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Dr. Yadav presented findings from the
Stenting and Angioplasty with Protection in Patients at High
Risk for Endarterectomy (SAPPHIRE) trial, which was designed
to compare carotid angioplasty with stent placement and emboli
protection against surgical treatment with endarterectomy. Among
those high risk patients whose condition permitted randomization
(307 cases), there was a significantly lower risk for the negative
outcomes of stroke, myocardial infarction, or death with carotid
stenting with emboli protection at 30 days of follow-up. Results
are pending for follow-up at 1 year.
Dr. Yadav opened by presenting the context within which
the Stenting and Angioplasty with Protection in Patients at
High Risk for Endarterectomy (SAPPHIRE) trial was designed.
The central question was whether carotid angioplasty with
stent placement and emboli protection was equivalent or preferable
to endarterectomy for patients whose comorbid conditions placed
them at high risk for complications after endarterectomy.
The angioplasty arm used a Cordis Precise Nitinol carotid
stent and an AngioGuard distal protection device.
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SAPPHIRE: Profile of high risk patients in trial
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・ CHF class III/IV and/or LVEF <30%
・ Open heart surgery within 6 weeks
・ Recent myocardial infarction (>24 hours
/ <4weeks)
・ Unstable angina (CCS class III/IV)
・ Severe pulmonary disease (FEV<1.0)
・ Contralateral carotid occlusion
・ Laryngeal nerve palsy
・ Radical neck surgery or radiation therapy
to neck
・ Previous carotid endarterectomy
・ Difficult surgical access: High or low lesions |
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The trial enrolled 723 patients, all of whom were either
asymptomatic with 80% or greater stenosis by ultrasound or
who were symptomatic and with 50% or greater stenosis by ultrasound.
High risk criteria included heart failure, severe chronic
obstructive pulmonary disease, severe coronary artery disease,
or previous carotid endarterectomy or previous radical neck
surgery or radiation therapy.
As expected, team evaluation of potential entrants showed
that many were ineligible for either surgery or angioplastic
intervention because of comorbidity. A total of 409 patients
entered a stent registry because they were ineligible for
surgery, and 7 patients entered a surgical registry because
of ineligibility for angioplasty. A total of 307 patients
were randomized to treatment, 156 patients to stent procedures
and 151 patients to endarterectomy. The 3 follow-up points
for all patients were the same: 30 days (with endpoints of
death, stroke, or myocardial infarction), 12 months, and 3
years. At the current conference, Dr. Yadav presented data
from the 30-day follow-up point.
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SAPPHIRE: Results at 30 days
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Stenting
with Emboli Protection |
Carotid
Endarterectomy |
P-value |
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Major
adverse event rate: death, any stroke, or myocardial
infarction (Q
wave or non-Q wave) |
5.8% (9/156) |
12.6%
(19/151) |
<0.05 |
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The proportion of patients with adverse outcomes by 30 days
was 7.8% for the group in the stent registry because of ineligibility
for surgery (32/409), whereas it was 14.3% (1/7) for the very
small group entered into the surgery registry.
The findings for the randomized groups are probably the
most important for future implications regarding treatment
of this high risk patient population: The 30-day adverse outcome
frequency for patients randomized to endarterectomy was 12.6%
(19/151), a significantly higher frequency than that found
for the patients who received angioplasty with stent placement
and emboli protection, 5.8% (9/156).
Data reflecting outcomes from 31 days after procedure to
1 year of follow-up are pending.
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