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 TYPHOON Trial

www. Clinical trial results.org 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.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.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. The Typhoon trial evaluates treatment with sirolimus- eluting stents in comparison to bare-metal stents among patients with Acute MI undergoing primary PCI.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.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

www. Clinical trial results.org TYPHOON Trial: Study Design Presented at ACC 2006  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  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 Cypher Stent Sirolimus-eluting n=355 Cypher Stent Sirolimus-eluting n=355 Bare-metal stent (any kind) n=357 Bare-metal stent (any kind) n= 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 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 Concomitant Medications: Aspirin (≥100mg) Clopidogrel (300mg load and 75 mg/day for 6 months) Concomitant Medications: Aspirin (≥100mg) Clopidogrel (300mg load and 75 mg/day for 6 months) Cardiac catheterization/primary PCI

www. Clinical trial results.org TYPHOON Trial: Primary Endpoint(s) 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.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 Target Vessel Failure * at one year TVF Presented at ACC 2006 p=0.0036

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

www. Clinical trial results.org TYPHOON Trial: Angiographic Substudy In-stent late lumen loss among angiographic cohort (mm) p< 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)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

www. Clinical trial results.org 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).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

www. Clinical trial results.org 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 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.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.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.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. 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 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.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.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.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