Outcomes 2019 - Baylor Scott & White Heart and Vascular Hospital BSWHHVH_646_2019 Outcomes JOOMAG MOD | Page 70

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Leading research studies in FY19 ALL OF US
CLEAR Outcomes is a phase 3 study to assess
the effects of bempedoic acid (ETC-1002) on
the occurrence of major cardiovascular events
in patients with, or at high risk for, cardiovascular
disease who are statin intolerant. Principal
investigator: Cara East, MD. Soltero Cardiovascular
Research Center, together
with Baylor Scott & White Heart and Vascular
Hospital – Dallas, became one of the first
enrolling sites in 2018 for the nationwide All
of Us Research Program, sponsored by the
National Institutes of Health. The objective of
this program is to help researchers understand
more about why people get sick or stay healthy.
People who join the study provide information
about their health, habits and environment. The
goal is to make advances in precision medicine,
which is healthcare based on each individual.
SPYRAL studies:
• SPYRAL ON MED is a study to obtain an
assessment of the efficacy and safety of renal
denervation in the presence of three standard
antihypertensive medications, sponsored by
Medtronic Vascular. The Dallas site is led by
principal co-investigators: James W. Choi, MD,
and Cara East, MD. Kyle Bass, MD, serves as
sub-investigator. This study was top-ranked
nationally.
• SPYRAL OFF MED is a global clinical study of
renal denervation with the Symplicity Spyral
multi-electrode renal denervation system in
patients with uncontrolled hypertension in
the absence of antihypertensive medications.
Principal investigators: James W. Choi, MD, and
Cara East, MD, with Kyle Bass, MD, serving as
sub-investigator.
PARADISE-MI is a randomized, double-blind,
active-controlled, parallel-group phase 3
study to evaluate the efficacy and safety of
Entresto compared to Ramipril on morbidity and
mortality in high risk patients following an acute
myocardial infarction. National leader for this
study is Cara East, MD, with Kyle Bass, MD, as the
principal investigator.
ALIDIAL is a phase 3 trial to evaluate the efficacy
and safety of biweekly alirocumab in patients on
a stable dialysis regimen. Soltero Cardiovascular
Research Center is the only enrolling site.
Cara East, MD, designed the study and serves as
the principal investigator.
All of the current clinical trials can be found
at BaylorHeartHospital.com/ClinicalTrials.
For more information, call 1.844.4US.BSWH
(1.844.487.2794).
Transcatheter Aortic Valve Replacement
Studies (TAVR)
In fiscal year 2019, Baylor Scott & White Heart
and Vascular Hospital – Dallas celebrated its
1,000th TAVR procedure since the beginning of
commercial TAVRs in 2011. Today, the program is
one of the largest TAVR programs in the US (see
page 28 for more information on the Center for
Valve Disorders in Dallas). Baylor Scott & White
Heart and Vascular Institute enrolled patients in
three new TAVR-related studies in fiscal year 2019:
• Low-Risk Bicuspid Valve Trial evaluates
the procedural safety and efficacy of the
Medtronic TAVR system in patients with
bicuspid aortic anatomy and severe aortic
stenosis at low risk for Surgical Aortic Valve
Replacement (SAVR).
• EXCEED evaluates the safety and effectiveness
of the Edwards CENTERA Transcatheter
Heart Valve (THV) System in patients with
symptomatic, severe, calcific aortic stenosis
who are at intermediate operative risk for
surgical aortic valve replacement (SAVR).
• Early TAVR is a prospective, controlled, multi-
center study where patients are randomized
1:1 to receive either transcatheter aortic valve
replacement (TAVR) with the Edwards SAPIEN
3 THV or clinical surveillance (CS).
Principal investigator for all three trials is
Robert M. Stoler, MD, co-medical director,
Cardiology and medical director, Catheterization
Laboratory – Baylor Scott & White Heart and
Vascular Hospital – Dallas.