TCT scientific symposium features major coronary intervention trials

From Oct. 11 to 15, leaders in interventional cardiovascular medicine will gather in San Francisco for the annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

Researchers will be presenting 20 late-breaking trials and first report investigations, several of which TCT co-director Gregg W. Stone, MD, said could help improve the outcomes of patients.

“The last several years, we’ve really focused on structural heart disease as the new breakthrough subspecialty in interventional cardiology,” said Stone, a professor of medicine at Columbia University. “This year there’s kind of a return to coronary intervention, especially as regards the landmark presentations for bioresorbable scaffolds.”

The Oct. 12 late-breaking sessions will focus on bioresorbable scaffolds, which Stone said are promising but are also more difficult to use than currently FDA-approved metallic drug-eluting stents.

The most highly anticipated trial is ABSORB III, in which patients with coronary artery disease were randomized to receive the Absorb BVS (an everolimus-eluting bioresorbable vascular scaffold) or the XIENCE everolimus-eluting cobalt chromium metallic drug-eluting stent. At TCT, researchers will present ABSORB III’s one-year results, which are powered to see if the Absorb BVS is noninferior to the XIENCE device.

Other noteworthy trials include the first results of the single-arm BIOSOLVE 2 study that examined a serolimus-coated magnesium dissolvable stent and the randomized LEADERS FREE study that evaluated a metallic drug-eluting stent with no polymer coating versus a bare metal stent.

Almost all of the 120,000 bioresorbable scaffolds implanted in patients have been done outside the U.S. except for the approximately 1,300 that have been implanted in U.S. clinical trials, according to Stone.

“Physicians are embracing this new technology,” Stone said. “It’s still a minority compared to metallic drug-eluting stents because of their ease of use and their long-term track record. I will say that even the metallic drug-eluting stents with no polymer or with a bioresorbable polymer have a high bar to go against because the current U.S.-approved drug-eluting stents before [the FDA approved the Synergy bioabsorbable polymer drug-eluting stent system], all of which had durable polymers, have gotten very, very good one-year results and long-term results. We don’t even know if these new metallic drug-eluting stents are better than the other approved durable polymer drug-eluting stents and we don’t know whether or not the bioresorbable scaffolds are as good within one year and then whether they’ll be superior within five years. Only very large scale, multicenter, randomized trials will be able to give us that answer, but those studies are underway.”

The TCT conference will also include several transcatheter aortic valve replacement (TAVR) trials, including one-year outcomes of the SAPIEN 3 trial that examined a balloon-expandable transcatheter aortic valve in high-risk and inoperable patients with aortic stenosis. The FDA approved the Sapien 3 system in June.

Follow the Cardiovascular Business website and Twitter feed for the latest news from the TCT conference. We will be providing daily updates of the late-breaking trials and keeping you informed of the top news from the meeting.

-Tim Casey
Executive Editor