TCT 2015: Disappearing Stents, TAVR Data, and Schwarzenegger Highlight Meeting

October 05, 2015

SAN FRANCISCO, CA — The City by the Bay seems to have it all—the Golden Gate Bridge, Alcatraz, wonderful restaurants, and a booming economy. And this year, physicians attending TCT 2015 will get to take it all in as the meeting of all things interventional once again returns to San Francisco, CA.

Billed as the "largest educational meeting specializing in interventional cardiovascular medicine," TCT 2015 will take place October 11 to 15, 2015 at the Moscone Center. This year there are a dozen late-breaking clinical trials spread over four sessions from Monday to Thursday (11:00 am in the main arena each day), as well as eight "first reports" that take place immediately following the late-breaking trial presentations (12:00 n in the main arena each day).

Speaking with the media, TCT codirector Dr Gregg Stone (Columbia University Medical Center, New York) said there were 1800 abstract submissions this year, with 950 accepted and to be presented during the plenary or poster sessions. Stone said TCT 2015 marks a return to coronary interventions after many years of having the meeting dominated by the interventional treatment of structural heart disease, such as transcatheter aortic-valve replacement (TAVR), for example.

TCT 2015 will also include an array of speakers and guests, including Arnold Schwarzenegger, the former governor of California, professional bodybuilder, including seven times as Mr Olympia, and actor. Schwarzenegger is scheduled to speak Monday, October 12, 2015 at 8:30 pm in the main arena.

The Cardiovascular Research Foundation (CRF) Skirball Center is hosting another celebrity, this one an evening with Carlo Ancelotti, former football (that's soccer, for the American attendees) manager of Milan, Chelsea, and most recently, Real Madrid. Ancelotti, who has been likened to the "Vince Lombardi of European football," is speaking Tuesday, October 13, 2015 at the Hilton San Francisco in Union Square.

And this year the CRF, the sponsor of TCT 2015, is hosting a 5-km run/walk fundraiser in honor of Dr Michael Davidson. In January, Davidson was tragically killed while working at the Brigham and Women's Hospital in Boston. Davidson, who was 44 when he died, was the director of endovascular cardiac surgery. The proceeds of the run/walk, which will take place along San Francisco's beautiful waterfront on October 11, 2015, will be put toward an educational fund for Davidson's four children.

Research Presented at TCT 2015

Starting Monday, October 12, 2015 in the main arena, codirector Dr Martin Leon (Columbia University Medical Center, New York) and Stone will moderate the first late-breaking clinical-trials session, one dominated by the presentation of the ABSORB III study. Speaking with the media, Stone highlighted this particular trial—a study testing a bioabsorbable scaffold—and its potentially practice-changing impact in interventional cardiology.

"The concept with these devices is that they supply the mechanical scaffolding ability of a regular metallic stent and the drug-elution capabilities of those devices within the first year," said Stone. "Over the next several years, they completely absorb. The advantage is that it removes all the potential late events that could happen with the presence of a metallic device."

Led by Dr Dean Kereiakas (The Christ Hospital, Cincinnati, OH), ABSORB III investigators are testing the safety and effectiveness of the everolimus-eluting Absorb stent (Abbott Vascular) with the bioresorbable scaffold against the everolimus-eluting Xience (Abbott Vascular) stent. The ABSORB III study is designed as a noninferiority trial and will be used to gain premarket approval in the US, where the bioresorbable stent is not yet available. The primary end point of the study is target lesion failure (TLF) compared with Xience at 1 year.

While there are many physicians and patients who like the idea of not having a permanent device left in the vasculature, Stone said the bioabsorbable stent is in tough against its comparator.

"In the first year, no one thinks these devices will be superior, but the question is are they as good?" Stone told the media. "That's actually a pretty high bar to reach, because current metallic drug-eluting stents have gotten very, very good. [They're] extremely low profile, extremely deliverable, and have very low stent-thrombosis rates."

Monday's late-breaking clinical-trials session will also include data from the ABSORB China trial, a study designed for regulatory approval but one that also has angiographic follow-up at 1 year. As part of the first of the first-report sessions, TCT 2015 will see the presentation of 2-year data from the ABSORB II study, a trial comparing the Absorb bioresorbable stent against Xience in patients with coronary artery disease.

Dr Michel Haude (Medical Clinic I, Neuss, Germany) wraps up the first-report session with 6-month clinical, angiographic, and imaging data from the BIOSOLVE II study. In the first-in-human nonrandomized study, investigators are testing the safety and clinical performance of the magnesium sirolimus-eluting stent with a bioresorbable scaffold (Biotronik). One potential advantage of the magnesium stent is that it is stronger than the other bioabsorbable scaffolds, which are polymers, said Stone.

Tuesday's Take

On Tuesday, the late-breaking clinical-trials session is cosponsored by the Lancet. Stone, along with Dr Richard Horton and Dr Stuart Spencer, the respective editor in chief and executive editor of the prestigious journal, will moderate the session.

One of three studies on slate for Tuesday includes RIVER-PCI, a study testing ranolazine (Ranexa, Gilead Sciences) in patients with incomplete revascularization after coronary intervention. As Stone noted, there are various reasons for leaving disease behind untreated, something that occurs in as many as 50% of PCI patients. RIVER-PCI will examine whether adjunctive pharmacotherapy with the anti-ischemic agent ranolazine can improve patient prognosis.

The two other trials include EXPLORE, a prospective study of chronic total occlusion (CTO) intervention vs medical therapy after angioplasty in STEMI patients, and TOTAL, a study looking at the 1-year outcomes of thrombus aspiration in STEMI patients. The 1-year outcomes data will be interesting, said Stone, as some researchers think the benefits of thrombus aspiration are more likely to manifest late.

As part of the first-report investigation session, Dr Mark Hlatky (Stanford University School of Medicine, CA) will present quality-of-life and economic data from the PLATFORM study. The main results of PLATFORM were presented at the European Society of Cardiology 2015 Congress in September. As reported by heartwire from Medscape, the study showed the use of a diagnostic strategy with fractional flow reserve (FFR) derived from computed tomography (CT) significantly reduced the number of patients requiring invasive coronary angiography.

Wednesday Sees LEADERS Emerge

On Wednesday, the late-breaking clinical-trials session, sponsored by the Journal of the American Medical Association and moderated by Stone and Dr Eric Peterson (Duke Clinical Research Institute, Durham, NC), includes the LEADERS-FREE, TUXEDO, and PANDA III studies.

LEADERS III is testing a polymer-free biolimus-eluting stent against a bare-metal stent in approximately 2500 patients with coronary artery disease at high risk of bleeding. Instead of a polymer, the stent is designed with a "microetched" surface to retain the biolimus, the hope being that removing the polymer will eliminate long-term complications thought related to the polymer (such as delayed healing, stent thrombosis). In addition, the trial is testing whether just 1 month of dual antiplatelet therapy (DAPT) is safe.

TUXEDO is evaluating a paclitaxel-eluting stent vs an everolimus-eluting stent in diabetic patients with coronary disease. Stone noted that the limus-eluting stents have been shown to be more potent than paclitaxel-eluting stents, but this has been challenged in diabetic patients, who seem to do as least as well if not better with the paclitaxel-eluting stent.

"This will probably be the best chance we ever have to put this issue to rest," said Stone.

And finally, the PANDA III study is a prospective randomized trial testing two sirolimus-eluting stents with a bioresorbable polymer, each with varying elution and absorption kinetics. The question is whether one stent fares better than the other with respect to healing and stent-thrombosis rates.

Thursday Dedicated to TAVR

The last of the late-breaking clinical trials sessions takes place on Thursday and will be hosted by Leon and Dr Jeffrey Popma (Beth Israel Deaconess Medical Center, Newtown, MA). Dr Howard Herrmann (University of Pennsylvania, Philadelphia) will present one-year data from SAPIEN 3, a TAVR study in high-risk and inoperable patients with aortic stenosis.

In addition, the long-term results from RESPECT, a patent-foramen ovale (PFO)–closure study in patients with cryptogenic stroke, will be presented. Stone told the media the trial is eagerly anticipated, as RESPECT was a "barely negative" study. When analyzed as "per-protocol," the investigators did show PFO closure reduced the recurrence of nonfatal embolic stroke vs medical therapy (also, the stroke-recurrence rates seemed to diverge over time, showing an advantage for PFO closure). Long-term follow-up will divulge whether that trend held and if PFO closure holds any advantage over medical therapy.

Finally, Thursday will see the presentation of BRAVO 3, a study comparing bivalirudin vs heparin in patients undergoing TAVR.

In Thursday's first-report session, Japanese researchers are testing two approaches—surgical vs conservative management—in patients with severe asymptomatic aortic stenosis. As Stone noted, these asymptomatic patients are typically managed conservatively, as natural history studies suggest that until the patient develops symptoms, prognosis is similar to patients without aortic stenosis. Stone, aware of the findings, said the results were "pretty surprising" and hypothesis-generating, if not practice changing.

TCT 2015 is famous for its live cases, and this year is no exception. Stone highlighted two scheduled live cases in particular, including the first transcatheter mitral-valve replacement ever performed live, which will be performed using the Tiara device (Neovasc). The second is an implant of the V-wave device, a left-to-right intra-atrial shunt designed to reduce left-atrial pressure in patients with heart failure.


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