The “Buzz” on ACC.14 Late-Breaking Clinical Trials
This post was authored by Dharam J. Kumbhani, MD, SM, MRCP, FACC, and Anthony A. Bavry, MD, MPH, FACC, members of the editorial board for CardioSource.
It’s that time of the year again! Spring is in the air, March Madness is nearing another exciting finish, and soon the cherry blossoms will be in full bloom in Washington, DC. Perfect time, therefore, to be in DC for the ACC’s Annual Scientific Session!
Like every year, this year will see the presentation of landmark late-breaking clinical trials (LBCTs) in our field. These span the breadth of clinical cardiology, ranging from interventional cardiology to preventive cardiology to venous thromboembolic disease. As team leaders for clinical trials and members of CardioSource’s editorial board, we have been present at the majority of LBCT presentations over the past seven years. We have shared in the enthusiasm during the presentation of some truly practice-changing trials, such as PARTNER Cohort A (ACC. 11), EINSTEIN PE (ACC. 12) and MASSCOM and PARTNER II (ACC. 13). We have also experienced the disappointment when long-held beliefs are dispelled by rigorously conducted clinical trials – for example, HPS2-THRIVE during ACC. 13.
This year’s presentations promise to be as exciting, if not even more, than prior years. Probably the most eagerly awaited presentation is Deepak Bhatt, MD, MPH, FACC’s presentation of the SYMPLICITY-HTN 3 trial on Saturday morning. Renal denervation is one of the hottest topics in cardiology right now, and there was great excitement among the cardiology community following the dramatic improvements in blood pressure control with renal denervation noted in SYMPLICITY-1 and SYMPLICITY-HTN 2. There was thus great disappointment and surprise when the sponsor issued a press release a couple of months ago stating that the trial failed to meet its primary efficacy endpoint. We’ll know further details after the presentation, but these results highlight the importance of blinding and sham controls in device trials, something which is not routinely done. Results of the Global SYMPLICITY Registry will also be presented on Sunday. The future of the renal denervation field will likely be extensively discussed at the meeting.
Another major trial at ACC.14 will be the results of the CoreValve US Pivotal High Risk trial, comparing outcomes in high-risk surgical patients with aortic stenosis undergoing transcatheter aortic valve replacement (TAVR) with a CoreValve compared with surgical aortic valve replacement (similar to PARTNER Cohort A). The results of the Extreme Risk cohort (analogous to PARTNER Cohort B) were presented last year, and the valve was approved for commercial use earlier this year in this patient population. A positive result in this trial (followed by eventual U.S. Food and Drug Administration approval) will help expand the treatment armamentarium for this sick patient population. In fact, TAVR remains center stage during ACC.14, with 1-year results of the STS/ACC TVT Registry and also a clinical trial comparing balloon expandable to self-expanding TAVR (CHOICE) presented on Monday.
Other important trials include NAPLES III and BRAVE 4, which will be presented on Saturday, and which seek to provide data on choosing the optimal antiplatelet and anticoagulation strategy in patients undergoing a percutaneous coronary intervention. Although company-issued press releases on the STABILITY (darapladib – negative for efficacy) and AleCardio (aleglitazar – concern for safety) trials have already been released, the full trial presentations, scheduled for Sunday, will be important for a complete understanding of the issues involved. More so, because both of these drugs have seen other agents in their respective classes report negative results (varespladib in VISTA-16 and muraglitazar in a meta-analysis).Other trials in the cardiometabolic space include LAPLACE-2 (PCSK9 antibody) and GIPS-III (metformin). The role of colchicine for the treatment of recurrent pericarditis will be assessed in the CORP 2 trial.
Thus, ACC.14 LBCT presentations promise to provide some really important insights and potential breakthroughs for the treatment of patients with cardiovascular disease. We can’t wait to hear these presentations soon, and hope to see you in DC shortly! For those of you who are unable to make it for these presentations, visit the meeting coverage page on CardioSource.org for in-depth same-day coverage and commentaries on these clinical trials.
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