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ACC.08/SCAI-ACCi2 Clinical Trial Summary Slides

ACC.08/SCAI-ACCi2 Clinical Trial Summary Slides. ACCOMPLISH. Systolic blood pressure ↓ by amlodipine/benazapril, compared with HCTZ/benazapril by 0.7 mm Hg (p < 0.05)

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ACC.08/SCAI-ACCi2 Clinical Trial Summary Slides

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  1. ACC.08/SCAI-ACCi2 Clinical Trial Summary Slides

  2. ACCOMPLISH Systolic blood pressure ↓ by amlodipine/benazapril, compared with HCTZ/benazapril by 0.7 mm Hg (p < 0.05) Primary endpoint : CV mortality, stroke, MI, revascularization, unstable angina, resuscitation from death 9.2% in amlodipine/benazapril arm, compared with 11.4% in HCTZ/benazapril arm (p = 0.0002) (p = 0.0002) Trial design:Patients with hypertension were randomized to fixed dose amlodipine/benazapril or hydrochlorothiazide (HCTZ)/benazapril. Patients were followed for 3 years. Results 11.4 9.2 12 8 % Conclusions 4 • Fixed dose combination of amlodipine/benazapril is better than HCTZ/benazapril in reduction in blood pressure as well as cardiovascular endpoints in patients with high-risk hypertension 0 Primary endpoint HCTZ/benazapril (n = 5,721) Amlodipine/benazapril (n = 5,741) Presented by Dr. Kenneth Jamersonat SCAI-ACC i2 Summit/ACC 2008

  3. Adjusted Clopidogrel Loading Doses According to VASP Phosphorylation Index Decrease Rate of Major Adverse Cardiovascular Events in Patients With Clopidogrel Resistance 86% of VASP-guided patients overcame resistance with 1-3 extra clopidogrel doses MACE: 0% for VASP-guided vs. 9.5% for control (p =0.007) Total bleeding: 3.9% vs. 4.8%, respectively (p = 1.0) (p = 0.007) (p = 1.0) 0 9.5 % 3.9 4.8 MACE Total bleeding VASP-guided extra clopidogrel (n = 78) No extra clopidogrel (n = 84) Trial design:Patients with clopidogrel resistance (VASP index >50%) randomized to VASP-guided extra clopidogrel dosing (n = 78) or PCI without add’l clopidogrel (n = 84). Results Conclusions • Clopidogrel resistance was reversed with VASP-guided additional clopidogrel dosing • Effective response to clopidogrel resulted in less MACE and similar bleeding Bonello L, et al. J Am Coll Cardiol 2008;51: [Published online 29 March 2008]

  4. A-F In-hospital MACE: 11.7% with FilterWire vs. 9.5% with standard PCI (p = ns) 30-day MACE: 12% vs. 11% (p = ns), respectively TIMI 3 flow post-PCI: 94% vs. 94% (p = ns), respectively Trial design: NSTEMI patients were randomized to PCI plus FilterWire EZ embolic protection (n = 77) or standard PCI without embolic protection (n = 74). Results (p = ns) (p = ns) 94 94 % 11.7 9.5 Conclusions In-hospital MACE TIMI 3 flow post-PCI • FilterWire EZ embolic protection is not beneficial in NSTEMI • PCI plus FilterWire results in similar in-hospital MACE, 30-day MACE, and TIMI 3 flow post-PCI compared with standard PCI PCI plus embolic protection Standard PCI Presented by Dr. Mark Webster at SCAI-ACC i2 Summit/ACC 2008

  5. ALLAY Change in LV mass index 4.9 ± 1, 4.8 ± 1, and 5.8 ± 0.9 with aliskiren, losartan, and combination, respectively (all p < 0.0001 compared with baseline) Aliskiren was noninferior to losartan (p < 0.0001), but combination not superior to losartan alone (p = 0.52) Incidence of serious side effects was similar (p = 0.77) Trial design: Overweight hypertensive patients with evidence of left ventricular (LV) hypertrophy were randomized to aliskiren, losartan, or the combination. Patients were followed for 36 weeks to assess the change in LV mass index on cardiac MRI. Results (p < 0.0001*) (p = 0.52**) 4.9 4.8 5.8 6 4 g/m2 Conclusions 2 • Aliskiren was noninferior to losartan in reducing LV mass index, but the combination was not superior to losartan alone • Clinical outcomes studies are awaited 0 Primary endpoint Aliskiren (n = 154) Losartan (n = 152) Combination (n = 154) * Aliskiren vs. losartan for noninferiority ** Combination vs. losartan Presented by Dr. Scott Solomonat SCAI-ACC i2 Summit/ACC 2008

  6. ARMYDA-RELOAD Approximately one-third had unstable angina MACE in entire study: 7% in reload group vs. 9% in placebo group (p = 0.70) MACE in ACS patients: 7% vs. 18% respectively, (p = 0.035) No major bleeds in either group Trial design:Patients on chronic clopidogrel therapy (>10 days) undergoing PCI were randomized to an additional 600 mg clopidogrel dose (n = 285) or placebo (n = 283) and followed for 30 days. Results (p = 0.70) (p = 0.035) 7 18 7 9 % Conclusions MACE in entire study population MACE in ACS patients • Among unselected patients on chronic clopidogrel, no benefit with reloading • Clopidogrel reloading may be of benefit in unstable patients • Favorable bleeding profile with reloading Clopidogrel reload No reload Presented by Dr. Germano Di Sciascio at SCAI-ACC i2 Summit/ACC 2008

  7. ASTRAL Baseline creatinine, 2.02 mg/dl; glomerular filtration rate, 40 ml/min; mean stenosis, 76%; anti-hypertensive medications, 2.8 per patient 93% of revascularized patients received a stent At follow-up, no difference in creatinine, blood pressure, time to first renal event, or mortality (p = ns for all outcomes) Trial design:Patients with significant renal artery stenosis were randomized to angioplasty and/or stenting plus medical therapy (n = 403) or medical therapy alone (n = 403) and followed for 27 months. Results (p = ns) (p = ns) 12 14 7.4 8.2 % Conclusions Cardiovascular mortality Hospitalization for fluid overload or heart failure • Renal artery revascularization is not superior to medical therapy alone • Renal artery stenting does not reduce creatinine, blood pressure, time to first renal event, adverse cardiac events, or mortality Renal stenting Medical therapy Presented by Dr. Philip Kalra at SCAI-ACC i2 Summit/ACC 2008

  8. ATHEROMA Significant reduction from baseline in USPIO-defined signal intensity was observed in 80 mg group at 6 and 12 weeks; no difference was observed in low-dose arm at 6 and 12 weeks Mean signal difference at 12 weeks between the two groups was 0.24 (p < 0.0001) (p < 0.0001) Trial design:Patients with carotid stenosis >40% and who demonstrated intraplaque accumulation of ultra small super-paramagnetic iron oxide (USPIO) on MRI at baseline were randomized to either 10 mg or 80 mg atorvastatin daily for 12 weeks. Results 0.5 0.20 0.038 0.4 0.3 Units Conclusions 0.2 • Aggressive lipid-lowering therapy with 80 mg of atorvastatin daily is associated with significant reduction in USPIO-defined inflammation in carotid plaques • USPIO-defined inflammation represents a novel imaging biomarker 0.1 0 Signal intensity at 12 weeks Atorvastatin 10 mg (n = 20) Atorvastatin 80 mg (n = 20) Presented by Dr. Tjun Tangat SCAI-ACC i2 Summit/ACC 2008

  9. BRAVE 3 Mean final infarct size: 15.7% vs. 16.5% in the abciximab and control groups (p = 0.47) Death, MI, stroke or urgent revascularization: 5.0% vs. 3.8% in the abciximab and control groups (p = 0.39) (p = 0.47) Abciximab (n = 401) Placebo (n = 399) Trial design:Patients with STEMI undergoing PCI were randomized to either abciximab or unfractionated heparin (UFH), after pretreatment with 600 mg of clopidogrel. LV infarct size was evaluated at 5-7 days. Results 20 15.7 16.5 18 16 % Conclusions 14 • No difference in infarct size or clinical outcomes with abciximab in patients with STEMI undergoing PCI following pretreatment with 600 mg of clopidogrel 12 10 Final infarct size Presented by Dr. Julinda Mehilli at SCAI-ACC i2 Summit/ACC 2008

  10. ECLIPSE 50% interventional procedures; 89% device success Time to hemostasis: 4.4 min for closure device and 20.1 min for manual pressure (p < 0.0001) Hematoma >6 cm: 1.9% vs. 0.7% (p = 0.67), respectively Trial design:Patients with diagnostic and interventional coronary/peripheral procedures were randomized to the ExoSeal closure device (n = 267) or manual pressure (n = 134). Results (p < 0.0001) (p = 0.67) 4.4 20.1 1.9 0.7 min % Conclusions Time to hemostasis Large (>6 cm) hematoma • The ExoSeal closure device reduces time to hemostasis compared with manual pressure • No adverse events in either group • Nonsignificant increase in large hematomas with ExoSeal closure device Closure device Manual pressure Presented by Dr. Shing-Chiu Wong at SCAI-ACC i2 Summit/ACC 2008

  11. ENHANCE Mean carotid IMT 0.0058 ± 0.0037 mm in the simvastatin arm vs. 0.0111 ± 0.0038 mm in the ezetimibe/simvastatin arm (p = 0.29) Mean LDL levels 192.7 mg/dl (39% ↓) in simvastatin arm, 141.3 mg/dl in the ezetimibe/simvastatin arm (56% ↓) (p < 0.01) (p = 0.20) (p < 0.01) Ezetimibe/ Simvastatin (n = 357) Simvastatin (n = 363) Trial design:Patients with heterozygous familial hypercholesterolemia were randomized to treatment with ezetimibe/simvastatin 10/80 mg or simvastatin 80 mg alone. Mean change in intima-media thickness (IMT) was measured in the carotid arteries over 2 years. Results 4.7 5 193 4 200 2.8 141 3 150 % mg/dl 2 Conclusions 100 • No additional benefit in carotid IMT reduction at 2 years with ezetimibe/simvastatin compared with high-dose simvastatin alone • LDL lowering greater with ezetimibe/simvastatin • Clinical outcomes and adverse events similar 1 50 0 0 LDL cholesterol New plaque formation Kastelein JJ, et al. N Engl J Med 2008;358:1431-43

  12. GENESIS In-stent late loss: 1.40 ± 0.67 mm, 0.96 ± 0.73 mm, and 0.58 ± 0.58 mm in CORIO, SYMBIO, and CoStar arms, respectively 6-month MACE: 39.0% vs. 14.4% vs. 2.0% for CORIO, SYMBIO, and CoStar arms Trial design: In this single-blinded study, patients were randomized 2:2:1 to CORIO (pimecrolimus-eluting), SYMBIO (pimecrolimus- and paclitaxel-eluting), or CoStar (paclitaxel-eluting) control arm. Results 39.8 20.4 7.1 40 30 Conclusions • First trial to successfully demonstrate dual drug delivery in patients with CAD undergoing PCI • Pimecrolimus ± paclitaxel is associated with higher incidence of in-stent restenosis and MACE compared with paclitaxel alone 20 % 10 0 In-stent restenosis CORIO (n = 100) SYMBIO (n = 101) CoStar (n = 49) Presented by Dr. Stefan Verheyeat SCAI-ACC i2 Summit/ACC 2008

  13. HAT All-cause mortality: 6.4% for AED and CPR vs. 6.5% for CPR alone (p = 0.77) 37.6% of deaths were due to tachyarrhythmia, with remainder due to heart failure or noncardiac causes Only 8 patients in each group were resuscitated at home Trial design:Intermediate-risk patients after an anterior myocardial infarction were randomized to automated external defibrillator (AED) and cardiopulmonary resuscitation (CPR) (n = 3,495) versus CPR alone (n = 3,506) and followed for 37 months. Results (p = 0.77) 6.4 6.5 % Conclusions All-cause mortality • AED and CPR are not superior to CPR alone in intermediate-risk patients after an MI • Relatively few deaths in this population are due to tachyarrhythmia AED and CPR CPR alone Bardy GH, et al. N Engl J Med 2008;358:1793-804.

  14. HORIZON-HF Systolic blood pressure: ↑ 10 mm Hg with 1.5 mcg/kg/min Istaroxime and ↑ 0.6 mm Hg with placebo (p < 0.001) Cardiac index: +0.3 L/min/m2 vs. -0.01 L/min/m2 (p = 0.04), respectively LV end-diastolic volume: -14.1 ml vs. +3.9 ml (p = 0.02), respectively Trial design:Decompensated heart failure patients were randomized to Istaroxime, an inotropic and lusitropic agent (n = 29 for 0.5 mcg/kg/min; n = 30 for 1.0 mcg/kg/min; n = 30 for 1.5 mcg/kg/min) or placebo (n = 31). Results (p = 0.04) (p = 0.02) +0.3 -0.01 -14.1 +3.9 L/min/m2 ml Conclusions • In this dose-finding study, Istaroxime 1.5 mcg/kg/min may be beneficial in improving hemodynamics and diastolic function in patients with decompensated heart failure Cardiac index Left ventricular end-diastolic volume Istaroxime, 1.5 mcg/kg/min Placebo Presented by Dr. Mihai Gheorghiade at the SCAI-ACC i2 Summit/ACC 2008

  15. HYVET Trial was terminated early Stroke ↓ 30% (p = 0.06), mortality ↓ 21% (p = 0.02), heart failure ↓ 64% (p < 0.001) in indapamide arm compared with placebo Number needed to treat at 2 years: 94 for stroke, 40 for mortality (p = 0.02) (p = 0.06) Indapamide (n = 1,933) Placebo (n = 1,912) Trial design: Hypertensive geriatric (age >80 years) patients were randomized to indapamide SR 1.5 mg or to placebo. Clinical outcomes were evaluated at 2 years. Results 15 5 2.6 3.6 10.1 12.3 4 10 3 % % 2 Conclusions 5 • Significant mortality benefit with treatment of BP >160 mm Hg in patients older than 80 years • Newer guidelines will need to consider this group of patients specifically 1 0 0 Strokes Mortality Presented by Dr. Nigel Beckett at SCAI-ACC i2 Summit/ACC 2008

  16. ISAR-REACT 3 Primary endpoint: death, MI, urgent target vessel revascularization, or in-hospital major bleeding was similar between the bivalirudin (8.3%) and UFH (8.7%) arms (p = 0.57) Bleeding significantly ↓ with bivalirudin compared with UFH: major (33%), minor (31%) (p = 0.57) (p = 0.008) 8.3 8.7 3.1 4.6 10 5 8 4 7 6 3 % % 5 2 4 3 2 1 0 0 Bivalirudin (n = 2,289) UFH (n = 2,281) Trial design:Troponin-negative patients undergoing PCI were randomized to either bivalirudin or unfractionated heparin (UFH), after pretreatment with 600 mg of clopidogrel. Clinical outcomes were evaluated at 30 days. Results 9 Conclusions • Bivalirudin is not superior to UFH as adjunct anticoagulation therapy for troponin-negative patients undergoing PCI, who were pretreated with 600 mg of clopidogrel • Bleeding was significantly reduced with bivalirudin compared with UFH 1 Composite endpoint Major bleeding Presented by Dr. Adnan Kastrati at SCAI-ACC i2 Summit/ACC 2008

  17. MEND-CABG II Median aortic cross-clamp time of 1.0 hour, internal mammary artery graft used in 90% Death or nonfatal MI: 9.3% in MC-1 group and 9.0% in control (p = 0.76) All-cause mortality: 1.0% vs. 0.3% at 4 days (p = 0.03) and 1.9% vs. 1.5% at 30 days (p = 0.44), respectively Trial design:Intermediate-risk patients undergoing CABG were randomized to MC-1 (n = 1,519) or placebo (n = 1,504) and followed for 30 days after surgery. Results (p = 0.03) (p = 0.44) 1.9 1.5 1 0.3 % Conclusions • In intermediate-risk patients undergoing CABG, MC-1 is not superior to placebo • MC-1 does not reduce death or MI at 30 days • MC-1 increased 4-day mortality; however, no difference at 30 days 4-day mortality 30-day mortality MC-1 Placebo Alexander JH, et al. JAMA 2008;299:1777-87

  18. MOMENTUM Cardiac index: increased to more than 2.4 L/min/m2 (p < 0.0001) with the device Death or heart failure hospitalization at 65 days: similar between the two groups (p = ns) Major bleeding: 16.5% vs. 5.1% (p = 0.05), respectively Trial design:Patients with refractory heart failure symptoms were randomized to the Orqis continuous aortic flow augmentation device for 4 days (superimposing low-level continuous flow on pulsatile flow) (n = 109) or continued medical management (n = 59). Results (p = 0.005) (p = 0.005) 16.5 5.1 26.6 8.5 % Conclusions • Continuous aortic flow augmentation for 4 days increases cardiac index, although death or heart failure hospitalization is similar • Major and minor bleeding are increased with the device Major bleeding Minor bleeding Continuous aortic flow augmentation Medical management Presented by Dr. Barry Greenberg at SCAI-ACC i2 Summit/ACC 2008

  19. ONTARGET Telmisartan (16.7%) noninferior; combination (16.3%) not superior to ramipril (16.5%) for primary endpoint (CV death, MI, stroke, heart failure) Greater incidence of hypotension in combination (4.8%) and telmisartan (2.7%) groups, compared with ramipril group (1.7%) (p < 0.001) (p < 0.004*) (p = ns) Trial design:Patients at high risk for cardiovascular events, but without heart failure, were randomized to telmisartan, ramipril, or the combination. Patients were followed for a median of 56 months. Results 16.7 16.3 16.5 11.6 12.5 11.8 15 20 % 10 10 % 5 Conclusions • Either telmisartan or ramipril, but not both, can be used in hypertensive patients at high risk for cardiovascular events • Side effects greater with combination therapy 0 0 Primary endpoint Mortality Telmisartan (n = 8,542) Combination (n = 8,502) Ramipril (n = 8,576) * Telmisartan vs. ramipril for noninferiority The ONTARGET investigators. N Engl J Med 2008;358:1547-59

  20. ON-TIME 2 Mean transportation distance: 25 km >3 mm ST-elevation post-PCI: 36.6% with tirofiban and 44.3% with placebo (p = 0.026) Mortality: 2.3% vs. 4.0% (p = 0.14), respectively Major bleeding: 4.0% vs. 2.9% (p = 0.36), respectively Trial design:STEMI patients who presented to a non-PCI center were randomized to tirofiban prior to transfer for primary PCI (n = 491) or placebo with provisional tirofiban in the catheterization laboratory(n = 493) and followed for 30 days. Results (p = 0.026) (p = 0.14) 36.6 44.3 % 2.8 4.0 Conclusions • In STEMI patients, tirofiban prior to transfer for PCI is beneficial • Upstream tirofiban reduces ST-elevation post-PCI and nonsignificantly decreases mortality • Potential for increased bleeding with upstream tirofiban >3 mm ST-elevation post-PCI Mortality Upstream tirofiban Provisional tirofiban Presented by Dr. Christian Hamm at SCAI-ACC i2 Summit/ACC 2008

  21. PERISCOPE Least square mean change in % atheroma volume from baseline ↑ 0.73% in the glimepiride arm while it ↓ 0.16% in the pioglitazone arm (p = 0.002) Composite endpoint: CV death, nonfatal MI, or stroke was similar between the glimepiride (2.2%) and pioglitazone (1.9%) arms (p = 0.78). CRP, triglycerides ↓, HDL ↑ with pioglitazone (p = 0.37) (p = 0.002) Trial design:Patients with CAD and diabetes were randomized to receive either glimepiride or pioglitazone. Baseline and 18-month IVUS measurements were performed. Results 0.73 -0.16 0.36 1.1 0.8 1.2 0.6 0.4 0.8 % change in atheroma volume 0.2 Conclusions % • Pioglitazone is better than glimepiride in reducing the progression of CAD in diabetic patients, in the background of optimal medical therapy • Pioglitazone has a favorable impact on biochemical parameters, with increased side effects 0.4 0 -0.2 0 Primary endpoint CV mortality glimepiride (n = 273) Pioglitazone (n = 270) Nissen S, et al. JAMA 2008;299:1561-73

  22. PROTECT Pilot Fewer patients with rolofylline 30 mg experienced >0.3 mg/dl increase in serum creatinine compared with placebo (p < 0.05) Death or rehospitalization for heart failure: 19% with rolofylline 30 mg and 33% for placebo (p = ns) No seizures in either group Trial design:Decompensated heart failure patients were randomized to rolofylline, an adenosine A1 receptor antagonist (30 mg, n = 74; 20 mg, n = 75; 10 mg, n = 74), or placebo (n = 78). Results (p = ns) 19 33 % Conclusions • Acute decompensated heart failure patients: less renal dysfunctionwith rolofylline 30 mg • Possible reduction in death or rehospitalization for heart failure with rolofylline Death or rehospitalization for heart failure Rolofylline Placebo Presented by Dr. Barry Massie at the SCAI-ACC i2 Summit/ACC 2008

  23. REVERSE Patients worsened: 16% with CRT vs. 21% with optimal medical therapy (p = 0.1) LV end-systolic volume index: decreased 18.4 ml/m2 vs. 1.3 ml/m2 (p < 0.0001), respectively Risk of heart failure hospitalization reduced with CRT (p = 0.03) Trial design:Patients with LV dysfunction (NYHA class I-II) and wide QRS were randomized to cardiac resynchronization therapy (CRT) (n = 419) or optimal medical therapy (n = 191). Results (p = 0.1) 16 21 % Conclusions • CRT for mild heart failure does not reduce the percentage of patients that clinically worsen • CRT improves LV end-systolic volume index and reduces the risk of hospitalization compared with optimal medical therapy Percentage worsened Medical therapy CRT Presented Dr. Cecilia Linde at SCAI-ACC i2 Summit/ACC 2008

  24. SEISMIC In treatment group, 8.3 years since MI and 31% ejection fraction Percentage with serious adverse event: 50% in myoblast group and 36% in control (p = ns) Change in ejection fraction: ↑ 0.3% vs. ↓ 0.1% (p = ns), respectively Trial design:Patients with myocardial scar were randomized to autologous skeletal myoblast cells (n = 31) or medical therapy (n = 16) and followed for 6 months. Results p = ns p = ns 50 36 +0.3 -0.1 % % Serious adverse events Conclusions Change in ejection fraction • In this small study, implantation of autologous skeletal myoblast cells after MI is feasible • No apparent excess in serious adverse events • Potential small increase in ejection fraction with myoblast cells at 6 months follow-up Autologous skeletal myoblast cells Medical therapy Presented by Dr. Patrick Serruys at SCAI-ACC i2 Summit/ACC 2008

  25. SPIRIT II In-stent late loss 0.11 mm (everolimus) and 0.36 mm (paclitaxel) at 6 months (p < 0.001). Similar at 2 years (0.33 mm vs. 0.34 mm, p = 0.61) MACE at 2 years: 6.6% vs. 11.0% (p = 0.31) Stent thrombosis at 2 years: 0.9% vs. 1.4% (p = ns) (p = ns) (p = 0.61) Trial design: This was a randomized study designed to evaluate the safety and efficacy of the XIENCE V everolimus-eluting stent compared with the TAXUS paclitaxel-eluting stent among patients with de novo coronary lesions. Results 0.33 0.34 0.36 1.1 0.5 1.6 0.4 1.2 0.3 Conclusions % mm 0.8 • Benefit in in-stent late lumen loss was seen with everolimus compared with paclitaxel at 6 months, but not seen at 2 years • Clinical outcomes were similar to paclitaxel-eluting stents at 2 years • Long-term data on stent performance necessary 0.2 0.4 0.1 0 0 In-stent late loss Stent thrombosis XIENCE V (n = 223) TAXUS (n = 77) Presented by Dr. Patrick Serruysat SCAI-ACC i2 Summit/ACC.08

  26. STRADIVARIUS Percent atheroma volume: +0.25% for rimonabant vs. +0.51% for placebo (p = 0.22) Psychiatric symptoms: 43% vs. 28% (p < 0.001), respectively Gastrointestinal track symptoms: 34% vs. 18% (p < 0.001), respectively Trial design:Obese patients with metabolic syndrome were randomized to the cannabinoid type 1 receptor inhibitor rimonabant 20 mg daily (n = 422) or placebo (n = 417) and underwent IVUS examination after 18 months of treatment. Results (p = 0.22) (p < 0.001) 0.25 0.51 43 28 % % Conclusions • Rimonabant is not superior to placebo in reducing percent atheroma volume in obese patients with metabolic syndrome • Rimonabant results in more psychiatric and gastrointestinal track symptoms compared with placebo Percent atheroma volume Psychiatric symptoms Rimonabant Placebo Nissen SE, et al. JAMA 2008;299:1547-60

  27. TAPAS Good myocardial blush: 46% with aspiration and 32% with standard PCI (p < 0.001) ST-segment resolution: 57% and 44%, respectively (p < 0.001) Death: 2.1% and 4.0%, respectively (p = 0.07) (p < 0.001) (p = 0.07) 60 46 32 % 30 4 2.1 0 Good myocardial blush Mortality Trial design:Patients with STEMI were randomized to thrombus aspiration prior to PCI (n = 535) or standard PCI without aspiration (n = 536). Results Conclusions • In STEMI, thrombus aspiration prior to PCI is superior to standard PCI without aspiration • Thrombus aspiration improves myocardial blush and ST-segment resolution • Thrombus aspiration may improve adverse events including survival PCI alone (n = 536) Thrombus aspiration and PCI (n = 535) Svilaas T, et al. N Engl J Med 2008;358:557-67

  28. TRANSFER-AMI Primary endpoint: death, MI, heart failure, severe recurrent ischemia, or shock 10.5% in pharmacoinvasive arm vs. 16.5% in standard treatment arm (p = 0.0013) Reinfarction: 3.3% vs. 6.0% (p = 0.044) Recurrent ischemia: 0.2% vs. 2.2% (p = 0.02) (p = 0.0013) (p = 0.94) Pharmacoinvasive arm (n = 522) Standard therapy (n = 508) Trial design:Patients with STEMI who presented to centers where timely primary PCI was not feasible were randomized to a pharmacoinvasive strategy (emergent transfer for PCI within 6 hours of fibrinolysis) or to standard treatment after fibrinolysis. Results 20 5 16.5 4 3.7 3.6 % 3 10.5 10 % 2 Conclusions 1 • Pharmacoinvasive approach safe and efficacious compared with treatment with thrombolytics and transfer for rescue PCI only • Optimal window: 6 hours 0 0 Primary endpoint Mortality Presented by Dr. Warren Cantor at SCAI-ACC i2 Summit/ACC.08

  29. VICTORY Years since CABG: 3.9 in rosiglitazone group and 3.7 in placebo group Saphenous vein graft plaque volume: +0.9% vs. +2.8% (p = 0.22), respectively Mortality: no deaths in either group MI: 0 vs. 1, respectively Trial design:Type 2 diabetic patients with prior CABG were randomized to rosiglitazone (n = 98) or placebo (n = 95) after baseline coronary angiography and IVUS. Results (p = 0.22) 0.9 2.8 % Conclusions Change in saphenous vein graft plaque volume • Rosiglitazone does not change saphenous vein graft plaque volume in type 2 diabetic patients after CABG • The incidence of mortality and MI is similar between rosiglitazone and placebo Rosiglitazone Placebo Presented by Dr. Olivier Bertrand at SCAI-ACC i2 Summit/ACC 2008

  30. VISION 302 Binodenoson was noninferior to adenosine. The mean paired summed difference scores difference of binodenoson vs. adenosine images was -0.09 (95% CI -0.44 to 0.27) 2nd or 3rd degree AV block was 0% with binodenoson and 3% with adenosine (p = 0.004) (p < 0.05) (p = 0.004) Trial design: Patients with known or suspected CAD undergoing a pharmacologic stress test with SPECT imaging were stratified and randomized to binodenoson or adenosine for the determination of the magnitude of ischemia. Results 30 50 0 3 3 50 40 2 30 % % Conclusions 20 • Binodenoson (selective A2A receptor agonist) is as effective as adenosine (nonselective agonist) as agent for detection of ischemia in pharmacologic stress tests in suspected/known CAD patients • Side effects are fewer and less intense with binodenoson compared with adenosine 1 10 0 0 2nd or 3rd degree AV block Flushing Binodenoson (n = 402) Adenosine (n = 404) Presented by Dr. James Udelson at SCAI-ACC i2 Summit/ACC 2008

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