ACC.13 preview: a greater focus on delivery than discovery?
By Victoria Hudson, Senior Analyst
11 March 2013
I am the senior analyst for Datamonitor Healthcare’s cardiovascular and metabolic team, and cover everything from acut...
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It’s that time of year again, with San Francisco playing host to the 2013 American College of Cardiology’s Scientific Session (ACC.2013) over March 9–11. With over 2,000 abstracts and 22 late-breaking clinical trials featured, the ACC meeting will reportedly focus on the “transformation of cardiovascular care, from discovery to delivery.”
With many of the late-breaking trials showcased at ACC.13 investigating current treatment strategies or previously revealed studies, the “discover” element of the meeting may not be particularly ground-breaking. The PREVAIL study, one of two trials to be presented at the Opening Showcase and Late-Breaking Clinical Trials session, examines the WATCHMAN left atrial appendage closure device in a long-term warfarin comparator trial in non-valvular atrial fibrillation patients. Despite the device receiving an advisory committee recommendation in April 2009, the FDA informed Atritech, WATCHMAN’s maker, that it would require further safety and efficacy data than could be provided from the device’s original Phase III trial, PROTECT-AF.
While the stroke prevention in atrial fibrillation market has moved on since 2009 with the launch of the novel oral anticoagulants – starting with Pradaxa (dabigatran; Boehringer Ingelheim) in November 2010 – physicians would welcome a device that could negate the need to anticoagulate patients. In particular, the device would be promising in the predominately elderly and frail patient atrial fibrillation population who are at risk of serious bleeding due to the likelihood of falls or compliance concerns due to memory loss. However, the insertion procedure and long-term safety of the device would need to be offset by the reduced risk of bleeding, a threshold which has been raised by the Phase III safety data of the novel oral anticoagulants in comparison to warfarin, and in particular their reduction in intracranial haemorrhage rates.
The other showcase trial to be presented at ACC.13 is HSP2-THRIVE (Heart Protection Study 2 – Treatment of HDL to Reduce the Incidence of Vascular Events). The trial investigated statin therapy combined with nicotinic acid/laropiprant, known commercially as Tredaptive (Merck), versus monotherapy statin. The preliminary results of the trial led to the removal of Tredaptive from the dyslipidemia market in the EU and suspension of commercial development in the US in January 2013. Preliminary results showed that the addition of Tredaptive to a statin showed no additional benefit in reducing the risk of a major vascular event versus monotherapy statin alone.
The results of the HSP2-THRIVE trial add to questions raised over our understanding of the high-density lipoprotein (HDL) hypothesis and the benefit of raising HDL and its impact on cardiovascular outcomes. Similar questions were raised in the dal-OUTCOMES and AIM-HIGH trials: the dal-OUTCOMES Phase III trial led to the suspension in development of the cholesteryl ester transfer protein inhibitor dalcetrapib, while the AIM-HIGH study, investigating the addition of extended-release niacin to statin therapy, showed no outcome benefit. The role of HDL in dyslipidemia will also be covered in the sessions titled “Lipids: Management in 2013 and Beyond” on Saturday 9 March as well as in “HDL and Triglycerides: Markers or Goals for Treatment” on Monday 11 March. Both sessions are expected to focus on the “delivery” element of ACC.13’s content.
Datamonitor will be also focusing on other delivery sessions, in particular those that cover oral prophylaxis to prevent stroke in atrial fibrillation. With the launch of the novel oral anticoagulants, Pradaxa (dabigatran; Boehringer Ingelheim) and Xarelto (rivaroxaban; Bayer/Johnson & Johnson), and the imminent launch of Eliquis (apixaban; Bristol-Myers Squibb/Pfizer) in the indication, physicians have greater choice in preventing stroke in their atrial fibrillation patients, who are at a five-fold increase risk of having a stroke. Until the launch of Pradaxa, warfarin was the only oral anticoagulant approved for this indication. However, uncertainty in prescribing the novel oral anticoagulants has led to slower than expected uptake, despite their clinical benefits over warfarin. The strong focus on stroke prevention in atrial fibrillation clinical education at ACC.13 will go some way to addressing this uncertainty.
Posted in Cardiovascular, Diseases. Tagged to ACC, apixaban, atrial fibrillation, Bayer, Boehringer Ingelheim, bristol-myers squibb, dabigatran, Eliquis, Johnson & Johnson, oral anticoagulants, Pfizer, Pradaxa, rivaroxaban, Stroke, Xarelto