October 18, 2012 (New York, New York) — Barring unforeseen weather, temperatures in Miami Beach next week should be 85°F, but given the jam-packed schedule for TCT 2012, it's unlikely that many of the 12 000 attendees from 70-plus countries will get a lot of time in the sunshine or on the beach. It is the first time in the meeting's history that it has been held in Miami Beach, and even though the weather might tempt some physicians outside the convention center doors, the meeting content, which includes 750 original peer-reviewed abstracts and 450 challenging case studies, is expected to keep attendees engaged and busy over the week.

Dr Gregg Stone (Columbia University, NY), codirector of TCT, led a conference call with journalists today to highlight some of the upcoming sessions. In particular, Stone said that two long-awaited studies, the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) and PC Trial, have the potential to be "blockbusters." Both studies are randomized trials comparing patent foramen ovale (PFO) closure with the transcatheter Amplatzer PFO occluder (St Jude Medical, St Paul, MN) vs medical therapy in patients with cryptogenic stroke.

As reported previously by heartwire , the RESPECT study has been long in the works, with the study investigators requiring more than eight years to meet the protocol-required number of primary events, stroke, and all-cause mortality in the trial. These PFO studies have struggled to enroll sufficient numbers of patients in large part due to the off-label use of closure devices by physicians already convinced that PFO closure can cure stroke.

RESPECT and the PC Trial, said Stone, have the potential "to create a whole new subspecialty or could arguably end that subspecialty." He said it's devastating when a young patient presents with stroke and there is no obvious cause, but physicians often "close these things without knowing it is going to help." Approximately 25% to 33% of the population has a PFO, and while PFO can be treated off-label, there is a lot of criticism and controversy about closing them, as there are no data to suggest that doing so will prevent stroke. The one clinical trial published to date, the controversial CLOSURE 1 study, showed that there was no benefit to treating PFO.

"Are we closing something that is true and unrelated, that just happens to be there but it's not the cause of the stroke, as desirable as a mechanism as that might be?" asked Stone. "So, this is very, very important."

PARTNER Cohort B, FAME-2 Cost-Effectiveness, and More

In addition to RESPECT and PC, Stone said there will be three-year data from the PARTNER cohort B study looking at the clinical and echocardiographic data from the so-called "inoperable" patients treated with transcatheter aortic-valve replacement (TAVR).

TAVR, or transcatheter aortic valve implantation (TAVI), will be highlighted as part of a featured clinical research session on Monday, October 22, 2012 and will also have a fairly high-profile role at the TCT meeting. There will be cases looking at paravalvular leak after TAVR, valve-in-valve implantations, registry results, sessions examining proper patient selection, and the potential for expanded indications, such as in patients with severe aortic stenosis or those with severe left ventricular dysfunction. In addition, there will be a host of presentations on new and iterative TAVR systems.

Fractional flow reserve (FFR) also gets another look, this time from a financial angle, with Dr William Fearon (Stanford University, CA) presenting a cost-effectiveness analysis of the FFR vs Angiography for Guiding PCI in Patients with Multivessel Coronary Artery Disease 2 (FAME-2) study. "FAME-2, of course, showed that an ischemia-guided PCI strategy markedly reduced symptoms and the need for future revascularization, but still, even in that trial, only about one in six people needed to be treated," said Stone. "So the question is whether that's cost-effective, or should we be treating with up-front medical therapy?"

On Wednesday, Stone will be presenting data from the MASTER study, a prospective, randomized trial of a mesh-covered stent vs standard stents in patients with STEMI. The stent, he explained, is designed to trap thrombus so that it doesn't embolize and move downstream. Staying true to form and keeping busy, Stone will also present data from the ADAPT-DES trial, a large-scale prospective, observational study of the impact of clopidogrel and aspirin hyperresponsiveness on patient outcomes.

In other late-breaking clinical-trial news, Dr Julinda Mehilli (Technische Universität Munich, Germany) will present data from ISAR-Left Main 2, a study comparing everolimus-eluting and zotarolimus-eluting stents in patients with unprotected left main coronary artery disease, while ISAR-DESIRE 3, a study comparing paclitaxel-eluting balloons, stents, and balloon angioplasty for restenosis of "limus"-eluting coronary stents, will be presented by Dr Robert Byrne (Deutsches Herzzentrum, Munich, Germany).

There will also be more data from the TRILOGY-ACS study, as well as a comparison of radial vs femoral PCI in patients with STEMI, and new data comparing the safety and effectiveness of everolimus-eluting stents vs bare-metal stents in octogenarians. There are studies examining the effect of optimal hydration for the prevention of contrast-induced nephropathy and another looking at the effectiveness of postconditioning in patients with STEMI. There will also be multiple sessions on the use of renal sympathetic denervation for the treatment of resistant hypertension, as well as in-depth focus sessions on the prevention of stroke, the treatment of acute MI (AMI), and dealing with patients with heart failure.

Remembering Dr Geoffrey Hartzler

In addition to the usual awards, this year's TCT meeting will also include a special memorial to Dr Geoffrey Hartzler, one of the pioneers of interventional cardiology who passed away in March this year after a battle with cancer. Hartzler, who was 65 years old when he died, began practice in 1974 and performed the first coronary angioplasty at the Mayo Clinic in 1979. He was doing successful percutaneous transluminal coronary angioplasty (PTCA) just two years after Dr Andreas Gruentzig performed the first procedure on a patient in Switzerland.

"Geoff Hartzler, other than Andreas Gruentzig, was in many people's beliefs responsible for interventional cardiology becoming a vibrant, important subspecialty," said Stone. "He took basically what Andreas Gruentzig did and expanded the use of angioplasty to acute myocardial infarction, doing the first AMI angioplasty ever." In addition, said Stone, Hartzler pushed the boundaries, treating patients with multivessel disease, left-main disease, and chronic total occlusions long before it became practice. Through the twice-annual Hartzler courses, he was responsible for teaching a generation of interventional cardiologists.

"He's still considered the greatest technical operator in our subspecialty's history," said Stone. The memorial will be held Wednesday, October 24, at 9:35 am in the main arena (Hall D).

processing....