Aortic Valve Stenosis: Medical Treatment, Still in the Pipeline?
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1 Aortic Valve Stenosis: Medical Treatment, Still in the Pipeline? Philippe Pibarot, DVM, PhD, FACC, FAHA, FESC, FASE Research Group in Valvular Heart Diseases Canada Research Chair in Valvular Heart Diseases Institut Universitaire de Cardiologie et de Pneumologie de Québec / Québec Heart & Lung Institute Université LAVAL
2 Disclosure: Philippe Pibarot Financial relationship with industry: Edwards Lifesciences: Echo CoreLab for PARTNER 2 SAPIEN 3, PARTNER 3, TAVR-UNLOAD, EARLY-TAVR trials V-Wave Ltd: Echo CoreLab for FIM Study Cardiac Phoenix: Echo CoreLab for BACE FIM Study Ionis Pharmaceuticals Other financial disclosure Foundation Grant, Canadian Institutes of Health Research Off label Use: None
3 The Changing Face of Aortic Stenosis Degenerative process as a result of wear and tear? AS shares many similarities (risk factors, mechanisms) with atherosclerosis AS: a potentially modifiable atherosclerotic disease? Hope for pharmacotherapy in AS: Statins!
4 Chan Circulation 121: , 2010 Effect of Statins on AS Progression: SALTIRE Randomized Trials SEAS Cowell, NEJM, 352: ,2005 ASTRONOMER Rossebo NEJM, 359: , 2008
5 Calcific AS has some similarities and some dissimilarities with atherosclerosis C Otto Circulation 1994 Dweck et al. JACC 2012
6 MetS is a Predictor of Faster Stenosis Progression: A Substudy of the ASTRONOMER Trial Progression rate of V Max (m.s -1.yr -1 ) 0,3 0,25 0,2 30% p = ,15 0,1 No MetS With MetS Capoulade et al. JACC 2012 ;60:216-23
7 Metabolic Abnormalities Linked to Visceral Obesity Predispose to Initiation and Progression of calcific AS Atherogenic dyslipidemia Insulin resistance Thrombotic state Inflammatory state Lifestyle Improvement Strategies From JAMA (2001) 285 :
8 Matrix Gla Protein Protects Against Ectopic Calcification: Effect of Diabetes Glu Glu Gla Gla Coagulation factor (inactive) Gamma-Glutamyl Carboxylase Coagulation factor (active) Vit KH 2 Vit K (diet) DT Diaphorase (mainly in liver) Vit KH 2 Vit K (recycled) KO reductase Vit KO Vit K K reductase MetS / Diabetes MetS / Diabetes Warfarin VKOR complex Glu Glu Vit KH 2 Gla Gla Inactive Glu MGP Gamma-Glutamyl Carboxylase MGP Gla Active Glu Glu Gla Gla
9 Patients with aortic sclerosis or mild/moderate AS were randomized to 2 mg VitK1 vs. placebo Brandenburg et al. Circulation 2017, 135:
10 atient with Mild AS and Rapid Progression during FU (B Stage) 57 y.o. man with mild calcific AS Baseline 2.5 years later V Peak : 2.3 m/s Peak/mean gradients: 22/12 mmhg AVA: 1.6 cm 2 Calcium score: 901 AU V Peak : 4.4 m/s (progression 0.8 m/s/yr) Peak/mean gradients: 77/44 mmhg AVA: 0.88 cm 2 Calcium score: 2007 AU Lipoprotein (a) level: 147 mg/dl
11
12 Association between LPA and Aortic Valve Calcification rs Thanassoulis G et al. N Engl J Med 2013;368: Genomewide significance prespecified = P<
13 Capoulade et al. J Am Coll Cardiol 2015;66: Lipoprotein(a) and AS Progression: Astronomer Trial B C D E
14 Lipoprotein(a) Oxidized Phospholipids and Calcific Aortic Stenosis Bouchareb et al. Circulation 2015
15 Rationale for Lipoprotein(a) Lowering in AS About 20% of the general population (65 Million people in North America) have elevated Lp(a) Lp(a) circulating levels are determined genetically and currently available drugs (Niacin) only achieve modest reduction in Lp(a) and have significant side effects Phase I and II trials report that oligonucleotide antisense directed to Apo(a), reduces Lp(a) levels by >80% with minimal side effects 1 in 7 cases of severe AS could be prevented by marked lowering of Lp(a) Tsimikas et al. Lancet 2015
16 Randomized Trial International Multicenter Randomized n=460 Asymptomatic Patients with mild/mod AS (V peak ) Lp(a)>50 mg/dl R ApoA OAS 40 mg/ month SC Placebo MDCT Progression of AS & AoV Ca by TTE, CT, and PET-CT (NaF) at 3 years Echo
17 Impact of ACEi and ARBs on AS Progression Rate Progression rate of Vmax (m.s -1.yr -1 ) Capoulade et al. Eur J Clin Invest. 2012
18 Impact of ACEi and ARBs on All-Cause Mortality
19 Women have less AoV calcification but more fibrosis compared to men Men Women Simard et al. Circ Res 2016
20 Breaking News!
21 Thériault S. Nature Comm. March 2018
22 A transcriptome-wide association study identifies PALMD (Palmdelphin) as a susceptibility gene for calcific AS rs ,009 AS Cases 1,017 Controls rs valves Thériault S. Nature Comm. March 2018
23 PALMD mrna expression levels in aortic valve tissues according to AS severity Thériault S. Nature Comm. March 2018
24 Replication in UK Biobank rs ,391 cases 352,195 Controls Thériault S. Nature Comm. March 2018
25 GWAS: 7,307 AS cases and 801,073 controls. Two new AS loci on chromosome 1p21 near PALMD (rs ; OR=1.20, P= ) on chromosome 2q22 in TEX41 (rs ; OR=1.15, P= ) Helgadotitr et al. Nature Comm. March 2018
26 PALMD: A New Susceptibility Gene in AS A new AS susceptibility gene, PALMD, was identified by 2 independent TWAS/GWAS studies The identified variants act by decreasing the expression of PALMD. PALMD is a mainly cytosolic protein, localized predominantly in actin filaments, and may be implicated in plasma membrane dynamics and cell shape control. PALMD is specific to AS and could be involved in the later stages of the disease
27 ATHEROSCLEROSIS Lp(a) lowering PCSK9 inhib. (statins) Lifestyle OSTEOBLASTIC DISEASE Lipid Deposition Lipid Oxidation Inflammation AORTIC STENOSIS Calcification Osteoblasts RunX2, BMP RANK/OPG Matrix Gla Prot Fetuin A ACE Inhibitors ARBs (ARBAS) Renin-Angiotensin System Valve fibrosis HYPERTENSION Bisphosphonates (SALTIRE2) RANK Antibodies (SALTIRE2) Vit K2 (BASIK2) PalmD? Adapted from Dweck et al. JACC 2012
28 Pharmacological Therapy for AS? Not yet but several promising targets have been identified and several RCTs are ongoing The «One drug fits all» will not work for AS Need to tailor therapy according to age, sex, and AS severity
29 Lp(a) lowering PCSK9i ARBs Anti-fibrotic therapy Bisphosphonates RANK Antibodies Vitamin K Younger patients Mild AS Women Older patients Men
30 The Team!
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