January 31, 2014
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ACC announces late-breaking clinical trials

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The American College of Cardiology has announced the line-up of late-breaking clinical trials scheduled for presentation at its Annual Scientific Session and TCT@ACC-i2 summit.

The meeting will be held March 29 to 31 in Washington, D.C.

The opening session will feature presentation of the main results from the SYMPLICITY HTN-3 trial, which assessed the Symplicity renal denervation catheter (Medtronic), and data on the self-expanding transcatheter CoreValve system (Medtronic) compared with surgical aortic valve replacement for severe aortic stenosis among high-risk patients.

Earlier this month, Medtronic announced that the SYMPLICITY HTN-3 trial failed to meet the trial’s primary efficacy endpoint of change in office systolic BP after 6 months, but did achieve the primary safety endpoint regarding the incidence of major adverse events and renal artery stenosis. The company also received FDA approval for CoreValve in January, without review by an advisory committee, due to favorable outcomes from the Extreme Risk study of the US pivotal trial, which assessed all-cause mortality and stroke at 12 months after implantation.

Other key late-breakers announced by the ACC include:

  • Two trials that assessed the safety and efficacy of evolocumab (AMG 145, Amgen) in patients with hypercholesterolemia. One study was conducted in patients unable to tolerate effective statin doses and the other assessed the drug administered in combination with statins in patients with primary hypercholesterolemia and mixed dyslipidemia.
  • STABILITY, which assessed the impact of lipoprotein-associated phospholipase A2 inhibitor darapladib (GlaxoSmithKline) on ischemic events among patients with chronic CHD.
  • AleCardio, which investigated the use of aleglitazar (Roche) for the reduction of CV events in patients with diabetes and ACS.
  • CORP-2, which evaluated colchicine as a treatment for recurrent pericarditis.
  • Three-year results from the STAMPEDE trial, which compared the impact of bariatric surgery on glycemic control and diabetes complications with that of intensive medical therapy.
  • CHOICE, which compared the use of self- and balloon-expandable prostheses during transfemoral transcatheter aortic valve replacement.
  • MSC-HF, which evaluated the use of autotransplanted bone marrow from mesenchymal stromal cells for severe ischemic HF.

Cardiology Today and Cardiology Today’s Intervention will report live from the ACC’s Annual Scientific Session and TCT@ACC-i2 summit. Visit Healio.com/Cardiology during the sessions for breaking news, videos, perspective from experts in the field on major results and announcements, and more.