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October 12, 2006
By
Sahar
Bedrood B.S. and Asher Kimchi M.D.
Paris, France-
While it has been known that Sirolimus-eluting
stents reduce the rates of restenosis and
reintervention, the safety and efficacy of such
stents in primary percutaneous coronary intervention
(PCI) for acute myocardial infarction was not
studied as extensively. Christian Spauling, M.D. et
al from the Cochin Hospital in Paris, France
performed a single-blind, multicenter, randomized
trial to compare sirolimus-eluting stents with
uncoated stents in primary PCI for patients with
acute myocardial infarction with ST-segment
elevation. Their study found among selected patients
with acute myocardial infarction, the use of
sirolimus-eluting stents significantly reduced the
rate of target-vessel revascularization at 1 year.
The trial
included 712 patients at 48 medical centers. Patients were
eligible for the trial if their symptoms began 12 hours before
catheterization and if the electrocardiogram showed ST-Segment
elevation. Patients received either a sirolimus-eluting stent or
any commercially available uncoated stent. Clinical follow-up
was performed at 30 days and at 6 and 12 months after the
procedure. The primary end point of the study was target-vessel
failure, including target-vessel revascularization, recurrent
infarction or target-vessel related death. Target
revascularization was defined as repeated PCI or bypass grafting
of the target-vessel, driven by clinical symptoms of myocardial
ischemia, a positive stress test, electrocardiographic evidence
of ischemic changes at rest, or an in-lesion stenosis of more
than 70% of the reference luminal diameter by visual estimate.
The rate of
primary end point was significantly lower in the sirolimus-stent
group than in the uncoated stent group (7.3% vs. 14.3%,
P=0.004). There was a decrease in the rate of target-vessel
revascularization (5.6% and 13.4%, respectively; P< 0.001).
There was no significant difference between the two groups in
the rate of death (2.3% and 2.2%, respectively; P=1.0),
reinfarction (1.1% and 1.4%, respectively; P= 1.0), or stent
thrombosis (3.4% and 3.6%, respectively; P=1.0).
The study
concluded that among selected patients with acute myocardial
infarction, the use of sirolimus-eluting stents significantly
reduced the rate of target-vessel revascularization at 1 year.
Co-authors:
Christian Spaulding, M.D., Patrick Henry, M.D., Ph.D., Emmanuel
Teiger, M.D., Ph.D., Kevin Beatt, M.B., B.S., Ph.D., Ezio
Bramucci, M.D., Didier Carrié, M.D., Michel S. Slama, M.D., Bela
Merkely, M.D., Ph.D., Andrejs Erglis, M.D., Ph.D., Massimo
Margheri, M.D., Olivier Varenne, M.D., Ph.D., Ana Cebrian,
Ph.D., Hans-Peter Stoll, M.D., David B. Snead, Ph.D., Christoph
Bode, M.D., for the TYPHOON Investigators
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