TCT 2016: Late-breakers and first report investigations announced

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The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 first report investigations that will be presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium (29 October–2 November, Washington DC, USA). The studies will examine the safety and effectiveness of minimally invasive techniques, pharmaceuticals, technologies, and devices that show potential to treat or prevent cardiovascular disease.

According to a CRF press release, all of the late-breaking clinical trials and first report investigations will be presented in the Main Arena. They are as follows:

30 October

Late-breaking trials

  • ILUMIEN III (OPTIMIZE PCI): A prospective, randomised trial of OCT-guided vs. IVUS-guided vs. angio-guided stent implantation in patients with coronary artery disease
  • BIO-RESORT (TWENTE III): A prospective, randomised three-arm trial comparing two different biodegradable polymer-based drug-eluting stents and a durable polymer-based drug-eluting stent in an all-comers population of patients with coronary artery disease
  • BIONICS: A prospective, randomised trial of a ridaforolimus-eluting coronary stent vs. a zotarolimus-eluting stent in a more-comers population of patients with coronary artery disease

First Report Investigations

  • ABSORB China: Two-year clinical outcomes from a prospective, randomised trial of an everolimus-eluting bioresorbable vascular scaffold vs. an everolimus-eluting metallic stent in patients with coronary artery disease
  • ABSORB II: Three-year clinical outcomes from a prospective, randomised 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, randomised trial of a polymer-free drug-coated stent and a bare metal stent in patients with coronary artery disease at high bleeding risk

31 October

Late-breaking trials

  • EXCEL: A prospective, randomised trial comparing everolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease
  • NOBLE: A prospective, randomised trial comparing biolimus-eluting stents and bypass graft surgery in selected patients with left main coronary artery disease

First Report Investigations

  • REVELUTION: 9-month cinical, Aangiographic, IVUS, and OCT outcomes with a polymer-free sirolimus-eluting drug-filled stent
  • FANTOM II: 6-month and 9-month clinical, angiographic and OCT results with a radiopaque desaminotyrosine polycarbonate-based sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease
  • MeRes-1: 6-month clinical, angiographic, IVUS and OCT results with a thin-strut PLLA-based sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease
  • FORTITUDE: 9-month clinical, angiographic, and OCT results with an amorphous PLLA-based sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease
  • FUTURE-I: 6-month clinical, angiographic, IVUS and OCT results with a thin-strut PLLA-based sirolimus-eluting bioresorbable vascular scaffold in patients with coronary artery disease

1 November

 Late-breaking trials

  • SENTINEL: A prospective, randomised trial evaluating cerebral protection in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement
  • PARTNER II QUALITY OF LIFE: Health status benefits from a prospective, randomised trial of transcatheter and surgical aortic valve replacement in intermediate-risk patients with severe aortic stenosis
  • PARTNER I FIVE-YEAR ECHO: Long-term haemodynamic and structural outcomes after transcatheter aortic valve replacement in high-risk and inoperable patients with aortic stenosis

First report investigations

  • RESPECT: Final long-term outcomes from a prospective, randomised trial of PFO closure in patients with cryptogenic stroke
  • COLOR: A prospective, multicentre registry evaluating the relationship between lipid-rich plaque and two-year outcomes after stent implantation in patients with coronary artery disease
  • PLATINUM DIVERSITY: Outcomes from a large-scale, prospective registry of coronary artery stent implantation in women and minorities
  • ReACT: A prospective, randomised trial of routine angiographic follow-up after coronary artery stent implantation

2 November

Late-breaking trials       

  • ILLUMENATE US: A prospective, randomised trial of a paclitaxel-coated balloon vs. an uncoated balloon for treatment of diseased superficial femoral and popliteal arteries
  • WATCHMAN US POST-APPROVAL STUDY: Multicentre, prospective, registry results with a left atrial appendage closure device for stroke prevention in patients with atrial fibrillation
  • AMULET OBSERVATIONAL STUDY: Multicentre, prospective, registry results with a left atrial appendage closure device for stroke prevention in patients with atrial fibrillation

First report investigations

  • PRISON IV: A prospective, randomised 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
  • TOSCA-5: A prospective, randomised trial evaluating collagenase infusion in patients with coronary artery chronic total occlusions
  • TRANSFORM-OCT: A prospective, randomised trial using OCT imaging to evaluate strut coverage at three months and neoatherosclerosis at 18 months in bioresorbable polymer-based and durable polymer-based drug-eluting stents
  • RIBS VI: A prospective, multicentre registry of bioresorbable vascular scaffolds in patients with coronary artery bare metal or drug-eluting in-stent restenosis—6–9 month clinical and angiographic follow-up results