Results from Previous Trials

Results from Previous Trials

Cardiovascular Outcomes

ACCELERATE Evacetrapib and Cardiovascular Outcomes in High-Risk Vascular Disease 2017 NEJM Primary
  ADCY9 genetic variants and cardiovascular outcomes with evacetrapib in patients with high-risk vascular disease a nested case-control study 2018 JAMA Secondary
  Elevated Levels of the Neutrophil to Lymphocyte Ratio Predicts Incidence of Major Adverse Cardiovascular Events in High Risk Patients: Insights from ACCELERATE 2018 JACC Secondary
  Gender Specific Factors Associated with Major Cardiovascular Events: Insights from ACCELERATE 2018 JACC Secondary
  Prior Cornoary Artery Bypass Grafting and Incident Cardiovascular Events in the Setting of Contemporary Medical Therapy: Insights from ACCELERATE 2018 JACC Secondary
  Baseline fasting plasma insulin levels predict risk for major adverse cardiovascular events among patients with diabetes and high-risk vascular disease: Insights from the ACCELERATE trial 2019 Diab Vasc Dis Res Secondary
  Impact of Baseline Glycemic Control on Residual Cardiovascular Risk in Patients With Diabetes Mellitus and High‐Risk Vascular Disease Treated With Statin Therapy 2019 CIRC Secondary
  Plasma aldosterone levels are not associated with cardiovascular events among patients with high-risk vascular disease: Insights from the ACCELERATE trial 2019 JAHA Secondary
  The role of lipoprotein (a) as a marker of residual risk in patients with diabetes and established cardiovascular disease on optimal medical therapy: a post-hoc analysis of ACCELERATE 2019 Diabetes Care Secondary
PRECISION Cardiovascular Safety of Celecoxib, Naproxen, or Ibuprofen for Arthritis 2016 NEJM Primary
  Cardiorenal Risks of Celecoxib compared to Naproxen, or Ibuprofen in Arthritis Patients: A Sub-Analysis From The PRECISION trial 2017 EHJ Secondary
  Differential Blood Pressure Effects of Ibuprofen, Naproxen and Celecoxib in Patients with Arthritis: The PRECISION - ABPM (Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen Ambulatory Blood Pressure Measurement) Trial 2017 EHJ Secondary
  Gastrointestinal Events in Arthritis Patients at Increased Cardiovascular Risk Treated Chronically with Celecoxib, Naproxen or Ibuprofen: the PRECISION Randomized Controlled Trial 2017 Gastroenterology Secondary
  The Risk of Major NSAID Toxicity with Celecoxib, Ibuprofen or Naproxen: A Secondary Analysis of the PRECISION Randomized Controlled Clinical Trial 2017 Am J Med Secondary
  Acute pancreatitis with long-term celecoxib vs. ibuprofen or naproxen: data from the PRECISION trial 2018 AJG Secondary
  Effect of Aspirin Coadministration on the Safety of Celecoxib, Naproxen, or Ibuprofen 2018 JACC Secondary
  Gastrointestinal events in arthritis patients treated with celecoxib, ibuprofen or naproxen in the PRECISION trial 2018 AP&T Secondary
  The potential benefits of aspirin for primary cardiovascular prevention in rheumatoid arthritis: A secondary analysis of the PRECISION trial 2018 Rheumatology Secondary
LIGHT Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors. A Randomized Clinical Trial 2016 JAMA Primary
VISTA-16 Varespladib and Cardiovascular Events in Patients With an Acute Coronary SyndromeThe VISTA-16 Randomized Clinical Trial 2014 JAMA Primary
  Association of Initial and Serial C-Reactive Protein Levels With Adverse Cardiovascular Events and Death After Acute Coronary Syndrome. A Secondary Analysis of the VISTA-16 Trial 2019 JAMA Secondary
dal – Outcomes Effects of dalcetrapib in patients with a recent acute coronary syndrome 2012 NEJM Primary
TRACER Thrombin-Receptor Antagonist Vorapaxar in Acute Coronary Syndromes 2012 NEJM Primary

Thrombin Inhibition

CHOOSE - ON Bivalirudin during cardiopulmonary bypass in patients with previous or acute heparin-induced thrombocytopenia and heparin antibodies: results of the CHOOSE-ON trial 2014 Ann Thorac Surg Primary

Atherosclerosis Progression

SATURN Effect of two intensive statin regimens on progression of coronary disease 2011 NEJM Primary
  Factors underlying regression of coronary atheroma with potent statin therapy 2013 EHJ Secondary
  Long-term effects of maximally intensive statin therapy on changes in coronary atheroma composition: insights from SATURN 2014 EHJ Secondary
  Lipoprotein(a) and coronary atheroma progression rates during long-term high-intensity statin therapy: Insights from SATURN 2017 Atherosclerosis Secondary
  Lipoprotein(a) and coronary atheroma progression rates during long-term high-intensity statin therapy: Insights from SATURN 2017 Atherosclerosis Secondary
GLAGOV Effect of Evolocumab on Progression of Coronary Disease in Statin-Treated PatientsThe GLAGOV Randomized Clinical Trial 2016 JAMA Primary

Effect of Evolocumab on Coronary Plaque Composition 2018 JACC Secondary

Elevated CRP Levels do not Adversely Modulate the Ability of Evolucumab to Regress Coronary Atherosclerosis: Insights from GLAGOV 2018 JACC Secondary

Greater Likelihood of Regression of Coronary Atherosclerosis with the PCSK9 Inhibitor, Evolcumab, in Patients with Higher Lp(a) Levels 2018 JACC Secondary

Levels of Non-High-Density Lipoprotein Cholesterol do not Negatively Impact the Ability of the PCSK9 Inhibitor, Evolucumab, to Promote Regression of Coronary Atherosclerosis 2018 JACC Secondary

Sex-Related Difference in the Regression of Coronary Atherosclerosis with the PCSK9 Inhibitor, Evolucumab: Insights from GLAGOV 2018 JACC Secondary
GAUSS-3 Efficacy and Tolerability of Evolocumab vs Ezetimibe in Patients With Muscle-Related Statin IntoleranceThe GAUSS-3 Randomized Clinical Trial 2016 JAMA Primary
ASSURE Effect of the BET Protein Inhibitor, RVX-208, on Progression of Coronary Atherosclerosis: Results of the Phase 2b, Randomized, Double-Blind, Multicenter, ASSURE Trial 2015 Am J Card Drugs Primary
MILANO PILOT  Effect of infusion of high-density lipoprotein mimetic containing recombinant apolipoprotein a-i milano on coronary disease in patients with an acute coronary syndrome in the milano-pilot trial: A randomized clinical trial 2018 JAMA Primary
EAIF Effects of the CETP Inhibitor Evacetrapib Administered asMonotherapy or inCombination With Statins on HDL and LDL Cholesterol A Randomized Controlled Trial 2011 JAMA Primary
CARAT  Effect of Serial Infusions of CER-001, a Pre-β High-Density Lipoprotein Mimetic, on Coronary Atherosclerosis in Patients Following Acute Coronary Syndromes in the CER-001 Atherosclerosis Regression Acute Coronary Syndrome Trial 2018 JAMA Primary

Diabetes

ALECARDIO Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus The AleCardio Randomized Clinical Trial 2014 JAMA Primary
STAMPEDE Bariatric Surgery versus Intensive Medical Therapy in Obese Patients with Diabetes 2012 NEJM Primary
STAMPEDE Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 3-Year Outcomes 2014 NEJM Primary
STAMPEDE Bariatric Surgery versus Intensive Medical Therapy for Diabetes - 5-Year Outcomes 2017 NEJM Primary

Metabolic Effects of Bariatric Surgery in Patients With Moderate Obesity and Type 2 Diabetes 2013 Diabetes Care Secondary

Improved acylated ghrelin suppression at 2 years in obese patients with type 2 diabetes: effects of bariatric surgery vs standard medical therapy 2013 Int J Obesity Secondary

Effect of Bariatric Surgery Versus Intensive Medical Management on Diabetic Ophthalmic Outcomes 2015 Diabetes Care Secondary

Two‐year outcomes on bone density and fracture incidence in patients with T2DM randomized to bariatric surgery versus intensive medical therapy 2015 Obesity Secondary

Impact of Weight Loss Trajectory Following Randomization to Bariatric Surgery on Long-Term Diabetes Glycemic and Cardiometabolic Parameters 2019 Endocrine Practice Secondary

Heart Failure

ASCEND-HF Effect of Nesiritide in Patients with Acute Decompensated Heart Failure 2011 NEJM Primary
VALOR-HCM Myosin Inhibition in Patients With Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy 2022 JACC Primary

Device

WRAP-IT Antibacterial Envelope to Prevent Cardiac Implantable Device Infection 2019 NEJM Primary
PARTNER 2A Outcomes in 937 Intermediate-Risk Patients Undergoing Surgical Aortic Valve Replacement in PARTNER 2A 2017 ATS Primary
  The incidence and prognostic implications of worsening right ventricular function after surgical or transcatheter aortic valve replacement: insights from PARTNER IIA 2018 EHJ Secondary
  Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Prior Cardiac Surgery in the Randomized PARTNER 2A Trial 2018 JACC Secondary
  Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis 2016 Lancet Secondary
  Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Results From the PARTNER 2 Trial 2018 CIRC Secondary
  Inter- and intrasite variability of mortality and stroke for sites performing both surgical and transcatheter aortic valve replacement for aortic valve stenosis in intermediate-risk patients 2019 JTCS Secondary

Acute Myocardial Infarction

PROTECTION AMI Inhibition of delta-protein kinase C by delcasertib as an adjunct to primary percutaneous coronary intervention for acute anterior ST-segment elevation myocardial infarction: results of the PROTECTION AMI Randomized Controlled Trial 2014 EHJ Primary
  Cardiac troponin I for prediction of clinical outcomes and cardiac function through 3-month follow-up after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction 2015 AHJ Secondary
AEGIS-1 Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I) 2016 CIRC Primary
Highlighted Publications 2022

Highlighted Publications 2022

Cardiorenal risk of celecoxib compared with naproxen or ibuprofen in arthritis patients: insights from the PRECISION trial. European Heart Journal - Cardiovascular Pharmacotherapy (2022) 0, 1–11. https://pubmed.ncbi.nlm.nih.gov/35234840/
Structural and Functional Evaluation of Coronary Arteries Treated With ABSORB Bioresorbable Vascular Scaffold at 5-Year Follow-Up. Am J Cardiol. 2022 Sep 6:S0002-9149(22)00846-3. https://pubmed.ncbi.nlm.nih.gov/36075756/
Long-Term Intracoronary Structural and Vasomotor Assessment of the ABSORB Bioresorbable Vascular Scaffold. Am J Cardiol. 2022 Apr 1;168:55-63. https://pubmed.ncbi.nlm.nih.gov/35058053/
Myosin Inhibition in Patients With Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy. J Am Coll Cardiol. 2022 Jul 12;80(2):95-108. https://pubmed.ncbi.nlm.nih.gov/35798455/
Dose-Blinded Myosin Inhibition in Patients with Obstructive HCM Referred for Septal Reduction Therapy: Outcomes Through 32-Weeks. Circulation. 2022 Nov 6. https://pubmed.ncbi.nlm.nih.gov/36335531/
Myosin Inhibition and Left Ventricular Diastolic Function in Patients with Obstructive Hypertrophic Cardiomyopathy Referred for Septal Reduction Therapy: Insights from the VALOR-HCM Study. Circulation: Cardiovascular Imaging 2022. https://pubmed.ncbi.nlm.nih.gov/36335645/
Single Ascending Dose Study of a Short Interfering RNA Targeting Lipoprotein(a) Production in Individuals With Elevated Plasma Lipoprotein(a) Levels. JAMA. 2022 May 3;327(17):1679-1687. https://pubmed.ncbi.nlm.nih.gov/35368052/
Independence of clinical events committees: A consensus statement from clinical research organizations. Am Heart J. 2022 Jun;248:120-129. https://pubmed.ncbi.nlm.nih.gov/35296411/
HbA1c Coronary atheroma progression and cardiovascular outcomes. Am J Prev Cardiol. 2022 Jan 18;9:100317. https://pubmed.ncbi.nlm.nih.gov/35112095/
Longitudinal High-Sensitivity C-Reactive Protein and Longer-Term Cardiovascular Outcomes in Optimally-Treated Patients With High-Risk Vascular Disease. Am J Cardiol. 2022 Oct 15;181:1-8. https://pubmed.ncbi.nlm.nih.gov/35970631/
Effects of long-term testosterone treatment on cardiovascular outcomes in men with hypogonadism: Rationale and design of the TRAVERSE study. Am Heart J. 2022 Mar;245:41-50. https://pubmed.ncbi.nlm.nih.gov/34871580/
Effect of Evolocumab on Coronary Plaque Phenotype and Burden in Statin-Treated Patients Following Myocardial Infarction. JACC Cardiovasc Imaging. 2022 Jul;15(7):1308-1321. https://pubmed.ncbi.nlm.nih.gov/35431172/
Association of Bariatric Surgery With Cancer Risk and Mortality in Adults With Obesity. JAMA. 2022 Jun 28;327 (24):2423-2433. https://pubmed.ncbi.nlm.nih.gov/35657620/
Single Ascending Dose Study of a Short Interfering RNA Targeting Lipoprotein(a) Production in Individuals With Elevated Plasma Lipoprotein(a) Levels. JAMA. 2022 May 3;327(17):1679-1687. https://pubmed.ncbi.nlm.nih.gov/35368052/
Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Gastric Bypass, Sleeve Gastrectomy, and Usual Care. Cardiovascular Diabetes Care 2021;44:2552-2563. Diabetes Care. 2022 May 1;45(5):e101. https://pubmed.ncbi.nlm.nih.gov/34503954/
Long-Term Cardiovascular Outcomes After Bariatric Surgery in the Medicare Population. J Am Coll Cardiol. 2022 Apr 19;79(15):1429-1437. https://pubmed.ncbi.nlm.nih.gov/35422238/
Determinants of Plaque Progression Despite Very Low Low-Density Lipoprotein-Cholesterol Levels With the PCSK9 Inhibitor, Evolocumab. JACC Cardiovasc Imaging. 2022 Apr;15(4):709-711. https://pubmed.ncbi.nlm.nih.gov/34922870/
Treatment and prevention of lipoprotein(a)-mediated cardiovascular disease: the emerging potential of RNA interference therapeutics. Cardiovasc Res. 2022 Mar 25;118(5):1218-1231. https://pubmed.ncbi.nlm.nih.gov/33769464/
Association of Weight Loss Achieved Through Metabolic Surgery With Risk and Severity of COVID-19 Infection. JAMA Surg. 2022 Mar 1;157(3):221-230. https://pubmed.ncbi.nlm.nih.gov/34964827/
Plaque microstructures during metformin therapy in type 2 diabetic subjects with coronary artery disease: optical coherence tomography analysis. Cardiovasc Diagn Ther. 2022 Feb;12(1):77-87 https://pubmed.ncbi.nlm.nih.gov/35282660/
Comparative Effects of Low-Dose Rosuvastatin, Placebo and Dietary Supplements on Lipids and Inflammatory Biomarkers. J Am Coll Cardiol. Nov 06, 2022. https://pubmed.ncbi.nlm.nih.gov/36351465/
Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction. Circulation: Arrhythmia and Electrophysiology, Oct 2022; 15(11). https://pubmed.ncbi.nlm.nih.gov/36306341/
Lipoprotein (a) levels in a global population with established atherosclerotic cardiovascular disease. Open Heart. 2022 Oct 1;9(2):e002060. https://pubmed.ncbi.nlm.nih.gov/36252994/
Diabetes Remission in the Alliance of Randomized Trials of Medicine Versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D). Diabetes Care 7 July 2022; 45 (7): 1574–1583. https://pubmed.ncbi.nlm.nih.gov/35320365/
Cardiorenal Risk of Celecoxib compared to Naproxen, or Ibuprofen in Arthritis Patients: Insights from the PRECISION trial. European Heart Journal-Cardiovascular Pharmacotherapy. 2022 Mar 2. https://pubmed.ncbi.nlm.nih.gov/35234840/
Postimplant Phosphodiesterase Type 5 Inhibitor Use in Centrifugal Flow Left Ventricular Assist Devices. JACC: Heart Failure, 10(2), 89-100 Feb 2022. https://pubmed.ncbi.nlm.nih.gov/35115092/
HbA1c, Coronary Atheroma Progression and Cardiovascular Outcomes. American Journal of Preventative Cardiology. 2022 Jan. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8790601/
Interleukin-1 Trap Rilonacept Improved Health-Related Quality of Life and Sleep in Patients With Recurrent Pericarditis: Results From the Phase 3 Clinical Trial RHAPSODY. J Am Heart Assoc. 2022; 11:e023252. https://pubmed.ncbi.nlm.nih.gov/36250662/
Risk factors for hematoma in patients undergoing cardiac device procedures: A WRAP-IT trial analysis. Heart Rhythm O2, Vol 3, No 5, October 2022. https://pubmed.ncbi.nlm.nih.gov/36340491/
New Weight-Loss Drugs Are Poised to Upend Preventive Cardiology Care in Patients With Obesity and Overweight: Two major trials promise key progress against the last unaddressed major risk factor. Consult QD, Dec. 19, 2022 / Heart, Vascular and Thoracic / Preventive Cardiology.https://consultqd.clevelandclinic.org/new-weight-loss-drugs-are-poised-to-upend-preventive-cardiology-care-in-patients-with-obesity-and-overweight/