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AHA 2008 Clinical Trial Summary Slides

AHA 2008 Clinical Trial Summary Slides. APPROACH. Change in percent atheroma volume: -0.21% with rosiglitazone vs. 0.43% with glipizide (p = 0.12) Change in total atheroma volume: -3.9 mm 3 vs. 1.2 mm 3 (p = 0.04), respectively Death: 2.4% vs. 2.1%, respectively

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AHA 2008 Clinical Trial Summary Slides

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  1. AHA 2008 Clinical Trial Summary Slides

  2. APPROACH Change in percent atheroma volume: -0.21% with rosiglitazone vs. 0.43% with glipizide (p = 0.12) Change in total atheroma volume: -3.9 mm3 vs. 1.2 mm3 (p = 0.04), respectively Death: 2.4% vs. 2.1%, respectively Myocardial infarction: 2.1% vs. 1.8%, respectively Trial design: Diabetic patients were randomized to rosiglitazone titrated to 8 mg daily (n = 333) vs. glipizide titrated to 15 mg daily (n = 339). IVUS was performed at baseline and 18 months. Results (p = 0.12) 0.43 % -0.21 Conclusions • Among type 2 diabetic patients, the use of rosiglitazone does not reduce percent atheroma volume compared with glipizide • There was a reduction in total atheroma volume with rosiglitazone • CV outcomes were similar between groups Change in percent atheroma volume Rosiglitazone Glipizide Presented by Dr. Richard Nesto at AHA 2008

  3. ATLAS TIMI 46 No difference between rivaroxaban and placebo in the primary outcome (death, MI, stroke, severe ischemia) (HR 0.79, 95% CI 0.60-1.05, p = 0.10) ↓ in death, MI, stroke with rivaroxaban (p = 0.028) Dose-response curve for bleeding with rivaroxaban, especially in the setting of dual antiplatelet therapy (p < 0.001) (p = 0.10) (p = 0.028) Placebo (n = 1,160) Rivaroxaban (n = 1,166) Trial design: Patients with ACS were randomized to either rivaroxaban twice daily, once daily, or placebo. Clinical outcomes were compared at 6 months. Results 20 20 15 15 % % 10 10 7.0 Conclusions 5.6 5.5 5 3.9 5 • Rivaroxaban has reasonable efficacy compared with placebo in patients with ACS, with a higher bleeding risk • ATLAS TIMI 46 was a phase II clinical trial conducted to identify safe and effective doses of rivaroxaban to be used in the phase III trial 0 0 Primary outcome Death/MI/Stroke Presented by Dr. C. Michael Gibson at AHA 2008

  4. BACH In the group admitted with CHF, MR-proADM was associated with a higher prognostic efficacy than both BNP and NT-proBNP (p < 0.001 for both) Log MR-proADM was associated with a significant improvement in prognostic ability for 90-day mortality in the multivariate model (p < 0.001) (p < 0.001) BNP MR-proADM Trial design: BACH was a biomarker trial, which compared the prognostic accuracy of mid regional pro-Adrenomedullin (MR-proADM), BNP, and NT-proBNP for 90-day mortality in patients presenting to the emergency room with shortness of breath. Results 100 73.5 63.6 60.8 50 % Conclusions • The diagnostic ability of MR-proADM for CHF is unclear • Clinical utility of these findings is limited 0 Prognostic accuracy in CHF patients NT-proBNP Presented by Dr. Stefan Anker at AHA 2008

  5. BICC Viral load reduction or elimination was better in IFNB-1b groups compared with placebo (p = 0.048) NYHA class was similar at 24 weeks (p = 0.073), quality of life was better in IFNB-1b group (p = 0.032) No change in echo or hemodynamic parameters Serious adverse events were similar (p > 0.05) (p = 0.048) Placebo (n = 48) IFNB-1b (n = 95) Trial design: Patients with CVC were randomized to either high-dose (8 million IU), low-dose (4 million IU) IFNB-1b, or placebo. Outcomes were compared at 24 weeks. Results 40 32 % 20 17 Conclusions • IFNB-1b was associated with a nearly twofold increase in viral load reduction or elimination compared with placebo in patients with CVC • Results of phase III trial are awaited 0 Viral load reduction or elimination Presented by Dr. Heinz Peter Schultheiss at AHA 2008

  6. FIT Heart Percent change in LDL: -1.0% for special intervention vs. -2.0% for control (p = NS) HDL at follow-up: 58.7 mg/dl vs. 57.6 mg/dl (p = 0.01), respectively BMI at follow-up: 27.7 kg/m2 vs. 28.4 kg/m2 (p = 0.88), respectively Trial design: Family members of a hospitalized cardiac patient were randomized to a special intervention program for risk factor modification (n = 250) vs control (n = 251). Follow-up was 1 year. Results Percent change in LDL cholesterol % -1.0 Conclusions • Among family members of a hospitalized cardiac patient, a special intervention program is not more effective than a control program in lowering LDL cholesterol • Special intervention was associated with a slightly higher HDL, although similar BMI at follow-up -2.0 (p = NS) Special intervention program Control Mosca L, et al. Circ Cardiovasc Qual Outcomes 2008;1:98-106

  7. HF-ACTION No difference in mortality/hospitalizations between the two arms (HR 0.93, 95% CI 0.84-1.02, p = 0.13). On adjustment for other prognostic factors, was ↓ in exercise training arm (p = 0.03) CV mortality & CV hospitalizations (p = 0.14), 6-minute walk distance (p = 0.26) similar, but peak VO2 higher in the exercise training arm Serious side effects similar between the two arms (p = 0.26) (p < 0.0001) Usual care (n = 1,172) Exercise training (n = 1,159) Trial design: Patients with symptomatic systolic CHF on optimal medical therapy were randomized to either exercise training or usual medical care. Clinical outcomes were compared at 3 years. Results 1.0 20 15 0.7 13 12 m 10 0.5 ml/min/kg Conclusions 5 • Prescribed exercise training program in patients with systolic CHF safe and effective, when added on to optimal medical therapy • Strengthens current recommendations for exercise in CHF patients 0.1 0 0 Change in 6-minute walk distance Change in Peak VO2 Presented by Dr. David Whellan at AHA 2008

  8. HF-ACTION Substudy Kansas City Cardiomyopathy Questionnaire score at follow-up: +5 points in the exercise group vs. +2 points in the usual care group (p = 0.001) Clinical improvement: 53% of the exercise group vs. 33% of the usual care group (p < 0.001) Trial design: Patients with CHF (NYHA II-IV) were randomized to an aerobic exercise training program (n = 1,159) vs. usual care (n = 1,172). Median follow-up was 2.5 years. Results (p = 0.001) 5 Points 2 Conclusions • Among patients with CHF due to LV systolic dysfunction, participation in an exercise program modestly improves health status compared with usual care • This benefit is seen early, within the first 3 months Change in Kansas City Cardiomyopathy Questionnaire at follow-up Exercise group Usual care Presented by Dr. Kathryn Flynn at AHA 2008

  9. I-PRESERVE No difference between irbesartan and placebo arms in the primary outcome (death/CV hospitalization) (HR 0.95, 95% CI 0.86-1.05, p = 0.35) Incidence of mortality (p = 0.98), worsening CHF (p > 0.05), change in NT-proBNP (p = 0.14) similar Most side effects similar, except ↑ risk of serious hyperkalemia with irbesartan (3% vs. 2%, p = 0.01) (p = 0.98) (p = 0.35) Placebo (n = 2,061) Irbesartan (n = 2,067) Trial design: Patients with heart failure and preserved ejection fraction (EF) were randomized to either irbesartan or placebo. Clinical outcomes were compared at 5 years. Results 100 20 15 % % 10.7 10.7 50 10 37.0 36.0 Conclusions 5 • Irbesartan was not associated with a reduction in CV mortality and morbidity in patients with heart failure and preserved EF • Results were similar to those for candesartan and perindopril 0 0 Primary outcome Mortality Massie BM, et al. N Engl J Med 2008;Nov 11:[Epub] Presented by Dr. Peter Carson at AHA 2008

  10. JPAD No difference between aspirin and nonaspirin group in the total atherosclerotic events (HR 0.80, 95% CI 0.58-1.10, p = 0.16) Significant ↓ in fatal coronary and cerebrovascular events (p = 0.0037) No difference in nonfatal MI (p = 0.5), hemorrhagic strokes (p = 0.48), mortality (p = 0.67) ↑ bleeding with aspirin, not statistically significant (p = 0.16) (p = 0.67) No aspirin (n = 1,277) Aspirin (n = 1,262) Trial design: Patients with type 2 diabetes and no prior coronary artery disease were randomized in an open-label fashion to either aspirin 81 or 100 mg daily or no aspirin. Clinical outcomes were compared at 5 years. Results 20 20 15 15 % % 10 10 6.7 Conclusions 5.4 5 5 3.0 2.7 • Findings suggest no reduction in total atherosclerotic events, but reduction in total coronary and cerebrovascular events with aspirin in diabetic patients • Findings need to be validated by other studies 0 0 Atherosclerotic events Mortality Ogawa H, et al. JAMA 2008;300:2134-41 Presented by Dr. Hisao Ogawa at AHA 2008

  11. JUPITER Rosuvastatin associated with a significant ↓ in the primary outcome of MI, stroke, unstable angina, revascularization, or cardiovascular death (HR 0.56, 95% CI 0.46-0.69, p < 0.00001) All-cause mortality ↓ with rosuvastatin (p = 0.02) Serious adverse effects were similar (p = 0.60) (p = 0.02) (p < 0.00001) Placebo (n = 8,901) Rosuvastatin (n = 8,901) Trial design: Apparently healthy patients with LDL cholesterol <130 mg/dl and hs-CRP ≥2 mg/L were randomized to rosuvastatin 20 mg daily or placebo. Clinical outcomes were compared at a median of 1.9 years. Results 2 2 1.36 1.25 Events/100 person-years Events/100 person-years 1.0 Conclusions 1 1 0.77 • Rosuvastatin was associated with a significant reduction in major cardiovascular events, including death, in patients with LDL <130 mg/dl, but high hs-CRP (≥2.0 mg/L) • May require revision of current guidelines 0 0 Primary outcome All-cause mortality Ridker PM, et al. NEJM 2008;359:2195-207 Presented by Dr. Paul Ridker at AHA 2008

  12. PHS II Neither vitamin C nor vitamin E associated with a reduction in major cardiovascular events compared with placebo (p = 0.86, 0.91, respectively) No difference in individual outcomes studied No increase in adverse events, except increased hemorrhagic stroke with vitamin E (p = 0.04) (p = 0.86) (p = 0.91) Vit E n = 7,315 Vit C n = 7,329 Placebo n = 7,326 Placebo n = 7,312 Trial design: PHS II randomized healthy males in a factorial design to active vitamins E & C, active vitamin E & placebo vitamin C, placebo vitamin E & active vitamin C, & placebo vitamins E and C. Clinical outcomes were compared at 10 years. Results 20 20 % 10 % 8.5 8.5 8.6 10 8.4 Conclusions 0 • Vitamins C or E not helpful in the primary prevention of cardiovascular events in healthy patients • Confirms earlier studies with vitamin E; one of the first studies with vitamin C 0 Major cardiovascular events Sesso HD, et al. JAMA 2008;300:2123-33 Presented by Dr. J. Michael Gaziano at AHA 2008

  13. SEARCH No difference in the incidence of major vascular events between high- vs. low-dose simvastatin, or folate + vitamin B12 vs. placebo (p > 0.05 for both) No difference in individual outcomes studied ↑ risk of myopathy in high-dose vs. low-dose simvastatin arms (0.88% vs. 0.05%, p < 0.05) (p > 0.05) (p > 0.05) Trial design: A 2 x 2 factorial study in which patients with a recent MI were randomized to either simvastatin 80 mg or 20 mg daily, and folic acid + vitamin B12 or placebo. Patients were followed for a mean of 6.7 years. Results 50 50 % % 25.7 24.5 25.5 24.8 0 0 Conclusions Major vascular events • Neither high-dose (vs. low-dose) simvastatin nor folate + vitamin B12 (vs. placebo) effective in reducing major vascular events in patients with a recent MI • Statin data contrary to other trials on this topic, folate + vitamin B12 data similar Folate/ Vit B12 n = 6,033 Simvastatin 80 mg n = 6,031 Simvastatin 20 mg n = 6,033 Placebo n = 6,031 Presented by Dr. Rory Collins at AHA 2008

  14. TIMACS No difference in primary outcome (death, MI, stroke) between the two arms (HR 0.85, 95% CI 0.68-1.06, p = 0.15), except in high-risk patients (HR 0.65, 95% CI 0.48-0.88, p = 0.005) Death, MI, refractory ischemia ↓ in early invasive arm (p = 0.0002), due to ↓ in refractory ischemia (p < 0.0001); death (p = 0.81), stroke (p = 0.74) similar Major bleeding was similar (p = 0.53) (p = 0.15) (p = 0.81) Delayed invasive (n = 1,438) Early invasive (n = 1,593) Trial design: Patients with NSTEMI were randomized to an early (within 24 hours) or delayed (after 36 hours) invasive strategy. Clinical outcomes were compared at 6 months. Results 20 20 15 15 11.4 % % 9.7 10 10 Conclusions 6.0 4.9 5 5 • An early invasive strategy (within 24 hours) is not associated with harm compared with a delayed invasive strategy (after 36 hours) in patients with NSTEMI, and may be beneficial in high-risk patients • Significant reduction in refractory ischemia with an early invasive strategy 0 0 Primary endpoint Mortality Presented by Dr. Shamir Mehta at AHA 2008

  15. THINRS Death, stroke, or major bleeding: 7.9% per patient-year for self-testing vs. 8.9% per patient-year for conventional testing (p = 0.1) Death: 3.4% vs. 3.7%, respectively Major bleeding: 3.9% vs. 4.5%, respectively Trial design: Patients who required chronic anticoagulation were randomized to patient self INR testing (n = 1,465) vs conventional monthly INR testing (n = 1,457). Follow-up was 4.5 years. Results (p = 0.1) 8.9 7.9 % per patient-year Conclusions • Patient self-testing for INR monitoring does not reduce the composite outcome of death, stroke, or major bleeding • No signal for increased adverse events, such as major bleeding, with self-testing Death, stroke, or major bleeding Patient self INR testing Conventional INR testing Presented by Dr. Alan Jacobson at AHA 2008

  16. VASP-Guided PCI Stent thrombosis more frequent in the routine PCI arm compared with VASP-guided PCI (p = 0.03) MACE ↓ in the VASP-guided PCI arm (p < 0.001), mainly due to ↓ in MI (p = 0.01). Rates of cardiovascular death, urgent revascularization were similar (p = 0.06 for both) Bleeding rates were similar (p = 0.8) (p = 0.03) (p = 0.06) Routine PCI (n = 215) VASP-guided PCI (n = 214) Trial design: Patients undergoing nonemergent PCI, and a VASP index of ≥50% were randomized to either routine management, or VASP-guided further loading doses of clopidogrel until VASP index <50%. Clinical outcomes were compared at 30 days. Results 20 20 15 15 % % 10 10 Conclusions 4.7 • VASP-guided PCI, with an aim to reduce the VASP index below 50%, was associated with better outcomes in patients undergoing nonemergent PCI and VASP index ≥50% • Needs to be corroborated by other studies 5 5 1.8 0.5 0 0 0 Stent thrombosis CV death Presented by Dr. Frank Paganelli at AHA 2008

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