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October 2010
Does MI Matter? A critical analysis of the CREST trial results: A surgeon's perspective.
The long-awaited CREST trial results were presented at the International Stroke Conference in February 2010 and published in the New England Journal of Medicine on July 1, 2010. When we designed the CREST trial more than 10 years ago, we decided to include nonfatal myocardial infarction (MI) as a primary endpoint along with the customary endpoints of death and stroke. The reason for this decision was based on the assumption that carotid artery stenting (CAS) has an advantage over carotid endarterectomy (CEA) because it is less invasive and therefore might show a lower incidence of MI. In fact, this turned out to be the case in this preliminary analysis. The question arises: should nonfatal MI carry the same weight as death and stroke?
BACKGROUND
The CREST trial is a prospective, multicenter, randomized
trial of symptomatic and asymptomatic patients
with carotid stenosis carried out in the United States and
Canada. The initial analysis was carried out when the last
patient had a minimum of 1-year follow-up; the mean follow-
up for the entire cohort was 2.5 years. One unique
aspect of the CREST trial was the selection process for
interventionists. An interventional management committee
first screened potential participants based on their
documented experience and results with CAS. Those who
met stringent criteria were invited to participate in the
lead-in phase of the trial. Each selected potential participant
was required to prospectively submit up to 20 leadin
cases of CAS. The patients were then carefully examined
by the established investigator team at the participating
hospital, and the results were submitted to the
management committee. If a participant in the lead-in
phase met the requirements of the committee, they
were then permitted to participate in the randomized
trial. In this manner, the best of the best interventionists
were selected for the trial.
CREST TRIAL RESULTS
The 30-day event rate combining death, stroke, and
MI was 4.5% for CEA versus 5.2% for CAS. These results
have been widely circulated by interventionists as showing
that CAS and CEA yield equivalent results. However,
we must explore the results in more detail before that
conclusion can be justified. Because the objective of
invasively treating carotid bifurcation disease is to
reduce the risk of death or disability from stroke, I submit
that these endpoints must be compared separately.
The 30-day incidence of death and stroke was 2.3% for
CEA versus 4.4% for CAS. That difference was statistically
significant (P = .005). The good news is that these event
rates for both CEA and CAS are the lowest reported to
date. However, it must be kept in mind that in this
study, as well as in the other European and international
studies, CEA is safer than CAS with respect to the endpoints
of death and stroke. In the case of CREST, the
event rates of death and stroke were twice as high in
CAS compared to CEA.
The CREST trial also looked at the effect of age with respect to adverse events of the two procedures. The inflection point occurred at age 70, with patients over the age of 70 having better outcomes with CEA and younger patients having better outcomes with CAS. In CREST, the higher incidence of MI in the CEA group, when compared to CAS, made the two procedures appear to be equivalent. Is this higher MI rate in CEA important? Apparently not from the patients' perspective.
A quality-of-life analysis was performed on patients who suffered from stroke and MI. At 1 year, neither the physical nor mental components of quality of life were adversely affected in patients experiencing MI compared with those who did not. In contrast, both major and minor stroke had a significant impact on the physical and mental wellbeing of patients experiencing that event compared to those who did not.
This leaves us to question the long-term consequence of a nonfatal MI. There is literature to suggest that the longterm survival for patients who experience MI is adversely affected. With a median follow-up of 2.5 years, this has not been shown to be the case in CREST to date. CREST is ongoing with respect to long-term follow-up, and the consequence of nonfatal MI will be shown in a future publication.
CONCLUSION
There is a possibility for reducing the MI rate with CEA.
When the study was designed more than 10 years ago, the
benefits of statins and beta-blockers in reducing perioperative
cardiac events was not known, and therefore the use
of those drugs was not part of the protocol. Today, it is
well established that statins and beta-blockers together
with an antiplatelet agent should be a part of the preoperative
preparation of patients selected for CEA. Also, careful
preoperative cardiac evaluation to identify patients
who are at an increased risk for MI should be a part of the
patient preparation. Using these modern concepts, it is
highly likely that future MI rates can be lowered for CEA.
In the meantime, the preponderance of evidence favors
CEA over CAS, as it is a safer procedure with respect to
lower complication rates of death and stroke.
Wesley S. Moore, MD, is Professor of Vascular Surgery, University of California in Los Angeles. He has disclosed that he is a paid consultant to W. L. Gore & Associates. Dr. Moore may be reached at wmoore@mednet.ucla.edu.
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