Carlier.qxp 10/10/08 2:21 pm Page 43
The CYPHER
®
Stent Receives the CE Mark for Acute Myocardial Infarction
should include a judgement regarding the risks of antiplatelet therapy.
Figure 1: TYPHOON – Death and Myocardial Infarction at
Special consideration should be given to those patients with recently
Three-year Follow-up
active gastritis or peptic ulcer disease, pre-morbid conditions that
Death: non-adjudicated events
increase the risk of a poor initial result or the risks of emergency 100
referral for bypass surgery. A review of the vessel location, reference
vessel size, lesion length, qualitative target lesion characteristics and
95
the amount of myocardium in jeopardy from acute or subacute
thrombosis must also be considered. After stenting, the persistence of
a thrombus or dissection should be considered a marker for
90
F
reedom of events (%)
subsequent thrombotic occlusion. These patients should be monitored CYHPER
® BMS p=0.69
very carefully during the first month after stent implantation. 85
0 180 360 540 720 900 1,080
Time (days from initial procedure)
The optimal duration of dual antiplatelet therapy (DAPT: aspirin with
clopidogrel or ticlopidine) remains unknown and DES thrombosis may
Q and non-Q MI: non-adjudicated events
still occur despite continued therapy. Data from several studies
100
suggest that a longer duration of clopidogrel than was recommended
post-procedurally in the pivotal DES trials might be beneficial. In 95
TYPHOON, DAPT was recommended for at least six months. At one-
year follow-up, in both the CYPHER stent group and the BMS goup
90
50% of the patients were still under DAPT. In MULTISTRATEGY, DAPT
F
reedom of events (%)
was recommended for at least three months. At eight months, in both
CYHPER
® BMS p=0.69
groups one-third of the patients were still on DAPT.
85
0180 360 540 720 900 1,080
Time (days from initial procedure)
Based on consensus opinion, practice guidelines recommend that
Error bars indicate a point-wise two-sided 95% confidence interval (1.98 ± standard error).
patients receive aspirin indefinitely plus a minimum of three months of Standard error based on the Greenwood formula.
clopidogrel therapy extended to 12 months in patients at low risk of
Source: Spaulding C, presented at EuroPCR 2008.
bleeding.
13,14
It is very important that patients are compliant with the
Figure 2: STRATEGY – Lower Three-year Major Adverse Cardiac
post-procedural antiplatelet recommendations, and their potential Event Rates versus Bare-metal Stents
non-compliance to DAPT should be evaluated. Early discontinuation
50
of prescribed antiplatelet medication could result in a higher risk of Hazard ratio 0.64
thrombosis, MI or death. Prior to PCI, if a surgical or dental procedure
(95% CI: 0.39–1.07); p=0.089
40
41%
is anticipated that requires early discontinuation of antiplatelet
therapy, the interventional cardiologist and patient should carefully
30
29%
consider whether a DES and its associated recommended antiplatelet
therapy is appropriate.
20
Probability of events (%)
Sirolimus-eluting Stents versus Other Drug-eluting Stents 10
In contrast to TYPHOON and MULTISTRATEGY, which demonstrated a Abciximab + BMS Tirofiban + SES
significant benefit of the CYPHER stent versus BMS in STEMI patients
0
0 200 400 600 800 1,000 1,200 1,400
regardless of angiographic follow-up, the PASSION study reported no
Days after randomisation
significant benefit for Taxus
®
compared with BMS for similar one-year
BMS = bare-metal stent; CI = confidence interval; SES = sirolimus-eluting stent;
end-points in patients with acute MI.
15,16
It is clear that not all DES are
TVR = target vessel revascularisation.
equal and there is no DES class effect. This was recently reinforced by
Figure 3: MULTISTRATEGY – Lower Major Adverse Cardiac Event*
the results of the PROSIT trial,
9
which showed superior angiographic
Rates versus Bare-metal Stents
outcome in the CYPHER stent group (n=154) compared with the Taxus
group (n=154), with a significantly lower late in-stent loss (0.19 versus
20
No pre-specified angiographic follow-up
0.43mm; p=0.004). There were also fewer MACE at 12 months: 5.8%
Broad inclusion criteria
for the CYPHER stent versus 11.7% for Taxus (p=0.07). These data
15
14.5%
remind us that DES are complex devices that incorporate drugs, stents,
Adjusted HR: 0.53 (97.5% CI: 0.33–0.83); p=0.006
p=0.0039 at log-rank test
polymers and elution, which all play a role in their respective safety
*
(%)
CE
10
and efficacy profiles. In AMI, differences may be compounded due to MA 7.8%
the platelet milieu pre- and post-implantation, which could influence
5
such items as uniform drug delivery or optimal stent deployment. No
randomised data are currently available on the treatment of AMI
CYHPER
® BMS
0
patients with either the Endeavor or Xience Stent.
02040 60 80 100 120 140 160 180 200 220 240 260
Days after randomisation
In conclusion, the CYPHER stent remains the most studied DES
* Death, myocardial infarction or target vessel revascularisation.
in AMI, with >3,000 patients enrolled in dedicated trials – more Source: Valgimigli M, et al., JAMA, 2008;299(15):1788–99.
INTERVENTIONAL CARDIOLOGY 43
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