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ACC.09/i2 Summit Clinical Trial Summary Slides. 2.1 1.7 0 0.5 1 1.5 2 2.5 Peak troponin-I ng/ml ABOARD Peak troponin-I: 2.1 vs. 1.7 ng/ml, p = 0.70 No.

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Presentation on theme: "ACC.09/i2 Summit Clinical Trial Summary Slides. 2.1 1.7 0 0.5 1 1.5 2 2.5 Peak troponin-I ng/ml ABOARD Peak troponin-I: 2.1 vs. 1.7 ng/ml, p = 0.70 No."— Presentation transcript:

1 ACC.09/i2 Summit Clinical Trial Summary Slides

2 Peak troponin-I ng/ml ABOARD Peak troponin-I: 2.1 vs. 1.7 ng/ml, p = 0.70 No difference in death/MI/urgent revascularization at 30 days Length of hospital stay: 55 vs. 77 hours, p < 0.01 Trial design: This study evaluated a strategy of immediate vs. next-day cardiac catheterization and revascularization in patients with NSTE ACS. Results Conclusions A strategy of immediate PCI does not impact the incidence of death or MI in NSTE ACS Length of hospital stay was significantly reduced with an immediate PCI strategy Presented by Dr. Gilles Montalescot at ACC.09/i2, Orlando, FL (p = 0.70) Immediate PCI (n = 175) Next-day PCI (n = 177)

3 StrokeMI Percent per year ACTIVE A Stroke/MI/systemic embolus/vascular death: 6.8 vs.7.6% per year, p = 0.01 Stroke: 2.4% vs. 3.3% per year, p < MI: 0.7% vs. 0.9% per year, p = 0.08 Major hemorrhage: 2.0% vs. 1.3% per year, p < Trial design: This study evaluated treatment with a combination of aspirin and clopidogrel versus aspirin alone in patients with AF who were not candidates for warfarin therapy. Results Conclusions Clopidogrel in addition to aspirin may reduce the risk of stroke in patients with AF who are unsuitable candidates for warfarin therapy The increased risk of major hemorrhage with aspirin + clopidogrel somewhat attenuates this benefit ACTIVE Investigators. N Engl J Med 2009;Mar 31:[Epub] (p < 0.001)(p = 0.08) Clopidogrel (n = 3,772) Placebo (n = 3,782)

4 MACECK-MB % Patients ARMYDA-RECAPTURE 30-day MACE: 3.4% vs. 9.1%, p = 0.04 CK-MB elevation: 13% vs. 23%, p = 0.02 Troponin-I elevation: 36% vs. 47%, p = 0.03 Peak CRP: 2.1 ± 6.7 vs. 3.0 ± 9.5, p = 0.12 Trial design: This study evaluated the efficacy of an atorvastatin reloading strategy in patients on chronic statin therapy undergoing PCI for stable angina or NSTEMI. Results Conclusions An 80 mg loading dose of atorvastatin followed by a 40 mg preprocedural dose may reduce the incidence of post-procedure MACE in patients on background statin therapy These data support a strategy of routine atorvastatin reloading prior to PCI in patients on background statin therapy Presented by Dr. Germano DiSciascio at ACC.09/i2, Orlando, FL Atorvastatin (n = 177) Placebo (n = 175) (p = 0.02)(p = 0.04)

5 CV deathMIStroke Events per 100 patient-years AURORA Per 100 patient-years: CV death: 7.2 vs. 7.3, p = 0.97 Nonfatal MI: 2.1 vs. 2.5, p = 0.23 Nonfatal stroke: 1.2 vs. 1.1, p = 0.42 Composite endpoint: 9.2 vs. 9.5, p = 0.59 Trial design: This study evaluated treatment with 10 mg rosuvastatin compared with standard therapy in patients with end-stage renal disease receiving hemodialysis. Results Conclusions Low-dose rosuvastatin therapy does not reduce the rate of cardiovascular events in patients with ESRD receiving hemodialysis Fellstrom B, et al. N Engl J Med 2009;360: (p = NS for all comparisons) Rosuvastatin (n = 1,391) Placebo (n = 1,384)

6 EARLY ACS Death, MI, revascularization, or thrombotic bailout at 96 hours: 9.3% with upstream eptifibatide vs. 10.0% with provisional eptifibatide (p = 0.23) Death or MI at 30 days: in 11.2% vs. 12.3% (p = 0.08), respectively TIMI major bleeding: 2.6% vs. 1.8% (p = 0.015), respectively Trial design: Patients with NSTE ACS were randomized to upstream eptifibatide and 18- to 24-hour infusion (n = 4,722) versus upstream placebo and provisional eptifibatide immediately prior to PCI (n = 4,684). Results Conclusions Among patients with NSTE ACS treated with aspirin, clopidogrel, and heparin, there was no benefit to upstream eptifibatide compared with provisional use immediately prior to PCI Upstream use of eptifibatide increased major bleeding Giugliano RP, et al. N Engl J Med 2009;Mar 30:[Epub] (p = 0.23)(p = 0.015) Upstream eptifibatide Delayed provisional eptifibatide % Death, MI, revascularization, or thrombotic bailout TIMI major bleeding

7 FIX-HF-5 Anaerobic threshold responder analysis: 17.6% with treatment vs. 11.7% with control (p = 0.093) 2Peak VO 2 improved by 0.65 ml/kg/min with treatment (p = 0.024) Quality of life improved by -9.7 points with treatment (p < ) Trial design: Patients with NYHA III or IV heart failure and narrow QRS were randomized to cardiac contractility modulation plus optimal medical therapy (n = 215) vs. optimal medical therapy alone (n = 213). Results Conclusions Among patients with advanced heart failure, low ejection fraction, and narrow QRS, cardiac contractility modulation failed to improve the primary efficacy outcome, anaerobic threshold Cardiac contractility modulation did improve peak VO 2 and quality of life Presented by Dr. William Abraham at ACC.09/i2, Orlando, FL (p = 0.093) Cardiac contractility modulation Control % Anaerobic threshold responder analysis

8 GENIUS-STEMI MACE: 24% with endothelial progenitor cell stent vs. 10% with bare-metal stent (p = 0.03) TLR: 14% vs. 4% (p = 0.04), respectively Stent thrombosis: 6% vs. 0% (p = NS), respectively Trial design: Patients with STEMI were randomized to the endothelial progenitor cell capture stent (n = 50) vs. a cobalt-chromium BMS (n = 50). Follow-up was 6 months. Results Conclusions Among patients with STEMI, the endothelial progenitor cell capture stent was inferior to a cobalt-chromium bare-metal stent This experimental stent resulted in increased MACE, TLR, and stent thrombosis Presented by Dr. Pavel Cervinka at ACC.09/i2, Orlando, FL (p = 0.03)(p = NS) Endothelial progenitor cell capture stent Placebo % MACE Stent thrombosis

9 All-cause mortality Percent IRIS Index diagnosis was STEMI in 77% PTCA in 63%; no reperfusion in 25% All-cause mortality: 22.9% vs. 22.0%, p = 0.76 Significant reduction in sudden cardiac death and significant increase in nonsudden cardiac death with ICD implantation Trial design: This study evaluated ICD implantation early after MI in patients with low ejection fraction or other high-risk criteria. Results Conclusions ICD implantation within 31 days after MI did not improve mortality over 3-year follow-up Routine ICD implantation early after MI cannot be recommended at this time ICD (n = 445) No ICD (n = 453) Presented by Dr. Gerhard Steinbeck at ACC.09/i2, Orlando, FL (p = 0.76)

10 CK-MBTroponin-I % Patients NAPLES II CK-MB >3x ULN: 9.5% vs. 15.8%, p = 0.01 Troponin-I >3x ULN: 26.6% vs. 39.1%, p < Reduction in MI was greatest in patients with high CRP No difference in death, unplanned revascularization, or stent thrombosis Trial design: This study evaluated the effectiveness of an 80 mg loading dose of atorvastatin vs. placebo in reducing periprocedural MI in statin-naïve patients undergoing elective PCI. Results Conclusions Pretreatment with a loading dose of atorvastatin may reduce the incidence of postprocedure MI in statin-naïve patients undergoing PCI Whether a single loading dose of atorvastatin is superior to a more extended course prior to PCI remains unclear Presented by Dr. Carlo Briguori at ACC.09/i2, Orlando, FL Atorvastatin (n = 338) Placebo (n = 330) Cardiac enzyme elevation >3x ULN (p = 0.01)(p < 0.001)

11 OMEGA Sudden cardiac death: 1.5% for omega-3 fatty acids vs. 1.5% for control (p = 0.84) All-cause mortality: 4.6% vs. 3.7%, respectively MI: 4.5% vs. 4.1%, respectively Arrhythmic events: 1.1% vs. 0.7%, respectively Trial design: Patients who were 3-14 days out from an NSTEMI or STEMI were randomized to omega-3 fatty acids and standard medical therapy (n = 1,940) vs. standard medical therapy alone. Follow-up was 1 year. Results Conclusions Among patients with NSTEMI or STEMI, omega-3 fatty acids did not reduce the primary outcome, sudden cardiac death Omega-3 fatty acids also did not appear to change any of the secondary outcomes Presented by Dr. Jochen Senges at ACC.09/i2, Orlando, FL (p = 0.84) ω-3 fatty acidsControl % 1.5 Sudden cardiac death

12 PRIMA Number of days alive outside the hospital: 685 with NT-proBNP management vs. 664 with control (p = 0.49) Total mortality: 26.5% vs. 33.0% (p = 0.20), respectively Trial design: Patients admitted for worsening HF and whose NT-proBNP decreased during admission were randomized to NT-proBNP guided HF management (n = 174) vs. clinically guided management (n = 171). Results Conclusions Among patients admitted with decompensated HF, NT-proBNP guided therapy did not reduce the number of days alive outside the hospital or total mortality compared with clinically guided management Presented by Dr. Luc Eurlings at ACC.09/i2, Orlando, FL (p = 0.49) NT-proBNP management Clinical management days Days alive outside the hospital

13 PROTECT-AF CV death, stroke, or systemic embolism: 3.4 events per 100 pt-yrs with closure vs. 5.0 events per 100 pt-yrs with control (p for non-inferiority < 0.05) Hemorrhagic stroke: 1 vs. 6 (p for superiority < 0.05), respectively Composite safety outcome: 8.7 events per 100 pt-yrs vs. 4.2 events per 100 pt-yrs (p for superiority < 0.05), respectively Trial design: Patients with nonvalvular AF were randomized to percutaneous LA appendage closure with the Watchman device followed by discontinuation of warfarin in 45 days (n = 463) vs. continued warfarin therapy (n = 244). Results Conclusions In patients with nonvalvular AF, use of Watchman for LA appendage closure is feasible Device demonstrated noninferior composite efficacy, although worse composite safety due to pericardial effusion Presented by Dr. David Holmes at ACC09/i2, Orlando, FL (p for non- inferiority < 0.05) (p for superiority < 0.05) Watchman Warfarin therapy Events per 100 pt-years Composite efficacy Composite safety

14 REVIVAL-3 LVEF at 6 months: 52% with erythropoietin vs. 52% with placebo (p = 0.91) Death: 1.5% vs. 2.9%, respectively MI: 2.9% vs. 1.4%, respectively Stroke 1.5% vs. 0%, respectively Stent thrombosis: 2.9% vs. 2.9%, respectively Trial design: After primary angioplasty, STEMI patients were randomized to intravenous erythropoietin (n = 68) vs. placebo (n = 70). Follow-up was 6 months. Results Conclusions Among STEMI patients treated with primary PCI, the use of high-dose erythropoietin did not improve LVEF at 6 months Adverse cardiac outcomes were similar between the two groups Presented by Dr. Ilka Ott at ACC.09/i2, Orlando, FL (p = 0.91) High-dose erythropoietin Placebo % 52 LVEF at 6 months

15 STICH Death or CV hospitalization: 58% vs. 59%, p = 0.90 No difference in quality of life, angina frequency, angina severity, or depression Increased cost with SVR + CABG ($70,717 vs. $56,122, p = 0.004) Trial design: This study evaluated CABG with and without SVR in patients with CAD and anterior-apical regional ventricular dysfunction. Results Conclusions Routine SVR in addition to CABG does not improve cardiovascular morbidity and mortality or quality of life compared to CABG alone Presented by Drs. Robert Jones & Daniel Mark at ACC.09/i DeathDeath or CV hospitalization % Patients CABG + SVR (n = 501) CABG (n = 499) (p = 0.98)(p = 0.90) 70

16 TIPS LDL lowering: mmol/L Heart rate lowering: -7.0 bpm Urinary 11-dehydrothromboxane B2 reduction: ng/mmol creatinine Blood pressure lowering: -7.4/5.6 mm Hg Trial design: This study evaluated the efficacy of the Polycap in controlling cardiac risk factors in patients at risk for CV disease. Results Conclusions The Polycap was well-tolerated and non- inferior to its individual components regarding blood pressure and heart rate lowering In terms of LDL cholesterol lowering and platelet inhibition, the Polycap did not achieve prespecified noninferiority criteria compared with simvastatin and aspirin alone TIPS Investigators. Lancet 2009;Mar 30:[Epub before print] Polycap (n = 412) HCTZ, atenolol, ramipril (n = 204) Systolic BP Diastolic BP (p < for noninferiority)

17 ZEST Death, MI, or TVR: 10.1% with ZES, 8.3% with SES, and 14.2% with PES (p = 0.25 for ZES vs. SES, p < for ZES vs. PES) TLR: 4.9% vs. 1.4% vs. 7.6% (p < for ZES vs. SES, p = for ZES vs. PES), respectively for ZES, SES, and PES Trial design: Patients with CAD undergoing PCI were randomized to ZES (n = 883), SES (n = 878), or PES (n = 884). Follow-up was 12 months. Results Conclusions Among patients with CAD, including a lot of ACS, zotarolimus resulted in similar adverse cardiac events compared with sirolimus, although less events compared with paclitaxel Lowest TLR observed with sirolimus intermediate with zotarolimus, and highest with paclitaxel Presented by Dr. Seung-Jung Park at ACC09/i2, Orlando, FL ZESSES % Death, MI, or TVRTLR PES


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