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Coronary Artery Disease: HELP
Articles by Martin B. Leon
Based on 86 articles published since 2010
(Why 86 articles?)
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Between 2010 and 2020, Martin Leon wrote the following 86 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 Transcatheter Aortic Valve Replacement 2016: A Modern-Day "Through the Looking-Glass" Adventure. 2016

Vahl, Torsten P / Kodali, Susheel K / Leon, Martin B. ·Columbia University Medical Center, New York Presbyterian Hospital, and Cardiovascular Research Foundation, New York, New York. Electronic address: tv2193@columbia.edu. · Columbia University Medical Center, New York Presbyterian Hospital, and Cardiovascular Research Foundation, New York, New York. ·J Am Coll Cardiol · Pubmed #27012409.

ABSTRACT: Transcatheter aortic valve replacement (TAVR) has become a safe and effective therapy for patients with severe aortic stenosis (AS). In recent trials, the hemodynamic performance and clinical outcomes of the latest generation of TAVR devices demonstrated at least parity with surgical outcomes in patients of similar risk. Many initial obstacles with TAVR have largely been overcome, including frequent access site complications and concerns about strokes and paravalvular leaks. Using a multidisciplinary heart team approach, patient selection, procedural planning, and device implantation have been refined and optimized such that clinical outcomes are generally predictable and reproducible. Future research will focus on the durability of TAVR devices, further enhancements in clinical outcomes, and adjunctive therapies. On the basis of initial results from ongoing clinical trials, the indication for TAVR will likely expand to lower-risk patients. This review provides an overview of recent progress in this field, and highlights future opportunities and directions.

3 Review An update on the clinical use of drug-coated balloons in percutaneous coronary interventions. 2016

Cheng, Yanping / Leon, Martin B / Granada, Juan F. ·a CRF-Skirball Center for Innovation , Orangeburg , NY , USA. · b Center for Interventional Vascular Therapy , Columbia University Medical Center , New York , NY , USA. ·Expert Opin Drug Deliv · Pubmed #26924794.

ABSTRACT: INTRODUCTION: Drug-coated balloons (DCB) promise to deliver anti-proliferative drugs and prevent restenosis leaving nothing behind. Although, randomized clinical trials have demonstrated their efficacy for the treatment of in-stent restenosis, clinical evidence supporting their use in other coronary applications is still lacking. AREAS COVERED: This review summarizes the development status of clinically available DCB technologies and provides an update on the current data for their coronary use. EXPERT OPINION: Current generation DCB prevent restenosis by delivering paclitaxel particles on the surface of the vessel wall. Although clinically available technologies share a common mechanism of action, important differences in pharmacokinetic behavior and safety profiles do exist. Future technological improvements include the development of coatings displaying: high transfer efficiency; low particle embolization potential; and alternative drug formulations. Optimized balloon-based delivery systems and drug encapsulation technologies also promise to improve the technical limitations of current generation DCB. Although proving clinical superiority against DES may prove to be difficult in mainstream applications (i.e., de novo), new generation DCB technologies have the potential to achieve a strong position in the interventional field in clinical settings in which the efficacy of DES use is not proven or justified (i.e., bifurcations).

4 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.

5 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.

6 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.

7 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.

8 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.

9 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.

10 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.

11 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.

12 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.

13 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 / Anonymous3000691. ·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).

14 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.

15 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.

16 Article The obesity paradox revisited: body mass index and -long-term outcomes after PCI from a large pooled patient-level database. 2020

Wolny, Rafal / Maehara, Akiko / Liu, Yangbo / Zhang, Zixuan / Mintz, Gary S / Redfors, Björn / Madhavan, Mahesh V / Smits, Pieter C / von Birgelen, Clemens / Serruys, Patrick W / Mehran, Roxana / Leon, Martin B / Stone, Gregg W. ·Institute of Cardiology, Warsaw, Poland. ·EuroIntervention · Pubmed #31659983.

ABSTRACT: AIMS: The aim of this study was to evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularisation. METHODS AND RESULTS: In 13 randomised trials, 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5 ≤BMI <25, used as reference), overweight (25 ≤BMI <30), and obese (Class I [30 ≤BMI <35], Class II [35 ≤BMI <40], or Class III [BMI ≥40]). The primary endpoint was all-cause death at five years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularisation (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality versus normal weight (HR 0.83, 95% CI: 0.71-0.96, and HR 0.83, 95% CI: 0.69-0.96, respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77, 95% CI: 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62, 95% CI: 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95% CI: 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis. CONCLUSIONS: Moderately increased BMI is associated with improved survival post PCI, mostly due to lower non-cardiac but not cardiac mortality.

17 Article Improvement in left ventricular function following higher-risk percutaneous coronary intervention in patients with ischemic cardiomyopathy. 2019

Russo, Juan J / Prasad, Megha / Doshi, Darshan / Karmpaliotis, Dimitrios / Parikh, Manish A / Ali, Ziad A / Popma, Jeffrey J / Pershad, Ashish / Ohman, E Magnus / Douglas, Pamela S / O'Neill, William W / Leon, Martin B / Moses, Jeffrey W / Kirtane, Ajay J. ·Columbia University Medical Center, New York, New York. · University of Ottawa Heart Institute, Ottawa, Ontario. · Massachusetts General Hospital, Boston, Massachusetts. · Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Banner - University Medical Center Phoenix, Phoenix, Arizona. · Duke University Medical Center, Durham, North Carolina. · Henry Ford Hospital, Detroit, Michigan. ·Catheter Cardiovasc Interv · Pubmed #31693292.

ABSTRACT: BACKGROUND: Surgical revascularization is associated with improved ventricular function and clinical outcomes among patients with ischemic cardiomyopathy. There are less extensive data on changes in ventricular function among patients with ischemic cardiomyopathy undergoing percutaneous coronary intervention (PCI). Accordingly, we sought to assess the extent and predictors of change in left ventricular ejection fraction (ΔLVEF) among patients undergoing hemodynamically-supported PCI. METHODS: We assessed ΔLVEF following hemodynamically-supported PCI (with Impella or intra-aortic balloon counterpulsation) among patients enrolled in the PROTECT II trial and cVAD registry. The ΔLVEF was compared among patients with paired echocardiography at baseline and at least 30 days of follow-up. Independent correlates of ΔLVEF (modeled continuously and with an absolute ΔLVEF≥5%) were assessed using multivariable models. RESULTS: Among the 689 patients with paired echocardiographic data included in the analysis, the mean LVEF improved from 24.8 ± 9.9% to 31.4 ± 13.3% after PCI, for a net increase of 6.5 ± 10.8% (p < .001). A total of 395 (57%) patients had ΔLVEF ≥ 5% following hemodynamically-supported PCI. The number of vessels treated was associated with ΔLVEF (ΔLVEF 5.5% with 1 vessel, 6.6% with 2 vessels, and 8.3% with 3 vessels, p for trend = .046). A lower baseline LVEF, absence of a history of congestive heart failure or aldosterone receptor antagonist use, and a greater number of vessels treated were independent correlates of LVEF improvement. CONCLUSIONS: Among patients with severe left ventricular systolic dysfunction and paired echocardiographic assessments, an improvement in LVEF was observed following hemodynamically-supported PCI.

18 Article The Smoker's Paradox Revisited: A Patient-Level Pooled Analysis of 18 Randomized Controlled Trials. 2019

Yadav, Mayank / Mintz, Gary S / Généreux, Philippe / Liu, Mengdan / McAndrew, Thomas / Redfors, Björn / Madhavan, Mahesh V / Leon, Martin B / Stone, Gregg W. ·Department of Medicine, Division of Cardiology, Bronx Lebanon Hospital Center, New York, New York. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Canada. · Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu. ·JACC Cardiovasc Interv · Pubmed #31521646.

ABSTRACT: OBJECTIVES: This study examined the smoker's paradox using patient-level data from 18 prospective, randomized trials of patients undergoing percutaneous coronary intervention (PCI) with stent implantation. BACKGROUND: Studies on the effects of smoking and outcomes among patients undergoing PCI have reported conflicting results. METHODS: Data from the RAVEL, E-SIRIUS, SIRIUS, C-SIRIUS, TAXUS IV and V, ENDEAVOR II to IV, SPIRIT II to IV, HORIZONS-AMI, COMPARE I and II, PLATINUM, and TWENTE I and II randomized trials were pooled. Patients were stratified by smoking status at time of enrollment. The 1- and 5-year ischemic outcomes were compared. RESULTS: Among 24,354 patients with available data on smoking status, 6,722 (27.6%) were current smokers. Smokers were younger and less likely to have diabetes mellitus; hypertension; hyperlipidemia; or prior myocardial infarction (MI), PCI, or coronary artery bypass grafting. Angiographically, smokers had longer lesions, more complex lesions, and more occlusions, but were less likely to have moderate or severe calcification or tortuosity. At 5 years, smokers had significantly higher rates of MI (7.8% vs. 5.6%; p < 0.0001) and definite or probable stent thrombosis (3.5% vs. 1.8%; p < 0.0001); however, there were no differences in the rates of death, cardiac death, target lesion revascularization, or composite endpoints (cardiac death, target vessel MI, or ischemic target lesion revascularization). After multivariable adjustment for potential confounders, smoking was a strong independent predictor of death (hazard ratio [HR]: 1.86; 95% confidence interval [CI]: 1.63 to 2.12; p < 0.0001), cardiac death (HR: 1.68; 95% CI: 1.38 to 2.05; p < 0.0001), MI (HR: 1.38; 95% CI: 1.20 to 1.58; p < 0.0001), stent thrombosis (HR: 1.60; 95% CI: 1.28 to 1.99; p < 0.0001), and target lesion failure (HR: 1.17; 95% CI: 1.05 to 1.30; p = 0.005). CONCLUSIONS: The present large, patient-level, pooled analysis with 5-year follow-up clearly demonstrates smoking to be an important predictor of adverse outcomes after PCI.

19 Article Accuracy of Fractional Flow Reserve Derived From Coronary Angiography. 2019

Fearon, William F / Achenbach, Stephan / Engstrom, Thomas / Assali, Abid / Shlofmitz, Richard / Jeremias, Allen / Fournier, Stephane / Kirtane, Ajay J / Kornowski, Ran / Greenberg, Gabriel / Jubeh, Rami / Kolansky, Daniel M / McAndrew, Thomas / Dressler, Ovidiu / Maehara, Akiko / Matsumura, Mitsuaki / Leon, Martin B / De Bruyne, Bernard / Anonymous821142. ·Division of Cardiovascular Medicine and Stanford Cardiovascular Institute, Stanford University School of Medicine, CA (W.F.F.). · Department of Cardiology, Friedrich-Alexander University Erlangen-Nürnberg, Germany (S.A.). · The Heart Center, Rigs Hospital, University of Copenhagen, Denmark (T.E.). · Department of Cardiology, Rabin Medical Center, Petach Tikva, Israel (A.A., R.K.). · Department of Cardiology, St. Francis Hospital, Roslyn, NY (R.S., A.J.). · Department of Cardiology, Cardiovascular Center Aalst OLV Hospital, Belgium (S.F., B.D.B.). · Columbia University Medical Center (A.J.K., A.M., M.B.L.), New York, NY. · Cardiovascular Research Foundation (A.J.K., A.M., M.B.L., T.M., O.D., M.M.), New York, NY. · Department of Cardiology, HaSharon Medical Center, Petach Tikva, Israel (G.G.). · Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel (R.J.). · Division of Cardiovascular Medicine, University of Pennsylvania School of Medicine, Philadelphia (D.M.K.). ·Circulation · Pubmed #30586699.

ABSTRACT: BACKGROUND: Measuring fractional flow reserve (FFR) with a pressure wire remains underutilized because of the invasiveness of guide wire placement or the need for a hyperemic stimulus. FFR derived from routine coronary angiography (FFR METHODS: Coronary angiography was performed in a routine fashion in patients with suspected coronary artery disease. FFR was measured in vessels with coronary lesions of varying severity using a coronary pressure wire and hyperemic stimulus. Based on angiograms of the respective arteries acquired in ≥2 different projections, on-site operators blinded to FFR then calculated FFR RESULTS: Ten centers in the United States, Europe, and Israel enrolled a total of 301 subjects and 319 vessels meeting inclusion/exclusion criteria which were included in the final analysis. The mean FFR was 0.81 and 43% of vessels had an FFR≤0.80. The per-vessel sensitivity and specificity were 94% (95% CI, 88% to 97%) and 91% (86% to 95%), respectively, both of which exceeded the prespecified performance goals. The diagnostic accuracy of FFR CONCLUSIONS: FFR CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique Identifier: NCT03226262.

20 Article Outcomes Among Diabetic Patients Undergoing Percutaneous Coronary Intervention With Contemporary Drug-Eluting Stents: Analysis From the BIONICS Randomized Trial. 2018

Konigstein, Maayan / Ben-Yehuda, Ori / Smits, Pieter C / Love, Michael P / Banai, Shmuel / Perlman, Gidon Y / Golomb, Mordechai / Ozan, Melek Ozgu / Liu, Mengdan / Leon, Martin B / Stone, Gregg W / Kandzari, David E. ·Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Division of Cardiology, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · Maasstad Ziekenhuis, Rotterdam, the Netherlands. · University of Manitoba, St. Boniface General Hospital, Winnipeg, Manitoba, Canada. · Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel. · Hadassah Hebrew University Medical Center, Jerusalem, Israel; Medinol Ltd., Tel Aviv, Israel. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · Piedmont Heart Institute, Atlanta, Georgia. Electronic address: david.kandzari@piedmont.org. ·JACC Cardiovasc Interv · Pubmed #30573057.

ABSTRACT: OBJECTIVES: The authors sought to investigate the impact of diabetes mellitus (DM) on outcomes following contemporary drug-eluting stent (DES) implantation in the BIONICS (BioNIR Ridaforolimus Eluting Coronary Stent System in Coronary Stenosis) trial. BACKGROUND: Patients with DM are at increased risk for adverse events following percutaneous coronary intervention (PCI). METHODS: A prospective, multicenter, 1:1 randomized trial was conducted to evaluate in a noninferiority design the safety and efficacy of ridaforolimus-eluting stents versus zotarolimus-eluting stents among 1,919 patients undergoing PCI. Randomization was stratified to the presence of medically treated DM, and a pre-specified analysis compared outcomes according to the presence or absence of DM up to 2 years. RESULTS: The overall prevalence of DM was 29.1% (559 of 1,919). DM patients had higher body mass index, greater prevalence of hyperlipidemia and hypertension, and smaller reference vessel diameter. One-year target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) was significantly higher among diabetic patients (7.8% vs. 4.2%; p = 0.002), mainly due to higher target lesion revascularization (4.5% vs. 2.0%; p = 0.002). Rates of cardiac death, myocardial infarction, and stent thrombosis did not statistically vary. Among 158 patients undergoing 13-month angiographic follow-up, restenosis rates were 3 times higher in diabetic patients compared with nondiabetic patients (15.2% vs. 4.7%; p = 0.01). Clinical and angiographic outcomes were similar between ridaforolimus-eluting stent- and zotarolimus-eluting stent-treated patients. CONCLUSIONS: Despite advances in interventional therapies, and the implementation of new-generation DES, diabetic patients still have worse angiographic and clinical outcomes compared with nondiabetic patients undergoing PCI.

21 Article Left Main Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Prior Cerebrovascular Disease: Results From the EXCEL Trial. 2018

Diamond, Jamie / Madhavan, Mahesh V / Sabik, Joseph F / Serruys, Patrick W / Kappetein, Arie Pieter / Leon, Martin B / Taggart, David P / Berland, Jacques / Morice, Marie-Claude / Gersh, Bernard J / Kandzari, David E / Dressler, Ovidiu / Stone, Gregg W. ·NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio. · Imperial College of Science, Technology and Medicine, London, United Kingdom. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · John Radcliffe Hospital, Oxford, United Kingdom. · Clinique Saint Hilaire, Rouen, France. · Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Massy, France. · Mayo Clinic College of Medicine, Rochester, Minnesota. · Piedmont Heart Institute, Atlanta, Georgia. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. ·JACC Cardiovasc Interv · Pubmed #30573053.

ABSTRACT: OBJECTIVES: The aim of this study was to determine whether high-risk patients with left main coronary artery disease (LMCAD) and prior cerebrovascular disease (CEVD) preferentially benefit from revascularization by percutaneous coronary intervention (PCI) compared with coronary artery bypass grafting (CABG). BACKGROUND: Patients with known CEVD requiring revascularization are often referred to PCI rather than CABG. There is a paucity of data regarding the impact of CEVD in patients with LMCAD undergoing revascularization. METHODS: In the EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial, patients with LMCAD and low or intermediate SYNTAX (Synergy Between PCI with Taxus and Cardiac Surgery) scores were randomized to PCI with everolimus-eluting stents versus CABG. The effects of prior CEVD, defined as prior stroke, transient ischemic attack, or carotid artery disease, on 30-day and 3-year event rates were assessed. RESULTS: Prior CEVD was present in 233 of 1,898 patients (12.3%). These patients were older and had higher rates of comorbidities, including hypertension, diabetes, peripheral vascular disease, anemia, chronic kidney disease, and prior PCI, compared with those without prior CEVD. Patients with prior CEVD had higher rates of stroke at 30 days (2.2% vs. 0.8%; p = 0.05) and 3 years (6.4% vs. 2.2%; p = 0.0003) and higher 3-year rates of the primary endpoint of all-cause death, stroke, or myocardial infarction (25.0% vs. 13.6%; p < 0.0001). The relative effects of PCI versus CABG on the 30-day and 3-year rates of stroke (p CONCLUSIONS: Patients with LMCAD and prior CEVD compared with those without CEVD have higher rates of stroke and reduced event-free survival after revascularization. Data from the EXCEL trial do not a priori support a preferential role of PCI over CABG in patients with known CEVD.

22 Article Outcomes Among Patients Undergoing Distal Left Main Percutaneous Coronary Intervention. 2018

Kandzari, David E / Gershlick, Anthony H / Serruys, Patrick W / Leon, Martin B / Morice, Marie-Claude / Simonton, Charles A / Lembo, Nicholas J / Banning, Adrian P / Merkely, Béla / van Boven, Ad J / Ungi, Imre / Kappetein, Arie Pieter / Sabik, Joseph F / Généreux, Philippe / Dressler, Ovidiu / Stone, Gregg W. ·Piedmont Heart Institute, Atlanta, GA (D.E.K.). · Leicester Biomedical Research Centre, University Hospitals of Leicester, University of Leicester, United Kingdom (A.H.G.). · Imperial College of Science, Technology and Medicine, London, United Kingdom (P.W.S.). · Center for Interventional Vascular Therapy, Division of Cardiology, New York-Presbyterian Hospital/Columbia University Medical Center (M.B.L., N.J.L., G.W.S.). · Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (M.B.L., N.J.L., P.G., O.D., G.W.S.). · Ramsay Générale de Santé, Hôpital Privé Jacques Cartier, Massy, France (M.-C.M.). · Abbott Vascular, Inc, Santa Clara, CA (C.A.S.). · John Radcliffe Hospital, Oxford, United Kingdom (A.P.B.). · Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.). · Medisch Centrum Leeuwarden, The Netherlands (A.J.v.B.). · Cardiology Center, University of Szeged, Hungary (I.U.). · Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands (A.P.K.). · Department of Surgery, UH Cleveland Medical Center, OH (J.F.S.). · Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (P.G.). · Hôpital du Sacré-Coeur de Montréal, Québec, Canada (P.G.). ·Circ Cardiovasc Interv · Pubmed #30354633.

ABSTRACT: BACKGROUND: Distal left main (LM) coronary artery bifurcation disease increases percutaneous coronary intervention (PCI) procedural complexity and is associated with worse outcomes than isolated ostial/shaft disease. The optimal treatment strategy for distal LM disease is undetermined. We sought to determine whether outcomes after PCI of LM distal bifurcation lesions are influenced by treatment with a provisional 1-stent versus planned 2-stent technique, and if so, whether such differences are conditioned by the complexity of the LM bifurcation lesion. METHODS AND RESULTS: The clinical and angiographic characteristics, procedural methods and outcomes, and clinical events through 3-year follow-up were compared in patients undergoing distal LM PCI with a 1-stent provisional versus planned 2-stent technique in the EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization). Among 529 patients undergoing planned distal LM PCI, 344 (65.0%) and 185 (35.0%) were treated with intended 1-stent provisional and planned 2-stent techniques, respectively. The primary composite end point rate of death, myocardial infarction, or stroke at 3 years was significantly lower in patients treated with the provisional 1-stent versus planned 2-stent method (14.1% versus 20.7%; adjusted hazard ratio, 0.55; 95% CI, 0.35-0.88; P=0.01), driven by differences in cardiovascular death (3.3% versus 8.3%, P=0.01) and myocardial infarction (7.7% versus 12.8%, P=0.06). The 3-year rate of ischemia-driven revascularization of the LM complex was also lower in the provisional group (7.2% versus 16.3%, P=0.001). In 342 patients with distal LM bifurcation disease that did not involve both major side branch vessels, the 3-year primary end point was lower with a provisional 1-stent versus planned 2-stent technique (13.8% versus 23.3%, P=0.04), whereas no significant difference was present in 182 patients with distal LM bifurcation disease that did involve both side branch vessels (14.3% versus 19.2%, P=0.36). CONCLUSIONS: Among patients with distal LM bifurcation disease in the EXCEL trial randomized to PCI, 3-year adverse outcomes were worse with planned 2-stent treatment compared with a provisional 1-stent approach, a difference that was confined to patients without major involvement of both LM side branch vessels. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01205776.

23 Article Radial versus femoral artery access in patients undergoing PCI for left main coronary artery disease: analysis from the EXCEL trial. 2018

Chen, Shmuel / Redfors, Björn / Liu, Yangbo / Ben-Yehuda, Ori / Morice, Marie-Claude / Leon, Martin B / Kandzari, David E / Mehran, Roxana / Lembo, Nicholas J / Banning, Adrian P / Merkely, Béla / Kappetein, A Pieter / Sabik, Joseph F / Serruys, Patrick W / Stone, Gregg W. ·Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA. ·EuroIntervention · Pubmed #30111521.

ABSTRACT: AIMS: We sought to compare clinical outcomes and procedural characteristics with transradial access (TRA) versus transfemoral access (TFA) in patients who were treated with PCI for left main (LM) coronary artery disease. METHODS AND RESULTS: The EXCEL trial was a prospective, international, open-label, multicentre trial that randomised 1,905 patients with LM disease and SYNTAX scores ≤32 to PCI with everolimus-eluting stents versus coronary artery bypass grafting. The present analysis cohort consisted of 931 patients undergoing PCI with TRA or TFA, but not both. The primary endpoint was a composite of death, myocardial infarction (MI), or stroke at three years. Multivariable Cox proportional hazards regression was used to adjust for differences in baseline covariates. PCI in EXCEL was performed exclusively with TRA in 248 (26.6%) patients and with TFA in 683 (73.4%) patients. TRA patients were younger and less likely to have hypertension and chronic kidney disease. The mean number of vessels and lesions treated was higher in TFA patients, although the SYNTAX score was similar in both groups. Patients undergoing TRA and TFA had similar 30-day rates of TIMI major or minor bleeding (2.4% versus 3.8%, respectively, p=0.30). At three years, TRA and TFA patients had similar rates of the primary endpoint (15.7% versus 14.8%, adjusted HR 1.11, 95% CI: 0.73-1.69, p=0.64), as well as the individual rates of death, MI, stroke, ischaemia-driven revascularisation and stent thrombosis. CONCLUSIONS: In the EXCEL trial, PCI of LM disease with TRA was associated with comparable early and late clinical outcomes to TFA.

24 Article Left Main Revascularization With PCI or CABG in Patients With Chronic Kidney Disease: EXCEL Trial. 2018

Giustino, Gennaro / Mehran, Roxana / Serruys, Patrick W / Sabik, Joseph F / Milojevic, Milan / Simonton, Charles A / Puskas, John D / Kandzari, David E / Morice, Marie-Claude / Taggart, David P / Gershlick, Anthony H / Généreux, Philippe / Zhang, Zixuan / McAndrew, Thomas / Redfors, Björn / Ragosta, Michael / Kron, Irving L / Dressler, Ovidiu / Leon, Martin B / Pocock, Stuart J / Ben-Yehuda, Ori / Kappetein, Arie Pieter / Stone, Gregg W. ·The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/g_giustinoMD. · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/Drroxmehran. · Imperial College of Science, Technology and Medicine, London, United Kingdom. · Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio. · Erasmus University Medical Center, Rotterdam, the Netherlands. · Abbott Vascular, Santa Clara, California. · Mount Sinai Heart at Mount Sinai St. Luke's, New York, New York. · Piedmont Heart Institute, Atlanta, Georgia. · Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France. · Department Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom. · University Hospitals of Leicester, Leicester, United Kingdom. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York. · London School of Hygiene and Tropical Medicine, London, United Kingdom. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu. ·J Am Coll Cardiol · Pubmed #30092952.

ABSTRACT: BACKGROUND: The optimal revascularization strategy for patients with left main coronary artery disease (LMCAD) and chronic kidney disease (CKD) remains unclear. OBJECTIVES: This study investigated the comparative effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in patients with LMCAD and low or intermediate anatomical complexity according to baseline renal function from the multicenter randomized EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial. METHODS: CKD was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m RESULTS: CKD was present in 361 of 1,869 randomized patients (19.3%) in whom baseline estimated glomerular filtration rate was available. Patients with CKD had higher 3-year rates of the primary endpoint compared with those without CKD (20.8% vs. 13.5%; hazard ratio [HR]: 1.60; 95% confidence interval [CI]: 1.22 to 2.09; p = 0.0005). ARF within 30 days occurred more commonly in patients with compared with those without CKD (5.0% vs. 0.8%; p < 0.0001), and was strongly associated with the 3-year risk of death, stroke, or MI (50.7% vs. 14.4%; HR: 4.59; 95% CI: 2.73 to 7.73; p < 0.0001). ARF occurred less commonly after revascularization with PCI compared with CABG both in patients with CKD (2.3% vs. 7.7%; HR: 0.28; 95% CI: 0.09 to 0.87) and in those without CKD (0.3% vs. 1.3%; HR: 0.20; 95% CI: 0.04 to 0.90; p CONCLUSIONS: Patients with CKD undergoing revascularization for LMCAD in the EXCEL trial had increased rates of ARF and reduced event-free survival. ARF occurred less frequently after PCI compared with CABG. There were no significant differences between PCI and CABG in terms of death, stroke, or MI at 3 years in patients with and without CKD. (EXCEL Clinical Trial [EXCEL]; NCT01205776).

25 Article Mortality Following Nonemergent, Uncomplicated Target Lesion Revascularization After Percutaneous Coronary Intervention: An Individual Patient Data Pooled Analysis of 21 Randomized Trials and 32,524 Patients. 2018

Palmerini, Tullio / Della Riva, Diego / Biondi-Zoccai, Giuseppe / Leon, Martin B / Serruys, Patrick W / Smits, Pieter C / von Birgelen, Clemens / Ben-Yehuda, Ori / Généreux, Philippe / Bruno, Antonio G / Jenkins, Paul / Stone, Gregg W. ·Polo Cardio-Toraco-Vascolare, Policlinico S. Orsola, Bologna, Italy. · Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Department of AngioCardioNeurology, IRCCS Neuromed, Pozzilli, Italy. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. · Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands. · Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, University of Twente, Enschede, the Netherlands. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. · NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: gs2184@columbia.edu. ·JACC Cardiovasc Interv · Pubmed #29680221.

ABSTRACT: OBJECTIVES: This study sought to investigate the impact of nonemergent, uncomplicated target lesion revascularization (TLR) on the risk of long-term mortality after percutaneous coronary intervention (PCI). BACKGROUND: Restenosis requiring TLR after PCI is generally considered a benign event. METHODS: The study pooled patient-level data from 21 randomized trials. Subjects dying the same day as or the day after the TLR procedure as well as those with myocardial infarction (MI) the day before, the same day as or the day after TLR were excluded. The primary endpoint of the study was all-cause mortality. RESULTS: The dataset included 32,524 patients who were stratified according to whether repeat TLR was performed during follow-up. During a median follow-up of 37 months, 2,330 (7.2%) patients underwent a nonemergent, uncomplicated TLR procedure. After adjusting for potential confounders, TLR was an independent predictor of mortality (hazard ratio: 1.23, 95% confidence interval: 1.04 to 1.45; p = 0.02). Patients undergoing nonemergent, uncomplicated TLR had significantly higher rates of non-procedure-related MI compared with those without TVR. Among patients undergoing elective TLR, MI occurring after TLR was an independent predictor of mortality (hazard ratio: 3.82; 95% confidence interval: 2.44 to 5.99; p < 0.0001). CONCLUSIONS: Nonemergent, uncomplicated TLR after PCI is an independent predictor of long-term mortality, an association in part explained by higher rates of MI occurring after TLR. Efforts aimed at reducing TLR risk may translate into prognostic benefits including reduced rates of MI and survival.

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