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| * These
news are selected from 'TCT Daily (2004)' provided
by Cardiovascular Research Foundation (CRF). |
The MAVERIC 1 and MAVERIC
2 trials evaluated the safety and efficacy of the
Exponent (Medtronic) stent and GuardWire (Medtronic)
temporary occlusion system for treating carotid
stenosis.
MAVERIC 1 was a feasibility trial that enrolled
99 patients at 16 centers; MAVERIC 2 included 399
patients at 34 centers.
Enrollment in the MAVERIC 2 trial has been completed,
and the one-year results are currently being prepared,
according to Stephen Ramee, MD, of the Ochsner Clinic
Foundation in New Orleans .
The GuardWire was successfully delivered in 80.8%
of the MAVERIC 1 group and in 87.5% of the MAVERIC
2 group, yielding a combined success rate of 85.1%.
The procedural success rate was 85.9% among patients
in the MAVERIC 1 trial. This improved to 90.1% among
patients in the MAVERIC 2 trial, yielding a combined
procedural success rate of 88.2%.
Overall, the combined major adverse event rate for
both the MAVERIC 1 and MAVERIC 2 trials was 5.2%
among a total of 498 patients, Ramee said, noting
the low incidence of stroke and morbidity (Figure
2).
“There were no subsequent events in
this trial during the one-year follow-up, which
is remarkable. This procedure does give you a durable
result,” Ramee said.
At 2%, the rate of target vessel revascularization
in the MAVERIC 1 trial was also low. Most adverse
events occurred during the actual surgical procedure. |
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