B.V, Rotterdam, Rotterdam, The Netherlands. · Paul Stradins Clinical University Hospital, Riga, Latvia. · Karol Marcinkowski University of Medical Sciences, Poznan, Poland. · Universitair Ziekenhuis Leuven, Leuven, Belgium. · Department of Cardiology, ZOL Ziekenhuis Oost-Limburg, Genk, Belgium. · University Medical Center Utrecht, Utrecht, The Netherlands. · Tryton Medical, Newton, Massachusetts. · Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. · Columbia University Medical Center/NewYork Presbyterian Hospital, New York, New York. · Dartmouth Medical School/Dartmouth-Hitchcock Medical Center, NH, Lebanon. · Cardiovascular Research Foundation, New York, New York. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #27083384.

ABSTRACT: OBJECTIVE: Randomized comparison between the Tryton Side Branch Stent (Tryton Medical, Durham, NC), used in combination with a main branch drug-eluting stent (DES), and side branch balloon angioplasty (SBBA, in combination with a main branch DES) using intravascular ultrasound (IVUS), and three-dimensional quantitative coronary angiography (3D-QCA). BACKGROUND: The Tryton stent has been developed to improve clinical outcomes after percutaneous coronary intervention (PCI) of bifurcation lesions. METHODS: We present the pre-specified IVUS (n = 159) and 3D-QCA (n = 190) sub-group analyses of the Tryton coronary bifurcation trial (randomizing Tryton vs. SBBA). RESULTS: There were no differences in the main branch with regard to minimal lumen area (MLA) (5.33 ± 1.37 in Tryton vs. 5.69 ± 1.72 mm CONCLUSIONS: There were no differences in 9-month luminal dimensions of the side branch between the Tryton Stent and Side Branch Balloon Angioplasty, as assessed with IVUS (MLA) and 3D QCA (MLD). Angiographic and ultrasound results of the main branch were not negatively influenced by the Tryton stent. © 2016 Wiley Periodicals, Inc.

25 Article Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry. 2016

Capodanno, Davide / Gargiulo, Giuseppe / Buccheri, Sergio / Chieffo, Alaide / Meliga, Emanuele / Latib, Azeem / Park, Seung-Jung / Onuma, Yoshinobu / Capranzano, Piera / Valgimigli, Marco / Narbute, Inga / Makkar, Raj R / Palacios, Igor F / Kim, Young-Hak / Buszman, Pawel E / Chakravarty, Tarun / Sheiban, Imad / Mehran, Roxana / Naber, Christoph / Margey, Ronan / Agnihotri, Arvind / Marra, Sebastiano / Leon, Martin B / Moses, Jeffrey W / Fajadet, Jean / Lefèvre, Thierry / Morice, Marie-Claude / Erglis, Andrejs / Alfieri, Ottavio / Serruys, Patrick W / Colombo, Antonio / Tamburino, Corrado / Anonymous4790888. ·Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: dcapodanno@gmail.com. · Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. · Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy. · Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy. · Interventional Cardiology Unit, A. O. Ordine Mauriziano Umberto I, Turin, Italy. · Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. · Bern University Hospital, Bern, Switzerland. · Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, and Institute of Cardiology, University of Latvia, Riga, Latvia. · Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. · Cardiac Catheterization Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. · Center for Cardiovascular Research and Development of American Heart of Poland, Katowice, Poland. · Interventional Cardiology, Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy. · Mount-Sinai Medical Center, New York, New York. · Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany. · Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York. · Clinique Pasteur, Toulouse, France. · Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France. ·JACC Cardiovasc Interv · Pubmed #27884354.

ABSTRACT: OBJECTIVES: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease. BACKGROUND: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance. METHODS: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers. RESULTS: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10). CONCLUSIONS: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.

Next