Are statins useful in aortic stenosis? Rome Cardiology Forum 2010

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1 Are statins useful in aortic stenosis? Rome Cardiology Forum 2010 Terje R. Pedersen Oslo, Norway

2 Aortic valve stenosis Virginia Commonwealth University, Department of Pathology *)Helsinki Ageing study, Cardiovascular Health Study Prevalence moderate - severe AS: 3-5% 75 years westernized societies* Photograph No from the Pathology Education Instructional Resource by the Department of Pathology, University of Alabama at Birmingham

3 ACC/AHA 2006 Guidelines for the management of patients with valvular heart disease Aortic stenosis HT: treat with appropriate antihypertensives There is no specific medical therapy for asymptomatic patients Circulation 2006

4 ESC Guidelines on the management of valvular heart disease 2007 Aortic stenosis Strongly recommended: Modification of atherosclerotic risk factors Heart failure when surgery contraindicated: Digitalis, diuretics, ACE-Inhibitors, A-II-B. BP-reduction Task Force: Eur Heart J 2007;28:

5 Association with atherosclerotic risk factors Study Year Associated factors Stewart et al (Cardiovascular Health Study Lindroos et al (Helsinki Ageing Study) 1997 Age, male, HT, Lp(a), LDL-C, smoke, height 1994 Horstkotte et al 1988 Wilmshurst et al 1997 Hyperlipidemia Deutscher et al 1984 Aronow et al 1987 TC>200 mg/dl, HDL<35 mg/dl, HT, DM Gahni et al 1998 HT, SBP, BMI, glucose, lipids Hoagland et al 1985 Mohler et al 1991

6 Degenerative Aortic Stenosis Risk Factors Age (double risk every 10 yrs) Male sex (double risk) Smoking (35% increased risk) Hypertension (20% increased risk) Elevated Lp(a) Elevated LDL-cholesterol Height Cardiovascular Health Study, JACC 1997;29:

7 Degenerative Aortic Stenosis Role of Inflammation Helske S et al. Curr Opin Lipidol. 2007;18(5):483-91

8 Valve histology vs anatomy Otto CM NEJM 2008;359:

9 Progression of Calcification by LDL-C Electron Beam Tomography 150 Annualized progression (%) LDL 3.36mmol/l LDL > 3.36mmol/l LDL 3.36mmol/l LDL > 3.36mmol/l Aortic valve calcification Coronary calcification Pohle K et al. Circulation 2001;104:

10 Change in EBT Aortic Valve Calcification Score (volumetric) AVC Change (% per year) p=0.006 No Statin Statin Shavelle DM et al. Lancet 2002;359:

11 Echocardiographic: Progression of Aortic Stenosis Over 21 Months 10 P=0.03 9,5 No statin Statin 0,00 Aortic Valve Area (cm 2 ) ,3 P=0.19 5,8-0,05 4 4,2-0,10-0,12 2-0, Peak Gradient (mm Hg) Mean Gradient (mm Hg) -0,20-0,19 Novaro GM et al. Circulation 2001;104:2205

12 The RAAVE Study Rosuvastatin Affecting Aortic Valve Endothelium Annualized Change Untreated Treated p-value Peak jet velocity (m/s/yr) 0,24 0, Aortic valve area (cm 2 /yr) Moura LM, et al. JACC 2007;49:554

13 SALTIRE Aortic Jet Velocity Cowell S et al. N Engl J Med 2005;352:

14 N= 1873 (Peak jet velocity: m/sec) Randomized Double-blind Placebo-controlled Follow-up: > 4 years

15 SEAS Study: Key Question Intensive cholesterol lowering: Will it slow the progression of aortic stenosis?

16 LDL-Cholesterol Intention to Treat Population 150 Placebo 125 Mean (mg/dl) ±SE EZ/Simva 10/40 mg Year

17 Primary Endpoint MCE 50 Intention to Treat Population Percentage of Patients With First Event Hazard ratio: 0.96, p=0.591 Placebo EZ/Simva 10/40 mg No. at Risk Placebo 0 EZ/Simva 10/40 mg Years in Study

18 2nd EP: 50 Aortic Valve Events Intention to Treat Population Percentage of Patients With First Event Hazard ratio: 0.97, p=0.732 Placebo EZ/Simva 10/40 mg No. at Risk 0 EZ/Simva 10/40 mg Placebo Years in Study

19 Aortic Valve Replacement 50 Intention to Treat Population Percentage of Patients With First Event Hazard ratio: 1.00, p=0.968 Placebo EZ/Simva 10/40 mg Years in Study No. at risk EZ/Simva 10/40 mg Placebo

20 Peak Aortic - Jet Velocity 0.75 Intention to Treat Population 0.60 Change from Baseline (m/sec) Mean (±SE) EZ/Simva 10/40 mg Placebo 0.00 Year 1 Year 2 Last Follow-up Time

21 Incidence of aortic valve events by baseline AS severity % 60 p= P=0.18 P=0.44 Placebo Simv+Eze 10 0 < >3.3 Aortic jet velocity m/sec

22 Major CV Events - Components Endpoints # of Events Placebo EZ/Simva ITT Population Hazard Ratio (95% CI) Major CV Events CV Death AVR CHF Nonfatal MI CABG PCI Hospitalized UAP Non hem. Stroke * *p=0.02 vs Placebo Favors EZ/Simva 10/40 mg Favors Placebo

23 2nd EP: 30 Ischemic CV Events Intention to Treat Population Percentage of Patients With First Event Hazard ratio: 0.78, p=0.024 Placebo EZ/Simva 10/40 mg Years in Study No. at risk EZ/Simva 10/40 mg Placebo

24 Coronary Artery Bypass Grafting (CABG) 30 Intention to Treat Population Percentage of Patients With First Event Hazard ratio: 0.68, p=0.015 Placebo EZ/Simva 10/40 mg No. at risk Years in Study EZ/Simva 10/40 mg Placebo

25 Lipid Components (LC) and ICE relationship Analysis of 1,570 SEAS patients Complete baseline JV data Baseline and 1-year LDL-C, HDL-C, and ApoB No ICE during first year Baseline JV tertiles with split points of 2.79 and 3.33 m/sec Relationship between Year-1 LC measurements (combined treatment groups) and time-to-ice (dependent variable) assessed totally and in JV tertiles by Cox model Mean treatment group differences in Year 1 LC were calculated to approximate observed average difference in LC exposure

26 Tertile Characteristics Variable Tertile 1 Tertile 2 Tertile 3 n= 534 n=514 n=522 Jet Vel. Range (m/s) < > 3.3 Jet Vel. Mean (m/s) Age Mean (years)

27 Mean LDL-C Levels at Baseline and Year 1 Combined Treatment Groups mmol/l 4 3,5 3 2,5 2 1,5 Baseline Year 1 1 0,5 0 Tertile 1 Tertile 2 Tertile 3

28 Incidence of ischemic events by baseline AS severity % 30 HR=1.10 p= HR= HR=0.54 p=0.004 p=0.033 Placebo Simv+Eze < >3.3 Aortic jet velocity m/sec

29 Endpoint Incidence from Year 1 onwards % AVR ICE Tertile 1 Tertile 2 Tertile 3

30 Distribution of first ICE % CABG AMI+UAP Other 10 0 Tertile 1 Tertile 2 Tertile 3

31 Hazard Ratios for ICE 1 SD Increase in Lipid Component at Year 1 HR (95% CI) LDL-C 1.52 *** ( ) Non-HDL-C 1.63 *** ( ApoB 1.66 *** ( ) TC/HDL-C 1.57 *** ( ) Tertile 1 Tertile 2 Tertile 3 HR (95% CI) 1.31 * ( ) 1.33 * ( ) 1.38 ** ( ) 1.29 * ( ) HR (95% CI) 1.05 ( ) 1.03 ( ) 1.08 ( ) 1.04 ( ) Interaction P *** p< ** P< 0.01 * P> 0.05 HR= hazard ratio; Interaction P: Wald test of product term between tertile number and lipoprotein component

32 ICE Reduction by LDL-C Lowering: SEAS vs CTT Proportional Reduction in Event Rate (SE) SEAS T1 Reduction in LDL-C (mmol/l) SEAS T2 SEAS T3

33 CONCLUSION Changes in lipid components predicted reductions in ICE as expected when patients with mild AS were treated with S+E Changes in lipid components were not predictive of ICE in patients with severe AS, probably due to confounding of aortic valve related endpoints shorter exposure to therapy before endpoint

34 ASTRONOMER Aortic Stenosis Progression Observation: Measuring Effects of Rosuvastatin Randomized double-blind placebo-controlled 269 patients, peak jet velocity m/sec Rx: rosuvastatin 40 mg Follow-up: median 3.5 yrs (max ~ 6 yrs) Chan KL, et al. Circulation 2010;121:

35 ASTRONOMER: Lipoprotein changes Chan, K. L. et al. Circulation 2010;121: American Heart Association, Inc. Published by American Heart Association.

36 ASTRONOMER Peak gradient Aortic valve area Chan, K. L. et al. Circulation 2010;121: American Heart Association, Inc. Published by American Heart Association.

37 ASTRONOMER: Cardiac Death or Aortic Valve Replacement Chan, K. L. et al. Circulation 2010;121: American Heart Association, Inc. Published by American Heart Association.

38 Effect of baseline characteristics (age, AS severity, aortic valve calcification, and morphology) and treatment on progression of AS Chan, K. L. et al. Circulation 2010;121:

39 Conclusion Evidence from randomized clinical trials: Cholesterol lowering with statins and ezetemibe does not slow the progression of aortic stenosis It will reduce the risk of coronary disease in patients with AS

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