Stent Thrombosis
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Stent Thrombosis |
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FDA Meeting Regarding Risk of Stent Thrombosis with Drug Eluting Stents
Slidesets from the Food and Drug Administration Circulatory System Devices Panel December 7 , 2006 Open Public Hearing
The Vascular Pathology of Drug Eluting Stents: Delayed Healing and Late Thrombotic Risk, Herman Gold, CVPath and Massachusetts General Hospital View / Download Slides (pdf)
Late Stent Thrombosis After DES: Role of Platelet Function Testing, Alan Michelson, Center for Platelet Function, University of Massachusetts Medical School View / Download Slides (pdf)
Impact of Stent Thrombosis on Outcomes of Death and MI after Drug-Eluting Stenting - Importance of Standard Definitions and Analytical Methods, Don Cutlip, Harvard Clinical Research Institute Harvard Medical School View / Download Slides (pdf)
Perspectives on Drug-eluting Stent Safety and Efficacy with Regulatory Recommendations, Gregg W. Stone, Columbia University Medical Center Cardiovascular Research Foundation View / Download Slides (pdf)
Four-Year Follow-up of Sirolimus-eluting Stents in Comparison with Bare Metal Stents: A Pooled Safety Analysis of the RAVEL, SIRIUS, E-SIRIUS, and C-SIRIUS Trials in 1,748 Patients, Patrick Serruys, Erasmus Medical Center View / Download Slides (pdf)
Incidence and Predictions of Drug Eluting Stent Thrombosis during and Following Discontinuation of Thienopyrdine Treatment, Antonio Colombo, Centro Cuore Columbus S. Raffaele Hospital View / Download Slides (pdf)
Long-term outcome of DES vs BMS implanted in Sweden 2003 – 2004, Lars Wallentin, Uppsala Clinical Research Centre, UCR, Uppsala University View / Download Slides (pdf)
Late Coronary Stent Thrombosis of DES in Routine Clinical Practice - Data from a Large Two-Institutional Cohort Study, Patrick Serruys, Erasmus Medical Center View / Download Slides (pdf)
Patrick Serruys – Thoraxcenter real world experience – Erasmus Medical Center View / Download Slides (pdf)
Preliminary One-Year Outocome After Sirolimus-eluting Stent Implantation The J-Cypher Registry Update, Takeshi Kimura Kyoto University Hospital View / Download Slides (pdf)
Meta-Analyses of Randomized Trials of Sirolimus-Eluting Stents vs. Paclitaxel-Eluting Stents or Bare Metal Stents: An Independent, Individual Patient Data Based Study, Adnan Kastrati, Deutsches Herzezentrum View / Download Slides (pdf)
ARTS II Data entitled: “ Adjudication of events for FDA Panel, Gerrit-Anne van Es, Cardialysis, the Netherlands View / Download Slides (pdf)
Drug-Eluting Stent Safety Profile Stent Thrombosis, Campbell Rogers, Cordis View / Download Slides (pdf)
“Real-World” Use of the CYPHER Sirolimus-Eluting Stent, Data from Randomized Controlled Trials and Registries, Sidney A. Cohen, Cordis View / Download Slides (pdf)
On-label Use of the TAXUS Drug-eluting Stent System, Donald S. Baim, Boston Scientific Corporation View / Download Slides (pdf)
Real-world use of the TAXUS Drug-eluting Stent System, Donald S. Baim, Boston Scientific Corporation View / Download Slides (pdf)
FDA Summary, Takahiro Uchinda, Andrew Farb, Andrea Holton, Hesha Duggirala View / Download Slides (pdf)
Stent Thrombosis: The Implications of Broader DES Use, Robert P. Fiorentino, FDA View / Download Slides (pdf)
December 8 , 2006 Open Public
Hearing Speakers
Dante Pazzanese, Alexandre Abizaid, Columbia University View / Download Slides (pdf)
A Prospective “All Comers” Single Arm Study in Complex Patients: The MATRIX Trial - IDE: G030229/S003CypherTM Sirolimus-Eluting Coronary Stent, Roxana Mehran, The Columbia University Medical Center View / Download Slides (pdf)
Drug-Eluting vs. Bare Metal Stents: Results from a Practice-Based Registry, David Kong View / Download Slides (pdf)
Longitudinal Outcomes Following Drug Eluting Stent Implantation, David Magid, Kaiser Permanente of Colorado, Kaiser Permanente of Northern California View / Download Slides (pdf)
Comparisons of Drug Eluting to Bare Metal Stents: Findings from the NHLBI-Dynamic and the DEScover Registries, David Williams, Rhode Island Hospital , Brown University View / Download Slides (pdf)
Prairie “Real World” Drug Eluting Stent Database, Gregory Mishkel, Prairie Cardiovascular, Springfield , Illinois View / Download Slides (pdf)
Mark A. Turco – Washington Adventist Hospital View / Download Slides (pdf)
DES Thrombosis Results From Contemporary Registries, Ron Waksman, Washington Hospital Center View / Download Slides (pdf) Drug Eluting Stents: Balancing Risks and Benefits, Sanjay Kaul, Cedars-Sinai Medical Center View / Download Slides (pdf)
A Clinician's Perspective on Drug-Eluting Stents:Balancing Safety and Efficacy, Jeffery Moses, Columbia University Medical Center View / Download Slides (pdf)
Relative Merits and Clinical Selection of CABG, Bare Metal Stents, and Drug Eluting Stents in Practice and in Evolution, Peter Smith, Duke University View / Download Slides (pdf)
History of Evidence Based Coronary Revascularization –Can we identify our mistakes and not repeat them?, Robert Guyton, Emory University School of Medicine View / Download Slides (pdf)
Summary Recommendations to FDA, Bruce Ferguson, Society of Thoracic Surgeons' Perspective, Brody School of Medicine at ECU View / Download Slides (pdf)
Impact of DES in STEMI The Minneapolis Heart Institute Level 1 MI Program, Timothy Henry, Minneapolis Heart Institute Foundation View / Download Slides (pdf)
DES in Thrombosed Coronary Lesions, Jim Gustafson, Possis Medical Inc. View / Download Slides (pdf)
What is the Right Dose, Timing and Duration of Clopidogrel Therapy when Used with Drug Eluting Stents?, Robert Hillman, Accumetrics Inc. View / Download Slides (pdf)
Medtronic Vascular - Endeavor Safety Analysis, Rick Kuntz, Medtronic, Inc. View / Download Slides (pdf)
Abbott Vascular Drug Eluting Stent Program, Krishna Sudhir, Abbott Vascular View / Download Slides (pdf)
Planned Combined Safety Analysis for Stents Utilizing Biolimus A9® and Biodegradable Polymer, Laura Mauri, Harvard Clinical Research Institute View / Download Slides (pdf) ACC Testimony, James T. Dove, American College of Cardiology View / Download Slides (pdf)
Gregory J. Dehmer, SCAI View /
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Unscheduled Speakers
Rick Dulin (pdf)
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BASKET Late Trial: Higher Risk of late Death/MI Among Pts Treated with DES vs Bare Metal Stents
Bern-Rotterdam Registry Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Daemen et al. Lancet. 2007 Feb 24; 369: 667-78
PREMIER Registry Discontinuation of clopidogrel associated with higher mortality following drug eluting stent implantation in STEMI, adds to concerns of BASKET Late
Bavry and Bhatt Meta Analysis of Risk of Thrombosis among Drug Eluting Stent vs Bare Metal stent in American Journal of Medicine Download slides
DEScover Registry: First large registry (n=7700) of DES vs BMS published including adjustment for baseline angiographic findings. BMS are put in higher risk pts such as STEMI clouding interpretation of results.
Future Trials of DES thrombosis
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