Late-Breaking Trials at ACC 2016: Three-drug Combo and TAVR Among the Positive News for Heart Patients

Presentations on three late-breaking clinical trials caught my attention at this year’s American College of Cardiology (ACC 2016) annual meeting in Chicago. One large trial supports the “polypill” approach and another the superiority of transcatheter aortic valve replacement (TAVR) over surgery when treating patients at intermediate risk of heart disease. A third study found cryoballoon ablation to be on par with radiofrequency ablation as measured by recurrence of atrial fibrillation. Here are the highlights:

Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial: Low-dose of statin combined with two antihypertensive medications (angiotensin receptor blocker and thiazide diuretic) was shown to significantly lower lipid levels and cardiovascular events in patients at intermediate risk for heart disease, as well as slightly lower (by 1.6 percent) their risk of death from cardiovascular causes. This randomized, placebo-controlled clinical trial included 12,705 patients from 21 countries and represents the first formal testing of the polypill concept. And while investigators say the results don’t support blanket lipid- and blood pressure-lowering in all patients at intermediate risk, they maintain that certain individuals—particularly those with higher baseline systolic blood pressure—could benefit from the simple, low-cost drug combo.

SAPIEN 3 observational trial: The Sapien 3 balloon-expandable transcatheter aortic valve (Edwards Lifesciences) was deemed superior to surgery among intermediate-risk patients based on lower rates of mortality, stroke and paravalvular leak at one year. The majority of the 1,077 patients in the study received TAVR via transfemoral access, so the findings aren’t necessarily transferable when other routes are taken. Results are similar to those of earlier trials involving high-risk patients. One outstanding concern is financial; the Sapien 3 is not yet indicated for use in intermediate-risk patients and therefore not eligible for reimbursement by the Centers for Medicare & Medicaid Services.

FIRE AND ICE trial: Cryoballoon ablation (“ice”) was shown to be just as good as radiofrequency current (“fire”) ablation in this randomized comparative study involving 762 patients with paroxysmal atrial fibrillation as measured by its recurrence (34.6 percent versus 35.9 percent). While safety outcomes were also similar between treatment groups, procedure times were the shortest with cryoablation (124 versus 142 minutes) and fluoroscopy times were the shortest with radiofrequency balloon ablation (17 minutes versus 22 minutes).

There remains much room for progress. Ablation therapy has been considered a standard treatment for atrial fibrillation for many years now, and yet has proven at best moderately successful.

Robin Cunningham, RN

Robin Cunningham, RN

Robin Cunningham, RN, is a director for Physician Services at HealthTrust. A cardiovascular care specialist, she previously served as a clinical director for SourceTrust and, prior to that, served in leadership positions with HCA for 25 years. Cunningham works with HealthTrust members on medical device contracting projects, product analysis, spend review and physician engagement. She is a member of the American College of Cardiology, serving as state liaison for Tennessee, as well as the American Heart Association Greater Southeast Affiliate for Mission Lifeline. Cunningham holds a bachelor’s degree in nursing from the Medical University of South Carolina and a master’s degree in nursing from Austin Peay State University.