TCT 2016: Inspiration and Perspiration Greet Left Main Stenting, Hoop Dreams, Valve Innovation, and Election Fever

The countdown to the US election, Halloween night, the Hindu festival of lights—there’s a heck of a lot going on in Washington, DC, next week, but TCT 2016 course directors say their meeting should offer the right mix of surprise and illumination.

Trimmed down to four and a half days, this year’s congress opens midday on Saturday, October 29, and runs through Wednesday, November 2. Crammed into the program are 11 late-breaking clinical trials, 16 first report investigations, and 15 featured clinical research presentations. All told, its organizers say, the program spans the breadth of interventions currently in use or under investigation in cardiovascular medicine.  

“[This is] a very, very exciting line up of different types of studies,” Gregg W. Stone, MD (NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, NY), told reporters during a preconference telebriefing last week. The mix of trials, he said, spans “coronary intervention, structural heart disease, and peripheral vascular interventions—many of which will change practice almost immediately while others will set the stage for future studies for many years to come.”

Similarly, Martin B. Leon, MD (NewYork-Presbyterian Hospital/Columbia University Medical Center), described some of the meeting highlights to TCTMD’s On Record. “We think TCT this year is going to be an explosive, inspirational—which is one of the main themes—and academically very, very strong meeting,” he predicted.

Late-Breaking Clinical Trials and First Reports

The late breakers kick off Sunday in the Main Arena with two trials of multiple novel DES (including two with biodegradable polymers) against a US Food and Drug Administration (FDA)-approved zotarolimus-eluting stent, as well as ILUMIEN III. The latter trial compares OCT, IVUS, and angiographic guidance for stenting in stable CAD. Speaking to TCTMD’s On Record, Gary Mintz, MD (Cardiovascular Research Foundation, New York, NY), called ILUMIEN III “the first real comparison of all three modalities.”

Monday morning’s Late-Breaking Clinical Trial session is dedicated to two trials comparing surgery and PCI for left main coronary artery disease. EXCEL, conducted in the United States and Europe, enrolled 1,905 patients and looked at the primary composite endpoint of all-cause mortality, myocardial infarction, or stroke. The Nordic-Baltic-British Left Main Revascularization Study (NOBEL) was designed with an intended enrollment of 1,200 subjects and a primary composite endpoint of death, stroke, non-index-treatment-related MI, and new revascularization (either PCI or CABG).

Stone, who is presenting the EXCEL results, called this left main session “one of the most anticipated highlights” of TCT 2016. In the SYNTAX trial, surgery was still superior to first-generation DES, he noted. “But of course, DES have gotten substantially better since then, and we also have evidence from subgroup analyses from those earlier studies that patients with low and intermediate anatomic complexity might do very well with PCI.”

On Tuesday, the late breakers step away from the coronary vasculature and instead focus on the aortic valve. The first of that session’s three TAVR trials is SENTINEL, looking at the use of embolic protection to prevent cerebrovascular events. That’s followed by 2-year quality of life results from PARTNER II and 5-year echocardiographic results from PARTNER I. “There have been issues raised about possible degeneration of valves over time from what I would call less than robust data,” Stone said, referring to a much-discussed EuroPCR 2016 presentation by Danny Dvir, MD (St. Paul’s Hospital, Vancouver, Canada). The findings to be presented by Pamela Douglas, MD (Duke Clinical Research Institute, Durham, NC), at TCT 2016 “will be very robust data from very carefully collected 5-year echocardiographic data, from within the confines of a randomized trial,” Stone said.

The fourth and final Late-Breaking Clinical Trial session on Wednesday again features three trials. ILLUMENATE US is testing a paclitaxel-coated balloon for the treatment of superficial femoral and popliteal arteries. The other two studies are focused on left atrial appendage closure for stroke prevention—one featuring the results of the WATCHMAN postapproval study and the other a registry study from Europe using the Amplatzer Amulet device.

Immediately following the late breakers Sunday through Wednesday are the four First Report Investigation sessions. Each has a mix of results ranging from mechanistic studies for a host of new bioresorbable scaffolds to longer-term clinical follow-up from ABSORB II and ABSORB China. “As you know, bioresorbable scaffolds have been shown to be noninferior to everolimus drug-eluting stents at 1 year, although there were trends towards increased adverse events that were noted,” Stone told reporters on the telebriefing. “Whether these results will be maintained at 2 or 3 years, we’ll get important information from these two trials.”

Other first reports include 5-year final outcomes from the RESPECT trial of PFO closure for cryptogenic stroke, the COLOR trial looking at lipid-rich plaque and 2-year outcomes after stenting, and PLATINUM DIVERSITY. The last study addresses outcomes of stent implantation in women and minorities; these, in Stone’s words, are “two cohorts of patients which we know to be at higher risk of adverse events long term.” The final First Report Investigation session, scheduled for Wednesday, includes a novel approach to “softening” chronic total occlusions prior to intervention in TOSCA-5 and permanent-scaffold stents with bioresorbable polymers in two studies.

Outside the Main Tent

Beyond the big trials and registries, there are roughly 2,000 oral presentations including 850 abstracts—out of nearly 1,800 submitted—and 48 challenging case presentations, as well as approximately 50 debates and a number of featured lectures, including one by the new FDA commissioner, Robert Califf, MD.

Live cases—one of the big draws at this meeting—will be broadcast from 20 international sites into four separate theatres, taking up more than 38 hours of this year’s program.

A new addition this year is the “Saturday Night Fights,” held during the Saturday night poster session. Gloves and showmanship will take the place of PowerPoint slides when eight debaters go toe-to-toe on four different controversial topics: bioresorbable scaffolds, low-risk TAVR, revascularization of stable CAD, and DAPT duration.

There are two special evening events. The first is a keynote address by basketball legend Earvin “Magic” Johnson on Monday night. Basketball fans who are willing to battle it out on the courts can register to play in a three-on-three charity basketball tournament Saturday midday. The winning team will get to meet Johnson in person, with proceeds from the tournament going to fund the Jason Kahn Fellowship in Medical Journalism, established by CRF to honor the memory of TCTMD’s long-time news editor who passed away in 2014.

Then, in a nod to the upcoming US elections, a second keynote will be given by presidential historian and Pulitzer Prize-winning author Jon Meacham on Tuesday night.

The TCTMD news team is also hoping to take the political pulse of attendees at this year’s meeting. Conference-goers will get mock ballots with their badges and can find additional ballots at ballot boxes around the convention center (please, no ballot-box stuffing). We’re hoping you will cast your (unofficial) vote for the next US president—whether you are an American citizen or not. All votes are anonymous. Results will be announced at the Meacham keynote.

For Hindu attendees who observe Diwali, an invitation-only event has been organized in partnership with TCT India, immediately following the TCT India Next Partnership session on October 31.

The entire TCTMD news team will be on the ground at TCT 2016. Find all our coverage on the new TCTMD website, with highlights also appearing in the TCT Daily newspaper. For color commentary, find and follow our reporters on Twitter.