Late-Breaking Science 5. Sunday, November 15, 7:15 PM - 8:30 PM CST
Slated for the session is the primary analysis of the PIONEER 3 trial, conducted in the United States, Europe, and Japan. It compared the BuMA Supreme biodegradable drug-coated stent (SinoMed) with the durable Xience (Abbott Vascular) and Promus (Boston Scientific) drug-eluting stents. The trial followed more than 1600 patients treated for chronic stable angina or acute coronary syndrome (ACS) for the 1-year composite of cardiac death, target-vessel-related MI, and clinically driven target-lesion revascularization.
Late-Breaking Science 6. Monday, November 16, 9:00 AM - 10:00 AM CST
The EARLY-AF trial enrolled 303 patients with symptomatic paroxysmal or persistent AF suitable for catheter ablation, assigning them to pulmonary vein isolation (PVI) by cryoablation using the Arctic Front (Medtronic) system or antiarrhythmic drug therapy for rhythm control. The primary end point is time to recurrence of AF, atrial flutter, or atrial tachycardia, whether symptomatic or asymptomatic, as determined by implantable loop recorder. Patients will also be followed for symptoms and arrhythmia burden.
Also in the session, the SEARCH-AF study randomized almost 400 patients undergoing cardiac surgery who were engaged subacutely with one of two commercial portable cardiac rhythm monitoring devices (CardioSTAT, Icentia; or SEEQ, Medtronic) or, alternatively, to receive usual postoperative care
The patients, considered to be at high risk for stroke with no history of AF, were followed for the primary end point of cumulative burden of AF or atrial flutter exceeding 6 minutes or documentation of either arrhythmia by 12-lead ECG within 30 days.
Two other studies in the session look at different approaches to AF screening, one using a handheld ECG monitor in the primary care setting and the other wearable monitors in the form of a patch or wristband. The VITAL-AF presentation is titled “Screening for Atrial Fibrillation in Older Adults at Primary Care Visits Using Single Lead Electrocardiograms.” The other presentation, on the study mSToPS, is called “Three-Year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening — Mhealth Screening to Prevent Strokes.”
Late-Breaking Science 7. Monday, November 16, 7:00 PM - 8:30 PM CST
In the randomized FIDELIO-DKD trial with more than 5700 patients with type 2 diabetes and associated kidney disease, those assigned to the novel mineralocorticoid receptor antagonist (MRA) finerenone (Bayer) showed an 18% drop in risk for adverse renal events, including death from renal causes (P = .001), over a median of 2.6 years. That primary outcome was previously presented in detail at a nephrology meeting and published in the New England Journal of Medicine in October.
Patients on the MRA showed a similar reduction in a composite CV-event end point, it was also reported at that time. A follow-up presentation at the AHA sessions promises to dive deeper into the trial’s CV outcomes.
In the RAPID-CTCA study, slated next for the session, 1749 patients with suspected or confirmed intermediate-risk ACS were randomly assigned to undergo computed tomographic coronary angiography (CTCA) for guiding treatment decisions or a standard-of-care strategy. It followed patients for the primary end point of death or nonfatal MI over 1 year.
Rilonacept (Arcalyst, Kiniksa/Regeneron) is an interleukin-1α and -1β inhibitor used in several autoinflammatory diseases that went unsuccessfully before regulators for the treatment of gout. The RHAPSODY trial has now explored its use against recurrent pericarditis in a randomized trial that entered 86 patients 12 years and older who had previously experienced at least three episodes.
In top-line results reported to investors in June, patients assigned to receive the drug instead of placebo in weekly injections showed a 96% drop in risk for pericarditis recurrence and “no or minimal pain” on more than 90% of days in the trial. A full presentation is expected during this LBS session.
Also on the schedule is the THALES study, which led the US Food and Drug Administration (FDA) to expand indications for ticagrelor to include stroke prevention in patients with a history of acute ischemic stroke or high-risk TIA based on the trial’s primary results published in July.
In THALES, more than 11,000 patients with mild to moderate acute noncardiogenic ischemic stroke or TIA were randomly assigned within 24 hours to start on daily aspirin with or without ticagrelor given as a 180 mg loading dose followed by 90 mg twice daily for 30 days.
At the end of a month, it was reported, those on dual antiplatelet therapy showed a 17% risk reduction (P = .02) for the primary end point of stroke or death, at the cost of a slight but significant increase in “severe” bleeding (0.5% vs 0.1%; P = .001).
The session is to conclude with two related studies that fell victim in part to the COVID-19 pandemic, both of which explored sotagliflozin (Zynquista, Sanofi/Lexicon), an inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2, respectively) in patients with type 2 diabetes.
SOLOIST-WHF had entered 1222 such patients hospitalized with urgent or worsening HF at 466 centers and randomly assigned them to receive sotagliflozin or placebo; they were followed for the composite of CV death or HF events. SCORED reached an enrollment of 10,584 patients with diabetes and chronic kidney disease at 754 hospitals, following them for the same primary end point.
Lexicon announced in March that the trials would be “closed out early” because of the unavailability of funding “together with uncertainties relating to the COVID-19 pandemic on the trials.” The LBS presentation is expected to include analyses of available data; SOLOIST-WHF launched in summer 2018 and SCORED began in November 2017.