American Heart Association

Saturday, Nov. 14

Trans-Catheter Aortic Valve Implantation in France: Early results of the French Multicenter Registry - Evaluate the safety and effectiveness of TAVI with the Edwards SAPIEN (Edwards Lifesciences LLC, Irvine, US) and the CoreValve (Medtronic, US) transcatheter heart valves in symptomatic adults with severe degenerative AS at high risk for AVR

Raptor - This trial was designed to evaluate the feasibility of switching from FA to RA as a routine strategy with regard to safety, comfort and resources.

PEPCAD III - The results will determine whether the drug-coated balloon in combination with a bare metal stent is an alternative to drug-eluting stents in the treatment of de-novo coronary lesions.

EXPIRA - In the present single-center, prospective randomized study, we sought to evaluate the safety and efficacy of thrombectomy in STEMI patients undergoing to primary angioplasty.

Sunday, Nov. 15

POPULAR - Prospective trial to assess which platelet function test is best to predict atherothrombotic events in patients treated with aspirin and clopidogrel undergoing PCI with stent implantation.

CHAMPION PCI trial will help determine the efficacy and safety of cangrelor versus pretreatment with a 600 mg loading dose of clopidogrel. These results may help define the necessary amount of ADP inhibition for PCI.

CHAMPION PLATFORM trial will help determine the efficacy and safety of potent procedural ADP receptor antagonism with cangrelor versus a 600 mg loading dose of clopidogrel given immediately after the procedure. In addition to important information about cangrelor, these results may help determine the relative merits of the timing of clopidogrel loading.

PLATO trial tested whether ticagrelor is superior to clopidogrelin preventing vascular events in patients with either non-ST-elevation ACS or ST-elevation ACS with planned primary percutaneous coronary intervention (PCI).

RELY - In the prospective randomized international multicentre RELY trial, we evaluated the efficacy and safety of two blinded doses of dabigatran, 110 mg b.d. and 150 mg b.d., versus open label warfarin for stroke prevention in AF and at least one risk factor for stroke.

REPLACE prospective multicenter registry was undertaken to estimate the procedure complication rates for patients undergoing a pacemaker, implantable cardioverter defibrillator (ICD) or cardiac resynchronization (CRT) generator replacement without (Cohort 1) or with planned lead addition (Cohort 2).

PACE -The Pacing to Avoid Cardiac Enlargement (PACE) trial is a prospective, multicenter, randomized, double blinded, parallel, controlled study, aiming to determine if biventricular (BiV) pacing is better than RVA pacing to preserve LV function and prevent LV remodeling.

RecordAF study is the first worldwide, prospective, observational survey of real-life management of atrial fibrillation (AF) in recently diagnosed patients. This analysis evaluates clinical outcomes of rhythm- and rate-control strategies in patients with paroxysmal or persistent AF.

Monday, Nov. 16

Outcomes Following Primary Percutaneous Coronary Intervention: A Comparison Between Hospitals With and Without Cardiac Surgery On-Site - To increase the number of ST-elevation myocardial infarction (STEMI) patients with timely access to primary percutaneous coronary intervention (PCI), the Massachusetts Department of Health approved a pilot program for primary PCI at hospitals without cardiac surgery on site (No SOS). To participate, No SOS hospitals were required to meet ACC/AHA guideline recommendations for hospital and operator volume of procedures. To determine the safety and efficacy of this strategy, we compared outcomes at 30 days and one-year between patients undergoing primary PCI at No SOS and SOS hospitals.

ARBITER 6-HALTS - Among patients at high cardiovascular risk already at their LDL-C goal on a statin but with low HDL-C, therapeutic options in the management of residual risk include combination therapy to raise HDL-C or further lower LDL-C. We compared these therapeutic approaches for their relative effects on carotid atherosclerosis

TREAT - The Trial to Reduce cardiovascular Events with Aranesp Therapy (TREAT) was initiated n 2004 as a randomized double-blind placebo-controlled trial to test the hypothesis that use of darbepoetin alfa to increase hemoglobin levels to 13 g/dL would reduce the likelihood of experiencing either death or cardiovascular morbidity (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) or the composite of death or need for long-term renal replacement therapy in patients with type 2 diabetes, chronic kidney disease (estimated glomerular filtration rate of 20 to 60 mL/min/1.73m2) and anemia (hemoglobin ≤ than 11g/dL). The yet to be unblinded results should provide a robust estimate of both the safety as well as potential efficacy of this form of anemia treatment for patients with diabetes and chronic kidney disease. This presentation will focus on the safety and efficacy data from the majority of patients with cardiovascular disease.

Impact of Transfusion Triggers on Postoperative Myocardial Infarction or Death - will report comparisons for ACS events and 30-day mortality.

CASCADE - This trial is the first prospective randomized study to evaluate whether the addition of clopidogrel to aspirin reduces SVG intimal hyperplasia and improves graft patency following CABG. Formal presentation of the CASCADE trial results will be made available for the first time at the American Heart Association Scientific Sessions in November 2009

Octopus Study - The Octostent trial is a randomized comparison of OPCAB versus PCI in 280 symptomatic coronary artery disease patients

Bypassing The Blues - Depression is common following CABG surgery and associated with worse clinical outcomes. Several treatment trials for depression have been conducted in cardiac populations but most achieved less than anticipated benefits at reducing mood symptoms or cardiovascular morbidity, and none utilized the “collaborative care” (CC) approach proven effective in primary care. The NHLBI-funded Bypassing the Blues trial is the first to examine the impact of CC for treating depressed patients with cardiovascular disease.

POPE - Non-steroidal anti-inflammatory drugs (NSAIDs) are widely prescribed in this setting, although no study has assessed their efficacy. We assessed whether the NSAID diclofenac was effective in reducing post operative PE (POPE) volume

Tuesday, Nov. 17

BARI2D - To examine the benefit of prompt coronary revascularization or insulin-sensitization therapy in type II diabetes (T2D) as treatment strategies to reduce non-fatal myocardial infarction (MI).

Quality of Life Results in the Bypass Angioplasty Revascularization Investigation 2 Diabetes - Duke Activity Status Index (DASI), a measure of daily activities performed without difficulty, and the RAND Medical Outcomes Study measures Energy, Health Distress and Self-rated Health were assessed at study entry and on an annual basis. Linear mixed models were used to evaluate the effect of randomized treatment on follow-up HRQoL adjusting for baseline level.

Economic Outcomes of the Bypass Angioplasty Revascularization Investigation 2 Diabetes - BARI2D trial randomized patients with type 2 diabetes and coronary disease in a 2x2 factorial design to 1) insulin sensitization vs. insulin provision, and 2) prompt revascularization vs. medical therapy. Prior to randomization, the physician declared whether CABG or PCI would be used if the patient were assigned to prompt revascularization. We followed 2005 patients from 46 clinical sites for medical utilization and assigned costs using U.S. Medicare cost weights.

STICH - This first report of STICH core laboratory data analysis will definitively confirm whether comprehensive analysis of LV function identified a specific patient population that benefited from adding SVR to CABG.

HEAAL - The results of HEAAL will provide the first definitive information regarding the relative outcome effects of different ARB dosing regimens in patients with symptomatic heart failure and reduced LVEF

FAIR-HF - This study will provide information on the efficacy and safety of iron repletion with ferric carboxymaltose in CHF patients with ID with and without anemia. Results of FAIR-HF are available by end of September and will be presented.

Japanese Chronic Heart Failure (J-CHF) - Even at 5 mg/day, carvedilol improved morbidity compared to placebo in Japanese patients with chronic heart failure (CHF) in the MUCHA trial, raising the question of whether an improvement in ejection fraction leads to a better outcome. Previous large trials investigated the effects of higher dose of β-blockers on mortality in CHF. However, the effective and safe minimal dose of β-blockers remains unknown. Moreover, prediction of mortality and responsiveness based on genetic variation in CHF has not been established because of racial and individual differences.

HeartMate II Destination Therapy - reports the outcomes of a multi-center, prospective, randomized trial comparing treatment with the currently approved PF- versus a CF-LVAD in patients ineligible for transplantation.

Wednesday, Nov. 18

CT-CTAT is a randomized, multicenter study that sought to compare the safety and efficiency of coronary computed tomographic angiography (CCTA) to standard of care (SOC) evaluation of low-intermediate risk patients with acute chest pain.

Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) was a double-blind, randomized, hypertension treatment trial. Active follow-up of 42,418 participants ended on March 31, 2002 (Feb. 15, 2000 for doxazosin participants), with an average follow-up of 4.9 years (3.2 years for doxazosin). Post-trial, passive follow-up of participants was conducted through 2006 to compare long-term effects of antihypertensive treatment with a thiazide-type diuretic, a CCB, an ACE-inhibitor, or an α-receptor blocker, each drug used as initial treatment, with step-up drugs added as needed. Specifically, we evaluated whether new differences emerged for in-trial outcomes that were not statistically different, especially CHD and total mortality, and whether in-trial observed differences for HF and aggregate CVD continued.

Enhanced Feedback for Effective Cardiac Treatment (EFFECT) - Public report cards on hospital performance are increasingly common, but whether they are an effective method for improving quality of care remains uncertain. Therefore, we conducted a population-based cluster randomized trial, called the Enhanced Feedback for Effective Cardiac Treatment (EFFECT) study, to evaluate whether public report cards could improve the quality of cardiac care delivery in Ontario, Canada.

RE-DEEM study is a phase II, randomized, double-blind, placebo-controlled, dose-escalation study evaluating the safety of four doses of dabigatran etexilate: 50, 75, 110 or 150 mg twice daily.