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Coronary Artery Disease: HELP
Articles by Charles Michael Gibson
Based on 33 articles published since 2008
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Between 2008 and 2019, C. Michael Gibson wrote the following 33 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 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.

2 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 --

3 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 --

4 Review Use of the TIMI frame count in the assessment of coronary artery blood flow and microvascular function over the past 15 years. 2009

Kunadian, Vijayalakshmi / Harrigan, Caitlin / Zorkun, Cafer / Palmer, Alexandra M / Ogando, Katherine J / Biller, Leah H / Lord, Erin E / Williams, Scott P / Lew, Michelle E / Ciaglo, Lauren N / Buros, Jacqueline L / Marble, Susan J / Gibson, William J / Gibson, C Michael. ·Cardiovascular Divisions, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. ·J Thromb Thrombolysis · Pubmed #18425623.

ABSTRACT: Since its introduction, the TIMI frame count method has contributed to the understanding of the pathophysiology of coronary artery disease. In this article, the evolution of the TFC method and its applicability in the assessment of various therapeutic modalities are described.

5 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.

6 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.

7 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.

8 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.

9 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.

10 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).

11 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.

12 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.

13 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.

14 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.

15 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.

16 Article Impact of Cerebrovascular Events Older Than One Year on Ischemic and Bleeding Outcomes With Cangrelor in Percutaneous Coronary Intervention. 2017

Sawlani, Neal N / Harrington, Robert A / Stone, Gregg W / Steg, Ph Gabriel / Gibson, C Michael / Hamm, Christian W / Price, Matthew J / Prats, Jayne / Deliargyris, Efthymios N / Mahaffey, Kenneth W / White, Harvey D / Bhatt, Deepak L. ·From the Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (N.N.S., D.L.B.) · Stanford University Medical School, CA (R.A.H., K.W.M.) · Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY (G.W.S.) · FACT (French Alliance for Cardiovascular clinical Trials), DHU FIRE, INSERM Unité 1148, Université Paris-Diderot, and Hôpital Bichat, Assistance-Publique-Hôpitaux de Paris, Paris, France and NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom (P.G.S.) · Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, MA (C.M.G.) · Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany (C.W.H.) · Scripps Clinic and Scripps Translational Science Institute, La Jolla, CA (M.J.P.) · The Medicines Company, Parsippany, NJ (J.P., E.N.D.) · and Green Lane Cardiovascular Service, Auckland City Hospital, New Zealand (H.D.W.). ·Circ Cardiovasc Interv · Pubmed #28039321.

ABSTRACT: BACKGROUND: Cangrelor is a potent intravenous adenosine diphosphate-receptor antagonist that in the CHAMPION trials reduced the 48-hour and 30-day rates of ischemic events during percutaneous coronary intervention without an increase in severe bleeding. METHODS AND RESULTS: CHAMPION PCI (A Clinical Trial to Demonstrate the Efficacy of Cangrelor), CHAMPION PLATFORM (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition), and CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention) were 3 randomized, double-blind, double-dummy trials in which cangrelor was compared with clopidogrel during percutaneous coronary intervention. The effect of cangrelor on ischemic events and bleeding was analyzed in the subgroup of patients with a history of cerebrovascular events at least 1 year prior to randomization; the Breslow-Day test was used to test for interaction of treatment effect in subgroups with and without such a history. The primary efficacy end point was a composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis at 48 hours. Among 24 910 randomized patients, 1270 patients (5.1%) had a cerebrovascular event >1 year old, including 650 assigned to cangrelor and 620 assigned to clopidogrel. Consistent with the overall trial results, the rate of the primary efficacy end point was 4.3% in the cangrelor group versus 5.3% in the clopidogrel group (odds ratio 0.80; 95% confidence interval 0.48-1.34; P=0.40; P for interaction =0.97), and the rate of GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) severe bleeding was 0.3% in both groups (P=0.97; P for interaction =0.81). CONCLUSIONS: Among patients in the CHAMPION trials with a prior cerebrovascular event at least 1 year before the percutaneous coronary intervention, the efficacy and bleeding profile of cangrelor compared with clopidogrel was similar to that in the overall trial.

17 Article Prediction of 1-year mortality and impact of bivalirudin therapy according to level of baseline risk: A patient-level pooled analysis from three randomized trials. 2016

Yu, Jennifer / Mehran, Roxana / Clayton, Tim / Gibson, C Michael / Brodie, Bruce R / Witzenbichler, Bernhard / Lincoff, A Michael / Deliargyris, Efthymios N / Gersh, Bernard J / Pocock, Stuart J / Stone, Gregg W / Dangas, George D. ·Mount Sinai Medical Center, Cardiovascular Institute, New York, New York. · Prince of Wales Hospital Clinical School, University of New South Wales, NSW, Australia. · Cardiovascular Research Foundation, New York, New York. · London School of Hygiene and Tropical Medicine, London, United Kingdom. · Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. · LeBauer Cardiovascular Research Foundation, Greensboro, North Carolina. · Helios Amper-Klinikum, Dachau, Germany. · Cleveland Clinic, Cleveland, Ohio. · The Medicines Company, Munich, Germany. · Mayo Clinic, Rochester, Minnesota. · Columbia University Medical Center, New York, New York. ·Catheter Cardiovasc Interv · Pubmed #26624854.

ABSTRACT: OBJECTIVES: We aimed to construct a predictive model for one-year mortality in patients undergoing invasive coronary evaluation and to examine the impact of bivalirudin on survival according to the level of baseline risk. BACKGROUND: Compared to heparin plus GP IIb/IIIa inhibitors (HEP/GPI), bivalirudin decreases bleeding complications in a range of clinical presentations. The impact of preprocedural risk assessment on survival and whether this is modified by bivalirudin, has not been investigated in detail. METHODS: We examined patient-level data from the REPLACE-2, ACUITY, and HORIZONS-AMI trials (n = 18,819) to construct a risk-adjusted mortality model using baseline clinical variables. RESULTS: One-year mortality occurred in 287 patients (3.1%) assigned to bivalirudin and 336 patients (3.6%) assigned to HEP/GPI (HR 0.85; 95% CI, 0.73-1.00; P = 0.048). Using 11 highly significant predictors of mortality, we developed an integer-risk score to classify patients into risk tertiles. High-risk patients had a rate of 1-year mortality over 9-fold greater than low-risk patients. Consequently, the absolute mortality reduction attributed to bivalirudin was more marked in high-risk patients: 3.1% (-0.8% to 7.0%) in the overall cohort, 4.8% (0.5% to 9.2%) in the PCI cohort (P-interaction versus intermediate and low risk categories, 0.09 and P = 0.02, respectively). CONCLUSIONS: In patients undergoing invasive coronary evaluation, 1-year mortality can be predicted using baseline variables. Bivalirudin treatment (versus HEP/GPI) conferred a survival benefit.

18 Article Outcomes with cangrelor versus clopidogrel on a background of bivalirudin: insights from the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI]). 2015

White, Harvey D / Bhatt, Deepak L / Gibson, C Michael / Hamm, Christian W / Mahaffey, Kenneth W / Price, Matthew J / Steg, Ph Gabriel / Stone, Gregg W / Cortese, Bernardo / Wilensky, Michael / Deliargyris, Efthymios N / Liu, Tiepu / Prats, Jayne / Harrington, Robert A. ·Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. Electronic address: HarveyW@adhb.govt.nz. · Brigham and Women's Hospital, Heart & Vascular Center, and Harvard Medical School, Boston, Massachusetts. · Beth Israel Hospital, Boston, Massachusetts. · University of Giessen and Kerckhoff Heart Center, Bad Nauheim, Germany. · Department of Medicine, Stanford University School of Medicine, Stanford, California. · Scripps Clinic and Scripps Translational Science Institute, La Jolla, California. · Institut National de la Santé et de la Recherche Médicale-Unité 114, Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; Royal Brompton Hospital, London, United Kingdom. · Columbia University Medical Center and The Cardiovascular Research Foundation, New York, New York. · Interventional Cardiology, A.O. Fatebenefratelli, Bastioni di Porta Nuova, Milan, Italy. · Cardiology PC, Birmingham, Alabama. · The Medicines Company, Parsippany, New Jersey. ·JACC Cardiovasc Interv · Pubmed #25703887.

ABSTRACT: OBJECTIVES: The aim of this study was to examine the efficacy and bleeding outcomes of cangrelor in patients in the CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention [PCI]) who underwent percutaneous coronary intervention with bivalirudin. BACKGROUND: Cangrelor is a potent intravenous P2Y12 inhibitor with rapid onset and offset. In the CHAMPION PHOENIX, cangrelor compared with clopidogrel significantly reduced 48-h ischemic events including stent thrombosis, without increasing major bleeding. Bivalirudin has demonstrated ischemic outcomes similar to those with heparin plus glycoprotein IIb/IIIa inhibition, with reduced bleeding but increased early stent thrombosis. METHODS: In the modified intent-to-treat population, 2,059 patients (18.8%) received bivalirudin, with 1,014 patients in the cangrelor treatment arm and 1,045 in the clopidogrel treatment arm. RESULTS: At 48 h, the primary endpoint of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis was lower with cangrelor versus clopidogrel (48 [4.7%] vs. 70 [6.7%]; odds ratio [OR]: 0.68, p = 0.047). Death was similar in both arms (2 [0.2%] vs. 2 [0.2%]). Myocardial infarction was reduced by cangrelor (37 [3.6%] vs. 59 [5.6%]; OR: 0.63, p = 0.03), as was death/myocardial infarction (39 [3.8%] vs. 61 [5.8%]; OR: 0.65, p = 0.04). Cangrelor was associated with a nonsignificant trend toward less stent thrombosis (7 [0.7%] vs. 15 [1.4%]; OR: 0.48, p = 0.10), which was evident within 2 h after percutaneous coronary intervention (p = 0.057). GUSTO (Global Use of Strategies to Open Occluded Arteries) severe bleeding was similar in both arms (2 of 1,021 [0.2%] vs. 2 of 1,055 [0.2%]) as were other bleeding definitions and transfusions. Efficacy and safety results were consistent in patients with stable angina, non-ST-segment elevation acute coronary syndrome, and ST-segment elevation myocardial infarction (p for interaction: 0.62 and 0.29). CONCLUSIONS: Cangrelor may offer an attractive benefit risk profile when used in combination with bivalirudin.

19 Article Saphenous vein graft failure after coronary artery bypass surgery: insights from PREVENT IV. 2014

Hess, Connie N / Lopes, Renato D / Gibson, C Michael / Hager, Rebecca / Wojdyla, Daniel M / Englum, Brian R / Mack, Michael J / Califf, Robert M / Kouchoukos, Nicholas T / Peterson, Eric D / Alexander, John H. ·From the Duke Clinical Research Institute, Duke Medicine, Durham, NC (C.N.H., R.D.L., R.H., D.M.W., B.R.E., E.D.P., J.H.A.) · Harvard Medical School, Harvard University, Boston, MA (C.M.G.) · Baylor Health Care System, Baylor, TX (M.J.M.) · Duke Translational Medicine Institute, Duke Medicine, Durham, NC (R.M.C.) · and Missouri Baptist Medical Center, St. Louis, MO (N.T.K.). ·Circulation · Pubmed #25261549.

ABSTRACT: BACKGROUND: Coronary artery bypass grafting success is limited by vein graft failure (VGF). Understanding the factors associated with VGF may improve patient outcomes. METHODS AND RESULTS: We examined 1828 participants in the Project of Ex Vivo Vein Graft Engineering via Transfection IV (PREVENT IV) trial undergoing protocol-mandated follow-up angiography 12 to 18 months post-coronary artery bypass grafting or earlier clinically driven angiography. Outcomes included patient- and graft-level angiographic VGF (≥75% stenosis or occlusion). Variables were selected by using Fast False Selection Rate methodology. We examined relationships between variables and VGF in patient- and graft-level models by using logistic regression without and with generalized estimating equations. At 12 to 18 months post-coronary artery bypass grafting, 782 of 1828 (42.8%) patients had VGF, and 1096 of 4343 (25.2%) vein grafts had failed. Demographic and clinical characteristics were similar between patients with and without VGF, although VGF patients had longer surgical times, worse target artery quality, longer graft length, and they more frequently underwent endoscopic vein harvesting. After multivariable adjustment, longer surgical duration (odds ratio per 10-minute increase, 1.05; 95% confidence interval, 1.03-1.07), endoscopic vein harvesting (odds ratio, 1.41; 95% confidence interval, 1.16-1.71), poor target artery quality (odds ratio, 1.43; 95% confidence interval, 1.11-1.84), and postoperative use of clopidogrel or ticlopidine (odds ratio, 1.35; 95% confidence interval, 1.07-1.69) were associated with patient-level VGF. The predicted likelihood of VGF in the graft-level model ranged from 12.1% to 63.6%. CONCLUSIONS: VGF is common and associated with patient and surgical factors. These findings may help identify patients with risk factors for VGF and inform the development of interventions to reduce VGF. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00042081.

20 Article A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. 2014

Rao, Sunil V / Hess, Connie N / Barham, Britt / Aberle, Laura H / Anstrom, Kevin J / Patel, Tejan B / Jorgensen, Jesse P / Mazzaferri, Ernest L / Jolly, Sanjit S / Jacobs, Alice / Newby, L Kristin / Gibson, C Michael / Kong, David F / Mehran, Roxana / Waksman, Ron / Gilchrist, Ian C / McCourt, Brian J / Messenger, John C / Peterson, Eric D / Harrington, Robert A / Krucoff, Mitchell W. ·The Duke Clinical Research Institute, Durham, North Carolina. Electronic address: sunil.rao@duke.edu. · The Duke Clinical Research Institute, Durham, North Carolina. · Unity Health System, Rochester, New York. · University of South Carolina School of Medicine-Greenville, Greenville, South Carolina. · The Ohio State University Medical Center, Columbus, Ohio. · McMaster University, Hamilton, Ontario, Canada. · Boston University School of Medicine, Boston, Massachusetts. · Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Mount Sinai Hospital, New York, New York. · Washington Hospital Center, Washington, DC. · Penn State Hershey Medical Center, Hershey, Pennsylvania. · The American College of Cardiology, Washington, DC. · Stanford University Medical Center, Palo Alto, California. ·JACC Cardiovasc Interv · Pubmed #25147030.

ABSTRACT: OBJECTIVES: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. BACKGROUND: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. METHODS: Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. RESULTS: The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. CONCLUSIONS: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236).

21 Article Advances in understanding percutaneous coronary intervention pharmacology: ischemia, bleeding, the ISAR research group, and a commitment to progress. 2014

Harrington, Robert A / Popma, Christopher J / Gibson, Charles Michael. ·aDepartment of Medicine, Stanford University, Stanford, California bBeth Israel-Deaconess Medical Center, Division of Cardiovascular Medicine, Department of Medicine cHarvard Medical School, Boston, Massachusetts, USA. ·Coron Artery Dis · Pubmed #25072657.

ABSTRACT: -- No abstract --

22 Article Angiographic validation of the American College of Cardiology Foundation-the Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies study. 2014

Chakrabarti, Anjan K / Grau-Sepulveda, Maria V / O'Brien, Sean / Abueg, Cassandra / Ponirakis, Angelo / Delong, Elizabeth / Peterson, Eric / Klein, Lloyd W / Garratt, Kirk N / Weintraub, William S / Gibson, C Michael. ·From the Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (A.K.C., C.M.G.) · PERFUSE Angiographic Core Laboratories and Data Coordinating Center, Beth Israel Deaconess Medical Center, Boston, MA (A.K.C., C.A., C.M.G.) · Duke Clinical Research Institute, Duke University, Durham, NC (M.V.G.-S., S.O., E.D., E.P.) · American College of Cardiology, Washington, DC (A.P.) · Division of Internal Medicine, Department of Medicine, Rush University, Chicago, IL (L.W.K.) · Northshore-LIJ/Lenox Hill Hospital, New York, NY (K.N.G.) · and Christiana Care Health System, Newark, DE (W.S.W.). ·Circ Cardiovasc Interv · Pubmed #24496239.

ABSTRACT: BACKGROUND: The goal of this study was to compare angiographic interpretation of coronary arteriograms by sites in community practice versus those made by a centralized angiographic core laboratory. METHODS AND RESULTS: The study population consisted of 2013 American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) records with 2- and 3- vessel coronary disease from 54 sites in 2004 to 2007. The primary analysis compared Registry (NCDR)-defined 2- and 3-vessel disease versus those from an angiographic core laboratory analysis. Vessel-level kappa coefficients suggested moderate agreement between NCDR and core laboratory analysis, ranging from kappa=0.39 (95% confidence intervals, 0.32-0.45) for the left anterior descending artery to kappa=0.59 (95% confidence intervals, 0.55-0.64) for the right coronary artery. Overall, 6.3% (n=127 out of 2013) of those patients identified with multivessel disease at NCDR sites had had 0- or 1-vessel disease by core laboratory reading. There was no directional bias with regard to overcall, that is, 12.3% of cases read as 3-vessel disease by the sites were read as <3-vessel disease by the core laboratory, and 13.9% of core laboratory 3-vessel cases were read as <3-vessel by the sites. For a subset of patients with left main coronary disease, registry overcall was not linked to increased rates of mortality or myocardial infarction. CONCLUSIONS: There was only modest agreement between angiographic readings in clinical practice and those from an independent core laboratory. Further study will be needed because the implications for patient management are uncertain.

23 Article Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. 2013

Mehran, Roxana / Baber, Usman / Steg, Philippe Gabriel / Ariti, Cono / Weisz, Giora / Witzenbichler, Bernhard / Henry, Timothy D / Kini, Annapoorna S / Stuckey, Thomas / Cohen, David J / Berger, Peter B / Iakovou, Ioannis / Dangas, George / Waksman, Ron / Antoniucci, David / Sartori, Samantha / Krucoff, Mitchell W / Hermiller, James B / Shawl, Fayaz / Gibson, C Michael / Chieffo, Alaide / Alu, Maria / Moliterno, David J / Colombo, Antonio / Pocock, Stuart. ·Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: roxana.mehran@mountsinai.org. ·Lancet · Pubmed #24004642.

ABSTRACT: BACKGROUND: Dual antiplatelet therapy (DAPT) cessation increases the risk of adverse events after percutaneous coronary intervention (PCI). Whether risk changes over time, depends on the underlying reason for DAPT cessation, or both is unknown. We assessed associations between different modes of DAPT cessation and cardiovascular risk after PCI. METHODS: The PARIS (patterns of non-adherence to anti-platelet regimens in stented patients) registry is a prospective observational study of patients undergoing PCI with stent implantation in 15 clinical sites in the USA and Europe between July 1, 2009, and Dec 2, 2010. Adult patients (aged 18 years or older) undergoing successful stent implantation in one or more native coronary artery and discharged on DAPT were eligible for enrolment. Patients were followed up at months 1, 6, 12, and 24 after implantation. Prespecified categories for DAPT cessation included physician-recommended discontinuation, brief interruption (for surgery), or disruption (non-compliance or because of bleeding). All adverse events and episodes of DAPT cessation were independently adjudicated. Using Cox models with time-varying covariates, we examined the effect of DAPT cessation on major adverse events (MACE [composite of cardiac death, definite or probable stent thrombosis, myocardial infarction, or target-lesion revascularisation]). Incidence rates for DAPT cessation and adverse events were calculated as Kaplan-Meier estimates of time to the first event. This study is registered with ClinicalTrials.gov, number NCT00998127. FINDINGS: We enrolled 5031 patients undergoing PCI, including 5018 in the final study population. Over 2 years, the overall incidence of any DAPT cessation was 57·3%. Rate of any discontinuation was 40·8%, of interruption was 10·5%, and of disruption was 14·4%. The corresponding overall 2 year MACE rate was 11·5%, most of which (74%) occurred while patients were taking DAPT. Compared with those on DAPT, the adjusted hazard ratio (HR) for MACE due to interruption was 1·41 (95% CI 0·94-2·12; p=0·10) and to disruption was 1·50 (1·14-1.97; p=0·004). Within 7 days, 8-30 days, and more than 30 days after disruption, adjusted HRs were 7·04 (3·31-14·95), 2·17 (0·97-4·88), and 1·3 (0·97-1·76), respectively. By contrast with patients who remained on DAPT, those who discontinued had lower MACE risk (0·63 [0·46-0·86]). Results were similar after excluding patients receiving bare metal stents and using an alternative MACE definition that did not include target lesion revascularisation. INTERPRETATION: In a real-world setting, for patients undergoing PCI and discharged on DAPT, cardiac events after DAPT cessation depend on the clinical circumstance and reason for cessation and attenuates over time. While most events after PCI occur in patients on DAPT, early risk for events due to disruption is substantial irrespective of stent type. FUNDING: Bristol-Myers Squibb and Sanofi-Aventis.

24 Article The determinants of side branch compromise after main vessel stenting in coronary bifurcation lesions. 2012

Vassilev, Dobrin / Gil, Robert J / Koo, Bon Kwon / Gibson, C Michael / Nguyen, Thach / Hoang, Thai / Gotcheva, Nina. ·Cardiac Catheterisation Laboratory, National Heart Hospital, 1309 Sofia, Bulgaria. dobrinv@gmail.com ·Kardiol Pol · Pubmed #23080087.

ABSTRACT: BACKGROUND AND AIM: The purpose of this analysis was to determine the factors responsible for side branch (SB) ostial stenosis after main vessel stent implantation. METHODS: Theoretical and bench-test bifurcation models with different lengths of carina were created. Bench-test experiments with a flexible bifurcation model were performed for the observation of changes in the bifurcation region after stent implantation. An angiographic analysis of 92 bifurcation lesions (84 patients) was performed to determine the role of theoretical parameters on SB compromise in practice. The theoretically predicted and actual SB compromise were compared in these patients. RESULTS: Bench tests revealed a complex change in the bifurcation region with carina displacement, SB lateral walls stretch and main vessel - SB proximal angle decrease after main vessel stent placement. In an angiographic analysis, actually measured SB% diameter stenosis was larger than expected in 35 (38%) lesions and the measured stenosis was smaller than expected in 49 lesions. Independent predictors of difference between theoretically predicted and observed SB stenosis were carina length mismatch (OR = 2.568, CI 1.336-4.896), main branch reference diameter (OR = 0.314, CI 0.101-0.972), and proximal main vessel - SB angle change after stenting (OR = 0.926, CI 0.870-0.985). In a plot comparing the values of carina length mismatch and deviations from the prediction in SB ostial stenosis, 30% (n = 27) of cases were located in a zone with a shorter carina and more SB compromise than expected, suggesting the role of plaque shift in these cases. CONCLUSIONS: The degree of SB jailing seems to be determined by carina deformation, the length of the carina, and plaque shifting.

25 Article Time-related impact of distal embolisation on myocardial perfusion and survival among patients undergoing primary angioplasty with glycoprotein IIb-IIIa inhibitors: insights from the EGYPT cooperation. 2012

De Luca, Giuseppe / Gibson, C Michael / Huber, Kurt / Dudek, Dariusz / Cutlip, Donald / Zeymer, Uwe / Gyöngyösi, Maryann / Bellandi, Francesco / Noc, Marko / Arntz, Hans-Richard / Maioli, Mauro / Secco, Gioel Gabrio / Zorman, Simona / Gabriel, H Mesquita / Emre, Ayse / Rakowski, Tomasz / Van't Hof, Arnoud W J / Anonymous370735. ·Division of Cardiology, "Maggiore della Carità" Hospital, Eastern Piedmont University, Novara, Italy. giuseppe.deluca@maggioreosp.novara.it ·EuroIntervention · Pubmed #22917731.

ABSTRACT: AIMS: Considerable interest has been focused in recent years on the role of distal embolisation as a major determinant of impaired reperfusion after primary angioplasty for STEMI. The aim of the current study was to evaluate in a large cohort of STEMI patients undergoing primary angioplasty with glycoprotein (Gp) IIb-IIIa inhibitors, whether the impact of distal embolisation on myocardial perfusion and survival may depend on time-to-treatment. METHODS AND RESULTS: Our population is represented by 1,182 patients undergoing primary angioplasty for STEMI included in the EGYPT database. Patients were grouped according to time-to-treatment (<3 hours, 3-6 hours, >6 hours). Distal embolisation was defined as an abrupt "cutoff" in the main vessel or one of the coronary branches of the infarct-related artery, distal to the angioplasty site. Myocardial perfusion was evaluated by angiography or ST-segment resolution, whereas infarct size was estimated by using peak creatine kinase (CK) and CK-MB. Follow-up data were collected between 30 days and one year after primary angioplasty. Distal embolisation was observed in 132 patients (11.1%) and tended to occur more frequently in late presenters (p=0.067). Patients with distal embolisation less often had post-procedural Thrombolysis In Myocardial Infarction (TIMI) 3 flow (p<0.001), post-procedural myocardial blush grade (MBG) 2-3 (p<0.001), complete ST-segment resolution (p=0.021) and larger infarct size (p=0.012). Distal embolisation was associated with a significantly higher mortality (9.2% vs. 2.7%, heart rate [HR] [95% CI]=3.41 [1.73-6.71], p<0.0001). The impact of distal embolisation on myocardial perfusion and survival persisted for all time intervals. CONCLUSIONS: This study showed that among STEMI patients treated with Gp IIb-IIIa inhibitors, the negative impact of distal embolisation on myocardial perfusion and mortality is independent of the time from symptom onset to balloon angioplasty.

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