Transcript Diapositiva 1 - metcardio.org

SIROLIMUS-ELUTING STENTS FOR IN-STENT
RESTENOSIS TREATMENT IN 278 UNSELECTED
PATIENTS: INSIGHTS ON LONG-TERM OUTCOMES
FROM A LARGE TWO-CENTER REGISTRY
I. SHEIBAN1, A. CHIRIBIRI1, S. GALLI2, G. BIONDI-ZOCCAI1,
P. MONTORSI2, S. BENINATI1, F. FABIOCCHI2,
C. MORETTI1, G. TREVI1, A. BARTORELLI2
(1) Interventional Cardiology, University of Turin, Turin, Italy ([email protected]);
(2) Interventional Cardiology, Centro Cardiologico Monzino, Milan, Italy
1
BACKGROUND
• In-stent restenosis (ISR) occurs not
infrequently after intracoronary stenting
• Many techniques have been proposed for
the treatment of ISR, but drug-eluting
stents (DES) seem to provide the best
early and mid-term results
• We aimed to appraise whether such
effectiveness of DES for ISR is maintained
even on the long-term
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OBJECTIVES
• To appraise the long-term results of
sirolimus-eluting stent (SES)
implantation for the management of
bare-metal stent (BMS) restenosis
3
METHODS
• All patients admitted from July 2002 to December 2004,
with known coronary artery disease, previously treated
with BMS, who demonstrated ISR and were treated
during the index hospitalization with SES implantation
(Cypher, Cordis, Miami, FL, USA), the prevalent DES in
our Institutions, were enrolled into a dedicated database
• SES were either implanted at high pressure or initially
expanded at moderate-to-high pressure, and then postdilated with semi-compliant or non-compliant balloons at
high pressure
4
METHODS
• At the time of discharge, all patients were receiving
100 mg of aspirin once daily, as well as 75 mg of
clopidogrel daily for at least 3 months
• The primary end point was freedom from major
cardiovascular events (MACE) at long-term (≥24
months) follow-up, defined as a composite end point
of death, non-fatal myocardial infarction, target vessel
revascularization (TVR), or stent thrombosis
5
METHODS
• Secondary end points were early complications (intraprocedural or in-hospital death, acute or subacute stent
thrombosis, stroke, need for urgent coronary artery
bypass, and peripheral vascular complications), technical
success of stent implantation, and individual components
of MACE
• Stent thrombosis was distinguished as acute (≤24 hours),
subacute (≤30 days), late (>30 days), or very late (>1
year).
A comprehensive
thrombosis
definition,
encompassing definite as well as probable thrombosis,
was used
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RESULTS
• A total of 271 consecutive patients were enrolled (331 sirolimuseluting stents). Procedural success was obtained in all patients
with no case of in-hospital death, acute/subacute stent
thrombosis, stroke, or urgent coronary bypass.
• Survival free from MACE decreased progressively from 98.8% at
1 month, to 95.7%, 83.7%, 75.4%, and 65.8% at 6 months, 12
months, 24 months and 30 months, respectively. Similarly, a
similar attrition in freedom from repeat target vessel was found
(from 97.6% at 6 months to 76.7% at 30 months).
• Finally, a total of 5 stent thrombosis were adjudicated, all
occurring several months after clopidogrel discontinuation and in
patients on life-long aspirin
7
BASELINE PATIENT
CHARACTERISTICS
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BASELINE ANGIOGRAPHIC
FEATURES
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OUTCOMES
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CONCLUSIONS
• This study supports the mid-term safety
and effectiveness of sirolimus-eluting
stents for the treatment of ISR
• Whether the late catch-up phenomenon
hereby observed in repeat target
revascularization and stent thrombosis is
an incidental finding deserve further
rigorous scrutiny
11
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