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Radial Angioplasty and
Angiography Safer For Elderly Patients
German Study Reports
That the Use of the Wrist for Catheter Access Results in Lower
Bleeding and Vascular Complications for Patients 75 Years and
Older; Chinese Study Finds Similar Safety for Elderly Patients
with Acute Myocardial Infarction
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November 20, 2008 -- A recent
study of 400 consecutive patients, published in Catheterization
and Cardiovascular Interventions, looked at the transradial
approach for catheterization,
angioplasty and stenting in patients 75 years of age
and older. The conclusion of the study:
"In elderly patients, transradial coronary angiography and intervention
has a high technical success rate and lower complication rates
than the
transfemoral approach."
Recent Studies Show Lower Complications for Radial
A number
studies have reported significantly lower complication
rates
when
the radial
approach
is
utilized.
The
M.O.R.T.A.L. study of over 30,000 patients showed 50% less
blood transfusions for radial patients, and associated that with
a
significant decrease in mortality. halving of reduction in mortality.
Sunil V.
Rao, MD, FACC
Duke Univ. Medical Center |
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In the August
issue of JACC: Interventions, a
study of 600,000 procedures showed a 58% reduction in
bleeding complications with the radial approach. Lead author
Dr. Sunil V. Rao told Angioplasty.Org:
"There's
a lot of attention being paid to bleeding complications
and their association with
mortality, and the focus has really been on the pharmacological
therapy.... What a lot of people have forgotten is that the
majority of bleeding complications in patients undergoing
stenting is
related to the access site. The radial approach has sort
of been in the background for a long time, but I think radial
is gaining."
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Results of New Study on Elderly Patients
However, this
new study, appearing in the November 1 issue of Catheterization
and Cardiovascular Interventions,
specifically looked at patients of advanced age, a population where
complications are known to be higher. The study was
conducted at the University
of Erlangen-Nürnberg
(incidentally, a pioneering locale in the development of angioplasty,
under the guidance of Dr. Eberhard Zeitler). 400 consecutive patients  75
years old with known or suspected coronary artery disease were enrolled.
93 were excluded because they had contraindications for one of the
approaches. The remaining
357
patients
were randomized to the femoral (leg) or radial (wrist) approach.
A diagnostic angiogram was performed and, if intervention was judged
to be efficacious, the procedure continued as an ad-hoc intervention
(balloon or stent).
Of the 152 patients randomized for transradial,
13 (9%) could not be done via the wrist, due to arterial spasm or
difficult
anatomy,
and
they crossed-over
to femoral. The authors note that 9% is similar to what other studies
have shown to be the rate of unselected patients who are contra-indicated
for the radial approach. In real-world
practice, the radial approach
usually
is performed only after an Allen's test or other criteria are examined,
so the actual success rate of transradials is very high. Even including
the time for patients to be crossed-over, the mean procedural
time for the radial cases was only three minutes longer (18 minutes)
than for femoral (15 minutes) -- the time was measured from the arterial
puncture
to completion
of
the
final
cine-angiogram.
In all randomized patients, the physicians
succeeded in obtaining the diagnostic angiograms -- and about 1/4
continued on to ad-hoc
intervention. Fluoroscopy time, dose-area product,
amount of contrast agent, and the number of diagnostic
and guiding catheters were not significantly different
between the two groups.
No Major Adverse Complications with Transradial
Approach
What
was different, however, was the incidence of major complications:
3.2%
in the femoral
group
versus
none in
the radial group. There
was one
stroke, three cases of severe bleeding with the need for
transfusion, and one local hematoma that required surgical
intervention -- all of which occurred in the transfemoral group. There were also
11 minor complications, defined as clinically
apparent bleeding of the access site which was symptomatic,
but did not lead to surgical intervention, transfusion,
or a drop in the hemoglobin level of more than
3 g/dl. Nine of these occurred in the transfemoral group. Interestingly,
the two minor complications in the transradial group were actually
cross-overs, and
the complications
occurred during the femoral procedure at the access site. So, in effect,
there were no complications, major or minor, that occurred in patients
where the transradial approach was performed.
The importance of this study
for treatment of elderly patients is explained by the authors:
"Numerous
studies have demonstrated the clinical utility of an invasive
strategy for the management of coronary artery disease in
elderly patients. On the other
hand, advanced age constitutes one of the major risk factors concerning complications
of coronary angiography. Arterial access complications are significantly
more frequent in patients above 75 years of age than in younger
individuals. Therefore,
the development and clinical use of strategies for invasive diagnosis and
therapy, with simultaneous reduction of vascular access complications,
would be important
especially for the increasing number of patients who are present with known
or suspected coronary artery disease at an advanced age."
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Co-author
Dr. Stephan
Achenbach |
The authors conclude:
"Our trial clearly demonstrates
that routine use of the transradial approach
for
coronary
angiography
and
intervention
in patients
at advanced age has a high clinical success rate and can
be performed without substantial disadvantages concerning procedural
duration,
radiation exposure, use of contrast agent, or other resources
such as catheters. However, it is associated with a substantially
lower
rate of complications as compared to the transfemoral approach
and a
more widespread use of the transradial route, especially in patients
at increased risk for
vascular complications, should be strongly encouraged."
Chinese Study Shows Similar Safety for
Elderly Patients Presenting With Acute MI
Another comparison between the transfemoral and transradial approach
in elderly patients was published in the May issue of the Chinese
Medical Journal. Physicians at Anzhen Hospital in
Beijing randomized
103
consecutive
patients
older
than 64 years who presented to the hospital with AMI to either transradial
or transfemoral intervention. There were no significant differences
in the success rates of puncture and PCI, puncture time, cannulation
time,
reperfusion
time,
total
time of the procedure, use rates of temporary pacemaker and IABP,
or MACE. However, the hospital stay of the transfemoral group was
longer than that of the transradial group ((10.1±4.6) vs (7.2±2.6)
days, P<0.01). As for complications, one radial occlusion was
observed in the radial group, but the patient experienced
no ischemic syndrome in hand. However, in the femoral contingent,
four patients had hematosis, one experienced a pseudoaneurysm, and
one had major bleeding. Vascular access
site
complications
were seven times higher in the femoral group (1.8 % vs 13.1%, P<0.05).
As more of these types of studies are published,
those physicians practicing the radial approach feel that the momentum
will grow and the demand increase for more radial procedures in the
United States, which currently account for less than 4% of all diagnostic
and interventional procedures.
Reported by Burt Cohen, November 20, 2008
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