Shelley Wood

October 23, 2013

SAN FRANCISCO, CA — Dr Gregg Stone, program chair for the upcoming TCT 2013 meeting, would not be drawn out on media questions as to what late-breaker, if any, will turn interventional cardiology on its head this year, nor hint that any of the trials will turn out according to preconceived notions about the technology.

"I think that every study . . . is open-ended enough that the results will be pretty exciting," he told a conference call for the press aimed at highlighting the big trials at what will be the 25th anniversary of one of cardiology's splashiest meetings.

That's despite the fact that a number of the big trials in the lineup are addressing questions for which many cardiologists already think they know the answer. This year's meeting has the "strongest" series of trials to date, he added.

Topping the list is the CoreValve Extreme Risk cohort, the first data from the US pivotal trial required for FDA approval of this self-expanding transcatheter aortic valve that has held CE Mark in Europe since 2007. Given the device's long track record outside the US, most observers are confident of a positive result. The second cohort, looking at high-risk surgical patients, will be reported at a later date.

Another biggie is SAFE-PCI , comparing radial vs femoral vascular access for diagnostic cath and PCI in women—a group that has been long been predicted to fare better with radial than femoral.

A third is OPTIMIZE , a randomized trial of three vs 12 months of dual antiplatelet therapy (DAPT) after PCI: another issue that has long been a sticking point among physicians arguing that longer durations of DAPT are exposing patients to risk without adding additional protection against stent thrombosis.

Stone, for his part, urged the media to look past preconceptions, adding that he himself had not seen all the trial outcomes. "We'll have to wait and see what the results are," he cautioned. Not just for these three, but for all of the nine formal late-breakers and an additional 11 "first-report" investigations.

"Some will be positive, some will be negative, and some will have nuanced interpretations," he said.

Stone also highlighted:

  • EuroMax , a randomized trial testing ambulance initiation of bivalirudin vs heparin with or without glycoprotein IIb/IIIa inhibitors in patients with STEMI being transported for primary PCI.

  • LEVANT 2 , the first report of a US-based study required for FDA approval testing a drug-coated balloon called Lutonix for the treatment of superficial femoral arteries. Early Wednesday, the company that makes the system (Bard) announced that the trial had met its primary safety and efficacy end points at 12 months.

  • TRYTON and the NORDIC-BALTIC BIFURCATION IV trials, both addressing strategies (and in the case of TRYTON, a dedicated side-branch stent) in the setting of bifurcation disease.

"TCT goes tablet"

What Stone seemed most excited about for TCT this year are the tablets that all registrants are receiving as part of this year's registration fees. Not just a choice piece of swag, the tablets and dedicated app that comes with them are intended to fully integrate participants in the "meeting experience," Stone said.

In the cardiology equivalent of devouring two different sports on side-by-side man-cave televisions, TCT attendees can be watching one presentation on stage while keeping tabs on a live case on their laps, so to speak. They can also use the tablets to ask questions of a panel during a live case or in other interactive sessions, view slides, take notes, or communicate with other conference-goers via a "chat-room environment."
This, said Stone, "is our first salvo at redefining the conference experience for attendees."

Happily for the hard-working journalist: tablets are being made available on loan to the press.

Keep up with breaking news from TCT 2013 by following the heartwire journalists on Twitter. The full list of late-breaking trials and first-report investigations is here.


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