CardioExchange Archive

The American College of Cardiology announced the lineup of late-breaking clinical trials for its upcoming annual meeting in Washington, DC. The opening session will include the most eagerly anticipated trials — the main results of Symplicity HTN-3 and the  comparison of Corevalve and surgery in high-risk patients. Subsequent sessions will include several phase-3 trials of  PCSK9 inhibitors. Here is the complete list of trials:

ACC.14 Opening Showcase and the Joint ACC/JACC Late-Breaking Clinical Trials

• March 29, 2014, 8:00 – 10:00 AM
• Chair: John Gordon Harold
• Panelists: Valentin Fuster, David E. Kandzari, Sanjay Kaul, Michael J. Mack

9:10 – 9:25 AM 451-13 – A Randomized Comparison of Self-expanding Transcatheter and Surgical Aortic Valve Replacement in Patients with Severe Aortic Stenosis Deemed High-Risk for Surgery

• David H. Adams, Michael J. Reardon, Steven J. Yakubov, Joseph S. Coselli, G. Michael Deeb, Thomas G. Gleason, Maurice Buchbinder, Blase Carabello, James Hermiller, Jr., Patrick W. Serruys, Neal S. Kleiman, Stanley Chetcuti, John Heiser, William Merhi, George Zorn, Peter Tadros, Newell Robinson, George Petrossian, G. Chad Hughes, J. Kevin Harrison, John Conte, Jae K. Oh, Jeffrey J. Popma, Mount Sinai Medical Center, New York, NY, USA

9:35 – 9:50 AM 451-15 – The Main Results of SYMPLICITY HTN-3

• Deepak L. Bhatt, David Kandzari, William O’Neill, Ralph D’Agostino, Murray Esler, John Flack, Barry Katzen, Martin Leon, Minglei Liu, Laura Mauri, Manuela Negoita, Suzanne Oparil, Krishna Rocha-Singh, Paul Sobotka, Raymond Townsend, George Bakris, for the SYMPLICITY HTN-3 Investigators, Brigham and Women’s Hospital Heart and Vascular Center, Boston, MA, USA, University of Chicago, Chicago, IL, USA

Joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials

• March 30, 2014, 8:00 – 9:15 AM Hall D (Main Tent)
• Co-Chairs: Howard C. Bauchner, Prediman K. Shah
• Panelists: Joseph S. Alpert, Roger S. Blumenthal, Jeffrey T. Kuvin, Roxana Mehran, Nathan D. Wong

8:00 – 8:10 AM 402-08 – Effect of Inhibition of Lipoprotein-Associated Phospholipase A2 with Darapladib on Ischemic Events in Patients with Chronic Coronary Heart Disease: The STABILITY (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb TherapY) Trial

• Harvey D. White, Claes Held, Ralph Stewart, Philippe Steg, Andrzej Budaj, Robert Harrington, Elizabeth Tarka, Rebekkah S. Brown, Christopher Cannon, Lars Wallentin, the STABILITY Investigators., Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand, Uppsala Clinical Research center, Uppsala, Sweden

8:15 – 8:25 AM 402-10 – The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2 Trial: A Phase 3, Double-blind, Randomized, Placebo and Ezetimibe Controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Combination With Statin Therapy in Subjects With Primary Hypercholesterolemia and Mixed Dyslipidemia

• Jennifer Robinson, Bettina S. Nedergaard, William Rogers, Jonathan Fialkow, Joel Neutel, David Ramstad, Ransi Somaratne, Jason Legg, Patric Nelson, Robert Scott, Scott Wasserman, Robert Weiss, for the LAPLACE-2 Investigators, Amgen Inc., Thousand Oaks, CA, USA

8:30 – 8:40 AM 402-12 – Evaluation of the Dual PPAR-αγ Agonist Aleglitazar to Reduce Cardiovascular Events in Patients with Acute Coronary Syndrome and Type 2 Diabetes Mellitus: the AleCardio Trial

• A. Michael Lincoff, Jean Claude Tardif, Bruce Neal, Stephen Nicholls, Lars Ryden, Gregory Schwartz, Klas Malmberg, John Buse, Robert Henry, Hans Wedel, Arlette Weichert, Anders Svensson, Ruth Cannata, Diederick Grobbee, AleCardio Study Investigators, Cleveland Clinic, Cleveland, OH, USA

8:45 – 8:55 AM 402-14 – Two-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)

• Masahiro Natsuaki, Ken Kozuma, Takeshi Morimoto, Kazushige Kadota, Toshiya Muramatsu, Yoshihisa Nakagawa, Takashi Akasaka, Keiichi Igarashi, Kengo Tanabe, Yoshihiro Morino, Tetsuya Ishikawa, Hideo Nishikawa, Masaki Awata, Mitsuru Abe, Hisayuki Okada, Yoshiki Takatsu, Nobuhiko Ogata, Kazuo Kimura, Kazushi Urasawa, Yasuhiro Tarutani, Nobuo Shiode, Takeshi Kimura, Kyoto University, Kyoto, Japan, Saiseikai Fukuoka General Hospital, Fukuoka, Japan

9:00 – 9:10 AM 402-16 – A Phase 3 Double-blind, Randomized Study to Assess the Safety and Efficacy of Evolocumab (AMG 145) in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of Statin

• Erik S.G. Stroes, David Colquhoun, David Sullivan, Fernando Civeira, Robert Rosenson, Gerald F. Watts, Eric Bruckert, Ricardo Dent, Allen Xue, Robert Scott, Scott Wasserman, Michael Rocco, GAUSS-2 Investigators, Amgen Inc., Thousand Oaks, CA, USA

Late-Breaking Clinical Trials III

• March 30, 2014, 10:45 – 12:00 PM Hall D (Main Tent)
• Co-Chairs: Rick A. Nishimura, Evan M. Zahn
• Panelists: George L. Bakris, Massimo Imazio, Allan S. Jaffe, Michael Shehata, Ronald G. Victor

10:45 – 10:55 AM 403-08 – Efficacy And Safety Of Colchicine In Patients With Multiple Recurrences Of Pericarditis: Results Of A Multicenter, Double-blind, Placebo-controlled, Randomized Study (corp-2 Trial).

• Massimo Imazio, Riccardo Belli, Antonio Brucato, Roberto Cemin, Stefania Ferrua, Yehuda Adler, David H. Spodick, Rita Trinchero, Cardiology Department, Maria Vittoria Hospital, Torino, Italy

11:00 – 11:10 AM 403-10 – The Global SYMPLICITY Registry: Safety and Effectiveness of Renal Artery Denervation In Real World Patients With Uncontrolled Hypertension

• Michael Bohm, Markus Schlaich, Krzysztof Narkiewicz, Luis Ruilope, Bryan Williams, Roland Schmieder, Felix Mahfoud, Giuseppe Mancia, Universitätskliniken des Saarlandes, Klinik für Innere Medizin III, Homburg/Saar, Germany

11:15 – 11:25 AM 403-12 – One Year Follow-up of the Melody Transcatheter Pulmonary Valve Multicenter Post Approval Study

• Aimee K. Armstrong, David Balzer, Allison Cabalka, Robert Gray, Alexander Javois, Jacqueline Kreutzer, John Moore, Jonathan Rome, Daniel Turner, Thomas Zellers, University of Michigan C.S. Mott Children’s Hospital, Ann Arbor, MI, USA, Children’s Hospital of Pittsburgh, Pittsburgh, PA, USA

11:30 – 11:40 AM 403-14 – Long-term Survival with Cardiac Resynchronization Therapy in Patients with Mild Heart Failure

• Ilan Goldenberg, Valentina Kutyifa, Helmut Klein, Scott McNitt, Scott Solomon, Arthur Moss, MADIT-CRT Executive Committee, University of Rochester Medical Center, Rochester, NY, USA, Sheba Medical Center, Tel Hashomer, Israel

11:45 – 11:55 AM 403-16 – Negative High-Sensitive Troponins in the Emergency Department and Risk of Myocardial Infarction

• Nadia Bandstein, Magnus Johansson, Rickard Ljung, Martin Holzmann, Karolinska Institutet, Stockholm, Sweden

Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials

• March 31, 2014, 8:00 – 9:15 AM Hall D (Main Tent)
• Co-Chairs: John A. Jarcho, Steven E. Nissen
• Panelists: Yochai Birnbaum, Scott Cunneen, Michael H. Davidson, D. Craig Miller, Freek W. A. Verheugt

8:00 – 8:10 AM 404-08 – The Impact of Acetyl-Salicylic Acid on Major Arterial and Venous Complications in Patients Undergoing Noncardiac Surgery

• P.J. Devereaux, POISE-2 Investigators, Population Health Research Institute, Hamilton, Canada

8:15 – 8:25 AM 404-10 – A Large International Trial Assessing the Effects of Clonidine on Major Arterial Events in Patients Having Noncardiac Surgery

• Daniel I. Sessler, P.J. Devereaux, POISE-2 Investigators, Outcomes Research, Cleveland Clinic, Cleveland, OH, USA

8:30 – 8:40 AM 404-12 – Steroids in Cardiac Surgery Trial (SIRS)

• Richard Whitlock, Population Health Research Institute, McMaster University/Hamilton Health Sciences, Hamilton, Canada

8:45 – 8:55 AM 404-14 – Metformin in Acute Myocardial Infarction

• Chris PH Lexis, Iwan CC van der Horst, Erik Lipsic, Jan Tijssen, Pim van der Harst, Dirk van Veldhuisen, GIPS-III Investigators, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands

9:00 – 9:10 AM 404-16 – Effect of Bariatric Surgery vs. Intensive Medical Therapy on Long-term Glycemic Control and Complications of Diabetes: 3-Year STAMPEDE Trial Results

• Philip Raymond Schauer, John Kirwan, Kathy Wolski, Stacy Brethauer, Sankar Navaneethan, Ali Aminian, Claire Pothier, Steven Nissen, Deepak Bhatt, Sangeeta Kashyap, Cleveland Clinic, Cleveland, OH, USA

Late-Breaking Clinical Trials V: TCT@ACC-i2

• March 31, 2014, 10:45 – 12:00 PM Hall D (Main Tent)
• Co-Chairs: Cindy L. Grines, Gregg Stone
• Panelists: David L. Brown, David E. Kandzari, Dean J. Kereiakes, Roxana Mehran, William W. O’Neill

10:45 – 10:55 AM 405-08 – One Year Outcomes from the STS/ACC Transcatheter Valve Therapy (TVT) Registry

• David R. Holmes, J. Matthew Brennan, John Rumsfeld, Dadi (David) Dai, Fred Edwards, John Carroll, David Shahian, Frederick Grover, E. Murat Tuzcu, Eric Peterson, Ralph Brindis, Michael Mack, Mayo Clinic, Rochester, MN, USA

11:00 – 11:10 AM 405-10 – A Randomized Comparison of Self-Expandable and Balloon-Expandable Prostheses in Patients Undergoing Transfemoral Transcatheter Aortic Valve Replacement – The CHOICE Trial

• Mohamed Abdel-Wahab, Julinda Mehilli, Ulrich Schäfer, FJ Neumann, Thomas Kurz, Ralph Toelg, Bettina Schwarz, Ken Gordian, Volker Geist, Steffen Massberg, Christian Frerker, Mohamed El-Mawardy, Gert Richardt, Heart Center, Segeberger Kliniken, Bad Segeberg, Germany

11:15 – 11:25 AM 405-12 – Unfractionated Heparin versus Bivalirudin in Primary Percutaneous Coronary Intervention: A Unique Randomized Controlled Trial with Consecutive, Unselected Patient Enrollment (using Delayed Consent), Designed to Reflect Real-World, Contemporary Practice

• Adeel Shahzad, Ian Kemp, Christine Mars, Rob Cooper, Claire Roome, Keith Wilson, Rod Stables, HEAT-PPCI investigators, Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital NHS Trust, Liverpool, United Kingdom

11:30 – 11:40 AM 405-14 – Bare Metal vs. Zotarolimus-eluting stent in Uncertain Drug-eluting Stent Candidates: A Randomized Controlled Trial

• Marco Valgimigli, ZEUS investigators, , Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands

11:45 – 11:55 AM 405-16 – Autotransplantation of Bone Marrow Derived Mesenchymal Stromal Cells in Patients with Severe Ischemic Heart Failure: The MSC-HF Trial

• Anders Bruun Mathiasen, Abbas Qayyum, Erik Jørgensen, Steffen Helqvist, Anne Fischer-Nielsen, Klaus Kofoed, Mandana Haack-Sørensen, Annette Ekblond, Jens Kastrup, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark, Denmark