TCT 2018: Mitral Interventions, Stent Wars, Practical Skills, and More

SAN DIEGO, CA—There are just 4 days to go before TCT 2018 kicks off, and according to meeting organizers, the conference is shaping up to be the most highly attended in its 30-year history.

In a pre-meeting briefing with reporters, course director Gregg Stone, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), credited the surge in attendance to a new format for this year’s meeting that puts a greater emphasis on hands-on training, as well as the mix of late-breaking studies poised for release. The meeting also offered a special, discounted “anniversary rate” this year as it heads into its fourth decade.

As Stone explained during the telebriefing, the new “training destination” debuting at this year’s TCT is made up of eight pavilions offering specialized training using cardiac CT, complex angioplasty, cadaver models, mitral valve repair, and more. Intended for physicians and allied health personnel, said Stone, the training pavilions will “all be very hands-on, so that more so than ever, they’ll leave the meeting having actually learned a practical skill that they can take back to their patients.”

There is also a “particularly rich slate of late-breaking clinical trials and late-breaking clinical science,” Stone said—27 presentations in total. Many of the trials in this year’s lineup are also being simultaneously published in major scientific journals, he added.

California Bound

This is the first time that TCT has been held in San Diego. Stone himself has guaranteed sunny skies and, while speaking to reporters last week, forecasted some illuminating new science as well.

The meeting opens Friday with a mix of how-to sessions; challenging cases; innovation sessions; endovascular, nurse/tech, and regional programming; as well as oral abstracts. This last, notably, constitutes almost 30 separate sessions packed into Friday afternoon, and contains the bulk of the oral abstracts at this year’s meeting. A separate session on Saturday morning groups the highest peer-reviewed oral abstracts from the 2018 submissions. Moderated poster abstracts, meanwhile, are being presented on Saturday, Sunday, and Monday.

Saturday morning opens with two blocks of late-breaking clinical trials (LBCTs), sponsored by the Lancet and Circulation, respectively. The first leads off with IMPERIAL, a rare head-to-head, randomized trial comparing two stents for peripheral vascular disease: the FDA-approved Zilver PTX self-expanding stent (Cook Medical) and the investigational Eluvia self-expanding stent (Boston Scientific). Both devices are paclitaxel-eluting peripheral stents, being tested here in femoropopliteal artery lesions.

The remainder of the Saturday late breakers are given over to coronary stents, with several head-to-head trials, including BIONYX, ReCre8, LEADERS FREE II, SORT OUT IX, and TALENT, evaluating a mix of thin-strut bioresorbable polymer stents and polymer-free stents. TALENT, in particular, is notable for being the first “all-comers,” randomized trial of an Indian-made stent, the SupraFlex (Sahajanand Medical Technologies), against the market-leading Xience (Abbott), conducted in centers across Europe.

Stone, speaking with reporters, said he thinks these trials will bring “a lot more clarity as to whether some of these innovations in metallic, drug-eluting stents have led to improvements in the field.” This, in turn, may point the way for stent developments in the years to come, he predicted.

The Sunday morning late-breaking session (LBCT 3) contains COAPT, which, for many, is the must-see data from this year’s slate of trials. Stone and Michael Mack are co-chairs and principal investigators for the trial, which randomized 610 patients with heart failure and moderate-to-severe mitral regurgitation (MR), deemed too high-risk for surgery, to medical therapy or leaflet repair using the MitraClip (Abbott). As previously reported by TCTMD, COAPT is the second trial this month to look at this device in functional MR: MITRA-FR, reported at the European Society of Cardiology Congress 2018, found no benefit of clip coaptation on a primary endpoint of death/heart failure rehospitalizations.  COAPT, however, is roughly twice the size of MITRA-FR and has heart failure rehospitalizations as its primary efficacy endpoint. “The studies are different, and hopefully when COAPT is presented, it will add some clarity to the field,” said Stone during the telebriefing last week. “The devil is going to be in the details.”

Sponsored by JAMA, LBCT 3 has two other late-breakers of note. REDUCE FMR can lay claim to being the only sham-controlled device trial in this year’s late-breaking lineup, comparing percutaneous mitral valve direct annuloplasty using the coronary-sinus-based Carillon Mitral Contour System (Cardiac Dimensions) to a sham procedure in patients with functional MR. REDUCE FMR randomized 163 patients 3:1 to an intervention or sham, with the option for patients in the sham group to undergo device implantation after 12 months. The trial’s primary endpoint is change in regurgitant volume at 1 year.

The third trial in this grouping is SOLVE-TAVI, a two-by-two randomized trial comparing both self-expanding to balloon-expandable TAVR devices and general versus local anesthesia in 444 patients with severe symptomatic aortic valve stenosis at high risk or with a contraindication for surgery.

Monday and Tuesday Late-Breakers

Monday morning’s late-breaking session (LBCT 4) is a mixed bag of imaging and oral anticoagulation studies. ULTIMATE, conducted at eight high-volume centers in China, randomized nearly 1,500 patients undergoing elective PCI to IVUS guidance or angiographic guidance with a primary outcome of target vessel failure at 12 months. The Lipid-Rich Plaque Study (LRP) is looking at the use of coronary near-infrared spectroscopy imaging to detect vulnerable plaques in patients presenting for coronary angiography. OAC-ALONE is comparing oral anticoagulant (OAC) monotherapy with warfarin or a non-vitamin K antagonist oral anticoagulant to OAC plus single antiplatelet therapy in patients with atrial fibrillation who have undergone coronary stenting at least 1 year prior. The primary endpoint in OAC-ALONE is a composite of all-cause death, myocardial infarction, or stroke/systemic embolism over an expected mean follow-up of 2.5 years.

The fifth and final late-breaking trial session (LBCT 5) has a blast-from-the-past feel. Two of the sessions, ABSORB IV and COMPARE ABSORB are looking at new data using the now-defunct Absorb bioresorbable scaffold. Stone believes Absorb continues to pique the curiosity of physicians despite the fact that it is no longer on the market. “There is tremendous interest, still, in these devices and there are other companies working on them avidly. And of course Abbott does have a thin-strut device that they may decide to go forward with,” Stone said.

The third trial rounding out this session also harkens to the past and potentially speaks to the future. RADIOSOUND-HTN, conducted in patients with resistant hypertension, is comparing three techniques—radiofrequency-based denervation of the main renal artery; radiofrequency-based denervation of the main renal artery plus its side branches and accessories; and ultrasound-based denervation of the main renal artery only. The primary outcome measure in this small, 120-patient trial is the change in daytime blood pressure acquired by ambulatory blood pressure measurement at 3 months.

Beyond the Late-Breaking Trials

An additional 12 trials submitted for inclusion in this year’s program were selected as “late-breaking clinical science” (LBCS). The studies have been loosely grouped across three LBCS sessions and cover a wide range of topics, including TAVR, atherectomy, fractional flow reserve, long-term data from the SYNTAX and MAIN-COMPARE trials, pulmonary artery denervation for pulmonary hypertension, and tricuspid valve interventions.

Live cases, always a big draw for this meeting, have been consolidated into two venues for TCT 2018: the main arena and the live case presentation theater. “In the past, that’s only run in the morning; now that’s going to be running all day long,” Stone said.

For attendees with a special interest in cases, this year’s meeting has a new frill: previews of the cases, including case descriptions and cine angiograms, have been added to the TCT app.

In all, the meeting will showcase about 1,500 abstracts, 600 to 700 challenging cases, and 30 or 40 “keynote interventional studies,” said Stone, plus “a very provocative FDA Town Hall Meeting.”

“We’re expending tremendous science and the cases look extraordinary,” he said. All of this, along with the new training destination, means this year’s meeting will “really deserve the 30-year anniversary designation and hopefully set us up for what you’ll see in the future,” he concluded.

For more tips on what to expect from TCT 2018, check out the latest episode of On Record. The entire TCTMD news team will be on the ground in San Diego. Keep up with news as it breaks by bookmarking the TCTMD conference page or follow along on Twitter.