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Coronary Artery Disease: HELP
Articles by Charles Michael Gibson
Based on 41 articles published since 2010
(Why 41 articles?)
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Between 2010 and 2020, C. Michael Gibson wrote the following 41 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Antithrombotic Therapy in Patients With Atrial Fibrillation Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention: A North American Perspective-2018 Update. 2018

Angiolillo, Dominick J / Goodman, Shaun G / Bhatt, Deepak L / Eikelboom, John W / Price, Matthew J / Moliterno, David J / Cannon, Christopher P / Tanguay, Jean-Francois / Granger, Christopher B / Mauri, Laura / Holmes, David R / Gibson, C Michael / Faxon, David P. ·Division of Cardiology, University of Florida College of Medicine-Jacksonville (D.J.A.). · St. Michael's Hospital, University of Toronto, and the Canadian Heart Research Centre, Canada (S.G.G.). · Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research Centre, University of Alberta, Canada (S.G.G.). · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B., C.P.C., L.M., D.P.F.). · Department of Medicine, Population Health Research Institute, Thrombosis & Atherosclerosis Research Institute, Hamilton, Canada (J.W.E.). · Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA (M.J.P.). · Division of Cardiovascular Medicine and Gill Heart Institute, University of Kentucky, Lexington (D.J.M.). · Department of Medicine, Montreal Heart Institute, Université de Montréal, Canada (J.-F.T.). · Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.). · Mayo Clinic, Rochester, MN (D.R.H.). · Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.). ·Circulation · Pubmed #30571525.

ABSTRACT: The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation represents a challenge in clinical practice. In 2016, an updated opinion of selected experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention was reported. After the 2016 North American consensus statement on the management of antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, results of pivotal clinical trials assessing the type of oral anticoagulant agent and the duration of antiplatelet treatment have been published. On the basis of these results, this focused update on the antithrombotic management of patients with atrial fibrillation undergoing percutaneous coronary intervention recommends that a non-vitamin K antagonist oral anticoagulant be preferred over a vitamin K antagonist as the oral anticoagulant of choice. Moreover, a double-therapy regimen (oral anticoagulant plus single antiplatelet therapy with a P2Y

2 Guideline Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention: A North American Perspective-2016 Update. 2016

Angiolillo, Dominick J / Goodman, Shaun G / Bhatt, Deepak L / Eikelboom, John W / Price, Matthew J / Moliterno, David J / Cannon, Christopher P / Tanguay, Jean-Francois / Granger, Christopher B / Mauri, Laura / Holmes, David R / Gibson, C Michael / Faxon, David P. ·From the Division of Cardiology, University of Florida College of Medicine-Jacksonville (D.J.A.) · St Michael's Hospital, University of Toronto, and the Canadian Heart Research Centre · Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.) · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B., D.P.F.) · Department of Medicine, Population Health Research Institute, Thrombosis & Atherosclerosis Research Institute, Hamilton, ON, Canada (J.W.E.) · Division of Cardiovascular Diseases, Scripps Clinic, La Jolla CA (M.J.P.) · Division of Cardiovascular Medicine and Gill Heart Institute, University of Kentucky, Lexington (D.J.M.) · Brigham and Women's Hospital, Harvard Clinical Research Institute, Harvard Medical School, Boston, MA (C.P.C., L.M.) · Department of Medicine, Montreal Heart Institute, Université de Montréal, QC, Canada (J.-F.T.) · Duke Clinical Research Institute, Duke University, Durham, NC (C.B.G.) · Mayo Clinic, Rochester, MN (D.R.H.) · and Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.). ·Circ Cardiovasc Interv · Pubmed #27803042.

ABSTRACT: The optimal antithrombotic treatment regimen for patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation is an emerging clinical problem. Currently, there is limited evidenced-based data on the optimal antithrombotic treatment regimen, including antiplatelet and anticoagulant therapies, for these high-risk patients with practice guidelines, thus, providing limited recommendations. Over the past years, expert consensus documents have provided guidance to clinicians on how to manage patients with atrial fibrillation undergoing percutaneous coronary intervention. Given the recent advancements in the field, the current document provides an updated opinion of selected North American experts from the United States and Canada on the treatment of patients with atrial fibrillation undergoing percutaneous coronary intervention. In particular, this document provides the current views on (1) embolic/stroke risk, (2) ischemic/thrombotic cardiac risk, and (3) bleeding risk, which are pivotal for discerning the choice of antithrombotic therapy. In addition, we describe the recent advances in pharmacology, stent designs, and clinical trials relevant to the field. Ultimately, we provide expert consensus-derived recommendations, using a pragmatic approach, on the management of patients with atrial fibrillation undergoing percutaneous coronary intervention.

3 Editorial Conundrum of Using Real-World Observational Data to Inform Real-World Conclusions About Safety and Efficacy. 2018

Gibson, C Michael / Nafee, Tarek / Kerneis, Mathieu. ·Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: mgibson@perfuse.org. · Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #30286923.

ABSTRACT: -- No abstract --

4 Editorial Bioresorbable vascular scaffolds in daily clinical practice: is the essential really invisible to the eyes? 2015

Abizaid, Alexandre / Costa, J Ribamar / Gibson, C Michael. ·Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. Electronic address: aabizaid@uol.com.br. · Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. · Harvard Medical School, Boston, Massachusetts. ·J Am Coll Cardiol · Pubmed #25720623.

ABSTRACT: -- No abstract --

5 Review Saphenous vein grafts in contemporary coronary artery bypass graft surgery. 2020

Caliskan, Etem / de Souza, Domingos Ramos / Böning, Andreas / Liakopoulos, Oliver J / Choi, Yeong-Hoon / Pepper, John / Gibson, C Michael / Perrault, Louis P / Wolf, Randall K / Kim, Ki-Bong / Emmert, Maximilian Y. ·Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. · Department of Cardiothoracic and Vascular Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden. · Department of Cardiovascular Surgery, University Hospital Giessen, Giessen, Germany. · Department of Cardiac and Thoracic Surgery, Heart Center of the University of Cologne, Cologne, Germany. · Department of Cardiothoracic Surgery, Royal Brompton Hospital, London, UK. · Boston Clinical Research Institute, Boston, MA, USA. · Department of Cardiac Surgery, Montreal Heart Institute, Université de Montréal, Montreal, Canada. · DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, TX, USA. · Department of Thoracic and Cardiovascular Surgery, Seoul National University Hospital, Seoul, South Korea. · Department of Cardiovascular Surgery, Charité-Universitätsmedizin Berlin, Berlin, Germany. emmert@dhzb.de. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Berlin, Germany. emmert@dhzb.de. ·Nat Rev Cardiol · Pubmed #31455868.

ABSTRACT: Myocardial ischaemia resulting from obstructive coronary artery disease is a major cause of morbidity and mortality in the developed world. Coronary artery bypass graft (CABG) surgery is the gold-standard treatment in many patients with complex multivessel coronary artery disease or left main disease. Despite substantial improvements in the outcome of patients undergoing CABG surgery in the past decade, graft patency remains the 'Achilles' heel' of this procedure. Whereas the use of the left internal mammary artery as a conduit is associated with the highest 10-year patency rate (>90%), saphenous vein grafts - the most commonly used conduit in CABG surgery - fail in 40-50% of treated patients by 10 years after surgery. Vein graft disease (VGD) and failure result from complex pathophysiological processes that can lead to complete occlusion of the graft, affecting long-term clinical outcomes. Optimal harvesting techniques, intraoperative preservation strategies and intraoperative patency control have important roles in the prevention of VGD. In addition, several studies published in the past decade have reported similar mid-term patency rates between vein grafts and arterial grafts when veins are used as a composite graft based on the internal mammary artery. In this Review, we present the latest evidence on the utilization of saphenous vein grafts for CABG surgery and provide an overview of the current practices for the prevention of VGD and vein graft failure.

6 Review ST-segment elevation myocardial infarction. 2019

Vogel, Birgit / Claessen, Bimmer E / Arnold, Suzanne V / Chan, Danny / Cohen, David J / Giannitsis, Evangelos / Gibson, C Michael / Goto, Shinya / Katus, Hugo A / Kerneis, Mathieu / Kimura, Takeshi / Kunadian, Vijay / Pinto, Duane S / Shiomi, Hiroki / Spertus, John A / Steg, P Gabriel / Mehran, Roxana. ·The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA. · Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, Kansas City, MO, USA. · University of Missouri-Kansas City, Kansas City, MO, USA. · Institute of Cellular Medicine, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK. · Department of Medicine III, Institute for Cardiomyopathies Heidelberg (ICH), University of Heidelberg, Heidelberg, Germany. · Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. · Department of Medicine (Cardiology), Tokai University School of Medicine, Isehara, Kanagawa, Japan. · Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan. · Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, UK. · Division of Cardiology, Richard A. and Susan F. Smith Center for Cardiovascular Outcomes Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. · FACT, French Alliance for Cardiovascular Trials, Paris, France. · Université Paris-Diderot, Paris, France. · The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Roxana.Mehran@mountsinai.org. ·Nat Rev Dis Primers · Pubmed #31171787.

ABSTRACT: ST-segment elevation myocardial infarction (STEMI) is the most acute manifestation of coronary artery disease and is associated with great morbidity and mortality. A complete thrombotic occlusion developing from an atherosclerotic plaque in an epicardial coronary vessel is the cause of STEMI in the majority of cases. Early diagnosis and immediate reperfusion are the most effective ways to limit myocardial ischaemia and infarct size and thereby reduce the risk of post-STEMI complications and heart failure. Primary percutaneous coronary intervention (PCI) has become the preferred reperfusion strategy in patients with STEMI; if PCI cannot be performed within 120 minutes of STEMI diagnosis, fibrinolysis therapy should be administered to dissolve the occluding thrombus. The initiation of networks to provide around-the-clock cardiac catheterization availability and the generation of standard operating procedures within hospital systems have helped to reduce the time to reperfusion therapy. Together with new advances in antithrombotic therapy and preventive measures, these developments have resulted in a decrease in mortality from STEMI. However, a substantial amount of patients still experience recurrent cardiovascular events after STEMI. New insights have been gained regarding the pathophysiology of STEMI and feed into the development of new treatment strategies.

7 Review Most Promising Therapies in Interventional Cardiology. 2019

Kerneis, Mathieu / Nafee, Tarek / Yee, Megan K / Kazmi, Hassan A / Datta, Sudarshana / Zeitouni, Michel / Afzal, M Khurram / Jafarizade, Mehrian / Walia, Sargun S / Qamar, Iqra / Pitliya, Anmol / Kalayci, Arzu / Al Khalfan, Fahad / Gibson, C Michael. ·PERFUSE Study Group, Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Ave, Boston, MA, 02215, USA. · ACTION Study Group, INSERM UMR_S 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Sorbonne Université - Univ Paris 06 (UPMC), Paris, France. · PERFUSE Study Group, Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, 930 Commonwealth Ave, Boston, MA, 02215, USA. mgibson@bidmc.harvard.edu. ·Curr Cardiol Rep · Pubmed #30868280.

ABSTRACT: PURPOSE OF REVIEW: The last 40 years of clinical research in interventional cardiology were extraordinarily innovative. This article will review the most promising up and coming interventional cardiovascular therapies, with a primary focus on the treatment of coronary artery disease. RECENT FINDINGS: From the first stent, to the first transcatheter aortic valve implantation (TAVI), and the left appendage closure technique, percutaneous interventions revolutionized the treatment of multiple diseases and dramatically improved the prognosis of many patients. While these advances have decreased the risk of mortality in some patients (such as ST-elevation myocardial infarction), 15% of acute coronary syndrome (ACS) patients still experience recurrent ischemic events within the first year, challenging us to develop new pharmaceutical targets and new devices. The continued emergence of data supporting inflammation as a risk factor and pharmacologic target as well as data supporting the importance of cholesterol efflux have identified novel therapeutic targets that may play a major role in the improvement of prognosis of patients with coronary artery disease. In addition, novel medical devices are being developed to allow even earlier detection of acute cardiac events and to support high-risk percutaneous coronary interventions. Advances in computing and the ability to analyze large datasets will allow us to use artificial intelligence to augment the clinician patient experience, both in and out of the catheterization laboratory, with live procedural guidance as well as pre- and post-operative prognostication tools.

8 Review The SYNTAX score: usefulness, limitations, and future directions. 2011

Chakrabarti, Anjan K / Gibson, C Michael. ·Division of Cardiology, Beth Israel Deaconess Medical Center, 185 Pilgrim Road, Boston, MA 02215 USA. akchakra@bidmc.harvard.edu ·J Invasive Cardiol · Pubmed #22147398.

ABSTRACT: -- No abstract --

9 Clinical Trial Assessment of the clinical effects of cholesteryl ester transfer protein inhibition with evacetrapib in patients at high-risk for vascular outcomes: Rationale and design of the ACCELERATE trial. 2015

Nicholls, Stephen J / Lincoff, A Michael / Barter, Philip J / Brewer, H Bryan / Fox, Keith A A / Gibson, C Michael / Grainger, Christopher / Menon, Venugopal / Montalescot, Gilles / Rader, Daniel / Tall, Alan R / McErlean, Ellen / Riesmeyer, Jeffrey / Vangerow, Burkhard / Ruotolo, Giacomo / Weerakkody, Govinda J / Nissen, Steven E. ·South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, Australia. · Cleveland Clinic Coordinating Center for Clinical Research and Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH. · University of New South Wales, Sydney, Australia. · Medstar Research Institute, Hyattsville, MD. · University of Edinburgh, Edinburgh, Scotland. · Harvard Medical School, Boston, MA. · Duke Clinical Research Institute, Durham, NC. · Pitie-Salpetriere University Hospital, Paris, France. · University of Pennsylvania, Philadelphia, PA. · Columbia University, New York City, NY. · Eli Lilly and Company, Indianapolis, IN. ·Am Heart J · Pubmed #26678626.

ABSTRACT: BACKGROUND: Potent pharmacologic inhibition of cholesteryl ester transferase protein by the investigational agent evacetrapib increases high-density lipoprotein cholesterol by 54% to 129%, reduces low-density lipoprotein cholesterol by 14% to 36%, and enhances cellular cholesterol efflux capacity. The ACCELERATE trial examines whether the addition of evacetrapib to standard medical therapy reduces the risk of cardiovascular (CV) morbidity and mortality in patients with high-risk vascular disease. STUDY DESIGN: ACCELERATE is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Patients qualified for enrollment if they have experienced an acute coronary syndrome within the prior 30 to 365 days, cerebrovascular accident, or transient ischemic attack; if they have peripheral vascular disease; or they have diabetes with coronary artery disease. A total of 12,092 patients were randomized to evacetrapib 130 mg or placebo daily in addition to standard medical therapy. The primary efficacy end point is time to first event of CV death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. Treatment will continue until 1,670 patients reached the primary end point; at least 700 patients reach the key secondary efficacy end point of CV death, myocardial infarction, and stroke, and the last patient randomized has been followed up for at least 1.5 years. CONCLUSIONS: ACCELERATE will establish whether the cholesteryl ester transfer protein inhibition by evacetrapib improves CV outcomes in patients with high-risk vascular disease.

10 Clinical Trial Phase II safety and clinical comparison with single-photon emission computed tomography myocardial perfusion imaging for detection of coronary artery disease: flurpiridaz F 18 positron emission tomography. 2013

Berman, Daniel S / Maddahi, Jamshid / Tamarappoo, B K / Czernin, Johannes / Taillefer, Raymond / Udelson, James E / Gibson, C Michael / Devine, Marybeth / Lazewatsky, Joel / Bhat, Gajanan / Washburn, Dana. ·Departments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: bermand@cshs.org. · Departments of Molecular Medicine and Pharmacology, David Geffen School of Medicine at UCLA, Los Angeles, California. · Departments of Imaging and Medicine, the Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. · Hôpital Hôtel-Dieu de Montréal, Montréal, Quebec, Canada. · Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts. · Perfuse Study Group, Boston, Massachusetts. · Lantheus Medical Imaging, North Billerica, Massachusetts. ·J Am Coll Cardiol · Pubmed #23265345.

ABSTRACT: OBJECTIVES: This was a phase II trial to assess flurpiridaz F 18 for safety and compare its diagnostic performance for positron emission tomography (PET) myocardial perfusion imaging (MPI) with Tc-99m single-photon emission computed tomography (SPECT) MPI with regard to image quality, interpretative certainty, defect magnitude, and detection of coronary artery disease (CAD) (≥50% stenosis) on invasive coronary angiography (ICA). BACKGROUND: In pre-clinical and phase I studies, flurpiridaz F 18 has shown characteristics of an essentially ideal MPI tracer. METHODS: One hundred forty-three patients from 21 centers underwent rest-stress PET and Tc-99m SPECT MPI. Eighty-six patients underwent ICA, and 39 had low-likelihood of CAD. Images were scored by 3 independent, blinded readers. RESULTS: A higher percentage of images were rated as excellent/good on PET versus SPECT on stress (99.2% vs. 88.5%, p < 0.01) and rest (96.9% vs. 66.4, p < 0.01) images. Diagnostic certainty of interpretation (percentage of cases with definitely abnormal/normal interpretation) was higher for PET versus SPECT (90.8% vs. 70.9%, p < 0.01). In 86 patients who underwent ICA, sensitivity of PET was higher than SPECT (78.8% vs. 61.5%, respectively, p = 0.02). Specificity was not significantly different (PET: 76.5% vs. SPECT: 73.5%). Receiver-operating characteristic curve area was 0.82 ± 0.05 for PET and 0.70 ± 0.06 for SPECT (p = 0.04). Normalcy rate was 89.7% with PET and 97.4% with SPECT (p = NS). In patients with CAD on ICA, the magnitude of reversible defects was greater with PET than SPECT (p = 0.008). Extensive safety assessment revealed that flurpiridaz F 18 was safe in this cohort. CONCLUSIONS: In this phase 2 trial, PET MPI with flurpiridaz F 18 was safe and superior to SPECT MPI for image quality, interpretative certainty, and overall CAD diagnosis.

11 Clinical Trial Edifoligide and long-term outcomes after coronary artery bypass grafting: PRoject of Ex-vivo Vein graft ENgineering via Transfection IV (PREVENT IV) 5-year results. 2012

Lopes, Renato D / Williams, Judson B / Mehta, Rajendra H / Reyes, Eric M / Hafley, Gail E / Allen, Keith B / Mack, Michael J / Peterson, Eric D / Harrington, Robert A / Gibson, C Michael / Califf, Robert M / Kouchoukos, Nicholas T / Ferguson, T Bruce / Lorenz, Todd J / Alexander, John H. ·Duke Clinical Research Institute, Durham, NC, USA. renatolopes@duke.edu ·Am Heart J · Pubmed #22980305.

ABSTRACT: BACKGROUND: Edifoligide, an E2F transcription factor decoy, does not prevent vein graft failure or adverse clinical outcomes at 1 year in patients undergoing coronary artery bypass grafting (CABG). We compared the 5-year clinical outcomes of patients in PREVENT IV treated with edifoligide and placebo to identify predictors of long-term clinical outcomes. METHODS: A total of 3,014 patients undergoing CABG with at least 2 planned vein grafts were enrolled. Kaplan-Meier curves were generated to compare the long-term effects of edifoligide and placebo. A Cox proportional hazards model was constructed to identify factors associated with 5-year post-CABG outcomes. The main outcome measures were death, myocardial infarction (MI), repeat revascularization, and rehospitalization through 5 years. RESULTS: Five-year follow-up was complete in 2,865 patients (95.1%). At 5 years, patients randomized to edifoligide and placebo had similar rates of death (11.7% and 10.7%, respectively), MI (2.3% and 3.2%), revascularization (14.1% and 13.9%), and rehospitalization (61.6% and 62.5%). The composite outcome of death, MI, or revascularization occurred at similar frequency in patients assigned to edifoligide and placebo (26.3% and 25.5%, respectively; hazard ratio 1.03 [95% CI 0.89-1.18], P = .721). Factors associated with death, MI, or revascularization at 5 years included peripheral and/or cerebrovascular disease, time on cardiopulmonary bypass, lung disease, diabetes mellitus, and congestive heart failure. CONCLUSIONS: Up to a quarter of patients undergoing CABG will have a major cardiac event or repeat revascularization procedure within 5 years of surgery. Edifoligide does not affect outcomes after CABG; however, common identifiable baseline and procedural risk factors are associated with long-term outcomes after CABG.

12 Clinical Trial Saphenous vein grafts with multiple versus single distal targets in patients undergoing coronary artery bypass surgery: one-year graft failure and five-year outcomes from the Project of Ex-Vivo Vein Graft Engineering via Transfection (PREVENT) IV trial. 2011

Mehta, Rajendra H / Ferguson, T Bruce / Lopes, Renato D / Hafley, Gail E / Mack, Michael J / Kouchoukos, Nicholas T / Gibson, C Michael / Harrington, Robert A / Califf, Robert M / Peterson, Eric D / Alexander, John H / Anonymous5100698. ·Duke Clinical Research Institute, Box 17969, Durham, NC 27715, USA. mehta007@dcri.duke.edu ·Circulation · Pubmed #21709060.

ABSTRACT: BACKGROUND: Limited information exists on the intermediate-term graft patency and 5-year clinical outcomes of patients receiving saphenous vein grafts with multiple (m-SVG) versus single distal targets (s-SVG) during coronary artery bypass graft (CABG) surgery in the current era. METHODS AND RESULTS: We studied the association of the use of m-SVG versus s-SVG conduits with 1-year SVG failure (defined as ≥75% angiographic stenosis) and 5-year clinical events (death; death or myocardial infarction [MI]; and death, MI, or revascularization) in 3014 patients undergoing their first CABG surgery enrolled in the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV. Of 3014 patients enrolled in PREVENT IV, 1045 (34.7%) had ≥1 m-SVGs during CABG. Vein graft failure at 1-year was higher for m-SVG compared with s-SVG (adjusted odds ratio 1.24, 95% confidence interval 1.03 to 1.48). At 5 years, the adjusted composite of death, MI (including perioperative MI), or revascularization (hazard ratio 1.15, 95% confidence interval 1.00 to 1.31) and death or MI (hazard ratio 1.21, 95% confidence interval 1.03 to 1.43) were significantly higher in patients receiving m-SVGs. CONCLUSIONS: In patients undergoing first CABG surgery, the use of m-SVG was associated with a higher 1-year vein graft failure rate and trends toward worse clinical outcomes. Additional studies are needed to better understand the most appropriate conduit to improve long-term graft patency and clinical outcomes of patients undergoing CABG surgery. In the meantime, these data should encourage the use of s-SVG over m-SVG when feasible.

13 Clinical Trial Rationale and design of the randomized, double-blind trial testing INtraveNous and Oral administration of elinogrel, a selective and reversible P2Y(12)-receptor inhibitor, versus clopidogrel to eVAluate Tolerability and Efficacy in nonurgent Percutaneous Coronary Interventions patients (INNOVATE-PCI). 2010

Leonardi, Sergio / Rao, Sunil V / Harrington, Robert A / Bhatt, Deepak L / Gibson, C Michael / Roe, Matthew T / Kochman, Janusz / Huber, Kurt / Zeymer, Uwe / Madan, Mina / Gretler, Daniel D / McClure, Matthew W / Paynter, Gayle E / Thompson, Vivian / Welsh, Robert C. ·Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. sergio.leonardi@duke.edu ·Am Heart J · Pubmed #20598974.

ABSTRACT: Despite current dual-antiplatelet therapy with aspirin and clopidogrel, adverse clinical events continue to occur during and after percutaneous coronary intervention (PCI). The failure of clopidogrel to provide optimal protection may be related to delayed onset of action, interpatient variability in its effect, and an insufficient level of platelet inhibition. Furthermore, the irreversible binding of clopidogrel to the P2Y(12) receptor for the life span of the platelet is associated with increased bleeding risk especially during urgent or emergency surgery. Novel antiplatelet agents are required to improve management of patients undergoing PCI. Elinogrel is a potent, direct-acting (ie, non-prodrug), selective, competitive, and reversible P2Y(12) inhibitor available in both intravenous and oral formulations. The INNOVATE-PCI study is a phase 2 randomized, double-blind, clopidogrel-controlled trial to evaluate the safety, tolerability, and preliminary efficacy of this novel antiplatelet agent in patients undergoing nonurgent PCI.

14 Article Patients with acute and chronic coronary syndromes have elevated long-term thrombin generation. 2020

Yip, Christina / Seneviratna, Aruni / Tan, Sock-Hwee / Khaing, Thet / Chan, Siew-Pang / Loh, Joshua / Lee, Chi-Hang / Low, Adrian F / Drum, Chester L / Poh, Sock-Cheng / Gibson, C Michael / Ohman, E Magnus / Richards, A Mark / Chan, Mark Y. ·Department of Laboratory Medicine, National University Hospital (Singapore) Pte Ltd, National University Health System (NUHS), Singapore, 1E Kent Ridge Road, #13-00, Singapore, 119228, Singapore. Christina_yip@nuhs.edu.sg. · Department of Cardiology, National University Heart Centre Singapore, NUHS, Singapore, Singapore. · National Public Health and Epidemiology Unit, National Centre for Infectious Diseases Singapore, Singapore, Singapore. · Department of Medicine, National University of Singapore, Singapore, Singapore. · National University Heart Centre, NUHS, Singapore, Singapore. · Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, #13-00, Singapore, 119228, Singapore. · Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, USA. · Duke Program for Advanced Coronary Disease, Duke Clinical Research Institute, Durham, NC, USA. · Cardiovascular Research Institute, NUHS, Singapore, Singapore. · Christchurch Heart Institute, University of Otago, Otago, New Zealand. · Department of Cardiology, National University Heart Centre Singapore, NUHS, Singapore, Singapore. Mark_chan@nuhs.edu.sg. · Yong Loo Lin School of Medicine, National University of Singapore, 1E Kent Ridge Road, #13-00, Singapore, 119228, Singapore. Mark_chan@nuhs.edu.sg. ·J Thromb Thrombolysis · Pubmed #32077007.

ABSTRACT: Coronary artery disease is a leading cause of morbidity and mortality worldwide. Despite significant advances in revascularization strategies and antiplatelet therapy with aspirin and/or P2Y

15 Article Geographical Variations in Patterns of DAPT Cessation and Two-Year PCI Outcomes: Insights from the PARIS Registry. 2019

Vogel, Birgit / Chandrasekhar, Jaya / Baber, Usman / Mastoris, Ioannis / Sartori, Samantha / Aquino, Melissa / Krucoff, Mitchell W / Moliterno, David J / Henry, Timothy D / Weisz, Giora / Gibson, C Michael / Iakovou, Ioannis / Kini, Annapoorna S / Farhan, Serdar / Sorrentino, Sabato / Faggioni, Michela / Colombo, Antonio / Steg, Philippe Gabriel / Witzenbichler, Bernhard / Chieffo, Alaide / Cohen, David J / Stuckey, Thomas / Ariti, Cono / Dangas, George D / Pocock, Stuart / Mehran, Roxana. ·The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, United States. · Duke University School of Medicine, Durham, North Carolina, United States. · University of Kentucky, Lexington, Kentucky, United States. · The Carl and Edyth Lindner Center for Research and Education, The Christ Hospital, Cincinnati, Ohio, United States. · Montefiore Medical Center, New York, New York, United States. · Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States. · Onassis Cardiac Surgery Centre, Athens, Greece. · San Raffaele Scientific Institute, Milan, Italy. · Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France. · Helios Amper-Klinikum, Dachau, Germany. · St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, United States. · Moses Cone Heart and Vascular Center, LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina, United States. · London School of Hygiene and Tropical Medicine, London, United Kingdom. ·Thromb Haemost · Pubmed #31365942.

ABSTRACT: BACKGROUND:  Data on geographical variations in dual antiplatelet therapy (DAPT) cessation and the impact on outcomes after percutaneous coronary intervention (PCI) are limited. We sought to evaluate geographical patterns of DAPT cessation and associated outcomes in patients undergoing PCI in the United States versus Europe. METHODS:  Analyzing data from the PARIS registry, we studied 3,660 U.S. patients (72.9%) and 1,358 European patients (27.1%) that underwent PCI with stent implantation. DAPT cessation was classified as physician-recommended discontinuation, interruption (< 14 days), or disruption due to bleeding or noncompliance. The primary endpoint was 2-year major adverse cardiovascular events (MACE) defined as a composite of cardiac death, stent thrombosis, myocardial infarction, or target lesion revascularization. RESULTS:  Cardiovascular risk factors were more common in the United States, whereas procedural complexity was greater in Europe. The incidence of 2-year DAPT discontinuation was significantly lower in U.S. versus European patients (30.7% vs. 65.6%; CONCLUSION:  DAPT cessation patterns, along with clinical and angiographic risk, vary substantially between PCI patients in the U.S. versus Europe. Despite such differences, cardiovascular risk associated with DAPT cessation remains uniform.

16 Article Influence of Baseline Anemia on Dual Antiplatelet Therapy Cessation and Risk of Adverse Events After Percutaneous Coronary Intervention. 2019

Faggioni, Michela / Baber, Usman / Sartori, Samantha / Chandrasekhar, Jaya / Cohen, David J / Henry, Timothy D / Claessen, Bimmer E / Dangas, George D / Gibson, C Michael / Krucoff, Mitchell W / Vogel, Birgit / Moliterno, David J / Sorrentino, Sabato / Colombo, Antonio / Chieffo, Alaide / Kini, Annapoorna / Farhan, Serdar / Ariti, Cono / Witzenbichler, Bernard / Weisz, Giora / Steg, Philippe Gabriel / Pocock, Stuart / Mehran, Roxana. ·Center for Interventional Cardiovascular Research and Clinical Trials, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, NY (M.F., U.B., S. Sartori, J.C., B.E.C., G.D., B.V., S. Sorrentino, A.K., S.F., R.M.). · Department of Internal Medicine, James J. Peters Veterans Affairs Medical Center, Bronx, NY (M.F.). · Department of Internal Medicine, Section: Cardiovascular Disease, St. Luke's Mid America Heart Institute, University of Missouri-Kansas City (D.J.C.). · Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.). · Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (C.M.G.). · Department of Internal Medicine, Duke University School of Medicine, Durham, NC (M.W.K.). · Gill Heart Institute and Division of Cardiovascular Medicine, University of Kentucky, Lexington (D.J.M.). · Cardio-Thoracic Department, San Raffaele Scientific Institute, Milan, Italy (A. Colombo, A. Chieffo). · Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (C.A., S.P.). · Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany (B.W.). · Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Montefiore Medical Center, Bronx, New York (G.W.). · Département Hospitalo-Universitaire (DHU) Fibrose Inflammation Remodelage (FIRE), University Paris Diderot, Assistance Publique - Hôpitaux de Paris (AP-HP), INSERM U-1148, France (P.G.S.). ·Circ Cardiovasc Interv · Pubmed #30998384.

ABSTRACT: BACKGROUND: Anemia is a well-recognized risk factor for both bleeding and ischemic events after percutaneous coronary intervention (PCI). We sought to determine the impact of baseline anemia on dual antiplatelet therapy (DAPT) cessation patterns ≤2 years after PCI and the subsequent risk of clinical adverse events. METHODS AND RESULTS: PARIS (Patterns of Non-Adherence to Dual Anti-Platelet Regimen in Stented Patients) was a prospective multicenter observational registry of PCI-treated patients (n=5018). Anemia was defined as baseline Hb (hemoglobin) <12 g/dL for men and <11 g/dL for women. DAPT cessation modes included physician-recommended discontinuation, temporary interruption (≤14 days), and disruption due to bleeding or noncompliance. The primary end point was 2-year major adverse cardiovascular events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization. We identified 824 (18%) anemic and 4194 (82%) nonanemic patients. Anemic patients were older and had a higher rate of diabetes mellitus, hypertension, and prior PCI. DAPT interruption and disruption were significantly more common in anemic patients throughout 2 years after PCI, whereas physician-recommended discontinuation occurred more often in anemic patients during the first year after PCI and in nonanemic patients during the second year. The 2-year adjusted risks of MACE and Bleeding Academic Research Consortium 3 or 5 bleeding events were significantly higher in anemic patients. Compared with uninterrupted DAPT, disruption, but not interruption and physician-recommended discontinuation, was associated with a higher risk of myocardial infarction in nonanemic patients and a higher risk of both myocardial infarction and MACE in anemic patients. There was no significant interaction between anemia and risk of clinical outcomes associated with each DAPT cessation mode. CONCLUSIONS: Baseline anemia was associated with a significantly higher adjusted risk of MACE and major bleeding. Physicians more frequently recommend DAPT discontinuation to anemic patients during the first year, and to nonanemic patients during the second year after PCI. DAPT disruption was associated with a higher risk of MACE outcomes.

17 Article Association of International Normalized Ratio Stability and Bleeding Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention. 2019

Kerneis, Mathieu / Yee, Megan K / Mehran, Roxana / Nafee, Tarek / Bode, Christoph / Halperin, Jonathan L / Peterson, Eric D / Verheugt, Freek W A / Wildgoose, Peter / van Eickels, Martin / Lip, Gregory Y H / Cohen, Marc / Fox, Keith A A / Gibson, C Michael. ·Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (M.K., M.K.Y., T.N., C.M.G.). · Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, NY (R.M., J.L.H.). · Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Germany (C.B.). · Duke Clinical Research Institute, Durham, NC (E.D.P.). · Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands (F.W.A.V.). · Janssen Pharmaceuticals, Inc, Beerse, Belgium, Inc, Titusville, NJ (P.W.). · Bayer Pharmaceuticals, Inc, Berlin, Germany (M.v.E.). · Institute of Cardiovascular Sciences, University of Birmingham, United Kingdom (G.Y.H.L.). · Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Denmark (G.Y.H.L.). · Division of Cardiology, Newark Beth Israel Medical Center, NJ (M.C.). · Centre for Cardiovascular Science, University of Edinburgh and Royal Infirmary of Edinburgh, United Kingdom (K.A.A.F.). ·Circ Cardiovasc Interv · Pubmed #30704287.

ABSTRACT: BACKGROUND: Among atrial fibrillation patients undergoing percutaneous coronary intervention enrolled in PIONEER AF-PCI (An Open-Label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention), it is unclear if the observed reduction in bleeding events with rivaroxaban regimens is consistent across a range of the international normalized ratio (INR) among subjects administrated Vitamin K antagonist (VKA)-triple therapy. This analysis compares the occurrence of clinically significant bleeding between rivaroxaban and VKA strategies, according to INR stability of subjects administrated VKA. METHODS AND RESULTS: A total of 2124 atrial fibrillation patients undergoing percutaneous coronary intervention were randomized to 3 groups: rivaroxaban 15 mg od plus a P2Y CONCLUSIONS: Among atrial fibrillation patients undergoing percutaneous coronary intervention, rivaroxaban-based therapy was superior to warfarin plus dual antiplatelet therapy in lowering bleeding outcomes regardless of the INR stability. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01830543.

18 Article Comparison of Outcomes and Frequency of Graft Failure With Use of Free Versus In Situ Internal Mammary Artery Bypass Conduits (from the PREVENT IV Trial). 2019

Ranney, David N / Williams, Judson B / Mulder, Hillary / Wojdyla, Daniel / Cox, Morgan L / Gibson, C Michael / Mack, Michael J / Daneshmand, Mani A / Alexander, John H / Lopes, Renato D. ·Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University School of Medicine, Durham, North Carolina. · Division of Cardiovascular and Thoracic Surgery, Department of Surgery, Duke University School of Medicine, Durham, North Carolina; Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina; WakeMed Clinical Research Institute, Raleigh, North Carolina. · Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. · Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Baylor Scott & White Health, Plano, Texas. · Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina. Electronic address: renato.lopes@duke.edu. ·Am J Cardiol · Pubmed #30538035.

ABSTRACT: Although in situ internal mammary artery (is-IMA) grafting remains the most frequent conduit in coronary artery bypass grafting (CABG), circumstances may necessitate free grafting of the IMA (f-IMA), though differences in outcomes have not been fully characterized. The purpose of this study was to compare clinical and angiographic outcomes of is-IMA versus f-IMA coronary bypass grafts in patients who underwent elective CABG surgery. In 1,829 patients in the angiographic cohort of PREVENT IV, 1,572 (85.9%) had at least 1 IMA graft; of these, 34 (2.2%) patients had at least 1 f-IMA graft and 1,538 (97.8%) had at least 1 is-IMA graft without additional f-IMA grafts. Characteristics of patients, procedure, and grafts/targets were compared between cohorts. Primary endpoints included death, myocardial infarction, and revascularization, as well as incidence of graft failure (stenosis >75%) on angiography at 12-18 months postoperatively. Patients receiving is-IMA grafts were more often of white race and higher weight. Aortic cross-clamp time was shorter in the f-IMA cohort (39.5 vs 57.0 min, p = 0.04), but duration of bypass was similar (93.5 vs 100.0 minutes, p = 0.793). Of the in situ grafts, 97.3% were via the left internal mammary artery (LIMA), 86.6% were of good quality, and the left anterior descending (LAD) was bypassed in 88.2%. This compares with free grafts, which were via the LIMA in 68.0%, of good quality in 96.1%, and bypassed the LAD in 58.8% and first obtuse marginal (OM1) in 23.5%. Rates of death, myocardial infarction, and revascularization were similar between groups. The rate of graft failure was higher in f-IMA grafts (23.3%) compared with is-IMA grafts (8.5%; p < 0.01). Although clinical outcomes were similar with use of free versus in situ IMA grafts, higher rates of graft failure were encountered with use of the f-IMA graft. In conclusion, in situ grafts should be the preferred conduit for patients who undergo CABG surgery.

19 Article Incidence, Patterns, and Impact of Dual Antiplatelet Therapy Cessation Among Patients With and Without Chronic Kidney Disease Undergoing Percutaneous Coronary Intervention: Results From the PARIS Registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients). 2018

Baber, Usman / Li, Shawn X / Pinnelas, Rebecca / Pocock, Stuart J / Krucoff, Mitchell W / Ariti, Cono / Gibson, C Michael / Steg, Philippe Gabriel / Weisz, Giora / Witzenbichler, Bernhard / Henry, Timothy D / Kini, Annapoorna S / Stuckey, Thomas / Cohen, David J / Iakovou, Ioannis / Dangas, George / Aquino, Melissa B / Sartori, Samantha / Chieffo, Alaide / Moliterno, David J / Colombo, Antonio / Mehran, Roxana. ·From the Mount Sinai School of Medicine, New York, NY (U.B., A.S.K., G.D., M.B.A., S.S., R.M.) · Dartmouth Geisel School of Medicine, Hanover, NH (S.X.L.) · New York University Medical Center (R.P.) · London School of Hygiene and Tropical Medicine, United Kingdom (S.J.P., C.A.) · Duke University School of Medicine, Durham, NC (M.W.K.) · Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts (C.M.G.) · Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France (P.G.S.) · Shaare Zedek Medical Center, Jerusalem, Israel (G.W.) · Helios Amper-Klinikum, Dachau, Germany (B.W.) · Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.) · Moses Cone Memorial Hospital, Greensboro, NC (T.S.) · Saint Luke's Mid America Heart Institute, Kansas City, MO (D.J.C.) · Onassis Cardiac Surgery Center, Athens, Greece (I.I.) · San Raffaele Scientific Institute, Milan, Italy (A. Chieffo, A. Colombo) · and University of Kentucky, Lexington (D.J.M.). ·Circ Cardiovasc Interv · Pubmed #29870385.

ABSTRACT: BACKGROUND: Patients with chronic kidney disease (CKD) experience high rates of ischemic and bleeding events after percutaneous coronary intervention (PCI), complicating decisions surrounding dual antiplatelet therapy (DAPT). This study aims to determine the pattern and impact of various modes of DAPT cessation for patients with CKD undergoing PCI. METHODS AND RESULTS: Patients from the PARIS registry (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients) were grouped based on the presence of CKD defined as creatinine clearance <60 mL/min. After index PCI, time and mode of DAPT cessation (discontinuation, interruption, and disruption) and clinical outcomes (major adverse cardiac events, stent thrombosis, myocardial infarction, and major bleeding [Bleeding Academic Research Consortium type 3 or 5]) were reported. Over 2 years, patients with CKD (n=839) had higher adjusted risks for death (hazard ratio, 3.16; 95% confidence interval, 2.26-4.41), myocardial infarction (hazard ratio, 2.43; 95% confidence interval, 1.65-3.57), and major bleeding (hazard ratio, 2.21; 95% confidence interval, 1.53-3.19) compared with patients without CKD (n=3745). Rates of DAPT discontinuation within the first year after PCI and disruption were significantly higher for patients with CKD. However, DAPT interruption occurred with equal frequency. Associations between DAPT cessation mode and subsequent risk were not modified by CKD status. Findings were unchanged after propensity matching. CONCLUSIONS: Patients with CKD display high and comparable risks for both ischemic and bleeding events after PCI. Physicians are more likely to discontinue DAPT within the first year after PCI among patients with CKD, likely reflecting clinical preferences to avoid bleeding. Risks after DAPT cessation, irrespective of underlying mode, are not modified by the presence or absence of CKD.

20 Article Effect of Procedure and Coronary Lesion Characteristics on Clinical Outcomes Among Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention: Insights From the PIONEER AF-PCI Trial. 2018

Kerneis, Mathieu / Gibson, C Michael / Chi, Gerald / Mehran, Roxana / AlKhalfan, Fahad / Talib, Usama / Pahlavani, Seyedmahdi / Mir, Mahshid / Bode, Christoph / Halperin, Jonathan L / Nafee, Tarek / Peterson, Eric D / Verheugt, Freek W A / Wildgoose, Peter / van Eickels, Martin / Lip, Gregory Y H / Fox, Keith A A / Cohen, Marc. ·Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. · Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: mgibson@bidmc.harvard.edu. · Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York, New York. · Heart Center, Department for Cardiology and Angiology I, University of Freiburg, Freiburg, Germany. · Duke Clinical Research Institute, Durham, North Carolina. · Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, the Netherlands. · Janssen Pharmaceuticals, Inc., Beerse, Belgium. · Bayer Pharmaceuticals, Inc., Berlin, Germany. · Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. · Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom; Royal Infirmary of Edinburgh, Edinburgh, United Kingdom. · Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey. ·JACC Cardiovasc Interv · Pubmed #29550085.

ABSTRACT: OBJECTIVES: This study sought to assess whether there were significant interactions of procedural access strategies and lesion characteristics with bleeding and ischemic events among atrial fibrillation (AF) patients anticoagulated with rivaroxaban or warfarin following a percutaneous coronary intervention. BACKGROUND: Among stented AF patients, the impact of procedural access strategies or lesion characteristics on antithrombotic safety and efficacy outcomes is unclear. METHODS: In the PIONEER AF-PCI (An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention) trial, 2,124 patients were randomized to 3 groups and followed for 12 months: 1) rivaroxaban 15 mg once daily plus a P2Y RESULTS: Compared with warfarin, both rivaroxaban regimens consistently reduced clinically significant bleeding across subgroups of radial versus femoral arterial access and by vascular closure device use. Treatment effect of rivaroxaban on major adverse cardiovascular events did not vary when stratified by ischemia-driven revascularization, urgency of revascularization, location of culprit artery, presence of bifurcation lesion, presence of thrombus, type, and length of stent or number of stents (interaction p > 0.05 for all subgroups). CONCLUSIONS: Among stented AF patients requiring long-term oral anticoagulation, there was no effect modification by procedure or lesion characteristics of either clinically significant bleeding or major adverse cardiovascular events. Rivaroxaban-based therapy was superior to warfarin plus DAPT in bleeding outcomes regardless of the type of stent or arterial access during the index coronary revascularization. (A Study Exploring Two Strategies of Rivaroxaban [JNJ39039039; BAY-59-7939] and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [PIONEER AF-PCI]; NCT01830543).

21 Article Comparison of Radial Access, Guided Femoral Access, and Non-Guided Femoral Access Among Women Undergoing Percutaneous Coronary Intervention. 2018

Koshy, Linda M / Aberle, Laura H / Krucoff, Mitchell W / Hess, Connie N / Mazzaferri, Ernest / Jolly, Sanjit S / Jacobs, Alice / Gibson, C Michael / Mehran, Roxana / Gilchrist, Ian C / Rao, Sunil V. ·Medical Education Program, Department of Medicine, Duke University Medical Center, DUMC Box 3182, Durham, NC 27710 USA. linda.koshy@duke.edu. ·J Invasive Cardiol · Pubmed #29035844.

ABSTRACT: OBJECTIVES: This study was conducted to determine the association between radial access, guided femoral access, and non-guided femoral access on postprocedural bleeding and vascular complications after percutaneous coronary intervention (PCI). BACKGROUND: Bleeding events and major vascular complications after PCI are associated with increased morbidity, mortality, and cost. While the radial approach has been shown to be superior to the femoral approach in reducing bleeding and vascular complications, whether the use of micropuncture, fluoroscopy, or ultrasound mitigates these differences is unknown. METHODS: We conducted a post hoc analysis of women in the SAFE-PCI for Women trial who underwent PCI and had the access method identified (n = 643). The primary endpoint of postprocedure bleeding or vascular complications occurring within 72 hours or at discharge was adjudicated by an independent clinical events committee and was compared based on three categories of access technique: radial, guided femoral (fluoroscopy, micropuncture, ultrasound), or non-guided femoral (none of the aforementioned). Differences between the groups were determined using multivariate logistic regression using radial access as the reference. RESULTS: Of the PCI population, 330 underwent radial access, 228 underwent guided femoral access, and 85 underwent non-guided femoral access. There was a statistically significant lower incidence of the primary endpoint with radial access vs non-guided femoral access; however, there was no significant difference between radial approach and femoral access guided by fluoroscopy, micropuncture, or ultrasound. CONCLUSIONS: This post hoc analysis demonstrates that while radial access is safer than non-guided femoral access, guided femoral access appears to be associated with similar bleeding events or vascular complications as radial access.

22 Article Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. 2018

Vaduganathan, Muthiah / Harrington, Robert A / Stone, Gregg W / Steg, Gabriel / Gibson, C Michael / Hamm, Christian W / Price, Matthew J / Lopes, Renato D / Leonardi, Sergio / Deliargyris, Efthymios N / Prats, Jayne / Mahaffey, Kenneth W / White, Harvey D / Bhatt, Deepak L. ·Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA, USA. ·EuroIntervention · Pubmed #28988157.

ABSTRACT: AIMS: The aim of this study was to determine the prognostic significance of periprocedural bleeding based on various definitions on 30-day and one-year all-cause mortality in patients undergoing routine or urgent percutaneous coronary intervention (PCI). METHODS AND RESULTS: In this exploratory analysis of 25,107 patients enrolled in the three phase-3 CHAMPION trials, we assessed the prognostic impact of four bleeding scales (GUSTO, TIMI, ACUITY, and BARC) at 48 hrs. Follow-up all-cause mortality data were available at 30 days in all three trials, and at one year in CHAMPION PCI and CHAMPION PLATFORM. Bleeding rates within 48 hrs of PCI were variably identified by each clinical definition (range: <0.5% to >3.5%). Severe/major bleeding, measured by all bleeding scales, and blood transfusion requirement were independently associated with increased mortality at 30 days and one year after PCI (p<0.001 for all associations). Mild/minor bleeding was not independently predictive of one-year mortality (p>0.07 for all associations). Each bleeding definition demonstrated only modest ability to discriminate 30-day and one-year mortality (adjusted C-statistics range: 0.49 to 0.67). CONCLUSIONS: Commonly employed clinical definitions variably identify rates of bleeding after PCI. Severe or major, but not mild or minor, bleeding is independently associated with increased 30-day and one-year mortality. These data may aid in selection of appropriate bleeding metrics in future clinical trials.

23 Article White Blood Cell Count and Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention in the Contemporary Era: Insights From the PARIS Study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry). 2017

Shah, Binita / Baber, Usman / Pocock, Stuart J / Krucoff, Mitchell W / Ariti, Cono / Gibson, C Michael / Steg, Philippe Gabriel / Weisz, Giora / Witzenbichler, Bernhard / Henry, Timothy D / Kini, Annapoorna S / Stuckey, Thomas / Cohen, David J / Iakovou, Ioannis / Dangas, George / Aquino, Melissa B / Sartori, Samantha / Chieffo, Alaide / Moliterno, David J / Colombo, Antonio / Mehran, Roxana. ·From the Department of Medicine (Cardiology), New York Harbor Health Care System, Manhattan VA Hospital (B.S.) · Department of Medicine (Cardiology), New York University School of Medicine (B.S.) · Department of Medicine (Cardiology), Icahn School of Medicine at Mount Sinai, New York, NY (U.B., A.S.K., G.D., M.B.A., S.S., R.M.) · Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (S.J.P., C.A.) · Department of Medicine (Cardiology), Duke University School of Medicine, Durham, NC (M.W.K.) · Department of Medicine (Cardiology), Harvard Medical School, Cambridge, MA (C.M.G.) · Department of Medicine (Cardiology), Hôpital Bichat-Claude Bernard, Paris, France (P.G.S.) · Department of Medicine (Cardiology), Columbia University Medical Center, New York, NY (G.W.) · Department of Medicine (Cardiology), HELIOS Amper-Klinikum Dachau, Germany (B.W.) · Department of Medicine (Cardiology), Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.) · Department of Medicine (Cardiology), Minneapolis Heart Institute Foundation, University of Minnesota (T.D.H.) · Department of Medicine (Cardiology), Moses Cone Heart and Vascular Center, LeBauer Cardiovascular Research Foundation, Greensboro, NC (T.S.) · Department of Medicine (Cardiology), St Luke's Mid America Heart Institute, University of Missouri-Kansas City (D.J.C.) · Department of Medicine (Cardiology), Onassis Cardiac Surgery Center, Athens, Greece (I.I.) · Department of Medicine (Cardiology), San Raffaele Hospital, Milan, Italy (A. Chieffo, A. Colombo) · and Department of Medicine (Cardiology), University of Kentucky, Lexington (D.J.M.). ·Circ Cardiovasc Interv · Pubmed #28916600.

ABSTRACT: BACKGROUND: Elevated white blood cell (WBC) count is associated with increased major adverse cardiovascular events (MACE) in the setting of acute coronary syndrome. The aim of this study was to evaluate whether similar associations persist in an all-comers population of patients undergoing percutaneous coronary intervention in the contemporary era. METHODS AND RESULTS: In the multicenter, prospective, observational PARIS study (Patterns of Non-Adherence to Anti-Platelet Regimens in Stented Patients Registry), 4222 patients who underwent percutaneous coronary intervention in the United States and Europe between July 1, 2009, and December 2, 2010, were evaluated. The associations between baseline WBC and MACE (composite of cardiac death, stent thrombosis, spontaneous myocardial infarction, or target lesion revascularization) at 24-month follow-up were analyzed using multivariable Cox regression. Patients with higher WBC were more often younger, smokers, and with less comorbid risk factors compared with those with lower WBC. After adjustment for baseline and procedural characteristics, WBC remained independently associated with MACE (hazard ratio [HR] per 10 CONCLUSIONS: Increased WBC is an independent predictor of MACE after percutaneous coronary intervention in a contemporary all-comers cohort. Further studies to delineate the underlying pathophysiologic role of elevated WBC across a spectrum of coronary artery disease presentations are warranted. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00998127.

24 Article Causes, Timing, and Impact of Dual Antiplatelet Therapy Interruption for Surgery (from the Patterns of Non-adherence to Anti-platelet Regimens In Stented Patients Registry). 2017

Schoos, Mikkel / Chandrasekhar, Jaya / Baber, Usman / Bhasin, Aarti / Sartori, Samantha / Aquino, Melissa / Vogel, Birgit / Farhan, Serdar / Sorrentino, Sabato / Kini, Annapoorna / Kruckoff, Mitchell / Moliterno, David / Henry, Timothy D / Weisz, Giora / Gibson, C Michael / Iakovou, Ioannis / Colombo, Antonio / Steg, P Gabriel / Witzenbichler, Bernhard / Chieffo, Alaide / Cohen, David / Stuckey, Thomas / Ariti, Cono / Dangas, George / Pocock, Stuart / Mehran, Roxana. ·Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Cardiology, Zealand University Hospital, Denmark. · Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York. · Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York; Department of Internal Medicine, Wyckoff Heights Medical Center, New York, New York. · Department of Cardiology, Duke University School of Medicine, Durham, North Carolina. · Department of Cardiology, University of Kentucky, Lexington, Kentucky. · Department of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California. · Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. · Department of Cardiology, Harvard Medical School, Cambridge, Massachusetts. · Department of Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece. · Department of Cardiology, San Raffaele Hospital, Milan, Italy. · Department of Cardiology, Hôpital Bichat-Claude Bernard, Paris, France. · Department of Cardiology, Helios Amper-Klinikum, Dachau, Germany. · Department of Cardiology, St Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. · Moses Cone Heart and Vascular Center, LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina. · Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, United Kingdom. · Department of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org. ·Am J Cardiol · Pubmed #28778417.

ABSTRACT: Temporary interruption of dual antiplatelet therapy (DAPT) is not infrequently required in patients undergoing percutaneous coronary intervention (PCI). We sought to describe the procedures and outcomes associated with DAPT interruption in patients treated with DAPT following successful PCI from the Patterns of non-adherence to anti-platelet regimens in stented patients registry (n = 5018). DAPT interruption was prespecified as physician recommended cessation for <14 days. Of the study cohort, 490 patients (9.8%) experienced 594 DAPT interruptions over 2 years following PCI. Only 1 antiplatelet agent was interrupted in 57.2% cases and interruption was frequently recommended by noncardiologists (51.3%). Where type of surgery was reported, majority of DAPT interruptions occurred for minor surgery (68.4% vs 31.6%) and a similar cessation pattern of single versus dual antiplatelet cessation was observed regardless of minor or major surgery. Subsequent to DAPT interruption, 12 patients (2.4%) experienced 1 thrombotic event each, of which 5 (1.0%) occurred during the interruption period. All events occurred in patients who either stopped both agents (8 of 12) or clopidogrel-only (4 of 12), with no events occurring due to aspirin cessation alone. In conclusion, in the Patterns of Non-adherence to Anti-platelet Regiments in Stented Patients registry, 1 in 10 patients were recommended DAPT interruption for surgery within 2 years of PCI. Interruption was more common for a single agent rather than both antiplatelet agents regardless of severity of surgery, and was frequently recommended by noncardiologists. Only 1% of patients with DAPT interruption experienced a subsequent thrombotic event during the interruption period, which mainly occurred in patients stopping both antiplatelet agents.

25 Article Cangrelor reduces the risk of ischemic complications in patients with single-vessel and multi-vessel disease undergoing percutaneous coronary intervention: Insights from the CHAMPION PHOENIX trial. 2017

Abnousi, Freddy / Sundaram, Vandana / Yong, Celina M / Prats, Jayne / Deliargyris, Efthymios N / Stone, Gregg W / Hamm, Christian W / Steg, Philippe Gabriel / Gibson, Charles Michael / White, Harvey D / Price, Matthew J / Généreux, Philippe / Desai, Manisha / Yang, Lingyao / Ding, Victoria Y / Harrington, Robert A / Bhatt, Deepak L / Mahaffey, Kenneth W. ·Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. · Quantitative Sciences Unit, Department of Medicine, Stanford University School of Medicine, Stanford, CA. · The Medicines Company, Parsippany, NJ. · Columbia University Medical Center and the Cardiovascular Research Foundation, NY, New York. · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · DHU (Département Hospitalo-Universitaire)-FIRE (Fibrosis, Inflammation, REmodelling), Hôpital Bichat, AP-HPb (Assistance Publique-Hôpitaux de Paris), Université Paris-Diderot, Sorbonne-Paris Cité, and FACT (French Alliance for Cardiovascular clinical Trials), an F-CRIN network, INSERM U-1148, Paris, France; NLHI, ICMS, Royal Brompton Hospital, Imperial College, London, United Kingdom. · Beth Israel Deaconess Medical Center, Division of Cardiology, Harvard Medical School Boston, Boston, MA. · University of Auckland, Auckland City Hospital, Auckland, New Zealand. · Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA. · Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA. · Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA. Electronic address: Kenneth.Mahaffey@stanford.edu. ·Am Heart J · Pubmed #28577670.

ABSTRACT: OBJECTIVE: To examine the safety and efficacy of cangrelor in patients with single-vessel disease (SVD) and multi-vessel disease (MVD). BACKGROUND: Cangrelor, an intravenous, rapidly acting P2Y METHODS: We studied a modified intention to treat population of patients with SVD and MVD from the CHAMPION PHOENIX trial. The primary efficacy outcome was the composite of death, myocardial infarction (MI), ischemia-driven revascularization (IDR), and stent thrombosis (ST) at 48hours. The key safety outcome was non-coronary artery bypass grafting GUSTO severe bleeding at 48hours. RESULTS: Among 10,921 patients, 5,220 (48%) had SVD and 5,701 (52%) had MVD. MVD patients were older and more often had diabetes, hyperlipidemia, hypertension, prior stroke, and prior MI. After adjustment, MVD patients had similar rates of 48-hour death/MI/IDR/ST (6.3% vs 4.2%, adjusted odds ratio [OR] 1.6 [95% CI 0.42-6.06]) and GUSTO severe bleeding (0.1% vs 0.2%, P=.67) compared with SVD patients. Consistent with overall trial findings, cangrelor use reduced ischemic complications in patients with both SVD (3.9% vs 4.5%; OR 0.86, 95% CI 0.65-1.12) and MVD (5.5% vs 7.2%; OR 0.74, 95% CI 0.6-0.92, P-interaction=.43). GUSTO severe bleeding outcomes were not significantly increased with cangrelor or clopidogrel in either SVD or MVD patients. CONCLUSION: In the CHAMPION PHOENIX trial, MVD and SVD patients had similar ischemic outcomes at 48hours and 30days. Cangrelor consistently reduced ischemic complications in both SVD and MVD patients without a significant increase in GUSTO severe bleeding. CLINICAL PERSPECTIVES.

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