January 22nd, 2013

Trials of Niacin and AF Device Will Headline American College of Cardiology Program

Two big trials will highlight this year’s American College of Cardiology (ACC) meeting in March in San Francisco. First is the PREVAIL trial testing Boston Scientific’s long-anticipated Watchman left atrial appendage closure device for stroke prevention in patients with atrial fibrillation (AF). Second is the detailed presentation of the controversial failed HPS2-THRIVE trial of extended-release niacin and laropiprant. The final list of trials has been posted on the ACC website.

Boston Scientific’s Watchman device has been the subject of intense interest since the PROTECT AF trial in 2009. However, the FDA raised numerous questions about the device and, despite a positive recommendation from the Circulatory Systems Devices panel, required the company to perform a new pivotal trial. That trial, PREVAIL (Prospective Randomized Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy), will be presented on Saturday, March 9, at the ACC. The trial was designed to confirm the overall finding of the earlier trial that Watchman was noninferior to standard warfarin therapy (PROTECT) and to address lingering safety and efficacy issues raised by that trial.

In December, Merck disclosed that the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) had failed to meet its primary endpoint. The trial, which was the largest-ever study of niacin, found no benefit, and a signal of harm, for the combination of a statin and the combination of extended-release niacin and laropiprant when compared to statin therapy alone in 25,673 patients at high risk for cardiovascular events. Interest in the detailed results of the trial is keen. Experts will sift the tea leaves for any clues the trial may provide about the viability of the HDL hypothesis, while some experts believe that niacin may yet prove to be found beneficial.

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Also of particular interest will be the PARTNER 2, Cohort B trial, testing the next generation of Edwards’ transcatheter aortic valve replacement (TAVR) system in patients with aortic stenosis who are not candidates for surgery. Partner 2, however, is not expected to attract the same attention as the original PARTNER trials, as TAVR this year has started to enter clinical practice in the U.S. and is no longer the subject of much controversy.

Another trial of interest is the CHAMPION PHOENIX Trial. According to the Medicines Company, which released top line results earlier this month, the trial found that the new antiplatelet drug cangrelor was superior to clopidogrel in reducing ischemic events at 48 hours in PCI patients. Nearly 11,000 patients scheduled for PCI for either stable angina or an acute coronary syndrome were enrolled in the study.

The REMINDER Trial tested the effect of the early adminstration of eplerenone in approximately 1,000 patients with acute MI but without heart failure. The primary endpoint is the time to cardiovascular mortality, rehospitalization, or extended initial hospital stay due to diagnosis of heart failure or sustained VT/VF.

Following the highly controversial presentation of the initial results of TACT (Trial to Assess Chelation Therapy) last year at the AHA, which raised the possibility that chelation therapy might be beneficial, the TACT investigators will present the results of the second part of the trial, in which patients were randomized to an oral high-dose vitamin and mineral supplement or placebo.

Here is the ACC’s complete list of late-breaking clinical trials:

Late-Breaking Clinical Trials I

Saturday, March 9, 8 – 10 a.m.

  • Final Results of Randomized Trial of Left Atrial Appendage Closure Versus Warfarin for Stroke/Thromboembolic Prevention in Patients with Non-Valvular Atrial Fibrillation (PREVAIL)
  • 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

Late-Breaking Clinical Trials II: Interventional

Sunday, March 10, 8 – 9:30 a.m.

  • Early High-Dose Rosuvastatin for Contrast-Induced Nephropathy Prevention in Acute Coronary Syndrome
  • 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
  • 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)
  • Comparison of DK crush versus culotte stenting for unprotected distal left main bifurcation lesions: Results from a multicenter, randomized, prospective DKCRUSH-III study
  • The Main Results of the CHAMPION PHOENIX Trial

Late-Breaking Clinical Trials III: Chronic CAD/Stable Ischemic Heart Disease and Acute Coronary Syndromes

Sunday, March 10, 10:45 a.m. – 12:15 p.m.

  • The STREAM Trial
  • Early Administration of Eplerenone in Patients with Acute Myocardial Infarction Without Heart Failure: Results of the Randomized, Double-Blind, Placebo-Controlled REMINDER Trial
  • Effects of the P-Selectin Antagonist Inclacumab in the Select-Acute Coronary Syndromes Trial
  • Randomized Comparison of High-dose Oral Vitamins vs. Placebo in the Trial to Assess Chelation Therapy
  • 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

Late-Breaking Clinical Trials IV: General Cardiology

Monday, March 11, 8 – 9:30 a.m.

  • Three-Year Outcomes after Transcatheter or Surgical Aortic Valve Replacement in High-Risk Patients with Severe Aortic Stenosis
  • A Randomized Trial to Compare Percutaneous Coronary Intervention between Massachusetts Hospitals With Cardiac Surgery On-Site and Community Hospitals Without Cardiac Surgery On-Site
  • The German Off-Pump Coronary Artery Bypass Grafting in Elderly Patients (GOPCABE) Study
  • CORONARY: The Coronary Artery Bypass Grafting Surgery Off or On Pump Revascularization Study. Results at 1 year
  • PRAGUE-6 Trial: Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery in Patients With EuroSCORE ≥6

Late-Breaking Clinical Trials V: Heart Failure

Monday, March 11, 10:45 a.m. – 12:15 p.m.

  • 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
  • Digoxin Reduces 30-Day All-Cause Hospital Admission in Ambulatory Older Patients with Chronic Heart Failure and Reduced Ejection Fraction
  • The ASTRONAUT Study: Aliskiren Trial On Acute Heart Failure Outcomes
  • Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Diastolic Heart Failure (RELAX) Trial

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