Transcatheter Cardiovascular Therapeutics 2016 Preview

The Transcatheter Cardiovascular Therapeutics (TCT) 2016 annual meeting will take place from Saturday, October 29 through Wednesday, November 2 in Washington, DC.

This year’s speakers include NBA star Earvin “Magic” Johnson (Monday, October 31) and presidential historian and Pulitzer Prize winner, Jon Meacham (Tuesday, November 1).

In addition to late-breaking clinical trials and first report investigations, TCT will present 3 Interventional Innovations:  Interventional Innovation and Best Technological Concepts 1, Interventional Innovation 2: “Shark Tank” Innovation Competition, and Interventional Innovation 3: Early Feasibility and First in Human Studies.

A special session titled, “TCT 2016 Transcatheter Heart Valve Innovation Session” will take place on Sunday, October 30 and will include the following topics:

• Bench to Bedside: The Conundrum of Pre-Clinical Testing for Transcathter Valve Therapies—When Is My Device Ready for Human Testing?
• First-In-Human Use: Device Failure Modes and Lessons Learned from Early Human Studies
• The Transition to Pivotal Clinical Trials: How to Launch the Clinical Pathway
• Ongoing Controversies (Clinical and Otherwise) in Transcatheter Valve Therapies 

There will also be 2 “FDA Town Hall Meetings” on Monday, October 31 and Tuesday, November 1. The first meeting will discuss topics such as US FDA and European regulatory priorities, a national evaluation system for health technology, the trend toward simple trials and big data, and implications of data sharing. The second meeting will focus on specific devices such as bioresorbable scaffolds, new metallic drug-eluting stents, transcatheter aortic valves,, mitral and tricuspid repair/replacement devices, and LAA closure devices.

TCT 2016 Clinical Trial Highlights (by day)

Sunday, October 30

ILUMIEN III (OPTIMIZE PCI)—A prospective, randomized trial of OCT-guided vs IVUS-guided vs angio-guided stent implantation in patients with coronary artery disease

ABSORB II—Three-year clinical outcomes from a prospective, randomized trial of an everolimus-eluting bioresorbable vascular scaffold vs an everolimus-eluting metallic stent in patients with coronary artery disease

LEADERS FREE—Two-year clinical and subgroup outcomes from a prospective, randomized trial of a polymer-free drug-coated stent and a bare metal stent in patients with coronary artery disease at high bleeding risk

Monday, October 31

EXCEL—A prospective, randomized trial comparing everolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease

NOBLE—A prospective, randomized trial comparing biolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease

REVELUTION—Nine-month clinical, angiographic, IVUS, and OCT outcomes with a polymer-free sirolimus-eluting drug-filled stent

Tuesday, November 1

SENTINEL—A prospective, randomized trial evaluating cerebral protection in patients with severe aortic stenosis undergoing transcather aortic valve replacement

WATCHMAN US post-approval study—Multicenter, prospective, registry results with a left atrial appendage closure device for stroke prevention in patients with atrial fibrillation

Wednesday, November 2

AMULET Observational Study—Multicenter, prospective, registry results with a left atrial appendage closure device for stroke prevention in patients with atrial fibrillation

ILLUMENATE US—A prospective, randomized trial of a paclitaxel-coated balloon vs an uncoated balloon for treatment of diseased superficial femoral and popliteal arteries

PRISON IV—A prospective, randomized trial of a bioresorbable polymer-based sirolimus-eluting stent and a durable polymer-based everolimus-eluting stent in patients with coronary artery chronic total occlusions

Reference

Cardiovascular Research Foundation. Transcatheter Cardiovascular Theraeputics 2016. October 29-November 2, 2016; Washington, DC. http://www.crf.org/tct. October 28, 2016.