ACC 2016: HOPE for Primary Prevention, TAVR in Moderate-Risk Patients, Deferred Stenting in STEMI, and More

The American College of Cardiology (ACC) 2016 Scientific Sessions are breezing into the Windy City later this week, bringing with them the new FDA commissioner, the First Lady of the United States (virtually), and a host of clinical trials already predicted to blow open new doors in the treatment of cardiovascular disease.

There are a total of 24 late-breaking clinical trials (LBCTs) across five dedicated sessions during the 3-day meeting in Chicago, IL. Two trials addressing the use of transcatheter aortic valve replacement in moderate-risk patients as well as a randomized study investigating a strategy of deferred stenting in primary PCI are two key interventional cardiology topics. A number of additional hot-button issues in interventional medicine are highlighted elsewhere in the program.

ACC 2016 opens Saturday morning with a welcome address from Michelle Obama—albeit one delivered to her hometown by video address—followed by a Simon Dack Lecture from David Nash, MD, of Thomas Jefferson University (Philadelphia, PA), whose talk will be focused on population health (“Is it the Secret Sauce?”). Nash’s talk, according to outgoing ACC President Kim Allan Williams, MD (Rush University Medical Center, Chicago, IL), whose tenure has been marked by a strong emphasis on lifestyle and nutrition, is intended to help “guide us into our next few decades as to how we can affect populations in a better manner . . . rather than mopping up the floor, turning off the faucet.”

Three Days, Five Sessions, 24 Late-Breakers

Immediately following Nash’s lecture is the first LBCT session of the meeting. It opens with 2-year results from PARTNER II Cohort A, the randomized clinical trial comparing TAVR using the earlier-generation Sapien XT valve (Edwards Lifesciences) to surgery in over 2,000 moderate-risk patients, with a primary endpoint of death or disabling stroke.

The rest of that first session is focused on primary prevention, with three separate presentations from the HOPE 3 trial. HOPE 3, conducted in 21 countries worldwide, randomized almost 13,000 patients with no known cardiovascular disease to receive rosuvastatin (Crestor, AstraZeneca) and/or candesartan/ hydrochlorothiazide versus placebo with the aim of preventing major cardiovascular events.

Program chair Athena Poppas (Cardiovascular Institute, Providence, RI), speaking with reporters during a recent telebriefing ahead of the meeting, drew parallels between HOPE 3 and the massive SPRINT trial, but noted that the newer study focuses on lower-risk patients in whom the role of cholesterol- and blood-pressure lowering through medication is unknown. She predicted the results would be “very novel, very impactful, and may change the way we do business". 

Both Sunday and Monday have two LBCT sessions each. Sunday’s first session, cohosted by JAMA, is heavily focused on lipids and offers new results for the CETP inhibitor evacetrapib (Eli Lilly and Company), the PCSK9 inhibitor evolocumab (Repatha, Amgen), and a study of familial hypercholesterolemia and coronary artery disease. Two additional trials in the lineup are patient-centered interventions, including a study addressing how to involve chest-pain patients in hospital discharge decisions.

Sunday’s second LBCT session, cohosted by the annual TCT meeting, is dedicated to interventional cardiology. It includes a second study looking at TAVR in moderate-risk patients—this time 1-year follow-up in a single-arm registry of 1,076 intermediate-risk patients treated with the next-generation Sapien 3 prosthetic (Edwards Lifesciences), with outcomes (all-cause mortality, stroke, and moderate/severe paravalvular leaks) compared to those of propensity-matched surgically-treated patients in PARTNER II Cohort A. Thirty-day results from this trial were previously presented at ACC 2015.

A second TAVR study in Sunday’s interventional LBCT session is an analysis of TAVR volumes and outcomes drawn from the STS/ACC TVT Registry.

The remaining trials in this mid-morning session are STEMI trials, including two presentations from DANAMI-3. The first looks at STEMI patients randomized to primary PCI and immediate DES placement or to primary PCI followed by deferred stent placement, a strategy hypothesized to reduce the risk of stent thrombosis. The second DANAMI-3 presentation looks at the other prespecified aim of this study, namely, the use of postconditioning to reduce infarct size. The last trial in this grouping, EARLY-BAMI, looks at the early administration of intravenous beta-blockers pre-PCI in STEMI patients.

On Monday, the final two LBCT sessions—the first of which is cohosted by the New England Journal of Medicine—are set to focus on heart rhythm and heart failure. Highlights here, ACC program planners said during the telebriefing, include the FIRE AND ICE trial comparing a cryoballoon catheter versus radiofrequency ablation with a ThermoCool catheter (Biosense Webster) in patients with paroxysmal atrial fibrillation and INOVATE-HF, a study of vagal nerve stimulation in chronic heart failure. Of particular note for interventionalists, the first LBCT session on Monday includes CARIN, a trial examining the use of CMX-2043 (Ischemix) for prevention of contrast-induced acute kidney injury.

All of the LBCT sessions are held in the Main Tent, North Hall B1. While the medical journals cosponsoring specific ACC sessions are not necessarily publishing the studies, a large number of this year’s trial results are also expected to go online simultaneously.

Beyond the Late Breakers

Outside of the LBCTs are a range of sessions of interest to clinicians with a focus on interventions. These include:

• Six coronary and structural heart disease live-case sessions broadcast from three North American centers on Saturday and Sunday only
• A series of sessions entitled “Great Minds Think Differently” offering multiple perspectives on the same topics, including completeness of revascularization, treatment of chronic limb ischemia, and catheter-based therapies for PE/DVT, among others
• A session dedicated to “Quality in the Cath Lab and Public Reporting: Friends or Foes?” on Saturday at 12:15 PM in room S104
• The first of two Featured Clinical Research sessions, this one Sunday at 12:30 PM in room S103cd, is focused on cardiovascular surgery and interventions and includes 3-year results from the pivotal randomized trial of the self-expanding CoreValve in high-risk patients as well as a second presentation that examines the incidence and outcomes of valve hemodynamic deterioration in TAVR by drawing on STS/ACC TVT Registry data
• A session dedicated to dual antiplatelet therapy addressing questions of optimal duration with new-generation stents, the role of aspirin, and triple therapy in the novel P2Y12 era, among others, on Saturday at 4:45 PM in room S103ab
• Several sessions on old and new treatments for primary and secondary mitral regurgitation, ranging from percutaneous approaches to optimal medical therapy
• A session devoted to Appropriate Use Criteria for coronary revascularization in 2016, including a debate over whether the categories “help or hinder”, on Sunday at 4:45 PM in room S103ab

Beyond Interventions

Newly minted FDA Commissioner Robert Califf, MD, will give the Eugene Braunwald Lecture, Monday 12:30 pm in the Main Tent, on future directions in cardiovascular medicine.

The second of two Featured Clinical Research sessions, this one on Monday at 2 pm, includes an update from the PROMISE trial of functional stress testing versus CT angiography in patients with suspected CAD, final 5-year outcomes from the STAMPEDE trial comparing bariatric surgery to intensive glycemic management in obese patients with type 2 diabetes, preliminary results from VINDICATE assessing vitamin D for heart failure, and RxEACH, a randomized controlled trial of community pharmacist prescribing and care on CV risk reduction.

In all, this year’s ACC meeting has a strong emphasis on prevention and patient-centered care. While not an official theme of the 2016 conference, Poppas called population health and primary and secondary prevention “a growing focus for the ACC” or, as Kim put it to reporters, “a strategic mission” for the organization. This emphasis was behind the decisions to put HOPE 3 in the opening showcase session, hold special activities in the new “patient pavilion,” and dedicate one of the half-day program “Intensives” to “Lifestyle Medicine: A Little Less Drug, a Little More Sex, and a Lot More Rock and Roll.”

“People may come for the catchy title, but they will stay for the science,” Williams predicted.

Expect whirlwind coverage from TCTMD’s team of reporters on the ground in Chicago. You can also follow breaking news and views on Twitter @TCTMD, @ShelleyWood2, @TCTMD_Caitlin, @TCTMD_Yael, 
@MichaelTCTMD, @ToddNeale, and @LAMcKeown1.