DENVER, CO — On its first visit to the Mile High City, the TCT 2017 conference is promising new insights on how to manage left main disease, more data on bioabsorbable scaffolds, and next steps in transcatheter repair—all delivered with a dose of old-time Hollywood star power.
Kicking off its late-breaking clinical-trial (LBCT) and First Report Investigation presentations on Monday, October 30, is CULPRIT-SHOCK, the largest randomized trial ever of MI patients in cardiogenic shock and "in my mind the clinical trial that I'm most looking forward to," TCT 2017 director Dr Gregg W Stone (Cardiovascular Research Foundation, New York, NY) told theheart.org | Medscape Cardiology.
The phase 4 trial is exploring whether standard infarct-artery-only PCI vs immediate multivessel PCI can improve the prognosis for patients with cardiogenic shock, the highest-risk CAD patients interventionalists deal with in the cath lab who still have 40% to 50% mortality despite successful PCI. "So that to me is a very, very important randomized trial," he said.
Next up are quality-of-life data in patients with left main CAD from the EXCEL trial, which should show the extent to which any early benefits of PCI translated into patients feeling better and whether over 3 years those benefits were maintained or bypass surgery possibly gained a benefit.
There will actually be 28 other EXCEL abstracts presented as original research at the meeting, including the complete 3-year data from EXCEL, which follow last year's report using median data showing PCI with the Xience everolimus-eluting stent (Abbott Vascular) was noninferior to bypass surgery for the primary clinical end point.
Rounding out the session is another left main trial, the DKCRUSH-V trial, one of the largest trials looking specifically at how to handle the distal left main bifurcation, which for the interventional cardiologist is the most difficult area to treat, Stone said. Most studies have favored the provisional one-stent approach over the two-stent technique, but this trial is looking at a very specific two-stent technique called the DK, or double kissing, crush technique, "which really gives you the best overall expansion of the entire carina of the left main bifurcation," he noted.
Immediately following Monday's LBCT session 1 is the First Report Investigations 1 session. It will feature the HARMONEE trial looking at whether a novel drug-eluting stent (DES) designed to capture endothelial progenitor cells will provide more rapid endothelialization to allow for shorter dual antiplatelet therapy (DAPT) in patients with non-ST-segment MI (NSTEMI).
"This is a real important theme right now in intervention; we've gone from feeling we need lifelong DAPT to prolonged DAPT in appropriate patients, but also shorter DAPT in appropriate patients," Stone said.
Two other high-profile studies taking on this hot topic are the SENIOR trial evaluating PCI with short DAPT duration in patients at least 75 years old and the open-label DAPT STEMI trial of 6-month vs 12-month DAPT after DES implantation in ST-segment MI. Both trials will be featured in Wednesday morning's LBCT 3 session.
Tuesday's LBCT 2 and First Report Investigations 2 line-ups lean heavily on the Absorb (Abbott Vascular) bioresorbable stent (BRS), including 3-year results from the pivotal ABSORB III, which led to its US approval; 30-day results from ABSORB IV, in which better techniques were used; and the first 4-year data from ABSORB II, covering the critical time point when the scaffold is completely absorbed and theoretically should carry an advantage.
But are cardiologists still interested in the troubled first-generation BRS, given its inferior early outcomes and Abbott's decision last month to halt sales due to low demand?
Adding to the BRS pessimism is Boston Scientific's recent decision to shelve development of its thinner-strut BRS, Renuvia, and a new European Society of Cardiology and European Association of Percutaneous Cardiovascular Interventions task force report stating that "at present, BRS should not be preferred to conventional DES in clinical practice."
Stone, a longtime enthusiast of the technology, said, "I don't think it's a problem at all; there's tremendous excitement about bioabsorbable scaffolds."
He observed that development is continuing on next-generation BRS, even by Abbott, and that if given the choice, most clinicians and patients would prefer a device that completely absorbs over time and returns the coronary artery to its normal or near-normal state.
"So continuing to learn everything we can from this first generation of devices in terms of the actual incidence and the mechanisms of failure and how technique may overcome some of those limitations is important," Stone added.
Closing out Tuesday's LBCT 2 is the much-anticipated PARTNER 2A and SAPIEN 3 cost-effectiveness data from intermediate-risk patients undergoing transcatheter aortic-valve replacement (TAVR) vs surgical valve replacement.
Now that TAVR is becoming a mature subspecialty, a lot of the emphasis has shifted to see whether clinicians can duplicate that success for patients with mitral and tricuspid regurgitation, both of which are much more complex diseases and have proven more challenging thus far.
Wednesday's First Report Investigations 3 session highlights mitral-valve (MV) technologies, with 30-day results following MV replacement in the MITRAL and INTREPID trials, 6-month outcomes after neochordal repair in TRACER, 6-month outcomes in secondary MV repair in MAVERIC, and 1-year data after MV replacement in TENDYNE.
Tricuspid-valve repair technologies get their due during Thursday's First Report Investigations 4 session, with 30-day outcomes with Valtech Cardio's Cardioband system expected from the TRI-REPAIR study and data on Edwards Lifesciences' Forma system from the early feasibility FORMA study.
A Most Provocative Trial
Thursday's LBCT 4 session features ORBITA, a small randomized trial with the unusual twist at an interventional meeting of being a sham-control trial so patients won't know if they received PCI or not but will be maintained on medical therapy. With only 200 patients with CAD, it's not powered for clinical events but will look at exercise duration and quality of life. Stone predicts it is "certainly going to be one of the most provocative trials at TCT."
Equally provocative will be the 5-year data from the PREVAIL trial of left atrial appendage (LAA) closure with the Watchman device, which is now approved for stroke prevention in atrial fibrillation. Results were favorable, particularly with long-term follow-up, in PROTECT AF, but a high procedure-related stroke rate prompted the FDA to call for a second trial, PREVAIL, which has elicited impassioned debate both pro and con.
Beyond the Big Trials
This year, TCT has reorganized the majority of its posters into moderated posters to be presented in eight pods beginning Monday and ending when the exhibition hall closes Wednesday. About 20% of posters will remain for fans of the old-school, push-pin poster boards.
The conference will also recognize the 40th anniversary of the first PCI and 15th anniversary of the first TAVR with a major exhibit on the second-floor corridor highlighting the early pioneers and companies that led to the seminal development of early devices and studies.
For those looking for a little inspiration or a break from 5 solid days of hard-core science, perennial nice guy Tom Hanks, who just released his first book of fictional short stories called Uncommon Type, will deliver Monday night's keynote address.
"We couldn't think of a better person that Tom Hanks to lift everyone's spirit in these somewhat-challenging times," Stone said.
Finally, TCT is making a special effort to embrace inclusiveness, diversity, and community as the theme of the conference to be discussed at Monday afternoon's FDA Town Hall meeting, dedicated sessions throughout the conference, and even walls where attendees can write on what diversity means to them.
"First, a lot of people don't have equal access to healthcare, and second, a lot of people don't have equal access to medical school or the same opportunities to progress through training, whether they're trying to become a physician, a nurse, a technologist; and we just thought it was time to openly make a statement to support equal access for all patients and healthcare providers," Stone said.
Stone disclosed no relevant financial relationships.
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Medscape Medical News © 2017
Cite this: TCT 2017: Rich in Clinical Trials, Star Power - Medscape - Oct 17, 2017.