 News by @CMichaelGibson FDA Re-Review of RECORD FDA Joint Meeting of the Endocrinilogic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee present: Open Public Hearing, June 6, 2013. Slides LT Dr. Justin A. Mathew, FDA Drug Utilization Data Analyst, Division of Epidemiology II, Office of Surveillance and Epidemiology, presents: Drug Utilization Patterns for Rosiglitazone- and Pioglitazone- Containing Products, July 2007 - December 2012, June 6, 2013. Slides Dr. Joyce Weaver, FDA Senior Drug Risk Analayst, Office of Surveillance and Epidemiology, Office of Medication Error Prevention and Risk Management, Division of Risk Management, presents: The Rosiglitazone Risk Evaluation and Management Strategy, June 6, 2013. Slides Dr. Ken Mahaffey, Associate Director of DCRI, and Dr. Robert Bigelow, Associate Director of DCRI Clinical Trials Statistics, present: DCRI Response to Clarifying Questions, June 6, 2013. Slides GlaxoSmithKline presents: GSK Response to Clarifying Questions, June 6, 2013. Slides Dr. Hertzel C. Gerstein, Professor and Population Health Research Institute Chair in Diabetes at McMaster University and Hamilton Health Sciences, presents: Feasibility of a Clinical Outcomes Trial with Rosiglitazone Today, June 6, 2013. Slides Dr. Ann Meeker O'Connell, FDA Division of Good Clinical Practice Compliance, Office of Scientific Investigations, Office of Compliance/CDER/FDA, presents: FDA Inspection of Duke Clinical Research Institute (DCRI) Re-adjudication of the RECORD Trial, June 5, 2013. Slides Dr. Karen Murry Mahoney, FDA Lead Medical Officer, Diabetes Team I, Division of Metabolism and Endocrinology Products, presents: How the Readjudication of RECORD Addressed Some of the Concerns from the Original RECORD Reviews, June 5, 2013. Slides Dr. Eugenio Andraca-Carrera, FDA Division of Biometrics, Office of Biostatistics, Office of Translational Sciences, presents: FDA Statistical Analyses of RECORD based on Re-adjudicated Outcomes, June 5, 2013. Slides Dr. Thomas A. Marciniak, FDA Division of Cardiovascular and Renal Products, presents: A Critical Review of the RECORD Re-adjudication, June 5, 2013. Slides GlaxoSmithKline presents: GSK's Perspective on the Independent Re-adjudication of RECORD, June 5, 2013. Slides Dr. Kenneth W. Mahaffey, Associate Director of DCRI, and Dr. Robert Bigelow, Associate Director of DCRI Clinical Trials Statistics, present: Re-evaluation of RECORD Endpoints, June 5, 2013. Slides Dr. Kate Gelperin, FDA Division of Epidemiology, presents: Systematic review of epidemiologic studies of cardiovascular risk in patients treated with rosiglitazone or pioglitazone - update since 2010, June 5, 2013. Slides Dr. Preston M. Dunnmon, FDA Division of Cardiovascular and Renal Products, presents: The Re-adjudication of Mortality and MACE from the RECORD Trial, June 5, 2013. Slides Dr. Ellis F. Unger, Director of FDA Office of Drug Evaluation-I, Office of New Drugs and Center for Drug Evaluation and Research, presents: The FDA Review of Cardiovascular Outcomes - An Overview, June 5, 2013. Slides This Week in Cardiology  Dr. Ahmed Magdy and Dr. Duane Pinto discuss: Cardiology from an
Egyptian Perspective.
VideoACC 2013  Dr.
Hisao Ogawa, Dr. Naotaka Nakayama, and Dr. Masahide Nagano present:
ACC Wrap-Up in Japanese, March 11, 2013.
Video Dr.
Ali Ahmed and Dr. C. Michael Gibson discuss: Digoxin Reduces 30-Day
All-Cause Hospital Admission in Ambulatory Older Patients with
Chronic Heart Failure and Reduced Ejection Fraction.
Video |
SlidesDr. Vinod Thourani presents: Three-Year Outcomes after Transcatheter or Surgical Aortic Valve Replacement in High-Risk Patients with Severe Aortic Stenosis. Slides Dr. Anno Diegeler presents: The German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) Study. Slides Dr. Stavros Konstantinides presents: Single-bolus Tenecteplase Plus Heparin Compared With Heparin Alone for Normotensive Patients With Acute Pulmonary Embolism Who Have Evidence of Right Ventricular Dysfunction and Myocardial Injury: The Pulmonary Embolism Thrombolysis (PEITHO) Study. Slides  Dr.
Sigmund Silber presents: ACC Wrap-Up in German, March 11, 2013.
Video Dr.
Sergio Leonardi and Dr. Marco Valgimigli present: ACC Wrap-Up in
Italian, March 11, 2013.
Video Dr.
Margaret Redfield and Dr. Matthew Cavender discuss:
Phosphodiesterase-5 Inhibition to Improve Clinical Status and
Exercise Capacity in Diastolic Heart Failure (RELAX) Trial.
Video |
SlidesDr. Kenneth M. McDonald presents: The St. Vincent's Screening to Prevent Heart Failure Study: Impact of Natriuretic Peptide Guided Screening and Treatment on Long-Term Prevalence of Left Ventricular Dysfunction, Heart Failure and Cardiovascular Events (STOP-HF). Slides  Dr.
Mihai Gheorghiade and Dr. C. Michael Gibson discuss: The ASTRONAUT
Study: Aliskiren Trial On Acute Heart Failure Outcomes.
Video |
SlidesDr. Jan Hlavicka presents: PRAGUE-6 Trial: Off-Pump versus On-Pump Coronary Artery Bypass Graft Surgery in Patients with EuroSCORE > 6. Slides  Dr.
Andre Lamy and Dr. C. Michael Gibson discuss: CORONARY: The Coronary
Artery Bypass Grafting Surgery Off or On Pump Revascularization
Study Results at 1 Year.
Video |
Slides Dr.
Christopher U. Meduri and Dr. Anjan K. Chakrabarti discuss:
Cost-Effectiveness of Surgical Aortic Valve Replacement versus
Transcatheter Aortic Valve Replacement in High-Risk Patients Using
Real-World Registry Data.
Video |
Slides Dr.
Alice K. Jacobs and Dr. C. Michael Gibson discuss: A Randomized Trial
to Compare Percutaneous Coronary Intervention between Massachusetts
Hospitals with Cardiac Surgery On-Site and Community Hospitals
without Cardiac Surgery On-Site.
Video |
SlidesDr. Martin B. Leon presents: A Randomized Evaluation of the SAPIEN XT Transcatheter Valve System in Patients with Aortic Stenosis Who Are Not Candidates for Surgery: PARTNER 2, Cohort B Outcomes. Slides  Dr.
Harvey White presents: ACC Wrap-Up from a Pacific Rim Perspective,
March 10, 2013.
Video Dr.
Gilles Montalescot presents: ACC Wrap-Up in French, March 10, 2013.
Video Dr.
Basil Lewis and Dr. Amit Segev present: ACC Wrap-Up in Hebrew, March 10, 2013.
Video Dr.
Anjan K. Chakrabarti and Dr. Christopher U. Meduri discuss:
Angiographic Validation of the American College of Cardiology
Foundation's Cardiac Catheterization Database.
Video |
Poster Dr.
Alexandre Quadros, Dr. Renato Lopes and Dr. Otavio Berwanger
present: ACC Wrap-Up in Portuguese, March 10, 2013.
Video Dr.
Mikhail Kosiborod and Dr. C. Michael Gibson discuss: Evaluation of Ranolazine in Patients
With Type 2 Diabetes Mellitus and Chronic Stable Angina: Results
From the Type 2 Diabetes Evaluation of Ranolazine in Subjects With
Chronic Stable Angina (TERISA) Randomized Clinical Trial.
Video |
Slides Dr.
Gervasio A. Lamas presents: Randomized Comparison of High-Dose Oral
Vitamins versus Placebo in the Trial to Assess Chelation Therapy.
Slides Dr.
Jean-Claude Tardif and Dr. Christopher U. Meduri discuss: Effects of
the P-Selectin Antagonist Inclacumab in the Select-Acute Coronary
Syndromes Trial (SELECT-ACS).
Video |
SlidesDr.
Gilles Montalescot and Dr. C. Michael Gibson discuss: Early Administration of Eplerenone in
Patients with Acute Myocardial Infarction Without Heart Failure:
Results of the Randomized, Double-Blind, Placebo-Controlled REMINDER
Trial.
Video |
Slides Dr. Frans J. J. Van de Werf presents: The STREAM Trial: Strategic Reperfusion Early After Myocardial Infarction. Slides The Main Results of the CHAMPION PHOENIX Trial. Slides  Dr. Junjie Zhang
presents: Comparison of DK Crush Versus Culotte
Stenting for Unprotected Distal Left Main Bifurcation Lesions:
Results From a Multicenter, Randomized, Prospective DKCRUSH-III
Study.
Video |
Slides Dr.
David R. Holmes and Dr. Freek W.A. Verheugt discuss: Final Results of Randomized Trial of Left
Atrial Appendage Closure Versus Warfarin for Stroke/Thromboembolic
Prevention in Patients with Non-Valvular Atrial Fibrillation
(PREVAIL).
Video |
Slides
 Dr.
Masahiro Natsuaki and Dr. Matthew Cavender discuss: One-Year Outcome
of a Trial Comparing Second Generation Drug-Eluting Stents Using
Either Biodegradable Polymer or Durable Polymer: the NOBORITM
Biolimus-Eluting versus XIENCETM/PROMUSTM
Everolimus-Eluting Stent Trial (NEXT).
Video |
Slides Dr.
Anna Toso and Dr. Christopher U. Meduri discuss: Early High-Dose
Rosuvastatin for Contrast-Induced Nephropathy Prevention in Acute
Coronary Syndrome (PRATO-ACS).
Video |
Slides Dr. Jane Margaret Armitage
presents: HPS2-THRIVE: Randomized Comparison Of Extended-Release
(ER) niacin/laropiprant 2g Daily Versus Placebo in 25,673 Patients
At High Risk Of Occlusive Vascular Events.
Video |
SlidesAHA 2012  Dr.
Robert Giugliano and Dr. C. Michael Gibson discuss: LDL-C Assessment
with PCSK9 monoclonaL Antibody inhibition Combined with statin
thErapy – Thrombolysis In Myocardial Infarction-57 (LAPLACE-TIMI57).
Video |
Slides Dr.
Gilles Montalescot presents: AHA Wrap-Up in French, November 6,
2012.
VideoDr.
Gilles Montalescot and Dr. C. Michael Gibson discuss: A Randomized
Trial of Bedside Platelet Function Monitoring to Adjust Antiplatelet
Therapy Versus Standard of Care in Patients Undergoing Drug Eluting
Stent Implantation: The ARCTIC Study.
Video |
Slides Dr.
Bradley A. Bart and Dr. C. Michael Gibson discuss: Cardiorenal
Rescue Study in Acute Decompensated Heart Failure: Results of
CARRESS-HF, for the Heart Failure Clinical Research Network.
Video |
Slides Dr.
Christoph Varenhorst presents: AHA Wrap-Up in Swedish, November 6,
2012.
Video Dr.
Anne B. Curtis and Dr. C. Michael Gibson discuss: Biventricular
Versus Right Ventricular Pacing in Patients with Left Ventricular
Dysfunction and Atrioventricular Block (BLOCK HF Study).
Video |
SlidesDr.
Hisao Ogawa presents: AHA Wrap-Up in Japanese, November 6, 2012.
Video Dr.
Gregory G. Schwartz and Dr. C. Michael Gibson discuss: Effects of
the Cholesteryl Ester Transfer Protein Inhibitor Dalcetrapib in
Patients with Recent Acute Coronary Syndrome.
Video |
Slides Dr.
Jay H. Traverse and Dr. C. Michael Gibson discuss: The Effect of
Timing of Stem Cell Delivery Following Acute Myocardial Infarction:
The NHLBI and CCTRN Time Trial.
Video |
Slides Dr.
Daniel Suerder and Dr. C. Michael Gibson discuss: Results of the
Swiss Multicenter Intracoronary Stem Cells Study in Acute Myocardial
Infarction (Swiss AMI) Trial.
Video |
Slides Dr.
Roberto Bolli and Dr. C. Michael Gibson discuss: Effect of Cardiac
Stem Cells in Patients with Ischemic Cardiomyopathy: Interim Results
of the SCIPIO Trial Up to 2 Years After Therapy.
Video Dr.
Frederick J. Raal and Dr. C. Michael Gibson discuss: Reduction of
LDL-C with PCSK9 Inhibition in Heterozygous Familial
Hypercholesterolemia Disorder (RUTHERFORD): Interim Results from a
Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial.
Video |
Slides Dr.
Thomas R. Porter and Dr. C. Michael Gibson discuss: Prospective
Evaluation of Outcomes With Stress Perfusion Imaging Versus Stress
Wall Motion Imaging During Dobutamine or Excercise Echocardiography.
Video |
Slides Dr.
Paul Armstrong, Dr. Jonathan Howlett, Dr. Robert Welsh and Dr. Shaun
Goodman discuss: AHA Wrap-Up from a Canadian Perspective, November
6, 2012.
Video Dr.
Shinya Goto and Dr. C. Michael Gibson discuss: Once-Daily Esomeprazole 20 mg Prevents
Recurrence of Peptic Ulcer in East Asian Low-Dose Aspirin Users at
Gastrointestinal Risk: The LAVENDER Study.
Video |
Poster Dr.
Lars Wallentin presents: AHA Wrap-Up from a Scandinavian
Perspective, November 5, 2012.
Video Dr.
Howard D. Sesso and Dr. C. Michael Gibson discuss: A Randomized
Trial of a Multivitamin in the Prevention of Cardiovascular Disease
in Men: The Physicians' Health Study II.
Video |
Slides Dr.
Freek W.A. Verheugt, Dr. Jan Hein Cornel and Dr. Ton Oude Ophuis
discuss: AHA Wrap-Up from a Dutch Perspective, November 5, 2012.
VideoDr.
Basil Lewis and Dr. Jacob Goldstein discuss: AHA Wrap-Up in Hebrew,
November 5, 2012.
Video.jpg) Dr.
Harvey White presents: AHA Wrap-Up from a Pacific Rim Perspective,
November 5, 2012.
Video Dr.
Renato Lopes, Dr. Otavio Berwanger, and Dr. Roberto Giraldez
discuss: AHA Wrap-Up in Portuguese, November 5, 2012.
Video Dr.
Stephen D. Wiviott and Dr. C. Michael Gibson discuss: Interpretation
of Platelet Substudies from TRILOGY.
VideoDr.
Stephen D. Wiviott and Dr. C. Michael Gibson discuss: TRILOGY ACS
Angiographic Cohort: A Prospective, Randomized Trial of Prasugrel
vs. Clopidogrel in Patients with Non-ST-Segment Elevation ACS Who
Are Medically Managed After Coronary Angiography.
Video |
Slides Dr.
Evan Stein and Dr. C. Michael Gibson discuss: Goal Achievement after
Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
(GAUSS): Interim Results from a Randomized, Double-blind,
Placebo-controlled Study.
Video |
Slides Dr.
Eric L. Eisenstein and Dr. C. Michael Gibson discuss: Economic
Outcomes of Percutaneous Coronary Intervention Perfomed at Sites
With and Without On-Site Cardiac Surgery.
Video |
Slides Sesame Street's Dr. Rooster and Dr. C.
Michael Gibson discuss: The Fight Against Childhood Obesity.
Video Dr.
Valentin Fuster and Dr. C. Michael Gibson discuss: Main Results of
the Future Revascularization Evaluation in Patients with Diabetes
Mellitus: Optimal management of Multivessel disease (FREEDOM) Trial.
Video |
Slides Dr.
George Dangas and Dr. C. Michael Gibson discuss: FREEDOM: The
Interventionalists' Perspective.
Video Dr.
Massimo Mancone presents: AHA Wrap-Up in Italian, November 4, 2012.
Video Dr.
Elizabeth A. Magnuson and Dr. C. Michael Gibson discuss:
Cost-Effectiveness of PCI with Drug Eluting Stents versus Bypass
Surgery for Patients with Diabetes and Multi-vessel Coronary Artery
Disease: Results from the FREEDOM Trial.
Video |
Slides Dr.
Timothy Brighton and Dr. C. Michael Gibson discuss: Aspirin for The
Prevention of Recurrent Venous Thromboembolism After a First
Unprovoked Event: Results of the ASPIRE Randomized Controlled Trial.
Video |
Slides Dr.
Paul Gurbel, Dr. Magnus Ohman and Dr. C. Michael Gibson discuss:
First Large-Scale Platelet Function Evaluation in an Acute Coronary
Syndromes Trial - The TRILOGY ACS Platelet Function Sub-study.
Video |
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