March 24th, 2014
ACC.14 Preview: Renal Denervation, TAVR Comparisons, and More
The ACC begins this Saturday in Washington, DC. Here’s a preview of some of the most highly anticipated late-breaking clinical trials:
On Saturday morning at the opening session the world will finally learn more about the failure of Symplicity HTN-3, the Medtronic trial of renal denervation. Until recently, renal denervation was thought to be an extremely promising new technology. Many different companies were working on devices that, they hoped, would deliver a cure for resistant hypertension. But then earlier this year Medtronic announced that this trial — the first rigorous, well-controlled test of the technology — had failed to meet its primary endpoint. On Saturday the details will become clear.
One day later findings will be presented from the Global Symplicity Registry, including information about the real-world application of renal denervation in over 1,000 patients who have received the device in Europe, where it is currently approved for marketing.
In sharp contrast to renal denervation, transcatheter aortic valve replacement (TAVR) has had a markedly more successful introduction. PK Shah, co-chair of the ACC.14 program, told reporters at an ACC news conference that he believes TAVR will largely replace conventional surgery in coming years. The first results of two important new TAVR trials will be presented. The first, also on Saturday at the opening session, is the high-risk subset of the CoreValve pivotal trial, in which patients were randomized to the CoreValve or surgical aortic valve replacement. This trial will provide the basis for the FDA’s decision whether or not to expand the CoreValve indication into this important subgroup. CoreValve recently received initial FDA approval for use in patients who are not surgical candidates.
On Sunday comes CHOICE, the first head-to-head clinical trial to compare TAVR devices. Investigators in Germany randomized 240 patients to either the Sapien XT (Edwards’ next generation TAVR device) or the Medtronic CoreValve device.
In 2009 the MADIT-CRT trial demonstrated the benefits of cardiac resynchronization therapy in patients with mild heart failure. On Sunday the long-term mortality findings from the trial will be presented.
Other late-breakers at ACC.14 will provide information about the much-anticipated PCSK9 monoclonal antibodies, the failure of darapladib in the Stability trial, the role of colchicine in recurrent pericarditis, and the effects of bariatric surgery on glycemic control and diabetes.