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VBWG Role of RAAS Modulation: Recent Clinical Trials • CAD • Diabetes • ACEIs and ARBs Benefit of ACE inhibition in CAD Post-MI, HF, LVEF <40% SOLVD SAVE AIRE TRACE SOLVD (prev) VBWG HOPE High risk EUROPA All CAD patients Bertrand ME. Curr Med Res Opin. 2004;20:1559-69. VBWG EUROPA: EUropean trial on Reduction Of cardiac events with Perindopril in stable coronary Artery disease Objective: Assess effects of the ACEI perindopril on CV risk in a broad-spectrum population with stable CAD and without HF Design: N = 12,218, age ≥18 years, with CAD/without HF at randomization Treatment: Perindopril 8 mg or placebo Follow-up: 4.2 years Primary outcome: CV death, nonfatal MI, cardiac arrest EUROPA Investigators. Lancet. 2003;362:782-8. EUROPA: Baseline characteristics Perindopril (%) (n = 6110) Placebo (%) (n = 6108) Female History of CAD – MI – PCI – CABG Documented CAD – Angiographic evidence (stenosis >70% ) 14.5 100 64.9 29.0 29.3 14.7 100 64.7 29.5 29.4 60.4 60.5 – Positive stress test (in men w/chest pain) History of stroke/TIA PVD Hypertension Diabetes Hypercholesterolemia 22.6 23.3 3.4 7.1 27.0 11.8 63.3 3.3 7.4 27.2 12.8 63.3 VBWG EUROPA Investigators. Lancet. 2003;362:782-8. EUROPA: Concomitant medications Baseline (%) 3 Years (%)* Platelet inhibitors 92 91 Beta-blockers 62 63 Lipid-lowering agents 58 69 Nitrates 43 NA Calcium channel blockers 32 NA 9 NA Diuretics *Concomitant medications recorded in 11,547 patients VBWG EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Primary outcome CV death, MI, cardiac arrest 14 RRR 20% (95% CI: 9%–29%) AR 8.0% vs 9.9% P = 0.0003 12 10 Primary outcome (%) Placebo Perindopril 8 mg 8 6 20% 14% 4 11% 2 P < 0.05 10% 0 P = 0.35 0 1 2 3 4 5 Time (years) AR = absolute risk (perindopril vs placebo) EUROPA Investigators. Lancet. 2003;362:782-8. Fox KM. Br J Cardiol. 2004;11:195-204. VBWG EUROPA: Effect of ACEI on fatal/nonfatal MI and HF hospitalizations Fatal and nonfatal MI 10 RRR 24% AR 5.2% vs 6.8% P < 0.001 8 Events (%) HF hospitalization RRR 39% AR 1.0% vs 1.7% P = 0.002 2.0 Placebo Placebo 1.5 Perindopril 8 mg 6 Perindopril 8 mg 1.0 4 0.5 2 0 0.0 0 1 2 3 4 5 Years AR = absolute risk (perindopril vs placebo) 0 1 2 3 4 5 Years EUROPA Investigators. Lancet. 2003;362:782–8. VBWG EUROPA: Benefit of ACEI on primary and secondary outcomes N = 12,218 Perindopril (%) (n = 6110) Placebo (%) (n = 6108) CV mortality, MI, cardiac arrest 8.0 9.9 Total mortality, MI, UA, cardiac arrest 14.8 17.1 CV mortality, MI 7.9 9.8 Total mortality 6.1 6.9 CV mortality 3.5 4.1 Fatal/nonfatal MI 5.2 6.8 Favors perindopril 0.5 Favors placebo 1.0 2.0 EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Benefit of ACEI on selected secondary outcomes N = 12,218 Perindopril (%) (n = 6110) Placebo (%) (n = 6108) Unstable angina 5.6 6.0 Cardiac arrest 0.1 0.2 Stroke 1.6 1.7 Revascularization 9.4 9.8 HF w/hospital admission 1.0 1.7 Favors perindopril 0.5 Favors placebo 1.0 2.0 EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Consistent benefits in predefined subgroups N = 12,218 Primary events (%) n Perindopril (n = 6110) Placebo (n = 6108) Male 10,439 8.2 10.1 Female 1779 6.9 8.8 Age (years) ≤55 3948 6.5 8.9 56–65 4439 6.9 8.1 ≥66 3831 10.7 12.9 0.5 Favors perindopril Favors placebo 1.0 2.0 EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Consistent benefits in predefined subgroups (continued) Primary events (%) n Perindopril (n = 6110) Placebo (n = 6108) Previous MI 7910 8.9 11.3 No previous MI 4299 6.4 7.3 Previous revascularization 6709 6.6 8.0 No previous revascularization 5509 9.6 12.2 Hypertension 3312 9.8 12.0 No hypertension 8906 7.3 9.1 Diabetes mellitus 1502 12.6 15.5 No diabetes mellitus 10,716 7.4 9.0 0.5 Favors perindopril Favors placebo 1.0 2.0 EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Benefit of perindopril was on top of recommended medications Primary events (%) Favors perindopril Placebo Perindopril (n = 6110) (n = 6108) Lipid-lowering drug No lipid-lowering drug 7.0 9.3 8.3 11.9 -blockers No -blockers 7.6 8.7 10.2 9.4 Calcium channel blockers No calcium channel blockers 9.9 7.1 11.7 9.0 0.5 Favors placebo 1.0 2.0 EUROPA Investigators. Lancet. 2003;362:782-8. VBWG EUROPA: Risk reduction with perindopril stratified by baseline systolic BP level N = 12,218 Baseline SBP (mm Hg) 0 <120 120 to <140 140 17 18 5 10 Primary endpoint relative risk reduction with perindopril (%) 15 20 25 No interaction between treatment and SBP: P = 0.464 30 35 40 39 Remme WJ. Circulation. 2004;110(suppl):III-628. VBWG EUROPA: Systolic BP reduction during run-in did not affect risk reduction during trial N = 12,218 12 10 RRR 20% n = 1841 n = 4263 n = 1804 n = 4303 8 Primary event (%) RRR 18% 6 4 2 0 SBP decrease during run-in Placebo Run in = 4 weeks when all patients received perindopril 8 mg No SBP decrease during run-in Perindopril Remme WJ. Circulation. 2004;110(suppl):III-628. EUROPA vs HOPE: Inclusion criteria EUROPA • Age ≥18 years • Females: 15% • No clinical HF • Documented CAD including – Previous MI, PCI/CABG – Angiographic evidence of CAD with/without previous coronary event – Positive stress test (men) VBWG HOPE • Age ≥55 years • Females: 27% • No HF or LV dysfunction • High-risk of CV events with history of – CAD, stroke, or peripheral vascular disease – Diabetes + ≥1 CV risk factor (hypertension, dyslipidemia, smoking, microalbuminuria) HOPE patients were at higher risk than EUROPA EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. EUROPA vs HOPE: Study populations Age, mean (yrs) BP (mm Hg) Known CAD (%) MI (%) PVD (%) Stroke/TIA (%) Revascularization (%) Diabetes (%) Hypertension (%) Hypercholesterolemia (%) EUROPA HOPE 60 66 137/82 139/79 100 65 7 3 58 12 27 63 80 53 43 11 44 39 47 66 VBWG EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. VBWG EUROPA vs HOPE: Event rates in placebo groups reflect differences in baseline risk 3.0 2.7 2.5 Annualized event rate in placebo groups (%) 2.0 1.8 1.5 1.5 1.0 1.0 0.5 0.0 CV mortality EUROPA Total mortality HOPE 80% higher annual rate of CV and total mortality in HOPE EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. EUROPA vs HOPE: Treatment more intensive in EUROPA than in HOPE VBWG Baseline medication 100 80 92 75 62 % 57 60 39 40 28 20 0 Antiplatelet drugs* Betablockers EUROPA *Mostly aspirin Lipidlowering drugs HOPE EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. EUROPA: Clinical implications • VBWG In optimally treated CAD patients, perindopril 8 mg significantly reduced – CV mortality + nonfatal MI + cardiac arrest: 20% – CV mortality + nonfatal MI: 19% – Fatal + nonfatal MI: 24% – Heart failure hospitalization: 39% • Benefits exhibited on top of recommended therapy (aspirin, -blockers, lipid-lowering agents) • Benefits consistent across all predefined subgroups • Baseline BP and changes in BP had no significant impact on outcome Treatment with perindopril should be considered in all CAD patients, including patients at low risk EUROPA Investigators. Lancet. 2003;362:782-8. Remme WJ. Circulation. 2004;110(suppl):III-628. VBWG PEACE: Prevention of Events with Angiotensin Converting Enzyme inhibition Objective: Assess effect of ACEI in patients with stable CAD and normal/slightly reduced LV function Design: N = 8290 randomized Treatment: Trandolapril 4 mg or placebo Follow-up: 4.8 years Primary outcome: CV death, nonfatal MI, CABG, PCI PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. VBWG PEACE: Primary outcome CV death, MI, CABG/PCI; N = 8290 30 4% Risk reduction HR 0.96 (0.88–1.06) P = 0.43 25 Placebo Trandolapril 4 mg 20 Patients (%) 15 10 5 0 0 1 2 3 4 5 6 Time (years) PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. VBWG EUROPA vs PEACE: Differences in compliance 3 Years 100 80 Patients (%) 93 81 74.5 68.6 60 40 20 0 On study ACEI EUROPA (perindopril 8 mg) At target ACEI dose PEACE (trandolapril 4 mg) EUROPA Investigators. Lancet. 2003;362:782-8. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. VBWG ACEI trials in CAD without HF: Primary outcomes 14 12 10 % 8 6 4 2 0 EUROPA 20% Risk reduction HR 0.80 (0.71–0.91) P = 0.0003 Placebo 15 % Perindopril 8 mg 1 2 3 Time (years) 4 Trandolapril 4 mg 10 2 3 Time (years) 50 4 All CV events 40 4% Risk reduction HR 0.96 (0.88–1.06) P = 0.43 1 QUIET Placebo 25 % 4% Risk increase HR 1.04 (0.89–1.22) P = 0.6 30 20 Quinapril 20 mg Placebo 10 5 0 Ramipril 10 mg 5 0 CV death/MI/CABG/PCI 30 15 22% Risk reduction HR 0.78 (0.70–0.86) P < 0.001 10 5 PEACE 20 Placebo CV death/MI/stroke 0 0 % HOPE 20 CV death/MI/cardiac arrest 0 1 2 3 4 Time (years) 5 6 0 1 2 Time (years) 3 HOPE Study Investigators. N Engl J Med. 2000;342:145-53. EUROPA Investigators. Lancet. 2003;362:782-8. Pitt B et al. Am J Cardiol. 2001;87:1058-63. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. ACEI trials in CAD patients without HF: Key baseline characteristics EUROPA N Follow-up (yrs) ACEI/dose (mg) Age (yrs) Men (%) CAD/Cor rev (%) Diabetes (%) Hypertension (%) Prior MI (%) Ejection fraction (%) PVD (%) 12,218 4.2 P-8 60 85 100/55 12 27 65 NA 7 VBWG HOPE PEACE QUIET 9297 4.5 R-10 66 73 80/44 39 47 53 NA 43 8290 4.8 T-4 64 82 100/72 17 46 55 58 NA 1750 2.3 Q-20 58 82 100/100 16 47 49 59 NA EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. Pitt B et al. Am J Cardiol. 2001;87:1058-63. VBWG EUROPA, HOPE, PEACE, QUIET: Totality of trial evidence Event rate (%) ACEI All-cause death 7.5 Placebo Favors ACEI Favors placebo P 0.0004 8.9 0.86 MI 6.4 Stroke 2.1 Revascularization 15.5 7.7 0.0004 0.86 2.7 0.0004 0.77 16.3 0.025 0.93 0.5 0.75 1 1.25 Odds ratio Pepine CJ, Probstfield JL. Vasc Bio Clin Pract. CME Monograph; UF College of Medicine. 2004;6(3). VBWG EUROPA, HOPE, PEACE, QUIET: CV therapies at entry/during study EUROPA HOPE PEACE QUIET Antiplatelet agents (%) 92 76 91 73 -Blockers (%) 62 40 60 26 Lipid-lowering agents (%) 58/69* 29/49† 70 0/14† Calcium antagonists (%) 31 47 36 0/7† Diuretics (%) 9 15 13 NA *at 3 yrs †at study end EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. Pitt B et al. Am J Cardiol. 2001;87:1058-63. VBWG ACEI outcome trials in CAD patients without HF: BP at entry/during study EUROPA HOPE PEACE QUIET At entry 137/82 139/79 133/78 123/74 BP in ACEI group 128/78* 136/76† 129/74‡ NA 5/2 3.3/1.2 3/1.2 NA BP (mm Hg) Difference in mean BP during follow-up (ACEI vs placebo) *Run-in BP maintained during study †at study end ‡at 3 years EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. Pitt B et al. Am J Cardiol. 2001;87:1058-63. VBWG HOPE, EUROPA, PEACE, QUIET: Differences in baseline CV risk 3.0 2.0 Annualized event rate in placebo group (%/yr) 1.0 2.7 2.0 1.8 1.5 1.1 1.0 0.8 0.7 0.0 CV death HOPE Nonfatal MI EUROPA PEACE QUIET HOPE Study Investigators. N Engl J Med. 2000;342:145-53. EUROPA Investigators. Lancet. 2003;362:782-8. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. Pitt B et al. Am J Cardiol. 2001;87:1058-63. EUROPA, HOPE: Consistent benefit of ACEI on CV outcomes Event rate (%) ACEI Placebo 14.0 17.8 8.0 9.9 CV mortality 6.1 3.5 8.1 4.1 Myocardial infarction 9.9 4.8 12.3 6.2 Stroke 3.4 1.6 4.9 1.7 0.8 1.3 0.1 0.2 Composite outcome Cardiac arrest VBWG Favors Favors ACE inhibitor Placebo HOPE (ramipril 10 mg) EUROPA (perindopril 8 mg) 0.5 1.0 Hazard ratio 1.5 EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. VBWG Should all patients with stable CAD without HF receive an ACEI? Interpreting evidence • Totality of clinical trial evidence supports ACEI for treatment of stable CAD patients with/without HF • Benefits have been shown in patients at all levels of risk • All ACEIs may not have comparable effects for all indications • Consider evidence and guidelines in selection of an ACEI and dose. • Both ramipril and perindopril reduce risk of CV events in stable CAD patients without HF – Ramipril 10 mg has proven efficacy in CAD patients ≥55 yrs – Perindopril 8 mg has proven efficacy in CAD patients ≥18 yrs Pitt B. N Engl J Med. 2004;351:2115-7. EUROPA Investigators. Lancet. 2003;362:782-8. HOPE Study Investigators. N Engl J Med. 2000;342:145-53. PEACE Trial Investigators. N Engl J Med. 2004;351:2058-68. VBWG Evidence-based medicine: Updated guide-lines for ACEI in CAD patients without HF “ACE inhibitors should be used as routine secondary prevention for patients with known CAD, particularly in diabetics without severe renal disease.” . . . R.J. Gibbons et al. “The HOPE trial…confirms that the ACE inhibitor ramipril reduced CV death, MI, and stroke in patients who were at high risk for, or had, vascular disease in the absence of heart failure.” . . . R.J. Gibbons et al. EUROPA “showed that an ACE inhibitor can have a vasculoprotective effect in patients at lower risk than those enrolled in the HOPE study.” . . . V. Snow et al. Gibbons RJ et al. 2002 ACC/AHA Practice Guidelines. www.acc.org; July 2005. Snow V et al. Ann Intern Med. 2004;141:562-7. ACP guidelines for ACEI in chronic stable angina or asymptomatic CAD VBWG • Symptomatic patients with chronic stable angina (Level of evidence: A) • Asymptomatic patients – CAD with systolic dysfunction (Level of evidence: A) – Diabetes with CAD (Level of evidence: A) – Diabetes without CAD (Level of evidence: B) Snow V et al. Ann Intern Med. 2004;141:562-7. PERSUADE: PERindorpil SUbstudy of coronary Artery disease and DiabEtes: The diabetic substudy of EUROPA Objective: VBWG Investigate the effect of long-term treatment with perindopril added to standard therapy on CV events in diabetic patients with CAD and without heart failure Population: N = 1502 with known diabetes at randomization Treatment: Perindopril 8 mg (n = 721) or placebo (n = 781) Follow-up: 4.2 years Daly CA et al. Eur Heart J. 2005;26:1369-78. VBWG PERSUADE: Primary outcome CV death, MI, cardiac arrest 20 RRR: 19% 95% CI: –7% to 38% P = 0.13 16 Placebo Perindopril 8 mg Cumulative 12 frequency (%) 8 4 0 0 1 2 3 4 5 Years from randomization Daly CA et al. Eur Heart J. 2005;26:1369-78. VBWG PERSUADE and EUROPA: Comparable outcomes Perindopril Placebo EUROPA n = 6110 n = 6108 PERSUADE n = 721 n = 781 RRR (%) CV mortality, nonfatal MI, cardiac arrest 488 91 603 121 20 19 Total mortality 375 73 420 93 11 15 CV mortality 215 47 249 60 14 16 Fatal and nonfatal MI 320 56 418 78 24 23 Non–Q-wave infarction 212 37 273 60 23 34 Stroke 98 18 102 23 4 15 Heart failure 63 13 103 26 39 46 Favors perindopril 0.5 1.0 EUROPA Favors placebo 2.0 PERSUADE Daly CA et al. Eur Heart J. 2005;26:1369-78. VBWG PERSUADE and MICRO-HOPE: Consistency of benefit Favors ACEI Favors placebo Primary outcome Total mortality MICRO-HOPE (N = 3577) CV mortality PERSUADE (N = 1502) All MI Stroke 0.2 0.4 0.6 0.8 1.0 1.2 1.4 1.6 1.8 Relative risk (95% CI) Daly CA et al. Eur Heart J. 2005;26:1369-78. HOPE Study Investigators. Lancet. 2000;355:253-9. PERSUADE: Clinical implications VBWG • Perindopril 8 mg once daily reduced CV events in patients with CAD and diabetes • Relative risk reduction in primary and secondary outcomes with perindopril was similar to EUROPA • Results extend the benefit of ACEI shown in MICRO-HOPE to a lower-risk population with diabetes and CAD Daly CA et al. Eur Heart J. 2005;26:1369-78. VBWG Are all ACEIs the same? Survival 1-year post-MI by ACEI at discharge N = 7512, Canadian pharmacy database 100 90 Unadjusted cumulative survival (%) Ramipril Perindopril n = 243 80 0 Reference = ramipril n = 905 Lisinopril n = 2201 Enalapril n = 2577 Quinapril n = 276 Fosinopril n = 889 Captopril n = 421 2 4 P < 0.001 log-rank 6 Months 8 10 12 Pilote L et al. Ann Intern Med. 2004;141:102-12. VBWG Multiple mechanisms of ACEI in atherosclerotic CVD Blood pressure lowering Cardioprotective effects Vasculoprotective effects • Direct antiatherogenic • Preload and afterload • Enhance endogenous fibrinolysis • LV mass • Inhibit platelet aggregation • Sympathetic stimulation • Antimigratory for mononuclear cells • Reperfusion injury • Matrix formation • Improved myocardial remodeling • Improve endothelial function Metabolic syndrome • Antioxidant • Lipid neutral • Anti-inflammatory • Improved glucose metabolism • Protection from plaque rupture • Improved arterial compliance and tone Lonn E et al. Eur Heart J. 2003;5(suppl):A43-8. Clinical trials of ARBs: CV outcomes Trial (year) Patients (Follow-up) Treatment BP VBWG CV outcomes LIFE (2002) Essential HTN N = 9193 (4.8 years) Losartan vs atenolol Similar VALUE (2004) Essential HTN, high CV risk N = 15,245 (4.3 years) Valsartan vs amlodipine Primary outcome similar Greater with at study end amlodipine (2.0/1.6 mm Hg) Trend favors amlodipine at 3 and 6 months Difficult to interpret due to BP difference HTN = hypertension 13% in primary outcome (CV death, MI, stroke) with ARB (P = 0.021) driven by 25% in stroke (P = 0.001) No difference in CV death/MI Dahlöf B et al. Lancet. 2002;359:995-1003. Julius S et al. Lancet. 2004;363:2022-31. VBWG LIFE: Effects of ARB vs -blockade on primary outcome and components N = 9193 with hypertension and ECG-LVH Primary composite endpoint (CV death/MI/stroke) Primary outcome components (Losartan vs atenolol) 16 12 Proportion of patients with first event (%) 10 Adjusted RR 13.0% P = 0.021 (losartan vs atenolol) Risk increase (%) 5 0 Losartan 4 0 18 30 Stroke 5 10 Risk reduction 15 (%) 20 0 6 CV death P = 0.491 Atenolol 8 MI 42 54 66 P = 0.206 25 P = 0.001 Time (months) LIFE = Losartan Intervention for Endpoint Reduction in Hypertension Dahlöf B et al. Lancet. 2002;359:995-1003. VALUE: Similar treatment effects on primary outcome at study end VBWG 14 Valsartan-based regimen 12 10 Proportion of patients with first event (%) 8 6 Amlodipine-based regimen 4 2 HR = 1.03; 95% CI 0.94–1.14; P = 0.49 0 0 6 12 18 24 30 36 42 48 54 60 66 Time (months) Julius S et al. Lancet. 2004;363:2049-51 VBWG VALUE: SBP and outcome differences during consecutive time periods Primary outcome Time interval (mos) All study 0–3 3–6 6–12 12–24 24–36 36–48 Study end ∆ SBP (mm Hg) Favors valsartan Myocardial infarction Favors amlodipine Favors valsartan Favors amlodipine 2.2 3.8 2.3 2.0 1.8 1.6 1.4 1.7 0.5 1.0 2.0 Odds ratio VALUE = Valsartan Antihypertensive Long-Term Use Evaluation 4.0 0.5 1.0 2.0 4.0 Odds ratio Julius S et al. Lancet. 2004;363:2022-31. VBWG Evidence of benefit: ACEI vs ARB ACE inhibitor ARB Heart failure √ √ Post-MI √ High CAD risk √ Diabetes √ √ Chronic kidney disease √ √ Recurrent stroke prevention √ High risk condition Evidence from clinical trials supports the use of ACEIs vs ARBs in a broader range of high-risk conditions JNC 7. JAMA. 2003;289:2560-72.