LAS VEGAS,
Sept. 21, 2016
/PRNewswire-USNewswire/ -- VIVA Physicians, a not-for-profit
organization dedicated to advancing the field of vascular medicine
and intervention through education and research, announces highly
anticipated late-breaking clinical trial results at VIVA 16 hosted
at the Wynn Las Vegas.
Below are highlights of today's late-breaking clinical
trial presentations. Full summaries can be found at
viva.vporoom.com:
ESPRIT I TRIAL: 3-YEAR RESULTS OF THE EVALUATION OF THE
ESPRIT BIORESORBABLE VASCULAR SCAFFOLD IN THE TREATMENT OF PATIENTS
WITH OCCLUSIVE VASCULAR DISEASE OF THE SFA OR COMMON OR EXTERNAL
ILIAC ARTERIES
Presenter: Michael R. Jaff, DO
The purpose of the ESPRIT I clinical investigation was to
evaluate the safety and performance of the Esprit
everolimus-eluting bioresorbable vascular scaffold (Abbott
Vascular) in subjects with symptomatic claudication from occlusive
vascular disease of the superficial femoral artery (SFA) or common
or external iliac arteries. The trial was a prospective,
single-arm, open-labeled, multicenter clinical investigation in
which 35 subjects were enrolled at seven clinical sites in
Europe.
Clinical assessment and peak systolic velocity ratio
assessed by duplex ultrasound was performed at 1, 6, and 12 months
and at 2 and 3 years. Angiographic follow-up was performed at 12
months. Thirty-five study scaffolds and one non-study stent were
placed in 35 patients who had lesion length of 35.5 mm and
reference vessel diameter of 4.9 mm. Acute device success was 100%.
The 3-year results confirm earlier data demonstrating the safety
and feasibility of treatment with the Esprit bioresorbable vascular
scaffold for SFA and iliac lesions, with no new events occurring
between 2 and 3 years.
12-MONTH RESULTS FROM THE DANCE TRIAL ATHERECTOMY
COHORT
Presenter: Chris Owens, MD, MSc
The DANCE study is a 281-patient, multicenter, single-arm
trial examining the local drug delivery of dexamethasone into the
adventitial and perivascular tissues via the Bullfrog microinfusion
device (Mercator MedSystems). The hypothesis was that dexamethasone
would safely reduce restenosis rates in patients with
atherosclerotic obstructive lesions of the superficial femoral
and/or popliteal arteries. Two revascularization treatment options
were evaluated: atherectomy and percutaneous transluminal
angioplasty. The primary efficacy endpoint is primary patency at 12
months.
This hypothesis was supported by demonstrating reduction
of circulating biomarkers of inflammation and the achieved clinical
outcomes. By placing the drug directly into the vessel wall outside
the external elastic lamina, traditional barriers to intima-based
delivery methods are overcome. The trial enrolled 157
patients who received primary atherectomy revascularization and 124
patients who received PTA without atherectomy. The trial had
angiographic, ultrasound, and clinical core laboratory adjudication
of lesion characteristics, surveillance, and clinical events. The
atherectomy group has completed 1-year follow-up, and the
intent-to-treat population had 1-year primary patency rate of
79.5%. The per-protocol population had a primary patency rate of
83.8% at 365 days and 80.2% at 395 days.
USE OF AN ePTFE
BALLOON-EXPANDABLE COVERED STENT FOR OBSTRUCTIVE LESIONS IN THE
ILIAC ARTERY: 9-MONTH RESULTS FROM THE PROSPECTIVE, MULTICENTER
BOLSTER TRIAL
Presenter: John Laird, MD
Patients were enrolled in 17 sites in the United States, Europe, and New Zealand. The LifeStream
balloon-expandable covered stent (Bard Peripheral Vascular)
comprises an electropolished, 316-L stainless steel
balloon-expandable stent encapsulated between two layers of
expanded polytetrafluoroethylene. It is premounted on a
noncompliant balloon on a 0.035-inch guidewire–compatible delivery
catheter. Radiopaque markers on the balloon shaft indicate the ends
of the covered stent.
In BOLSTER, the LifeStream covered stent was successfully
deployed in 98.3% of cases, with an acute procedural success rate
of 97.4%. At 9 months, 11.6% of evaluated patients met the primary
composite endpoint. The primary patency rate was 89.1%, and the
rate of freedom from target lesion revascularization was 96.7% at
270 days. The BOLSTER trial is ongoing, with duplex ultrasound
imaging follow-up to continue through 3 years.
CAROTID STENT FRACTURES ARE NOT ASSOCIATED WITH DEATH,
STROKE, MYOCARDIAL INFARCTION AND STENT RESTENOSIS: RESULTS FROM
THE ACT 1 MULTICENTER RANDOMIZED TRIAL
Presenter: Ido Weinberg, MD
The objective of this study was to report the stent
fracture rate as well as its association with carotid in-stent
restenosis and clinically meaningful adverse outcomes in
ACT-1. ACT-1 is the largest prospective, multicenter
randomized trial of standard-risk asymptomatic patients with
severe carotid artery stenosis randomized to carotid artery
stenting (CAS) or carotid endarterectomy (Abbott Vascular).
All patients were required to undergo duplex ultrasound
surveillance at 30 days and annually thereafter. After 771 patients
had been randomized, all subsequent randomized patients were
required to also undergo annual radiographic analysis for stent
fracture.
The primary endpoint was the composite of death or
myocardial infarction during the 30 days after the procedure and
ipsilateral stroke during the 365 days after the procedure.
Stent fracture was reported in 51 patients. Adverse clinical
outcomes up to 5 years occurred in 47 CAS patients enrolled in ACT
1. Neither stent fracture nor restenosis was associated with the
primary endpoint to 5 years. ACT-1 demonstrates that carotid
stent fracture rate was low and was not associated major adverse
clinical events or with in-stent restenosis.
NOVEL NITINOL STENT FOR LONG LESIONS IN THE SUPERFICIAL
FEMORAL ARTERY AND PROXIMAL POPLITEAL ARTERY: 24-MONTH RESULTS FROM
THE TIGRIS RANDOMIZED TRIAL
Presenter:
John Laird, MD
The TIGRIS trial is a prospective, multicenter,
randomized controlled noninferiority clinical study. Patients were
randomized 3:1 to treatment with either the Tigris stent or
LifeStent (Bard Peripheral Vascular). There were 33 enrollment
sites in the United States and
three in Europe; 274 patients were
enrolled on an intention-to-treat basis, and 267 patients were per
protocol.
The Kaplan-Meier estimates for 24-month primary patency
and freedom from target lesion revascularization are 63% and 76.6%
for the Tigris stent, respectively, versus 67.4% and 80.6% for
LifeStent. There were no stent fractures observed at 12-month
follow-up with the Tigris stent, whereas the LifeStent fracture
rate was 28.8%. The challenging, head-to-head,
real-world, long-lesion trial met its endpoints and demonstrated
Tigris' safety and efficacy. The high LifeStent fracture rate was
notable. The novel design of the Tigris stent matches the demands
of high-flexion areas.
PRISM: ASSESSING THE SAFETY AND TECHNICAL EFFECTIVENESS OF
THE PENUMBRA INDIGO ASPIRATION SYSTEM WHEN USED AS A FRONT-LINE
TOOL AND AS SALVAGE THERAPY FOR THE TREATMENT OF THROMBOEMBOLISM IN
THE PERIPHERAL VASCULATURE
Presenter:
Richard R. Saxon, MD,
FSIR
A total of 85 patients were enrolled in PRISM. In 43
patients, aspiration thromboembolectomy with the Indigo aspiration
system (Penumbra, Inc.) was used as the initial therapy. In an
additional 42 patients, thrombolysis or other mechanical
intervention was attempted before the study device was used. Vessel
patency was determined via angiogram before and after the various
treatments and at completion of all therapies using the
thrombolysis in myocardial infarction (TIMI) scale to evaluate
efficacy.
Overall, complete restoration of flow was achieved in
77.6% of patients. Mechanical aspiration
thromboembolectomy using the Indigo system is effective for
revascularization of peripheral arterial occlusions. The study
device was equally effective as a front-line, primary therapy and
as a salvage therapy after other endovascular techniques had
failed.
About VIVA Physicians
VIVA
Physicians strive to be the premier educators in the field of
vascular medicine and intervention. Our team of specialists in
vascular medicine, interventional cardiology, interventional
radiology, and vascular surgery is driven by the passion to advance
the field of vascular medicine with a spirit of collegiality by
synergizing their collective talents to promote awareness and
innovative therapeutic options for vascular disease
worldwide. To learn more about VIVA Physicians,
visit
www.vivaphysicians.org.
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SOURCE VIVA Physicians