Clinical Trial Results. org RAAVE Luis M. Moura, MD; Sandra F. Ramos, MSc; José L. Zamorano, MD, PhD; Isabel M. Barros, MD; Luis F. Azevedo, MD; Francisco.

Slides:



Advertisements
Similar presentations
STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic.
Advertisements

Robert K Huff PharmD. Candidate May Objectives The study was designed to examine 3 main aspects Biochemical effects Safety Tolerability Evacetrapib.
Slide Source: Lipids Online Slide Library Pravastatin or Atorvastatin Evaluation and Infection Therapy (PROVE IT): Design Cannon CP.
The Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) The LIPID Study Group N Engl J Med 1998;339:
ACC 2015 Jae K. Oh, MD On Behalf of the US CoreValve Investigators Remodeling of Self-Expanding Transcatheter Aortic Valve Is Responsible for Regression.
Facts and Fiction about Type 2 Diabetes Michael L. Parchman, MD Department of Family & Community Medicine September 2004.
Clinical Trial Results. org Value of Lipoprotein Particle Number and Size as Predictors of Coronary Artery Disease in Apparently Healthy Men and Women:
Clinical Trial Results. org Statins, High-Density Lipoprotein Cholesterol, and Regression of Coronary Atherosclerosis Stephen J. Nicholls, MBBS, PhD; E.
Diabetes Trials Unit University of Oxford WebSite: Lipids in Diabetes Study.
University Medical Center Groningen Thrombus aspiration during primary PCI FZ Thrombus Aspiration during Percutaneous coronary intervention in Acute.
Department of Family & Community Medicine
Lipid Lowering Substudy Trial of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial JAMA 2002;288: ALLHAT- LLT.
Non-Surgical Periodontal Therapy Reduces Coronary Heart Disease Risk Markers: A Randomized Controlled Trial Bokhari SAH, Khan AA, Butt AK, Azhar M, Hanif.
Impact of Concomitant Tricuspid Annuloplasty on Tricuspid Regurgitation Right Ventricular Function and Pulmonary Artery Hypertension After Degenerative.
Fenofibrate Intervention and Event Lowering in Diabetes FIELDFIELD Presented at The American Heart Association Scientific Sessions, November 2005 Presented.
2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College.
BackgroundBackground HDL-C levels are inversely related to CV event rates. HDL-C levels are inversely related to CV event rates. Torcetrapib, a cholesteryl.
Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese (MEGA) Trial MEGA Trial Presented at The American Heart Association.
Combination Therapy for Hypertension Summary and Comment by Harlan M. Krumholz, MD, SM Published in Journal Watch Cardiology December 3, 2008Journal Watch.
Comparison of the Progression of Coronary Atherosclerosis for Two High Efficacy Statin Regimens with Different HDL Effects: SATURN Study Results SJ Nicholls,
High Versus Standard Clopidogrel Maintenance Dose After Percutaneous Coronary Intervention: Effects on Platelet Inhibition, Endothelial Function and Inflammation.
Laura Mucci, Pharm.D. Candidate Mercer University 2012 Preceptor: Dr. Rahimi February 2012.
Incremental Decrease in Clinical Endpoints Through Aggressive Lipid Lowering (IDEAL) Trial IDEAL Trial Presented at The American Heart Association Scientific.
Copyleft Clinical Trial Results. You Must Redistribute Slides HYVET Trial The Hypertension in the Very Elderly Trial (HYVET)
Randomized Trial of Ea rly S urgery Versus Conventional Treatment for Infective E ndocarditis (EASE) Duk-Hyun Kang, MD, PhD on behalf of The EASE Trial.
SATURN: Objective To compare the effects of rosuvastatin 40 mg versus atorvastatin 80 mg on progression of coronary atherosclerosis assessed by intravascular.
Jim Hoehns, Pharm.D.. Lancet 2013;382: Albers G et al. Chest. 2001; 119 (suppl): 300S. Ischemic stroke 85% Hemorrhagic stroke 15% Other 5% Cryptogenic.
Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 2 ARBITER-2 Trial Presented at The American Heart Association Scientific.
Clinical Trial Results. org SAGE Trial Prakash Deedwania, MD; Peter H. Stone, MD; C. Noel Bairey Merz, MD; Juan Cosin-Aguilar, MD; Nevres Koylan, MD; Don.
Federal Study of Adherence to Medications (FAME) Trial Presented at The American Heart Association Annual Scientific Session 2006 Presented by Dr. Allen.
Kimberly Dunbar, PA-S2 Follow-up of Cardiovascular Risk Markers in Hypertensive Patients Treated with Irbesartan: Results of the i-SEARCH Plus Registry.
Clinical Trial Results. org Anti-Inflammatory Effects of Pioglitazone and/or Simvastatin in High Cardiovascular Risk Patients With Elevated High Sensitivity.
Slide Source: Lipids Online Slide Library ASTEROID Population at Baseline (n=507) Patients Completing (n=349) Patients Not Completing.
BRIAN CLAYTON INTERNAL MEDICINE ADVISOR: ANNA MAE SMITH PRECEPTOR: DR. RAJESH PATEL Evidence Based Medicine Spring 2009.
Effect of on Oral Agent Inducing ApoA-I Synthesis on Progression of Coronary Atherosclerosis: Results of the ASSURE Study SJ Nicholls, CM Ballantyne, PJ.
Preoperative Hemoglobin A1c and the Occurrence of Atrial Fibrillation Following On-pump Coronary Artery Bypass surgery in Type-2 Diabetic Patients Akbar.
Clinical Trial Results. org METEOR Trial Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. John R.
Ridker PM, et al. Lancet 2009;373: Baseline clinical characteristics of the study population in the placebo and rosuvastatin groups according.
The JUPITER Trial Reference Ridker PM. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195–2207.
Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.
Clinical Trial Results. org Impact of Epicardial Anterior Fat Pad Retention on Postcardiothoracic Surgery Atrial Fibrillation Incidence: The AFIST-III.
Clinical Trial Results. org ILLUSTRATE Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Steven E.
Statins The AURORA Trial Reference Fellstrom BC. Rosuvastatin and cardiovascular events in patients undergoing hemodialysis. N Engl J Med. 2009;360. A.
Copyleft Clinical Trial Results. You Must Redistribute Slides ASTEROID Trial A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound-Derived.
Longest Follow-up After Implantation of a Self-Expanding Repositionable Transcatheter Aortic Valve: Final Follow-up of the Evolut R CE Study Stephen Brecker,
The American College of Cardiology Presented by Dr. Steven E. Nissen
Updates From NOTION: The First All-Comer TAVR Trial
Elevated Circulating Levels of Inflammatory Markers in
Baseline Characteristics of the Patients Part I
The American Heart Association Presented by Dr. Steven E. Nissen
First time a CETP inhibitor shows reduction of serious CV events
SPIRE Program: Studies of PCSK9 Inhibition and the Reduction of Vascular Events Unanticipated attenuation of LDL-c lowering response to humanized PCSK9.
Oxford Niacin Trial.
FATS- Familial Atherosclerosis Treatment Study
The ASSERT Study.
Late Follow-Up from the PARTNER Aortic Valve-in-Valve Registry
Neil J. Stone et al. JACC 2014;63:
The following slides highlight a report on a presentation at the Canadian Cardiovascular Congress held in Toronto, Ontario from October 24 to 29, 2003.
The Hypertension in the Very Elderly Trial (HYVET)
Figure 2 A patient with aortic stenosis and mitral regurgitation
Contemporary Evidence-Based Guidelines
These slides highlight a presentation from a Special Session of the Late-Breaking Clinical Trials sessions during the American College of Cardiology 2005.
LRC-CPPT and MRFIT Content Points:
Khurram Nasir et al. JACC 2015;66:
Stephen J. Nicholls, MBBS, PhD; E
Baseline Clinical Characteristics
PROSPER: trial design                                                                                                                                                                 
SPIRE Program: Studies of PCSK9 Inhibition and the Reduction of Vascular Events Unanticipated attenuation of LDL-c lowering response to humanized PCSK9.
James H O'Keefe, Jr et al. JACC 2004;43:
Section 6: Update on lipid treatment guidelines
Presentation transcript:

Clinical Trial Results. org RAAVE Luis M. Moura, MD; Sandra F. Ramos, MSc; José L. Zamorano, MD, PhD; Isabel M. Barros, MD; Luis F. Azevedo, MD; Francisco Rocha-Gonçalves, MD, PhD; Nalini M. Rajamannan, MD Published in the Journal of the American College of Cardiology February 6, 2007 Rosuvastatin Affecting Aortic Valve Endothelium to Slow the Progressions of Aortic Stenosis: RAAVE

Clinical Trial Results. org RAAVE: Background Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis.Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The objective of this study was to test the effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (Rosuvastatin) on the progression of moderate to severe aortic stenosis as measured by echocardiography.The objective of this study was to test the effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (Rosuvastatin) on the progression of moderate to severe aortic stenosis as measured by echocardiography. Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis.Recent retrospective studies support the hypothesis that statins slow the progression of aortic stenosis. The objective of this study was to test the effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (Rosuvastatin) on the progression of moderate to severe aortic stenosis as measured by echocardiography.The objective of this study was to test the effect of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (Rosuvastatin) on the progression of moderate to severe aortic stenosis as measured by echocardiography. Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Study Design  Primary Endpoint: Progression of aortic stenosis  Secondary Endpoint: Improvement in inflammatory (serum) markers and improvement in LDL cholesterol  Primary Endpoint: Progression of aortic stenosis  Secondary Endpoint: Improvement in inflammatory (serum) markers and improvement in LDL cholesterol Rosuvastatin (LDL > 130mg/dl) n=61 Rosuvastatin (LDL > 130mg/dl) n=61 Control Group (LDL < 130mg/dl) n=60 Control Group (LDL < 130mg/dl) n= patients presenting consecutively with moderate to severe aortic stenosis as defined by an aortic valve area between 1.0 and 1.5cm 2 Open-Label. Prospective. Follow-up every 6 months for 18 months Exclusion Criteria: Patients on angiotensin-converting enzyme inhibitors, coronary artery disease as measured by clinical history, echocardiographic evidence of rheumatic mitral valve disease, previous statin therapy, congenital heart disease (bicuspid aortic valve), subaortic obstruction, creatinine > 2.0 mg/dl, active or chronic liver disease, mild aortic regurgitation, and previous aortic valve surgery. 121 patients presenting consecutively with moderate to severe aortic stenosis as defined by an aortic valve area between 1.0 and 1.5cm 2 Open-Label. Prospective. Follow-up every 6 months for 18 months Exclusion Criteria: Patients on angiotensin-converting enzyme inhibitors, coronary artery disease as measured by clinical history, echocardiographic evidence of rheumatic mitral valve disease, previous statin therapy, congenital heart disease (bicuspid aortic valve), subaortic obstruction, creatinine > 2.0 mg/dl, active or chronic liver disease, mild aortic regurgitation, and previous aortic valve surgery. every 6 mos. for 18 mos. Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Baseline Characteristics Characteristic Statin Treated n=61Untreatedn=60p-value Age (yrs) 73.4 ± ± Men, n (%) 21 (34.4) 36 (60.0) Arterial Hypertension, n (%) 45 (73.8) 32 (53.3) Diabetes, n (%) 26 (42.6) 13 (21.7) Smokers, n (%) 0 (0) 4 (6.7) Total Cholesterol (mg/dl) ± ± 45.8 <0.001 Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Baseline Characteristics Characteristic Statin Treated n=61Untreatedn=60p-value HDL (mg/dl) 55.0 ± ± LDL (mg/dl) ± ± 20.9 <0.001 Peak Jet Velocity (m/s) 3.65 ± ± Peak Gradient (mm Hg) 54.7 ± ± Mean Gradient (mm Hg) 35.3 ± ± Aortic Valve Area (cm 2 ) 1.23 ± ± Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Primary Endpoint (Cont’d) Aortic Valve Area (cm 2 /yr) n = 60 Moura, et al. JACC 2007; 49(5): Peak Aortic Valve Velocity (m/s/yr) n =61 n = P=0.041 Control Treated n = 60 n =61 P=0.007 Data indicate a slowing of progression of aortic valve disease by echocardiography. Data indicate a slowing of progression of aortic valve disease by echocardiography.

Clinical Trial Results. org RAAVE: Primary Endpoint Characteristic Control Group Baseline Follow-Up P-Value Treated Group Baseline Follow-up p-value Peak Jet Velocity (m/s) 3.56 ± ± 0.62 < ± ± Peak Gradient (mm HG) 52.1 ± ± 19.4 < ± ± Mean Gradient 34.7 ± ± 14.7 < ± ± Aortic Valve Area 1.24 ± ± 0.35 < ± ± Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Secondary Endpoints Characteristic Control Group Baseline Follow-Up p-val Treated Group Baseline Follow-Up p-value Cholesterol (mg/dl) ± ± ± ± 31.6 <0.001 LDL (mg/dl) ± ± ± ± 21.1 <0.001 Triglycerides (mg/dl) ± ± ± ± HS-CRP (mg/l) 2.4 ( ) 1.9( ) ( )2.3( IL-612.5( )2.9( )< ( )2.9( )<0.001 sCD40L 2.01 ± ± 0.55 < ± ± 0.93 <0.001 HS-CRP=high-sensitivity C-reactive protein, IL-6=Interleukin 6, sCD40L=soluble cd40 ligand Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Secondary Endpoints (cont’d) Treated patients had lowering of all the serum markers: total cholesterol, LDL cholesterol, triglycerides, hsCRP, IL-6, and sCD40L.Treated patients had lowering of all the serum markers: total cholesterol, LDL cholesterol, triglycerides, hsCRP, IL-6, and sCD40L. Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Limitations This was a relatively small prospective trial that did not take into account timing of therapy and characteristics of the valve lesion.This was a relatively small prospective trial that did not take into account timing of therapy and characteristics of the valve lesion. Moura, et al. JACC 2007; 49(5):

Clinical Trial Results. org RAAVE: Summary The clinical, epidemiologic, and experimental evidence of this prospective study suggests that aortic valve stenosis progression can be slowed with the treatment of statins.The clinical, epidemiologic, and experimental evidence of this prospective study suggests that aortic valve stenosis progression can be slowed with the treatment of statins. The RAAVE study also suggests that earlier treatment with statins is more efficacious in the prevention of progression of aortic valve stenosis than late treatment.The RAAVE study also suggests that earlier treatment with statins is more efficacious in the prevention of progression of aortic valve stenosis than late treatment. The clinical, epidemiologic, and experimental evidence of this prospective study suggests that aortic valve stenosis progression can be slowed with the treatment of statins.The clinical, epidemiologic, and experimental evidence of this prospective study suggests that aortic valve stenosis progression can be slowed with the treatment of statins. The RAAVE study also suggests that earlier treatment with statins is more efficacious in the prevention of progression of aortic valve stenosis than late treatment.The RAAVE study also suggests that earlier treatment with statins is more efficacious in the prevention of progression of aortic valve stenosis than late treatment. Moura, et al. JACC 2007; 49(5):