1. TYPHOON Trial
Trial to Assess the Use of the Cypher Stent in Acute Myocardial Infarction Treated with Balloon Angioplasty (TYPHOON) Trial
Presented at
The American College of Cardiology
Scientific Session 2006
Presented by Dr. Christian Spaulding

2. TYPHOON Trial: Background
The Typhoon trial evaluates treatment with sirolimus-eluting stents in comparison to bare-metal stents among patients with Acute MI undergoing primary PCI.
Several large randomized studies have been performed with drug-eluting stents in the setting of elective PCI, but little randomized data exist in the setting of ST-segment elevation MI.
Presented at ACC 2006

3. TYPHOON Trial: Study Design
712 patients with acute MI (prolonged chest pain with ST segment elevation) < 12 hours since onset, culprit lesion in a native suitable for stenting
Randomized, 22% female, mean age 59 years, mean follow-up 1 year
71% received Glycoprotien llb/llla inhibitors, Door to balloon time=60 minutes
Cardiac catheterization/primary PCI
Cypher Stent Sirolimus-eluting
n=355
Bare-metal stent (any kind)
n=357
Concomitant Medications:
Aspirin (≥100mg)
Clopidogrel (300mg load and 75 mg/day for 6 months)
Primary Endpoint: Target vessel failure at one year, defined as target vessel revascularization, recurrent MI or cardiac death.
Secondary Endpoint: In- hospital, 1, 6 & 12 months major adverse cardiac event
Presented at ACC 2006

4. TYPHOON Trial: Primary Endpoint(s)
Target Vessel Failure* at one year
Target vessel Failure (TVF) was lower in the Cypher stent group compared to the bare-metal stent group (7.3% vs 14.3%; p=0.0036) with no difference in death or MI.
*a composite of TVR, MI, cardiac death
p=0.0036
TVF
Presented at ACC 2006

5. TYPHOON Trial: Target Lesion Revascularization
Rate of Target Lesion Revascularization (%)
p<0.0001
Target vessel failure is driven by a reduction in TLR (3.7% vs.12.6% p<0.0001)
Stent thrombosis did not differ between groups, (3.4% Cypher vs 3.6% Bare-metal; p=NS) though high overall
TLR
Presented at ACC 2006

6. TYPHOON Trial: Angiographic Substudy
In-stent late lumen loss among angiographic cohort (mm)
p<0.0001
In-stent lumen loss was lower in the Cypher stent group than the bare-metal stent group (0.13 mm vs mm; p<0.0001)
Millimeters
Presented at ACC 2006

7. TYPHOON Trial: Angiographic Substudy (cont.)
Rate of Binary Restenosis (%)
p=0.001
Binary restenosis (>50% diameter stenosis at follow up) occurred significantly more often in patients with a bare-metal stent than in patients with the sirolimus-eluting Cypher stent (20.3% vs 3.5%; p=0.001).
% Restenosis
Presented at ACC 2006

8. TYPHOON Trial: Summary
The TYPHOON trial showed the sirolimus-eluting stent (Cypher stent) was associated with a significant reduction in target vessel failure compared to bare metal stents in patients undergoing primary PCI for AMI with no difference in death or MI.
The primary endpoint was driven by a reduction in TLR.
Angiographic substudy cohort showed that in-stent late lumen loss was significantly reduced in the sirolimus-eluting stent group.
The recently published, PASSION trial, did not demonstrate a reduction in TLR with paclitaxel-eluting stents over bare-metal stents; however, key differences between the two trial designs must be considered when comparing the trial: different drug-eluting stents, only bare Express stent patients enrolled in PASSION, and the absence of angiographic follow-up in PASSION, which may have decreased the repeat revascularization rate.
Presented at ACC 2006