The ACC.20/WCC Sessions Are Virtually Here:
A Preview

March 23, 2020

CYBERSPACE — Online learning rises to the next level starting March 28 with the ambitious, pioneering response from the American College of Cardiology (ACC) to the cancellation of its annual scientific sessions live meeting forced by the COVID-19 pandemic, uncharted territory in most every way.

The sessions are going online in three simultaneous real-time streams and videos and slides on demand, archived for 30-day access. And it will be free to literally anyone with internet and a computer, tablet, or smartphone.

Planned presentations for the ACC.20/World Congress of Cardiology Virtual meeting are to drop on the same days, and in many cases the same schedule, that had been established for the live sessions; all times on the agenda are Central Time.

The line-up includes, among many others:

  • a large, international trial of a promising, already-available candidate drug for heart failure and reduced ejection fraction (HFrEF)

  • a randomized trial exploring the use of e-cigarettes for smoking cessation

  • a sham-controlled trial of renal denervation for medically untreated hypertension that could potentially add to the once out-of-favor technique's revival

  • a test of a direct oral anticoagulant (DOAC) in patients with symptomatic peripheral artery disease (PAD) and recent lower-extremity revascularization

The ACC says the pioneering 3-day virtual conference will include all cases and peer-reviewed scientific presentations that were accepted for the live meeting, major keynote lectures, educational sessions, young investigator awards, and late-breaking clinical trials and featured research presentations.

Among the late-breaking clinical trial sessions that will figuratively take center stage:

Joint ACC/JACC Late-Breaking Clinical Trials I (Sat., March 28, 9 AM–10 AM)

The session leads off with a heart-failure (HF) trial that has already tipped its hand, the 42-country Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction (VICTORIA).

The presentation will expand on top-line primary results unveiled in November: a significant advantage in rate of cardiovascular death or HF hospitalization for its patients with worsening chronic HFrEF treated with the soluble guanylate cyclase stimulator vericiguat (Merck/Bayer) on top of standard meds.

VICTORIA had randomly assigned 5050 such patients to receive or not receive vericiguat or placebo following a decompensation event, defined as an HF hospitalization or receiving an intravenous diuretic for HF without hospitalization. They were also followed for a slew of secondary endpoints that included all-cause mortality.

Following up is the VOYAGER-PAD trial, which randomized 6564 patients with moderate to severe symptomatic PAD in the lower extremities to receive or not receive rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals), 2.5 mg twice daily, on top of standard therapy including aspirin.

For entry, patients were required to have had successful peripheral artery revascularization, distal to the external iliac artery, for symptomatic PAD within 10 days of randomization. They were followed for the primary endpoint of acute myocardial infarction (MI), ischemic stroke, cardiovascular death, acute limb ischemia, or major amputation.

The TAILOR-PCI trial, a major outcomes test of genotype-guided antiplatelet therapy for patients who have undergone percutaneous coronary intervention (PCI), will round out the session. A number of trials have suggested the strategy, in which genetically poor metabolizers of clopidogrel are steered toward an alternative second antiplatelet for dual-antiplatelet therapy (DAPT), is feasible, safe, and in some cases perhaps clinically beneficial.

Open-label TAILOR PCI randomly assigned about 5300 patients to receive standard antiplatelet therapy with clopidogrel (Plavix, Sanofi/Bristol-Myers Squibb) 75 mg/d or antiplatelet therapy prospectively guided by genotyping for the clopidogrel reduced-function CYP2C19 alleles. Genotype-negative patients were put on standard clopidogrel, and those positive for the alleles instead received ticagrelor (Brilinta/Brilique, AstraZeneca) 90 mg twice daily.

Patients were followed for the primary composite of nonfatal MI, nonfatal stroke, cardiovascular mortality, severe recurrent ischemia, or stent thrombosis at 1 year.

Joint ACC/N Engl J Med Late-Breaking Clinical Trials II
(Sunday, March 29, 8 AM–9:30 AM)

Well into the age of transcatheter aortic valve replacement (TAVR), the choice of long-term postprocedure antithrombotic therapy remains something of a frontier. For example, asks the open-label POPULAR-TAVI trial: one antithrombotic agent or two? 

POPULAR TAVI randomly assigned an estimated 1000 patients undergoing TAVR to one of four long-term treatment regimens: aspirin with vs without clopidogrel, or an oral anticoagulant (OAC) with vs without clopidogrel.

The trial has followed patients for bleeding unrelated to the TAVR procedure over 1 year as the primary endpoint; and for the composite of cardiovascular death, nonprocedure-related bleeding, MI, or stroke over 1 year as a main secondary endpoint.

As presented at this meeting a year ago, the PARTNER-3 trial scored big for TAVR when it saw a significant reduction in 1-year death, stroke, or hospitalization in low-surgical-risk patients who received the SAPIEN 3 valve (Edwards Lifesciences) instead of surgical aortic valve replacement.

But what happened after 2 years? Late-Breaking Clinical Trials II aims to answer that question with a presentation on the 2-year PARTNER-3 clinical and echocardiographic outcomes.

Other presentations scheduled for the session:

Late-Breaking Clinical Trials III (Sunday, March 29, 10:45 AM–12:15 PM)

For anyone keen on chiaroscuro and art of the High Renaissance, not to mention the DOACs, the session will lead with the CARAVAGGIO trial. Conducted in Europe, Israel, and the United States, the trial compared anticoagulation with dalteparin, which is parenteral, to apixaban, which is oral, in 1168 adults with most any cancer and confirmed proximal lower-limb deep venous thrombosis (DVT) or pulmonary embolism (PE). The primary endpoint is recurrent DVT or PE over 6 months.

The DOACs have been previously tested in similar clinical settings, with mixed but promising results that suggest they protect against recurrence but also can also pose a high risk of bleeding.

Hopes are high for a comeback of renal denervation as a treatment for hypertension, which had fallen out of favor after 2014 results from the SYMPLICITY HTN-3 trial showing little or no benefit.

In 2017, after modifications to the technique, a SPYRAL HTN OFF-MED pilot study renewed interest in renal denervation, suggesting it significantly lowered blood pressure in 80 patients with medically untreated mild-to-moderate hypertension.

Now, in 2020, the third Late-Breaking Clinical Trial session includes a presentation of primary outcomes of the full sham-controlled SPYRAL HTN-OFF MED Pivotal trial, which extended the pilot study to include 433 patients with hypertension not treated with drugs. Those primary outcomes include the efficacy endpoint of change in ambulatory systolic blood pressure over 3 months and safety endpoint of major adverse events at 1 month.

The session is also to include:

  • Rivaroxaban Versus Enoxaparin in Nonmajor Orthopedic Surgery (PRONOMOS)

  • Benefit and Risk of Rivaroxaban Plus Aspirin in Patients With Peripheral Artery Disease After Lower Extremity Revascularization With and Without Concomitant Clopidogrel: A Key Subgroup Analysis From VOYAGER-PAD

  • Randomized Clinical Trial of Pre-hospital Sodium Nitrite in Out-of-hospital Cardiac Arrest Patients (SNOCAT)

Late-Breaking Clinical Trials IV (Monday, March 30, 8:00 AM–9:30 AM)

Last year, the TWILIGHT trial showed superior outcomes from ticagrelor monotherapy after PCI in patients at high risk for complications, achieved by dropping aspirin from the DAPT regimen after 3 months. Ischemic protection provided by ticagrelor monotherapy was comparable to continued DAPT but with a significantly lower risk of bleeding.

Now at the ACC sessions, the first of several TWILIGHT subanalyses, dubbed TWILIGHT COMPLEX, should help clarify whether complex coronary anatomy should influence decisions when considering patients for ticagrelor monotherapy after PCI.

But would such a strategy work in patients who underwent PCI for acute coronary syndromes (ACS)? The TICO trial aimed to find out by randomly assigning an estimated 3056 patients receiving sirolimus-eluting coronary stents for ACS to continued DAPT or ticagrelor monotherapy starting at 3 months. They were followed for major adverse cardiovascular clinical events and for major bleeding at 1 year.

Other presentations in the session:

  • Ten-year Outcomes After Drug-eluting Stents vs Coronary Artery Bypass Grafting for Left Main Coronary Disease  (PRECOMBAT)

  • Radial Artery Versus Saphenous Vein for Coronary Bypass Surgery at Long Term Follow-up

  • Ticagrelor With and Without Aspirin in High-Risk Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention: Insights From the TWILIGHT Trial   

Joint ACC/JAMA Late-Breaking Clinical Trials V (Monday, March 30,
10:45 AM–12:15 PM)

E-cigarettes, also called vapes and other names, have a dark side that health professionals know about, but whether a long-speculated potential bright side actually exists needs to be tested in trials. One such trial, called Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3), is scheduled for presentation on Monday of the ACC.20 sessions.

The study enrolled 376 adults who smoked an average of 10 cigarettes per day and wanted to quit; they were randomly assigned to use e-cigarettes that did or did not provide nicotine for 12 weeks. The primary endpoint looks at smoking abstinence at 1 year on intention-to-treat basis, confirmed by patient self-reporting and measurements of exhaled carbon monoxide.

The session also includes 2 trials of state-of-the-art lipid-lowering therapy for homozygous familial hypercholesterolemia (HoFH). One of the presentations, on a novel agent still in its early investigational phase, telegraphs its results with the title "Evinacumab Significantly Reduces LDL-C in Patients With Homozygous Familial Hypercholesterolemia."

The antibody evinacumab (Regeneron Pharmaceuticals) blocks the activity of angiopoietin-like protein 3 (ANGPTL3) and thereby inhibits lipoprotein lipase and endothelial lipase. Studies have suggested it can lower levels of triglyceride as well as lipoprotein-bound cholesterol.

The other HoFH study, the randomized, double-blinded ODYSSEY HoFH, looked at LDL-C changes in 69 patients assigned to receive the PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron) or placebo for 10 weeks. Thereafter, all patients went on open-label active therapy throughout the rest of the 22-week trial.

Previously in the ODYSSEY ESCAPE trial, patients with the heterozygous form of familial hypercholesterolemia who took alirocumab showed less reliance on apheresis therapy.

Also in the lineup:

  • Eicosapentaenoic Acid Levels in REDUCE-IT and Cardiovascular Outcomes  

  • Natural History Of Symptoms and Stress Echo Findings in Patients With Moderate or Severe Ischemia and No Obstructive CAD: The NHLBI-funded CIAO Ancillary Study to the ISCHEMIA Trial

Social media is poised to play an unprecedented role in the ACC sessions as a nearly complete proxy for the ubiquitous hallway exchanges on exiting live-meeting presentations. The meeting's Twitter hashtags are #ACC20 and #WCCardio.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from theheart.org | Medscape Cardiology, follow us on Twitter and Facebook.

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