Late breaking clinical trials in interventional cardiovascular medicine to be presented at TCT 2010

Full program now available and searchable online

Clinical trials in a variety of areas within interventional cardiovascular medicine that will be presented at TCT 2010 will directly affect the way that people with cardiovascular disease are treated. Breakthroughs in science and medical research, presented exclusively at TCT, will lead to new treatments that are minimally invasive and involve shorter recovery times. Among the topics being covered are stenting in the femoral artery, polymer-free drug-eluting stents, valves and drug-eluting balloons used in angioplasty.

"The late breaking clinical trials and first report investigations scheduled for presentation at TCT 2010 will lead to important breakthroughs in patient care that are highly anticipated by the field of interventional cardiovascular medicine," said Gregg W. Stone, MD, Professor of Medicine at Columbia University College of Physicians and Surgeons, Director of Cardiovascular Research and Education at the Center for Interventional Vascular Therapy at NewYork-Presbyterian Hospital/Columbia University Medical Center and Co-Director of the Medical Research and Education Division at the Cardiovascular Research Foundation. TCT is organized by the Cardiovascular Research Foundation and will be held September 21-25, 2010 in Washington, DC

The TCT 2010 final program is now available at: http://www.tctconference.com/pdf/TCT2010-final-program.pdf. The program is also now searchable online by presentations and speakers at: http://www.tctconference.com/program/program-agenda.html

• Heart Valves: PARTNER is the first randomized transcatheter aortic valve implantation (TAVI) trial worldwide and should address the important question of whether less invasive trans-femoral TAVI is the preferred therapy in non-operable patients with severe aortic stenosis.

• Drug-Eluting Stents and Diabetes: SPIRIT IV is the largest randomized trial to date comparing two drug-eluting stents. The two-year outcomes from this trial will provide important insights into the absolute and relative long-term safety and efficacy outcomes of everolimus-eluting and paclitaxel-eluting stents in a complex patient population, including 1,185 randomized patients with diabetes.

• Drug-Eluting Stents: The COMPARE trial compares the outcomes of the everolimus-eluting stent versus the paclitaxel-eluting stent in an all-comer population after 2 years.

• Pharmaceutical Therapy: The LANCELOT ACS study evaluates the safety and efficacy of a reversible PAR-1 thrombin receptor antagonist in patients with Acute Coronary Syndrome.

• Drug-Coated Catheter: The LEVANT 1 trial assesses the safety and efficacy of a novel drug-coated angioplasty balloon catheter for the treatment of femoropopliteal disease after 6 months.

• Drug-Eluting Catheter: The PERfECT STENT study evaluates whether treatment with a drug-eluting stent and a paclitaxel-eluting balloon catheter is superior to treatment with the drug-eluting stent alone.

• Stenting in the Femoral Artery: The ZILVER PTX trial examines the first drug-eluting stent approved (currently CE marked, investigational in the U.S.) for the superficial femoral artery (SFA). This study compares the safety and effectiveness of the Zilver PTX drug-eluting peripheral stent to balloon angioplasty (PTA) and bare-metal stenting (BMS) after 12 months.

• Drug-Eluting Stents: The SORT OUT-4 trial compares the safety and efficacy of the sirolimus-eluting stent, which has demonstrated the least amount of late lumen loss among previously released drug-eluting stents, with a next-generation everolimus-eluting stent in patients with coronary artery disease after 9 months.

• Drug-Eluting Stents: The ISAR TEST-4 trial will feature angiographic and clinical 2 year results from a randomized comparison of everolimus-eluting stents versus sirolimus-eluting stents. The study will shed important light on comparative outcomes of the leading first- and second generation drug-eluting stents as well as provide direct insight into the relative late performance characteristics of both devices.

• Drug-Eluting Stents: The DES-BTK trial is a prospective, double-blind randomized trial comparing a polymer-free sirolimus-eluting stent with a bare-metal stent in patients with infrapopliteal disease.

• Venous Thromboembolism: TORPEDO is the first prospective randomized controlled trial of the efficacy of percutaneous endovenous intervention in the reduction of venous thromboembolism and post-thrombotic syndrome, 2 common complications of deep venous thrombosis.

• Restenosis Therapy: The BLAST study will provide important insights on the safety and effectiveness of LABR-312 as a systemic anti-restenosis therapy after vascular intervention in patients with coronary stenoses. The novel use of this monocyte-specific inhibitor and the quantitative correlation of angiographic and clinical effects along a biological continuum of cellular modulation may change the paradigm of concomitant drug therapy to prevent restenosis.

• Drug-Eluting Stents: ISAR-TEST-5 is a prospective, randomized trial of the polymer-free sirolimus/probucol-eluting stents compared to zotarolimus-eluting stents in patients with coronary artery disease stents after 1 year.

• Pharmaceutical Therapy; Drug-Eluting Stents: HORIZONS-AMI is the largest completed randomized trial of different pharmacologic regimens and stent types in heart attack patients. At 1 year, bivalirudin alone compared to heparin plus glycoprotein IIb/IIIa inhibitors resulted in significantly reduced rates of major bleeding and mortality, while paclitaxel-eluting stents compared to bare-metal stents safely reduced clinical and angiographic restenosis. The final 3 year outcomes from this trial will determine whether these results are maintained with longer-term follow-up.

• Drug-Eluting Stents: The CRISTAL trial provides results of a 1 year comparison between implantation of a new sirolimus-eluting stent and repeat balloon angioplasty in patients with restenosis in sirolimus-eluting stents.

• New Stents: The BIOFREEDOM trial is a first-in-man evaluation of a new generation polymer-free drug-eluting stent. The new technology used in this stent allows adhesion of a potent antiproliferative agent (BA9) to the stent's abluminal surface and further controlled release of the drug without the use of a polymer or binder.

• Imaging: The AVIO trial investigates whether intravascular ultrasound (IVUS) optimized drug-eluting stent (DES) implantation demonstrates an advantage over angiography in complex lesions.

• Drug-Eluting Stents: The EXCELLENT trial will determine whether an everolimus-eluting stent is non inferior to a sirolimus-eluting stent in preventing in-stent late loss at 9 months. 1 year clinical outcomes will also be presented.