CYBERSPACE — On-line studying rises to the subsequent degree beginning March 28 with the bold, pioneering response from the American School of Cardiology (ACC) to the cancellation of its annual scientific periods dwell assembly pressured by the COVID-19 pandemic, uncharted territory in most each manner.
The periods are logging on in three simultaneous real-time streams and movies and slides on demand, archived for 30-day entry. And it will likely be free to actually anybody with web and a pc, pill, or smartphone.
Deliberate displays for the ACC.20/World Congress of Cardiology Digital assembly are to drop on the identical days, and in lots of instances the identical schedule, that had been established for the dwell periods; all instances on the agenda are Central Time.
The road-up contains, amongst many others:
a big, worldwide trial of a promising, already-available candidate drug for coronary heart failure and diminished ejection fraction (HFrEF)
a randomized trial exploring using e-cigarettes for smoking cessation
a sham-controlled trial of renal denervation for medically untreated hypertension that would doubtlessly add to the as soon as out-of-favor approach’s revival
a check of a direct oral anticoagulant (DOAC) in sufferers with symptomatic peripheral artery illness (PAD) and up to date lower-extremity revascularization
The ACC says the pioneering Three-day digital convention will embody all instances and peer-reviewed scientific displays that have been accepted for the dwell assembly, main keynote lectures, instructional periods, younger investigator awards, and late-breaking medical trials and featured analysis displays.
Among the many late-breaking medical trial periods that may figuratively take middle stage:
Joint ACC/JACC Late-Breaking Scientific 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 World Examine in Topics with Coronary heart Failure with Diminished Ejection Fraction (VICTORIA).
The presentation will develop on top-line main outcomes unveiled in November: a major benefit in fee of cardiovascular demise or HF hospitalization for its sufferers with worsening continual HFrEF handled with the soluble guanylate cyclase stimulator riociguat (Merck/Bayer) on prime of ordinary meds.
VICTORIA had randomly assigned 5050 such sufferers to obtain or not obtain vericiguat or placebo following a decompensation occasion, outlined as an HF hospitalization or receiving an intravenous diuretic for HF with out hospitalization. They have been additionally adopted for a slew of secondary endpoints that included all-cause mortality.
Following up is the VOYAGER-PAD trial, which randomized 6564 sufferers with average to extreme symptomatic PAD within the decrease extremities to obtain or not obtain rivaroxaban (Xarelto, Bayer/Janssen Prescription drugs), 2.5 mg twice every day, on prime of ordinary remedy together with aspirin.
For entry, sufferers have been required to have had profitable peripheral artery revascularization, distal to the exterior iliac artery, for symptomatic PAD inside 10 days of randomization. They have been adopted for the first endpoint of acute myocardial infarction (MI), ischemic stroke, cardiovascular demise, acute limb ischemia, or main amputation.
The TAILOR-PCI trial, a serious outcomes check of genotype-guided antiplatelet remedy for sufferers who’ve undergone percutaneous coronary intervention (PCI), will spherical out the session. Plenty of trials have instructed the technique, through which genetically poor metabolizers of clopidogrel are steered towards an alternate second antiplatelet for dual-antiplatelet remedy (DAPT), is possible, protected, and in some instances maybe clinically helpful.
Open-label TAILOR PCI randomly assigned about 5300 sufferers to obtain normal antiplatelet remedy with clopidogrel (Plavix, Sanofi/Bristol-Myers Squibb) 75 mg/d or antiplatelet remedy prospectively guided by genotyping for the clopidogrel reduced-function CYP2C19 alleles. Genotype-negative sufferers have been placed on normal clopidogrel, and people constructive for the alleles as a substitute acquired ticagrelor (Brilinta/Brilique, AstraZeneca) 90 mg twice every day.
Sufferers have been adopted for the first composite of nonfatal MI, nonfatal stroke, cardiovascular mortality, extreme recurrent ischemia, or stent thrombosis at 1 12 months.
Joint ACC/N Engl J Med Late-Breaking Scientific Trials II
(Sunday, March 29, eight AM–9:30 AM)
Nicely into the age of transcatheter aortic valve alternative (TAVR), the selection of long-term postprocedure antithrombotic remedy stays one thing of a frontier. For instance, asks the open-label POPULAR-TAVI trial: one antithrombotic agent or two?
POPULAR TAVI randomly assigned an estimated 1000 sufferers present process TAVR to one in all 4 long-term therapy regimens: aspirin with vs with out clopidogrel, or an oral anticoagulant (OAC) with vs with out clopidogrel.
The trial has adopted sufferers for bleeding unrelated to the TAVR process over 1 12 months as the first endpoint; and for the composite of cardiovascular demise, nonprocedure-related bleeding, MI, or stroke over 1 12 months as a major secondary endpoint.
As offered at this assembly a 12 months in the past, the PARTNER-Three trial scored huge for TAVR when it noticed a major discount in 1-year demise, stroke, or hospitalization in low-surgical-risk sufferers who acquired the SAPIEN Three valve (Edwards Lifesciences) as a substitute of surgical aortic valve alternative.
However what occurred after 2 years? Late-Breaking Scientific Trials II goals to reply that query with a presentation on the 2-year PARTNER-Three medical and echocardiographic outcomes.
Different displays scheduled for the session:
Late-Breaking Scientific Trials III (Sunday, March 29, 10:45 AM–12:15 PM)
For anybody eager on chiaroscuro and artwork of the Excessive Renaissance, to not point out the DOACs, the session will lead with the CARAVAGGIO trial. Carried out in Europe, Israel, and the USA, the trial in contrast anticoagulation with dalteparin, which is parenteral, to apixaban, which is oral, in 1168 adults with most any most cancers and confirmed proximal lower-limb deep venous thrombosis (DVT) or pulmonary embolism (PE). The first endpoint is recurrent DVT or PE over 6 months.
The DOACs have been beforehand examined in comparable medical settings, with blended however promising outcomes that recommend they shield towards recurrence but additionally can even pose a excessive threat of bleeding.
Hopes are excessive for a comeback of renal denervation as a therapy for hypertension, which had fallen out of favor after 2014 outcomes from the SYMPLICITY HTN-Three trial displaying little or no profit.
In 2017, after modifications to the approach, a SPYRAL HTN OFF-MED pilot examine renewed curiosity in renal denervation, suggesting it considerably lowered blood stress in 80 sufferers with medically untreated mild-to-moderate hypertension.
Now, in 2020, the third Late-Breaking Scientific Trial session features a presentation of main outcomes of the complete sham-controlled SPYRAL HTN-OFF MED Pivotal trial, which prolonged the pilot examine to incorporate 433 sufferers with hypertension not handled with medication. These main outcomes embody the efficacy endpoint of change in ambulatory systolic blood stress over Three months and security endpoint of main hostile occasions at 1 month.
The session can be to incorporate:
Rivaroxaban Versus Enoxaparin in Nonmajor Orthopedic Surgical procedure (PRONOMOS)
Profit and Danger of Rivaroxaban Plus Aspirin in Sufferers With Peripheral Artery Illness After Decrease Extremity Revascularization With and With out Concomitant Clopidogrel: A Key Subgroup Evaluation From VOYAGER-PAD
Randomized Scientific Trial of Pre-hospital Sodium Nitrite in Out-of-hospital Cardiac Arrest Sufferers (SNOCAT)
Late-Breaking Scientific Trials IV (Monday, March 30, eight:00 AM–9:30 AM)
Final 12 months, the TWILIGHT trial confirmed superior outcomes from ticagrelor monotherapy after PCI in sufferers at excessive threat for issues, achieved by dropping aspirin from the DAPT routine after Three months. Ischemic safety supplied by ticagrelor monotherapy was akin to continued DAPT however with a considerably decrease threat of bleeding.
Now on the ACC periods, the primary of a number of TWILIGHT subanalyses, dubbed TWILIGHT COMPLEX, ought to assist make clear whether or not complicated coronary anatomy ought to affect selections when contemplating sufferers for ticagrelor monotherapy after PCI.
However would such a method work in sufferers who underwent PCI for acute coronary syndromes (ACS)? The TICO trial aimed to seek out out by randomly assigning an estimated 3056 sufferers receiving sirolimus-eluting coronary stents for ACS to continued DAPT or ticagrelor monotherapy beginning at Three months. They have been adopted for main hostile cardiovascular medical occasions and for main bleeding at 1 12 months.
Different displays within the session:
Ten-year Outcomes After Drug-eluting Stents vs Coronary Artery Bypass Grafting for Left Predominant Coronary Illness (PRECOMBAT)
Radial Artery Versus Saphenous Vein for Coronary Bypass Surgical procedure at Lengthy Time period Observe-up
Ticagrelor With and With out Aspirin in Excessive-Danger Sufferers With Diabetes Mellitus Present process Percutaneous Coronary Intervention: Insights From the TWILIGHT Trial
Joint ACC/JAMA Late-Breaking Scientific Trials V (Monday, March 30,
10:45 AM–12:15 PM)
E-cigarettes, additionally known as vapes and different names, have a darkish aspect that well being professionals find out about, however whether or not a long-speculated potential brilliant aspect truly exists must be examined in trials. One such trial, known as Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation (E3), is scheduled for presentation on Monday of the ACC.20 periods.
The examine enrolled 376 adults who smoked a median of 10 cigarettes per day and needed to give up; they have been randomly assigned to make use of e-cigarettes that did or didn’t present nicotine for 12 weeks. The first endpoint appears at smoking abstinence at 1 12 months on intention-to-treat foundation, confirmed by affected person self-reporting and measurements of exhaled carbon monoxide.
The session additionally contains 2 trials of state-of-the-art lipid-lowering remedy for homozygous familial hypercholesterolemia (HoFH). One of many displays, on a novel agent nonetheless in its early investigational part, telegraphs its outcomes with the title “Evinacumab Considerably Reduces LDL-C in Sufferers With Homozygous Familial Hypercholesterolemia.”
The antibody evinacumab (Regeneron Prescription drugs) blocks the exercise of angiopoietin-like protein Three (ANGPTL3) and thereby inhibits lipoprotein lipase and endothelial lipase. Research have instructed it may possibly decrease ranges of triglyceride in addition to lipoprotein-bound ldl cholesterol.
The opposite HoFH examine, the randomized, double-blinded ODYSSEY HoFH, checked out LDL-C adjustments in 69 sufferers assigned to obtain the PCSK9 inhibitor alirocumab (Praluent, Sanofi/Regeneron) or placebo for 10 weeks. Thereafter, all sufferers went on open-label lively remedy all through the remainder of the 22-week trial.
Beforehand within the ODYSSEY ESCAPE trial, sufferers with the heterozygous type of familial hypercholesterolemia who took alirocumab confirmed much less reliance on apheresis remedy.
Additionally within the lineup:
Eicosapentaenoic Acid Ranges in REDUCE-IT and Cardiovascular Outcomes
Pure Historical past Of Signs and Stress Echo Findings in Sufferers With Reasonable or Extreme Ischemia and No Obstructive CAD: The NHLBI-funded CIAO Ancillary Examine to the ISCHEMIA Trial
Social media is poised to play an unprecedented position within the ACC periods as a virtually full proxy for the ever present hallway exchanges on exiting live-meeting displays. The assembly’s Twitter hashtags are #ACC20 and #WCCardio.
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