My name is John Jarcho. I'm a cardiologist at Brigham and Women's Hospital in
Boston and a deputy editor at the New England Journal of Medicine.
I'm speaking from the floor of the 2019 American College of Cardiology
Scientific Sessions in New Orleans. I'm delighted to be able to share with you
some of the exciting research that we are publishing in the New England
Journal online to coincide with some of the presentations here at the meeting.
I'd like to begin by talking about two very long-awaited clinical trials that
were presented in the joint ACC/NEJM late-breaking clinical trial session.
These were two randomized trials of transcatheter aortic valve replacement,
or TAVR, compared to surgical aortic valve replacement in patients at low
risk. TAVR was originally developed as a way to treat severe aortic stenosis in
patients who could not undergo surgical aortic valve replacement because
they had high or prohibitive surgical risk.
TAVR was subsequently shown to be superior to, or non inferior to, surgical
aortic valve replacement in patients first at high risk, and subsequently at
intermediate risk, of surgical complications. However, most patients with
severe aortic stenosis are at low surgical risk, and therefore these two
trials were designed to fill an important evidence gap by evaluating
patients who had not been studied in previous trials. In one trial, the PARTNER 3
trial, the SAPIEN 3 transcatheter aortic valve was compared
to surgical aortic valve replacement. In that trial, the primary endpoint was a
composite of death, stroke, or hospitalization at one year, and TAVR
was superior to surgery for this endpoint. In the other trial, three
different transcatheter aortic valves were studied -- the CoreValve, the Evolut R,
and the Evolut PRO. Again, the comparison group was surgical aortic
valve replacement. In this trial, the primary endpoint was a composite of
death or disabling stroke at two years, and TAVR
was non inferior to surgery in this trial. These two trials taken together
strongly suggest that TAVR may actually be the preferred treatment for severe
aortic stenosis even in patients at low surgical risk. Another interesting trial
that was presented in a late-breaking session here is called WRAP-IT --
WRAP-IT spelled "wrap - it." WRAP-IT evaluated a novel approach to preventing infection
in patients undergoing implantation of a cardiac pacemaker or defibrillator who
were deemed to be at increased risk of such an infection. The experimental group
in this trial received a novel envelope made of a woven absorbable material and
impregnated with antibiotics. The pacemaker or defibrillator was
inserted into the envelope, and the envelope was then implanted in the
patient. The antibiotics with which the envelope were impregnated were
minocycline and refampin, and these two antibiotics gradually eluded from the
envelope into the surrounding tissue over the course of several days. In the
control group, a standard implantation of pacemaker or defibrillator was performed
without the envelope. The primary endpoint in this trial was
infection serious enough to require extraction or revision of the device, or
requiring prolonged antibiotic therapy with infection recurrence or leading to
death at one year. The patients who received the antibiotic-impregnated
envelope had a significantly lower rate of such serious infections than the
control group. The last trial that I'd like to mention is the COACT trial. This
is a trial that studied patients who had been resuscitated from out of hospital
cardiac arrest and were comatose but stable upon presentation to the
emergency room. Many patients who suffer cardiac arrest have coronary artery
disease, and for some of those patients, the coronary disease may be responsible
for the cardiac arrest. But when a patient presents to the emergency
department after a resuscitation, it isn't always clear whether the coronary
disease is the cause or not. In patients who have an electrocardiogram showing ST-segment
elevation at the time of emergency room presentation, it is
generally agreed that immediate cardiac catheterization should be performed. But
what about those who do not? So in the COACT trial, patients who had been
resuscitated from cardiac arrest and were presenting to emergency room
comatose but without ST-segment elevation on their electrocardiogram, the
patients were randomized to either immediate coronary angiography or to
delayed coronary angiography which was typically performed after neurological
recovery. The primary endpoint in this trial was survival to ninety days, and
there was no significant difference between the two groups in this endpoint
or in the endpoint of survival with good neurological status. So this trial is
important because it demonstrates that if a patient suffers out of hospital
cardiac arrest and is resuscitated and presents to an emergency room
without ST-segment elevation in emergent coronary angiography
is not necessary and the procedure can be deferred until neurological recovery.
These are just some of the trials that the New England Journal of Medicine has
published online to coincide with presentations here at the meetings of
the American College of Cardiology. If you'd like to read about all of these
trials you can go to the American College of Cardiology page at the New
England Journal of Medicine website at www.nejm.org/acc. Thank you very much.