ACC.12 late-breaking trials cover gamut of clinical advances
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| David R. Holmes, Jr., MD Source: American College of Cardiology (ACC) |
The Cardiovascular Business editorial team will provide comprehensive coverage of the event, which offers more than a dozen late-breaking clinical trials that not only cover treatments ranging from therapeutics to imaging, but also incorporate a large body of data from international studies.
“This is an amazing lineup of late-breaking clinical trials that are aimed at broad and different ideas, patient care strategies and patient groups,” Holmes said. The late-breaking trials and the date they will be presented are provided below.
Saturday, March 24
FOCUS Study: A randomized clinical trial to study the efficacy of bone marrow cells to improve indices of heart function in patients with coronary disease and reduced heart function. In the study, autologous bone marrow mononuclear cells were harvested from patients with ischemic heart failure and then re-injected into their functioning myocardium. The study is supported by the National Institutes of Health’s Cardiovascular Cell Therapy Research Network.
TIMI 50 Trial: A double-blind prospective clinical trial to assess whether vorapaxar (Merck), a novel antiplatelet agent, added to standard care helps reduce adverse cardiovascular outcomes such as death, MI or stroke in patients with chronic ischemic heart disease. Vorapaxar has been found to be beneficial in the acute setting.
Sunday, March 25
CPORT-E Trial: A randomized trial designed to evaluate the safety and efficacy of performing elective PCI in hospitals without cardiac surgery backup compared with hospitals with onsite cardiac surgery available if an emergency develops during the procedure. The final nine-month results will be presented.
INFUSE-AMI trial: A multicenter, prospective, randomized evaluation of the efficacy of the combination abciximab (ReoPro, Eli Lilly), an intravenous antiplatelet agent, with the use of aspiration thrombectomy at the time of anterior STEMI in patients undergoing primary PCI.
HOST-ASSURE trial: A randomized trial designed to compare two antiplatelet strategies—adding cilostazol (Pletal, Otsuka Pharmaceutical) in combination with aspirin versus doubling the dose of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) in combination with aspirin—after patients receive PCI. The trial is based in Seoul, South Korea, where cilostazol is frequently used to prevent stent thrombosis.
BRIDGE-ACS trial: A Brazilian registry study of an intervention designed to increase the frequency that patients receive evidence-based medications and treatments following presentation of ACS.
Monday, March 26
CORONARY trial: A large, international trial designed to compare the risks and benefits of off-pump CABG to on-pump CABG and to determine if one is better than the other. It is the largest comparison trial of the two techniques, based on data from nearly 5,000 patients at 80 centers across 20 countries.
ACRIN-PA trial: A multicenter, randomized controlled study of the American College of Radiology Imaging Network (ACRIN) to compare coronary CT angiography (CCTA) versus standard care of low-risk patients in emergency departments who present with potential ACS. In the study, patients were randomized to either a traditional “rule out” care group or a CCTA group to determine whether CCTA can be safely used to discharge low-risk patients to home from the emergency department.
EINSTEIN PE trial: An investigation of the use of oral, direct Factor Xa inhibitor rivaroxaban (Xarelto, Janssen Research & Development) compared with standard care in the treatment of patients with pulmonary embolism.
PARTNER trial: The two-year results on Cohort A of the PARTNER trial, focusing on the clinical and echocardiographic outcomes after transcatheter versus surgical aortic valve replacement. The Partner A cohort consists of high-risk patients. In this study, half of the high-risk patients were randomized to transcatheter and half to standard aortic valve replacement surgery.
STAMPEDE trial: A three-armed randomized study to compare two types of bariatric surgery for the treatment of type 2 diabetes in patients with moderate obesity. The study stratifies patients into one of two surgical arms or advanced medical therapy.
An LDL trial: This trial, which has no acronym, is a randomized controlled trial of the long-term reduction in low-density lipoprotein cholesterol (LDL-C) beginning early in life. The study includes an examination of genetic factors that control LDL-C and long-term outcomes to determine if early recognition and intervention have long-term health benefits.
A monoclonal antibody trial: A novel randomized, double-blind, placebo-controlled trial of the safety and efficacy of a monoclonal antibody to alter the lipid profiles in patients with primary hypercholesterolemia. The target is proprotein convertase subtilisin/kexin type 9 serine protease, which plays a role in the production of LDL.
ISSUE-3 trial: An Italian trial to evaluate the use of pacemakers in patients with neutrally mediated syncope and documented asystole. The study compares the use of a pacemaker therapy in patients with both low-heart rate and low-blood pressure syncope compared with patients with either low-heart rate syncope or low-blood pressure syncope.
Tuesday, March 27
ASCERT registry analysis: Results from the ACC-Society of Thoracic Surgeons database collaboration on the comparative effectiveness of revascularization strategies. This is an analysis of the overall results of an examination of clinical outcomes in patients with multivessel CAD who are managed with either PCI or CABG.
ROMICAT II trial: A multicenter, randomized comparative effectiveness trial of cardiac CT compared with alternative triage strategies in patients who present with nondiagnostic chest pain in the emergency department. This study examines whether integrating cardiac CT improves the efficiency of the management of these patients.
IMMEDIATE trial: A double-blind randomized controlled trial that examines the use of intravenous glucose, insulin and potassium (GIK) for managing patients with ACS in Emergency Medical Services (EMS) settings. The study looks at the clinical effectiveness of this intervention in up to 32 EMS systems in the U.S. treating patients with more than a 75 percent probability of ACS or obvious STEMI.
MOPETT trial: A trial to study the efficacy of using thrombolytic therapy in patients with moderate pulmonary embolism; typically this approach is reserved for patients with massive or sub-massive pulmonary emboli.
ACC Chair Patrick T. O’Gara, MD, and ACC-i2 Chair E. Murat Tuzcu, M.D., emphasized that the trials address a number of questions of clinical importance, with international presenters selected to shed light on high priority topics in the U.S. “We are particularly excited to be able to feature an international trial from Asia,” O’Gara said, referring to the HOST-ASSURE trial. “We think it will have great relevance and provide insights to our interventional community.”
Holmes is a cardiologist at the Mayo Clinic in Rochester, Minn; O’Gara is the director of clinical cardiology at Brigham and Women’s Hospital in Boston; and Tuzcu is an interventional cardiologist at the Cleveland Clinic.
More information about the ACC.12 scientific session is available here.