Shelley Wood

March 04, 2013

SAN FRANCISCO — Tenecteplase, digoxin, off-pump vs on-pump CABG: glance too quickly at the line-up of late-breaking clinical trials at the upcoming American College of Cardiology (ACC) 2013 Scientific Sessions and you might think you'd traveled back in time.

There's a discernible theme to this year's late-breaking studies: that of researchers looping back to dot some i's and cross some t's with drugs and strategies that are already widely in use or that have debuted at previous meetings.

PREVAIL, one of just two "showcase" trials airing on the opening day of the meeting, features a device that first made headlines at the ACC four years ago. The trial, examining the use of the Watchman left atrial appendage (LAA) closure device vs warfarin alone in patients with nonvalvular atrial fibrillation, was the manufacturer's response to the FDA's request for more data in 2010--this despite a vote of 7 to 5 by FDA advisors in favor of approval for the novel device, based on the PROTECT-AF results.

Of all the trials in the program, PREVAIL carries the biggest potential to change practice, ACC 2013 meeting chair Dr Miguel Quiñones (Methodist DeBakey Heart and Vascular Center, Houston, TX) told reporters at a press telebriefing. That's because it's a new form of treatment for a growing population of patients--those with nonvalvular AF--and they face catastrophic consequences if their disease goes untreated, he said.

The other trial sharing the spotlight during the opening LBCT session is HPS2-THRIVE. As reported by heartwire , the trial missed its primary end point, showing no clinical benefit of extended-release niacin/laropiprant after nearly four years of follow-up. The sponsor, Merck, released top-line results in late 2012; Dr Jane Armitage (University of Oxford, UK) will present the full results on Saturday.

Heart Failure, CABG, and Vitamins

This year's ACC meeting is three days instead of four but will still feature over 2100 abstracts and 22 late-breaking clinical trials across five sessions. After the first day, the late-breaking sessions, two per day, are grouped by theme: interventional, ischemic heart disease and ACS, general cardiology, and heart failure.

These sessions feature a mix of old and new. As with HPS2-THRIVE, results from CHAMPION PHOENIX, testing the P2Y12-receptor antagonist cangrelor (the Medicines Company) against clopidogrel in patients undergoing PCI, have already made headlines, based on top-line results released in January. For another trial, Trial to Assess Chelation Therapy (TACT), the primary chelation results were released at AHA 2012; results from a high-dose vitamin randomization will be presented at this year's meeting.

New transcatheter-valve data have dominated the late-breaking clinical trials at the major cardiology meetings in recent years, and ACC 2013 is no exception. Three-year follow-up from PARTNER A will be presented in a Monday session, while the first of two sessions on Sunday features results from PARTNER 2, Cohort B, looking at a next-generation Sapien (Edwards Lifesciences) device in nonsurgical patients, as compared with patients treated with the first-generation device.

The conspicuously unrecognizable agent in this year's late-breaking line-up is the p-selectin antagonist inclacumab (Genmab/Roche), being tested in the SELECT ACS trial. By contrast, the rest of the late-breaking program is notable for the number of older drugs being tested in new settings: sildenafil (Revatio/Viagra, Pfizer) in diastolic heart failure (RELAX), tenecteplase plus heparin vs heparin alone in acute pulmonary embolism (PEITHO), and digoxin in older patients with chronic HF and reduced ejection fraction.

A fourth heart-failure trial is trying to stay ahead of the curve, testing a strategy of natriuretic-peptide–guided screening and treatment as a means of mitigating progression to heart failure. A related concept is at the heart of REMINDER, testing early administration of eplerenone (Inspra, Pfizer) in patients with acute MI without heart failure, looking at future CV events related to the development of heart failure.

On the surgery front, three late-breaking clinical trials (GOPCABE, CORONARY, and PRAGUE-6) are addressing the question of off-pump vs on-pump surgery in different clinical scenarios. Another trial is comparing PCI outcomes at hospitals with and without on-site surgical backup in the state of Massachusetts.

Media-relations staff confirmed that a number of late-breakers will be simultaneously published in major journals, as will several abstracts elsewhere in the program.

Meeting Tips and Tricks

Meeting content is grouped according to 16 "learning pathways," and sessions start early and run late, into ticketed dinner sessions. The theme of ACC 2013 is "from discovery to delivery," and if many of the items in the late-breaking lineup seem already discovered, their delivery will be cutting edge. In a departure from previous years, this year ACC is dispensing entirely with the heavy paper program book, relying entirely on a downloadable "planner app" and the online program planner. A separate ACC.13 Attendee Portal app links directly to the online planner and also offers live streaming of certain key sessions, presentation slides within 24 hours, ePosters, and the option to add on iScience (this last purchased separately).

Luddites with $20 to spare can buy one of "a limited number" of printed PDFs in the attendee registration area "on a first-come, first-served basis," although a smaller, print, program-at-a-glance will be issued to one and all.