ACC 2019: A Smartwatch, Low-risk TAVR, and Bempedoic Acid Are Hoping for Luck Saint Paddy’s Day Weekend

Devices—both medical and consumer—are set to take center stage at the American College of Cardiology (ACC) 2019 Scientific Session over Saint Patrick’s Day weekend in New Orleans, LA. In what must be a first for a major cardiology meeting, a consumer gizmo, the Apple Watch, is the focus of the opening late-breaking clinical trial (LBCT) session, while the second is devoted to transcatheter heart valves.

According to program chair Andrew Kates, MD (Washington University in St. Louis, MO), who, with co-chair Pamela Morris, MD (Medical University of South Carolina, Charleston), walked journalists through a preview of the program, more than 3,000 oral and poster abstracts were chosen from more than 5,500 submissions. A full 131 studies were submitted and 21 of these were ultimately selected as late-breaking clinical trials, with an additional 15 accepted as featured clinical research.

LBCT I, in its entirety, is given over to the Apple Heart Study, described by Morris as a “very interesting” research foray into the exploding growth of wearable, personal, health-monitoring devices. The Apple-funded study was designed to enroll up to 500,000 adults wearing the smartwatch who received a notification if the device detected an irregular heartbeat. These individuals were then followed up with an ECG to determine if they did, indeed, have atrial fibrillation.

Investigators, Morris continued, are looking at the concordance between the watch-based report and the subsequent ECG, and how this impacts patient-physician interaction within the 3 months following the irregular pulse notification.

“I think this study is of considerable interest both to consumers who wear these devices but also physicians who are caring for these patients,” Morris said. “We know atrial fibrillation is associated with an increased risk of stroke and other clotting events, but sometimes [the A-fib] is asymptomatic for patients, which is where these devices could come in, in recognizing rhythm disturbance. So, if the study shows that there is good accuracy in detecting A-fib then these devices could encourage patients to get medical attention and begin therapy before a catastrophic event. On the other hand, if devices do not accurately detect the rhythm and possibly create artifacts, . . . then it could result in unnecessary concern on the part of consumers and unnecessary healthcare visits or diagnostic tests.”

TAVR and COAPT Return to the Spotlight

Next up, the first of the two LBCT sessions on Sunday is dedicated to the TAVR low-risk trials, two COAPT analyses, and a TVT/STS registry analysis of balloon-expandable TAVR devices in bicuspid valve disease. The PARTNER 3 trial, sponsored by Edwards Lifesciences, kicks things off with a randomized comparison of the Sapien 3 device with surgery in approximately 1,300 patients at low risk for surgical aortic valve replacement. Immediately following is the self-expanding TAVR, low-risk trial, sponsored by Medtronic, which randomized 1,200 low-risk patients to surgery or transcatheter replacement using the CoreValve or Evolut devices.

Listings for both of these eagerly awaited trials on ClinicalTrials.gov reveal some important differences between these two studies. PARTNER 3 has a primary outcome of all-cause mortality, all stroke, and rehospitalization at 1 year, while the primary endpoint in the Medtronic trial is all-cause mortality or disabling stroke at 2 years.

The bicuspid trial, meanwhile, is assessing the use of the Sapien 3 in patients with bicuspid aortic stenosis—a group previously excluded from the trials that led to the early approval of these devices in high- and then intermediate-risk patients.

COAPT first made headlines at the TCT 2018 meeting last year when it showed a substantial reduction in not only the primary endpoint of heart failure rehospitalizations, but also mortality at 2 years with MitraClip therapy in patients with mitral regurgitation and severe heart failure. Fast forward 6 months and ACC attendees will get to see detailed echocardiographic results as well as a quality of life analysis.

Kates, speaking during the briefing, acknowledged the excitement generated by the original COAPT hard endpoint results, but stressed that these softer quality-of-life results are still extremely important.

“In this high-risk patient population, it’s important to show reductions in hospitalizations and other outcomes like heart failure, but also to show that [the clip] actually improves their quality of life. . . . If it doesn’t improve quality of life, this may give us some equipoise in how much we utilize this as a technology moving forward.”

Interventional Cardiology Trials

Interventional cardiology has a strong showing among this year’s ACC late-breakers and featured clinical trials. LBCT V, on Monday, includes a comparison of femoral versus radial access for STEMI and two studies looking at single versus dual antiplatelet therapy following DES implantation (STOPDAPT-2 and SMART-CHOICE). COACT, meanwhile, is investigating the role of an early invasive strategy in post-cardiac arrest patients without STEMI, a group in whom the value of early angiography is uncertain.

Featured Clinical Research II, on Sunday, is dedicated to interventional studies and includes results from DEFINE PCI, looking at the blinded physiological assessment of residual ischemia after PCI, 1-year results from the ADVANCE registry, which is looking at the impact of FFRCT, and the MRUSMI first-in-man trial, looking at the use of sonothrombolysis in STEMI patients undergoing PCI.

Other LBCTs

Morris flagged a number of other closely watched trials in this year’s program.

• AUGUSTUS is a 2x2 factorial, randomized trial comparing apixaban (Eliquis; Bristol-Myers Squibb) with warfarin plus aspirin versus placebo in 4,600 atrial fibrillation patients, following an acute coronary syndrome diagnosis or PCI.
• CLEAR Wisdom is an 800-patient trial looking at the safety and efficacy of novel oral agent bempedoic acid versus placebo on top of maximal statins in patients with hypercholesterolemia and high cardiovascular risk. The study’s primary endpoint is percent change in LDL cholesterol at 12 weeks, but as Morris noted, the cardiology community is eager for less expensive, oral, lipid-lowering medications and would be eager to see hard outcomes trials following this trial, if positive. The manufacturer, Esperion, has already announced plans to price its pills, assuming efficacy and regulatory approval, cheaper than the PCSK9 inhibitors, which are injectable drugs.
• INFINITY, coming in the wake of the controversy over the 2017 blood pressure guidelines, is looking at intensive versus standard ambulatory blood pressure control to slow functional declines—namely mobility and cognition—in the elderly.

Beyond the Big Trials

Kates, speaking to the media, highlighted additional bells and whistles in this year’s meeting, including the “diverse and experienced” invited faculty. The annual Simon Dack keynote lecture will be given by pediatric cardiologist Roberto Canessa, MD, one of just 16 survivors of the 1972 plane crash in the Andes Mountains. Canessa, who was travelling with his rugby team, trekked 10 days with one of his teammates through extreme conditions to summon help. A medical student at the time, Canessa was also the one who proposed eating the bodies of passengers who’d perished in order to survive and, as his website attests, was the first to perform “the terrible task of cutting and swallowing the first piece of flesh.”

The ACC is also continuing its focus on physician well-being and work/life balance. The Louis F. Bishop Keynote on Saturday, delivered by Tait Shanafelt, chief wellness officer at Stanford University, is addressing individual and organizational approaches to minimizing burnout and maximizing well-being. Following Shanafelt’s keynote are two “clinician wellness intensives,” Kates noted, including a range of “Crash and Burn” personal stories from ACC members. “Nearly 50% of physicians experience burnout and clinician wellness is a key part of the ACC’s strategic plan,” Kates said.

And, for the second year in a row, the ACC is trying to up its game on Twitter with the designation of a new crop of “pathway tweeters” using designated hashtags to differentiate their subspecialty topics on #CardioTwitter.

Of course, the @TCTMD news team will also be tweeting at #ACC19. Follow @TCTMD_Yael, @MichaelTCTMD, @TCTMD_Caitlin, @LAMckeown1 and @ShelleyWood2 for news and views from New Orleans. Breaking news, big and small, can be found on our conference coverage page. Got a tip to tell us about? Let us know.