Transcatheter therapies and drug-eluting balloons are hot topics at TCT
Stone, director of TCT and director of Cardiovascular Research and Education at Columbia University Medical Center/New York-Presbyterian Hospital in New York City, said that attendees can expect to see an “unprecedentedly high attendance rate,” up 1,000 to 2,000 more than the 12,000 recorded at last year’s meeting. With nearly 100 countries represented, meeting content will cover a breadth of materials, including coronary and endovascular interventions, as well as peripheral interventions, among others.
The late-breaking clinical trials—always the meeting’s attention grabbers—begin Wednesday, Nov. 9.
The late-breaking clinical trials presented Wednesday, Nov. 9, will focus on both PCI pharmacology and stent thrombosis:
- ADAPT-DES: A large-scale, prospective, multicenter registry examining the relationship of platelet responsiveness to stent thrombosis after DES implantation.
- DESERT: A large-scale, multicenter case-controlled study examining the predictors of stent thrombosis.
- PARIS: A large-scale, prospective, multicenter registry studying the patterns of and reasons for nonadherence to antiplatelet agents in stented patients.
- RAPID GENE: A prospective, randomized trial of prasugrel (Effient, Eli Lilly/Daiichi-Sankyo) versus clopidogrel (Plavix, Bristol-Myers Squibb, Sanofi Aventis) in CYP2C19*2 carriers identified by rapid point-of-care genotyping. Stone said that this is the first study to look at point-of-care testing to assess risk of stent thrombosis and clopidogrel response, which could be done right at the bedside.
- TRIGGER-PCI: A prospective, randomized trial of prasugrel versus clopidogrel in clopidogrel hyporesponsive patients with stable ischemic heart disease undergoing percutaneous coronary intervention.
- BRIDGE: A prospective, double-blind, multicenter, randomized placebo-controlled trial of intravenous cangrelor in patients awaiting surgery.
The late-breakers presented Thursday, Nov. 10, will focus both on transcatheter aortic valve replacement and primary PCI in STEMI:
- PARTNER Cohort B: Two-year data from the previously reported PARTNER B trial, a prospective, randomized trial evaluating transcatheter aortic valve replacement versus standard therapy in patients with inoperable aortic stenosis, will be reported. “The marked benefits seen at one-year were in a very elderly, high-risk population, but whether these advantages are maintained over a longer duration of follow-up will become important,” Stone offered.
- PARTNER Cohort A: These data will provide a cost and quality of life assessment from the prospective, randomized PARTNER cohort A trial, which evaluated transcatheter aortic valve replacement therapies versus surgical aortic valve replacement in patients at a high-risk for surgery, who also have aortic stenosis. “Cohort A showed noninferiority, so understanding the quality of life and cost-effective of these two strategies is important, especially when the clinician is deciding to choose between the two,” Stone says.
- STACCATO: A small, prospective, randomized trial of transapical transcatheter aortic valve replacement vs. surgical aortic valve reaplcement in low-surgical-risk elderly patients with aortic stenosis. “This is the first trial of its kind to look at transapical aortic valve replacement vs. surgical aortic valve replacement in patients at a low-risk. This is the lowest risk population studied in a trial,” Stone said.
- RIFLE STEACS: A prospective, randomized trial of radial vs. femoral vascular access in patients with STEMI.
- MUSTELA: A prospective, randomized trial of thrombectomy vs. no thrombectomy in patients with STEMI and thrombus-rich lesions.
- DEB-AMI: A prospective, randomized trial of paclitaxel-coated balloons plus bare-metal stents versus paclitaxel-eluting stents versus BMS-alone in patients with STEMI.
The late-breaking clinical trials presented on Friday, Nov. 11, will focus on novel drug-eluting stents (DES) and drug-coated balloons, as well as optimal PCI therapies and peripheral vascular disease:
- EVOLVE: A prospective, randomized trial of two dose formulations of a bioabsorbable polymer-based everolimus-eluting stent versus a durable polymer-based everolimus-eluting stent.
- REMEDEE: A prospective, randomized trial of a combination bioabsorbable polymer-based anti-CD34 antibody sirolimus-eluting stent versus a durable polymer-based paclitaxel-eluting stent.
- NEXT: A prospective, randomized trial comparing Cre8, a polymer-free stent eluting sirolimus stent, to a paclitaxel-eluting stent.
- PEPCAD-DES: A prospective, randomized trial of a paclitaxel-coated balloon versus uncoated balloon angioplasty in patients with restenosis of DES.
- TWENTE: A prospective, randomized trial of zotarolimus-eluting stents and everolimus-eluting stents in patients with coronary artery disease.
- ROTAXUS: A prospective, randomized trial of high-speed rotational atherectomy prior to paclitaxel-eluting stent implantation in complex calcified coronary artery lesions.
- ADVISE: Validation of a vasodilator-independent measure of coronary fractional flow reserve.
- COBRA: A prospective, randomized trial of cryoplasty versus conventional balloon postdilation of nitinol stents in the superficial femoral artery of patients with diabetes mellitus.
- PROFI: A prospective, randomized trial of proximal-balloon occlusion versus distal filter embolic protection in patients undergoing carotid stenting.
Stone said a number of presentations will discuss how to establish hybrid catheterization labs, what it takes to start a transcatheter valve program, and the mitral valve space, including the mitral clip, which has gained momentum in Europe.
“There will also be two new exciting areas, which include hypertension therapies (artisan technologies) and stroke prevention therapies,” Stone said. Additionally, he said the meeting will focus discussions on appropriate use criteria, how to best choose between medical therapy, PCI and surgery, and how to assess lesions.
The meeting will also explore the iFR system, a new pressure-derived vasodilator free measure of fractional flow reserve (FFR), which is successful, could replace standard FFR and integrate physiological lesion assessment in the cath lab, Stone said.
Stone said that longitudinal compression, a complication of stents, will be a hot topic with three added talks on Monday, Nov. 7. “The question really is to understand how frequent [compression] is, when it occurs, how to prevent it, and how to manage,” Stone offered.