TCT.15: Bioresorbable scaffold sessions highlight late-breaking clinical trials

For the past few years, the Transcatheter Cardiovascular Therapeutic (TCT) conference has focused on structural heart disease as a major subspecialty in interventional cardiology. This year’s conference, which runs Oct. 10-15 in San Francisco, will have more of an emphasis on coronary intervention, according to TCT co-director Gregg W. Stone, MD.

Of the 20 late-breaking trials and first report investigations, 12 will be simultaneously published in major medical journals.

On Oct. 12, researchers will present data on bioresorbable scaffolds, including 1-year results from the ABSORB III trial that enrolled approximately 2,000 patients with coronary artery disease. Patients were randomized to receive the Absorb BVS (an everolimus-eluting bioresorbable vascular scaffold) or the XIENCE everolimus-eluting cobalt chromium metallic drug-eluting stent. The 1-year results are designed to show noninferiority.

Researchers will also discuss 6-month clinical, angiographic and imaging outcomes of the single-arm BIOSOLVE II study that examined a sirolimus-coated magnesium dissolvable stent.

“Bioresorbable scaffolds have the potential to become the next revolutionary, if not evolutionary, development in coronary intervention,” said Stone, a professor of medicine at Columbia University. “The concept of these devices is that they supply the mechanical scaffolding ability of a regular permanent, metallic stent and the drug-elution capability of those devices within the first year and then over the next several years, they completely absorb. The advantage of doing that is it removes potentially all the late adverse events that could happen from the presence of a permanent, metallic device…There are many, many patients and physicians that really like the concept of not having a permanent device ever left in their body. It is our hope that these devices will improve long-term outcomes compared to metallic, drug-eluting stents.”

On Oct. 13, researchers will present results of the prospective, double-blind, placebo-controlled RIVER-PCI trial of approximately 2,600 patients with incomplete revascularization after PCI. Patients were randomized to receive ranolazine or placebo and followed for several years. The primary endpoint is ischemia-driven revascularization or hospitalization.

On Oct. 14, researchers will present 1-year results of the prospective, double-blind, randomized LEADERS FREE trial that enrolled more than 2,500 patients with coronary artery disease at high risk for bleeding with prolonged dual antiplatelet therapy. Patients were randomized to be treated with a polymer-free biolimus-eluting stent or a bare metal stent. All patients received only one month of dual antiplatelet therapy.

The late-breaking sessions on Oct. 15 will focus on transcatheter aortic valve replacement (TAVR) and include 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. In June, the FDA approved the Sapien 3 system, a third generation TAVR device from Edwards Lifesciences.