Highlighted Publications 2024

Highlighted Publications 2024

Single Ascending and Multiple-Dose Trial of Zerlasiran, a Short Interfering RNA Targeting Lipoprotein(a): A Randomized Clinical Trial Steven E. Nissen, Kathy Wolski, Gerald F. Watts, Michael J. Koren, Henry Fok, Stephen J. Nicholls, David A. Rider, Leslie Cho, Steven Romano, Carrie Melgaard, Curtis Rambaran
JAMA. 2024 May14;331(18):1534-1543
CLEAR Outcomes- (secondary pub)
Impact of Bempedoic Acid on Total Cardiovascular Events A Prespecified Analysis of the
CLEAR Outcomes Randomized Clinical Trial. 
Stephen J. Nicholls, MBBS, PhD; Adam J. Nelson, MBBS, PhD; A. Michael Lincoff, MD; Danielle Brennan, MS; Kausik K. Ray, MD, MPhil; Leslie Cho, MD; Venu Menon, MD; Na Li, PhD; LeAnne Bloedon, MS; Steven E. Nissen, MD. JAMA Cardiol. January 17, 2024. doi:10.1001/jamacardio.2023.5155 https://jamanetwork.com/journals/jamacardiology/article-abstract/2813647
TRAVERSE – (secondary pub)
Testosterone Treatment and Fractures in Men with Hypogonadism.
Snyder PJ, Bauer DC, Ellenberg SS, Cauley JA, Buhr KA, Bhasin S, Miller MG, Khan NS, Li X, Nissen SE. N Engl J Med. 2024 Jan 18;390(3):203-211. doi:10.1056/NEJMoa2308836. PMID: 38231621 https://www.nejm.org/doi/10.1056/NEJMoa2308836
Male Sex is Associated with Worse Right Ventricular Function and Survival in Pulmonary Hypertension in the PVDOMICS Cohort.  Nicholas J. Shelburne, Hui Nian, Gerald J. Beck, Nancy G. Casanova, Ankit A. Desai, Hilary M. DuBrock, Serpil Erzurum, Robert P. Frantz, Paul M. Hassoun, Nicholas S. Hill, Evelyn M. Horn, Miriam S. Jacob, Christine L. Jellis, Elizabeth Joseloff, Deborah H. Kwon, A. Brett Larive, Jane A. Leopold, Margaret M. Park, Franz P. Rischard, Erika B. Rosenzweig, Rebecca R. Vanderpool, Chang Yu, Anna R. Hemnes, and the PVDOMICS Study Group. 15 February 2024 https://doi.org/10.1016/j.chpulm.2024.100046https://www.chestpulmonary.org/article/S2949-7892(24)00012-6/pdf

AEGIS-II
Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction

C. Michael Gibson, MD, Danielle Duffy, MD, Serge Korjian, MD, M. Cecilia Bahit, MD, Gerald Chi, MD, John H. Alexander, MD, MHS, A. Michael Lincoff, MD for the AEGIS-II Committees and Investigators.
New England Journal of Medicine April 6, 2024

TACTiC
A Technology-Assisted Web Application for Consumer Access to a Nonprescription Statin Medication
Steven E. Nissen, Howard G. Hutchinson, Kathy Wolski, Karol Watson, Seth S. Martin, Erin D. Michos, William S. Weintraub, Melanie Morris, Leslie Cho, Luke Laffin, Douglas Jacoby, Christie M. Ballantyne, Jan Ekelund, Filip Birve, Venu Menon, Michelle Strzelecki, and Paul M. Ridker
J Am Coll Cardiol. Apr 08, 2024 

CSL300_2301 Phase 2b publication, Clazakizumab
IL-6 inhibition with Clazakizumab in patients receiving maintenance dialysis: a randomized phase 2b trial.

Glenn M. Chertow, Anna Marie Chang, G. Michael Felker, Mark Heise, Elena Velkoska, Bengt Fellström, David M. Charytan, Regina Clementi, C. Michael Gibson, Shaun G. Goodman, Meg Jardine, Adeera Levin, Yuliya Lokhnygina, Jenny Mears, Roxana Mehran, Peter Stenvinkel, Angela Wang, David C. Wheeler, Carmine Zoccali, Paul M. Ridker, Kenneth W. Mahaffey, Pierluigi Tricoci & Myles Wolf. Nature Medicine 30,2328-2336, (2024).

VALOR-HCM
Mavacamten in Obstructive Hypertrophic Cardiomyopathy Patients Referred for Septal Reduction: Health Status Analysis Through Week 56 in VALOR-HCM Trial

Milind Y Desai, Anjali Owens, Kathy Wolski, Jeffrey B Geske, Sara Saberi, Andrew Wang, Mark Sherrid, Paul C Cremer, Neal K Lakdawala, Albree Tower-Rader, David Fermin, Srihari S Naidu, Nicholas G Smedira, Hartzell Schaff, Ellen McErlean, Christina Sewell, Yue Zhong, Kathleen W Wyrwich, Kathy L Lampl, Amy J Sehnert, Steven E Nissen, John A Spertus; VALOR-HCM InvestigatorsJ Am Coll Cardiol.202410;84(11):1041-1045. 
CLEAR Outcomes
Impact of the COVID-19 Pandemic on Conduct and Results of CLEAR Outcomes Trial 

Abhayjit Singh , Luke J Laffin, Ashish Sarraju, A Michael Lincoff, Stephen J Nicholls, LeAnne Bloedon, William J Sasiela, Na Li, Paula Robinson, Stephanie Kelly, Denise Mason, Steven E Nissen. Clin Cardiol 2024 Aug;47(8):e24328.

 Design and Rationale of the V-Wave Shunt MitraClip Study Grant W Reed, Evan K Harmon, Serge Harb, James Yun, Amar Krishnaswamy, William T Abraham, Samir Kapadia
Am J Cardiol 2024 Sep 15:227:29-36. 
Highlighted Publications 2023

Highlighted Publications 2023

CLEAR Outcomes
Bempedoic acid and cardiovascular outcomes in statin-intolerant patients.
Nissen SE, Lincoff AM, Brennan D, Ray KK, Mason D, Kastelein JJ, Thompson PD, Libby P, Cho L, Plutzky J, Bays HE. New England Journal of Medicine. 2023 Apr 13;388(15):1353-64. https://www.nejm.org/doi/full/10.1056/NEJMoa2215024
CLEAR Outcomes
Bempedoic Acid for Primary Prevention of Cardiovascular Events in Statin-Intolerant Patients.

Nissen SE, Menon V, Nicholls SJ, Brennan D, Laffin L, Ridker P, Ray KK, Mason D, Kastelein JJ, Cho L, Libby P, Na Li, PhD6; JoAnne Foody, MD6; Michael J. Louie, MD, MPH, MSc6; A. Michael Lincoff, MD, JAMA. 2023; 330(2):131-140
https://jamanetwork.com/journals/jama/article-abstract/2806646

CLEAR Outcomes
Efficacy and safety of bempedoic acid among patients with and without diabetes: prespecified analysis of the CLEAR Outcomes randomised trial.

Kausik K Ray FMedSci, Stephen J Nicholls, PhD, Na Li, PhD, Michael J Louie, MD, Danielle Brennan, MS, A. https://www.thelancet.com/journals/landia/article/PIIS2213-8587(23)00316-9/fulltext

CLEAR Outcomes
Background ezetimibe use among participants in the CLEAR Outcomes trial.
Luke J. Laffin, Danielle Brennan, LeAnne Bloedon, Na Li, Steven E. Nissen. American Journal of Preventive Cardiology, Volume 15, Supplement, September 2023, 100551. https://www.sciencedirect.com/science/article/ pii/S2666667723000922 Michael Lincoff, MD, Steven E. Nissen, MD. Submitted to Lancet Diabetes
CLEAR Outcomes
Inflammation and Cholesterol as Predictors of Cardiovascular Events Among 13970 Contemporary High-Risk Patients With Statin Intolerance.
Paul M. Ridker, Lei Lei, Michael J. Louie, Tariq Haddad, Stephen J. Nicholls, A. Michael Lincoff, Peter Libby and Steven E. Nissen. 2023. https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.123.066213
ELEKT-D
Ketamine versus ECT for Nonpsychotic Treatment-Resistant Major Depression.
Anand A, Mathew SJ, Sanacora G, Murrough JW, Goes FS, Altinay M, Aloysi AS, Asghar-Ali AA, Barnett BS, Chang LC, Collins KA. New England Journal of Medicine. 2023 Jun 22;388(25):2315-25. https://www.nejm.org/doi/full/10.1056/NEJMoa2302399
TRAVERSE
Cardiovascular Safety of Testosterone-Replacement Therapy.
Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson Jr IM, Wang Q. New England Journal of Medicine. 2023 Jun 16. https://www.nejm.org/doi/full/10.1056/NEJMoa2215025
TRAVERSE
Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism.
Pencina KM, Travison TG, Cunningham GR, Lincoff AM, Nissen SE, Khera M, Miller MG, Flevaris P, Li X, Wannemuehler K, Bhasin S. J Clin Endocrinol Metab. 2023 Aug 17:dgad484. doi: 10.1210/clinem/dgad484
TRAVERSE
Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism. A Randomized Clinical Trial.
Karol M. Pencina, PhD; Thomas G. Travison, PhD; Andrew S. Artz, MD, MS; A. Michael Lincoff, MD4; Steven E. Nissen, MD; Panagiotis Flevaris, MD, PhD; Anna Chan, PharmD; Xue Li, PhD; Scott A. Diegel, MS; Kathleen Wannemuehler, PhD; Shalender Bhasin, MB, BS. JAMA Netw Open. 2023;6(10):e2340030. . https://jamanetwork.com/journals/jamanetworkopen/article-abstract/2811115
TRAVERSE
Testosterone Treatment and Fractures in Men with Hypogonadism.
Snyder PJ, Bauer DC, Ellenberg SS, Cauley JA, Buhr KA, Bhasin S, Miller MG, Khan NS, Li X, Nissen SE. N Engl J Med. 2024 Jan 18;390(3):203-211. doi: 10.1056/NEJMoa2308836. PMID: 38231621. https://www.nejm.org/doi/10.1056/NEJMoa2308836
Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials. Ridker PM, Bhatt DL, Pradhan AD, Glynn RJ, MacFadyen JG, Nissen SE; for the PROMINENT, REDUCE-IT, and STRENGTH Investigators. The Lancet. 2023 Apr 15;401(10384):1293-301. https://www.thelancet.com/journals/lancet/article/ PIIS0140-6736(23)00215-5/fulltext
VALOR
Dose-blinded myosin inhibition in patients with obstructive hypertrophic cardiomyopathy referred for septal reduction therapy: outcomes through 32 weeks.
Desai MY, Owens A, Geske JB, Wolski K, Saberi S, Wang A, Sherrid M, Cremer PC, Naidu SS, Smedira NG, Schaff H. Circulation. 2023 Mar 14;147(11):850-63. https://www.ahajournals.org/doi/epub/10.1161/ CIRCULATIONAHA.122.062534
VALOR
Improvement in Multi-Domain Patient-Reported Outcome Scores with Mavacamten Treatment in Obstructive Hypertrophic Cardiomyopathy: Insight from the VALOR-HCM Study.
Desai MY, Spertus JA, Owens AT, Geske JB, Wolski K, Saberi S, Wang A, Sherrid MV, Cremer P, Lakdawala NK, Fifer MA. Journal of the American College of Cardiology. 2023 Mar 7;81(8_Supplement):323-. https://www.jacc.org/doi/10.1016/S0735-1097%2823%2900767-2
VALOR
Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction: Week 56 Results From the VALOR-HCM Randomized Clinical Trial.
Desai MY, Owens A, Wolski K, Geske JB, Saberi S, Wang A, Sherrid M, Cremer PC, Lakdawala NK, Tower-Rader A, Fermin D. JAMA cardiology. 2023 Aug 28. https://jamanetwork.com/journals/jamacardiology/article-abstract/2809050#:~:text=Findings%20Results%20of%20A%20Study,56%2C%205%20of%2056%20patients%20
VALOR-HCM
Mavacamten in Patients With Hypertrophic Cardiomyopathy Referred for Septal Reduction Week 56 Results From the VALOR-HCM Randomized Clinical Trial.
Milind Y. Desai, MD, MBA; Anjali Owens, MD; Kathy Wolski, MPH; Jeffrey B. Geske, MD; Sara Saberi, MD, MS; Andrew Wang, MD; Mark Sherrid, MD; Paul C. Cremer, MD, MS; Neal K. Lakdawala, MD; Albree Tower-Rader, MD; David Fermin, MD; Srihari S. Naidu, MD; Nicholas G. Smedira, MD, MBA; Hartzell Schaff, MD; Ellen McErlean, RN, MSN; Christina Sewell, RN; Lana Mudarris, PharmD; Zhiqun Gong, MS; Kathy Lampl, MD; Amy J. Sehnert, MD; Steven E. Nissen, MD. JAMA Cardiol. 2023;8(10):968-977. doi:10.1001/jamacardio.2023.3342. https://jamanetwork.com/journals/jamacardiology/article-abstract/2809050
TARGET-HTN
Aldosterone Synthase Inhibition With Lorundrostat for Uncontrolled Hypertension. The Target-HTN Randomized Clinical Trial.
Laffin LJ, Rodman D, Luther JM, Vaidya A, Weir MR, Rajicic N, Slingsby BT, Nissen SE; for the Target-HTN Investigators. JAMA.2023;330(12):1140-1150.doi:10.1001/jama.2023.16029
Coronary atheroma regression with evolocumab in stable and unstable coronary syndromes. Cardiovascular Imaging. Nicholls SJ, Kataoka Y, Nissen SE, Prati F, Windecker S, Puri R, Hucko T, Aradi D, Herrman JP, Hermanides RS, Wang B. 2023 Jan 1;16(1):130-2. https://www.jacc.org/doi/10.1016/j.jcmg.2022.07.020
Muvalaplin, an Oral Small Molecule Inhibitor of Lipoprotein(a) Formation: A Randomized Clinical Trial. Nicholls SJ, Nissen SE, Fleming C, Urva S, Suico J, Berg PH, Linnebjerg H, Ruotolo G, Turner PK, Michael LF. 2023Aug28:e2316503.doi: 10.1001/jama.2023.16503.
Inflammation and cholesterol as predictors of cardiovascular events among patients receiving statin therapy: a collaborative analysis of three randomised trials. Prof Paul M Ridker, MD , Prof Deepak L Bhatt, MD, Aruna D Pradhan, MD, Prof Robert J Glynn, ScD, Jean G MacFadyen, BA, Prof Steven E Nissen, MD; on behalf of the PROMINENT, REDUCE-IT, and STRENGTH Investigators. VOLUME 401, ISSUE 10384, P1293-1301, APRIL 15, 2023. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00215-5/fulltext
SPORT
Are dietary supplements beneficial in lowering cholesterol? SPORT reflections and the path forward.
Luke J Laffin, Dennis Bruemmer, Steven E Nissen. European Heart Journal, Volume 44, Issue 8, 21 February 2023, Pages 638–640, https://doi.org/10.1093/eurheartj/ehac729.
Global Cardio Oncology Registry (G-COR)
Global Cardio Oncology Registry (G-COR): Registry Design, Primary Objectives, and Future Perspectives of a Multicenter Global Initiative.
Arco J. Teske, Rohit Moudgil, Teresa López-Fernández, Ana Barac, Sherry Ann Brown, Anita Deswal, Tomas G. Neilan, Sarju Ganatra, Husam Abdel Qadir, Venu Menon, Aaron L. Sverdlov, Richard K. Cheng, Silvia Makhoul, Arjun K. Ghosh, Sebastian Szmit, Vlad Zaha, Daniel Addison, Lili Zhang, Joerg Herrmann, Jun H. Chong, Vivek Agarwala, Zaza Iakobishvili, Patricia Guerrero, Eric H. Yang, Monika Leja, Nausheen Akhter, Avirup Guha, Tochukwu M. Okwuosa, Carolina Carvalho Silva, Patrick Collier, Jeanne DeCara, Brenton Bauer, Carrie E. Lenneman and Diego Sadler. Originally published13 Sep 2023. Circulation: Cardiovascular quality and Outcomes, Volume 16, Number 10
WATCH-TAVR
Concomitant Left Atrial Appendage Occlusion and Transcatheter Aortic Valve Replacement (WATCH-TAVR Study)
Samir R. Kapadia, MD; Amar Krishnaswamy, MD; Brian Whisenant, MD; Srinivasa Potluri, MD, Vijay Iyer, MD; Joseph Aragon, MD; Philip Gideon, MD; Justin Strote, MD; Robert Leonardi, MD; Himanshu Agarwal, MD; German Larrain, MD; Carlos Sanchez, MD; Sidakpal S. Panaich, MD, James Harvey, MD; Torsten Vahl, MD; Venu Menon, MD; Kathy Wolski, MS, Qiuqing Wang, MS, Martin B. Leon12, MD. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.123.067312
Lepodisiran Phase 1
A Phase 1 Single Ascending Dose Trial of an Extended Duration Short-interfering RNA Targeting Lipoprotein(a): A Randomized Clinical Trial.
Steven E. Nissen, MD, Helle Linnebjerg PhD, Xi Shen PhD, Kathy Wolski, MPH, Xiaosu Ma, PhD, Shufen Lim PhD, Laura F. Michael PhD, Giacomo Ruotolo, MD, PhD, Grace Gribble MS, Ann Marie Navar MD, and Stephen J. Nicholls, MBBS, PhD. JAMA. Published online November 12, 2023. doi:10.1001/jama.2023.21835 https://jamanetwork.com/journals/jama/fullarticle/2811935
Association of pulse pressure with risk of major adverse cardiovascular events among cardiovascular outcome trial participants. N Agarwal, J St Jean, E H Van Iterson, L Laffin. European Heart Journal, Volume 44, Issue Supplement_2, November 2023, ehad655.2317, https://doi.org/10.1093/eurheartj/ehad655.2317. https://academic.oup.com/eurheartj/article/44/Supplement_2/ehad655.2317/7393132
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/
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 JAHA 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 Cardiol 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 Circulation Primary