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BARCELONA -- The promise of a heart failure drug that can not only reduce hospitalizations, but also produce a measurable reduction in mortality, is poised to dominate the buzz leading up to the
Excitement about the drug, known as LCZ696, has been building since last March when the data safety monitoring board for shut down the trial when an interim analysis showed that patients treated with LCZ696 were less likely to die or be hospitalized than those randomized to enalapril.
Last May at the co-principal investigator of UT Southwestern Medical Center in Dallas, primed the pump even more with a presentation on the trial's design and baseline characteristics of the 8,442-patient trial. Those patients all had severe heart failure (NYHA class 2-4, with an LV ejection fraction <35%).
At that time, , of the University of Glasgow in Scotland, another PARADIGM-HF co-investigator, called the findings "remarkable" and cautiously used the term "breakthrough."
, executive director of interventional cardiovascular programs at Brigham and Women's Hospital and a professor at Harvard ľֱ School, told ľֱ that he interpreted the early word on the drug -- including a press release from Novartis, which is developing the compound – as "it certainly meets its endpoint (reduction in hospitalization and/or mortality) and if it actually does reduce mortality that would be huge and really practice changing."
But Bhatt, who reviewed the slate of 27 ESC "Hot Line" studies for On the Scene from the American College of Cardiology and ľֱ, agreed that, historically, heart failure trials have failed to live up to the advance hype.
If, however, PARADIGM-HF does deliver practice-changing findings, it will follow a tradition for ESC meetings in Barcelona.
It was here that data on the first new oral anticoagulant -- dabigatran (Pradaxa) – were reported in 2009, and back in 2006, it was in Barcelona that late stent thrombosis became the adverse event that temporarily derailed the drug-eluting stent locomotive.
Other trials topping Bhatt's checklist include:
- which compares a strategy of treating only the culprit lesion in MI with a one-stop option in which all lesions are treated.
- , a study from the U.K. that investigates the use of fractional flow reserve versus angiography to guide management and optimize outcomes.
- which tests in-ambulance administration of ticagrelor (Brilinta) against cath-lab administration in STEMI patients.
Bhatt said ATLANTIC is particularly noteworthy because, in the U.S., it is difficult to initiate in-ambulance therapy, but "in this case it is just giving the patient a pill, it's like aspirin administration. It will be interesting to see if this improves outcomes because it is a simple change in procedure."
Other trials that are likely to make headlines, if not front page news, include:
- trial of the PLA2 inhibitor darapladib in MI.
- for vagal stimulation of systolic heart failure.
- A trio of , a novel lipid-lowering treatment.
With 27 trials designated as Hot Lines culled from a record number of abstract submissions -- more than 11,400 -- the sizzle generated in Barcelona may last well beyond Sept. 3, when the ESC folds its tent.