VIVA 2009 Late-Breaking Trials Highlight Advances in Interventional Treatments of Peripheral Arterial Disease

LAS VEGAS--(Business Wire)--
The latest data from seven studies focused on the treatment of peripheral
arterial disease were presented in the late-breaking trials session of the VIVA
2009: Vascular Interventional Advances annual meeting held on October 19-23 in
Las Vegas, Nevada. Full summaries of the results can be found online in a
special VIVA 2009 edition of the Endovascular Today eNews at
www.evtoday.com/eNews/eNews102909.htm.

COBEST

Patrice Mwipatayi, FCS (SA), MMed, FRACS, presented preliminary 18-month results
for the COBEST (Covered Versus Balloon Expandable Stent Trial) study. COBEST is
a prospective, multicenter, randomized, controlled trial that compares the
Advanta V12 polytetrafluoroethylene-covered stent (Atrium Medical Corporation,
Hudson, NH) to bare-metal stents (BMS) in patients with iliac occlusive disease.
The data showed a statistically significant difference in restenosis and freedom
from occlusion rates when using the Advanta V12 versus a BMS.

The study enrolled 123 patients (167 limbs). At 18 months, there were 69 limbs
in the V12 group and 63 limbs in the BMS group. The results showed that 95.4% of
patients in the V12 group had < 50% binary restenosis (Duplex scan) compared to
82.2% in the BMS group (P < .05). The investigators found that there was a
significant difference showing superiority of the V12 stent compared to BMS for
TASC C and D lesions, whereas in TASC B lesions the V12 and BMS patency rates
were similar.

FlexStent System in the SFA

William A. Gray, MD, presented interim 6-month clinical results on the safety
and efficacy of the FlexStent femoropopliteal self-expanding stent system
(Flexible Stenting Solutions, Inc., Eatontown, NJ) in the superficial femoral
artery in a first-in-man study conducted in Auckland, New Zealand (n=15) and a
supplementary study conducted in Leipzig, Germany (n=20).

The angiographic results showed that periprocedural lesion success (restenosis <
30%) was 100% in both group. The 30-day safety endpoints showed no adverse
events (0%). The interim 6-month efficacy endpoints demonstrated 100% freedom
from major adverse cardiovascular events and no fractures. In the pooled data
set, there was a 92.3% patency rate with an 86.6-mm average lesion length. Among
the secondary endpoints, average treadmill, ankle brachial index, and Rutherford
scores improved.

ARMOUR

L. Nelson Hopkins, MD, presented results from the prospective, multicenter
ARMOUR (Proximal Protection with the Mo.Ma Device During Carotid Stenting) trial
showing that use of the Mo.Ma Ultra proximal protection device (Invatec, Inc.,
Bethlehem, PA) for cerebral protection during carotid artery stenting in
high-surgical-risk patients with any FDA-approved carotid stent is safe and
effective.

The results showed a 30-day major adverse cardiac and cerebrovascular events
(MACCE) rates of 2.7% for intention-to-treat (ITT) patients and 2.3% overall.
There were no myocardial infarctions. There was a 0.9% death rate for ITT
patients and 0.8% overall. The stroke rates were 2.3% for ITT patients and 1.9%
overall. The MACCE rates were 1.5% for both groups. In the ITT patients, 16.4%
had site-reported serious adverse events. There were no unanticipated adverse
device effects. At 30 days, the restenosis rate was 1.6%, and the target lesion
revascularization rate was 0%. The Mo.Ma device success rate was 98.2%. The
technical success rate was 94.6%, and the procedural success rate was 93.2%.

Symplicity HTN-1

Krishna Rocha-Singh, MD, presented results from the Symplicity HTN-1 study
showing that catheter-based renal denervation yields significant and sustained
reductions in blood pressure in patients with multidrug-resistant hypertension.
The Symplicity HTN-1 study, sponsored by Ardian, Inc. (Palo Alto, CA), was a
pilot evaluation of the safety and blood pressure-lowering efficacy of
percutaneous renal sympathetic denervation in patients with resistant
hypertension. Twenty patients were enrolled, 15 of which had qualifying anatomy.

The results (93% responder rate) showed average decreases in blood pressure of
-28/-10, -24/-8, and -30/-13 mm Hg at 1, 3, and 6 months, respectively. Four
patients had their medications reduced (by an average of three medications), and
no patients had their medications increased.

VIBRANT

Gary M. Ansel, MD, presented 1-year interim results from the multicenter,
real-world VIBRANT (Viabahn Versus Bare-Nitinol Stent) study showing that the
Gore Viabahn endoprosthesis (W. L. Gore & Associates, Inc., Flagstaff, AZ) in
the treatment of long-lesion (≥ 8 cm) superficial femoral artery occlusive
disease is clinically safe and effective.

The outcomes of the Viabahn group versus the control group, respectively,
include technical success (97% vs 97%; P = 1.00); primary patency (53% vs 58%; P
= .58); freedom from target lesion revascularization (73% vs 69%; P = .69);
assisted primary patency (84% vs 91%; P = .41); and secondary patency (93% vs
98%; P = .19). Device occlusion was reported in nine patients in the Viabahn
group compared to six patients in the bare-nitinol stent group (P = .18).
Focal-edge stenosis comprised 87% of failures in the Viabahn group whereas
in-stent stenosis comprised 93% of bare-nitinol stent failures. There was one
stent fracture in the 47 Gore Viabahn patients compared to 16 stent fractures in
the 52 bare-nitinol stent patients (2% vs 30.8%; P < .01).

VIVA I: Xcell

Krishna J. Rocha-Singh, MD, also presented 6-month clinical results from the
VIVA I: Xcell trial that demonstrated the feasibility of the Xpert nitinol stent
(Abbott Vascular, Santa Clara, CA) for below-the-knee primary stenting in
patients with critical limb ischemia. The data show that revascularization via
percutaneous transluminal angioplasty plus nitinol stenting is promising with
limb salvage rates that are similar to surgery with lower early morbidity and
mortality.

At 6-month follow-up in 115 patients, there were 36 (31.3%) target lesion
revascularizations, of which 21 (18.3%) were symptomatic. There were seven
(6.1%) major amputations, six (5.2%) deaths, four (3.5%) target vessel
revascularizations, and one (0.9%) access-site complication requiring
transfusion. For 127 analyzable wounds, 68 (53.5%) were 100% healed, 43 (33.9%)
had significant decreased wound area, and 16 (12.6%) had increased wound area. A
secondary analysis of complete wound healing showed significant trends including
that 68 of 127 wounds (53.5%; in 44 of 77 patients) were 100% healed at 6
months.

PATRIOT

James D. Joye, DO, presented findings from the PATRIOT (Peripheral Approach to
Recanalization in Occluded Totals) pivotal trial of the Crosser catheter
(FlowCardia, Inc., Sunnyvale, CA) to mediate chronic total occlusion (CTO)
recanalization. The data showed the device to be a safe and valuable tool for
crossing CTOs in the lower extremities.

Primary efficacy endpoints demonstrated that 84% of the guidewire-resistant CTOs
were successfully recanalized with the Crosser catheter. Regarding the primary
safety endpoint, there were no clinical perforations related to the Crosser.
Another endpoint was freedom from limb loss, clinical perforation, and repeat
revascularization through 30 days in 80 of 85 patients (94.1%). The Crosser
catheter safely traversed 84% of guidewire resistant CTOs without any clinical
perforations. There was an 81% efficacy in lesions ≥ 15 cm. The average lesion
length was 12 cm, and average activation time was 126 seconds.

About VPI

VPI is a multi-disciplinary group of independent physicians who are nationally
known experts in the diagnosis and management of all peripheral vascular
diseases, and who are joined together to advance education in vascular medicine
and support research and innovative treatment options. In 2002, the group of 10
specialists in vascular medicine, vascular surgery, interventional cardiology
and interventional radiology, organized VIVA: The National Education Course for
Endovascular Interventions, an annual educational symposium held in Las Vegas
that provides a highly interactive educational forum.

Media Contact:
for VIVA Physicians, Inc.
Craig McChesney, 484-581-1816
or cmcchesney@bmctoday.com

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