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IIR 16-072 – HSR&D Study

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IIR 16-072
Determining and targeting reasons for low statin use to improve guideline-concordant statin therapy in high-risk patients
Salim Virani MD
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, TX
Funding Period: July 2017 - June 2021

Optimal statin therapy reduces cardiovascular events. We have shown that optimal statin therapy is underused in Veterans with CVD. This can be due to clinical inertia or statin associated side effects which providers usually document in text notes and may not be well captured in structured datasets.

Our objectives are to (Aim 1) identify reasons for suboptimal statin use using structured data and provider text notes using NLP; (Aim 2) understand provider and patient perspectives on statin intolerance and refine a communication aid targeting providers to improve guideline-concordant statin use; and (Aim 3) pilot test an intervention to improve optimal statin use in Veterans with CVD using the communication aid refined in Aim 2.

For Aim 1, we will randomly identify VA patients with CVD on optimal, suboptimal and no statins, and partition them into training and test sets. We will train our NLP system to achieve sensitivity and specificity of >90%, compared with manual chart review to identify reason for suboptimal stain use. In Aim 2, we will conduct interviews with providers and patients to elicit their perspectives on clinical inertia and statin intolerance. These interviews will help refine the communication aid for Aim 3. In Aim 3, we will conduct a pilot trial with Houston and Nashville VAMC PACTs serving as intervention sites. PACTs at intervention sites will receive the communication aid to assist them with statin initiation and/or titration in CVD patients on suboptimal statins. At usual care sites, PACT providers will only receive a quarterly report of the proportion of their CVD patients on suboptimal statins. Our primary outcome is change in the proportion of CVD patients receiving optimal statin therapy.

We developed an initial corpus of 465 patients for training/testing the NLP system. We selected notes with standard titles that were most likely to contain documentation of adverse events related to statin usage. We used an iterative process to develop an annotation schema consisting of concepts of interest within the documents. Two nurse annotators identified an initial group of concepts within a small batch of 10-20 documents. Upon completion, annotation was discussed among the research team for further refinement and finalization.
To create document sets for annotation, we used one document from each patient. Documents were stratified so that each set of documents contained approximately 25% African Americans and 75% Non-African Americans, 25% females and 75% males, and 50% were on no statins, 25% on low statin, and 25% on moderate statin. Currently, a total of 171 documents (3 groups of 57) from 171 patients were selected for annotation. Within the first 57 documents, we identified 8 patients with statin-related adverse events, which corresponds to a prevalence rate of 14%.

Our results identify the vast majority of high-risk Veterans not on optimal statin therapy due to intolerance versus clinical inertia. Our communication aid will identify strategies to initiate or titrate statins in high-risk Veterans. These results will be important for the VA Health Care System to identify patients with "true statin intolerance" who will be future candidates for expensive new drugs recently approved by the FDA.


Journal Articles

  1. Mszar R, Grandhi GR, Valero-Elizondo J, Caraballo C, Khera R, Desai N, Virani SS, Blankstein R, Blaha MJ, Nasir K. Cumulative Burden of Financial Hardship From Medical Bills Across the Spectrum of Diabetes Mellitus and Atherosclerotic Cardiovascular Disease Among Non-Elderly Adults in the United States. Journal of the American Heart Association. 2020 May 18; 9(10):e015523.
  2. Virani SS, Smith SC, Stone NJ, Grundy SM. Secondary Prevention for Atherosclerotic Cardiovascular Disease: Comparing Recent US and European Guidelines on Dyslipidemia. Circulation. 2020 Apr 7; 141(14):1121-1123.
  3. Mahtta D, Ahmed ST, Shah NR, Ramsey DJ, Akeroyd JM, Nasir K, Hamzeh IR, Elgendy IY, Waldo SW, Al-Mallah MH, Jneid H, Ballantyne CM, Petersen LA, Virani SS. Facility-Level Variation in Cardiac Stress Test Use Among Patients With Diabetes: Findings From the Veterans Affairs National Database. Diabetes Care. 2020 May 1; 43(5):e58-e60.
  4. Al Rifai M, Mirbolouk M, Obisesan OH, Jia X, Nasir K, Merchant AT, Blaha M, Virani S. The Association of Electronic Cigarette Use and the Subjective Domains of Physical and Mental Health: The Behavioral Risk Factor Surveillance System Survey. Cureus. 2020 Feb 24; 12(2):e7088.
  5. Agarwala A, Michos ED, Samad Z, Ballantyne CM, Virani SS. The Use of Sex-Specific Factors in the Assessment of Women's Cardiovascular Risk. Circulation. 2020 Feb 18; 141(7):592-599.
  6. Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW, American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3; 141(9):e139-e596.
  7. Mahtta D, Rodriguez F, Jneid H, Levine GN, Virani SS. Improving adherence to cardiovascular guidelines: realistic transition from paper to patient. Expert Review of Cardiovascular Therapy. 2020 Jan 1; 18(1):41-51.
  8. Rifai MA, Blaha MJ, Patel J, Xiaoming J, Cainzos-Achirica M, Greenland P, Budoff M, Yeboah J, Nasir K, Al-Mallah MH, Virani SS. Coronary Artery Calcification, Statin Use and Long-Term Risk of Atherosclerotic Cardiovascular Disease Events (from the Multi-Ethnic Study of Atherosclerosis). The American journal of cardiology. 2020 Mar 15; 125(6):835-839.
  9. Ahmed ST, Mahtta D, Rehman H, Akeroyd J, Al Rifai M, Rodriguez F, Jneid H, Nasir K, Samad Z, Alam M, Petersen LA, Virani SS. Association between frequency of primary care provider visits and evidence-based statin prescribing and statin adherence: Findings from the Veterans Affairs system. American heart journal. 2020 Mar 1; 221:9-18.
  10. Agarwala A, Kohli P, Virani SS. Popular Media and Cardiovascular Medicine: "with Great Power There Must Also Come Great Responsibility". Current Atherosclerosis Reports. 2019 Oct 31; 21(11):43.
  11. Dixon DL, Sharma G, Sandesara PB, Yang E, Braun LT, Mensah GA, Sperling LS, Deedwania PC, Virani SS. Therapeutic Inertia in Cardiovascular Disease Prevention: Time to Move the Bar. Journal of the American College of Cardiology. 2019 Oct 1; 74(13):1728-1731.
  12. Xian Y, Navar AM, Li S, Li Z, Robinson J, Virani SS, Louie MJ, Koren A, Goldberg A, Roger VL, Wilson PWF, Peterson ED, Wang TY. Intensity of Lipid Lowering With Statin Therapy in Patients With Cerebrovascular Disease Versus Coronary Artery Disease: Insights from the PALM Registry. Journal of the American Heart Association. 2019 Oct 1; 8(19):e013229.
  13. Khan MR, Kayani WT, Ahmad W, Manan M, Hira RS, Hamzeh I, Jneid H, Virani SS, Kleiman N, Lakkis N, Alam M. Effect of increasing age on percutaneous coronary intervention vs coronary artery bypass grafting in older adults with unprotected left main coronary artery disease: A meta-analysis and meta-regression. Clinical Cardiology. 2019 Nov 1; 42(11):1071-1078.
  14. Kazi DS, Virani SS. Implications of cost-effectiveness analyses of lipid-lowering therapies: From the policy-maker's desk to the patient's bedside. Progress in Cardiovascular Diseases. 2019 Sep 1; 62(5):406-413.
  15. Mitchell S, Malanda B, Damasceno A, Eckel RH, Gaita D, Kotseva K, Januzzi JL, Mensah G, Plutzky J, Prystupiuk M, Ryden L, Thierer J, Virani SS, Sperling L. A Roadmap on the Prevention of Cardiovascular Disease Among People Living With Diabetes. Global heart. 2019 Sep 1; 14(3):215-240.
  16. Nanna MG, Wang TY, Xiang Q, Goldberg AC, Robinson JG, Roger VL, Virani SS, Wilson PWF, Louie MJ, Koren A, Li Z, Peterson ED, Navar AM. Sex Differences in the Use of Statins in Community Practice. Circulation. Cardiovascular quality and outcomes. 2019 Aug 16; 12(8):e005562.
  17. Virani SS, Akeroyd JM, Smith SC, Al-Mallah M, Maddox TM, Morris PB, Petersen LA, Ballantyne CM, Grundy SM, Stone NJ. Very High-Risk ASCVD and Eligibility for Nonstatin Therapies Based on the 2018 AHA/ACC Cholesterol Guidelines. Journal of the American College of Cardiology. 2019 Aug 6; 74(5):712-714.
  18. Pokharel Y, Mouhanna F, Schneider ALC, Rawlings AM, Knopman DS, Nambi V, Virani SS, Hoogeveen RC, Alonso A, Heiss G, Coresh J, Mosley T, Gottesman R, Selvin E, Ballantyne C, Power MC. High-Sensitive Troponin T, Natriuretic Peptide, and Cognitive Change. Journal of the American Geriatrics Society. 2019 Nov 1; 67(11):2353-2361.
  19. Rehman H, Ahmed ST, Akeroyd J, Mahtta D, Jia X, Rifai MA, Nasir K, Jneid H, Khalid MU, Alam M, Toth PP, Virani SS. Relation Between Cardiology Follow-Up Visits, Evidence-Based Statin Prescribing, and Statin Adherence (from the Veterans Affairs Health Care System). The American journal of cardiology. 2019 Oct 15; 124(8):1165-1170.
  20. Quispe R, Elshazly MB, Zhao D, Toth PP, Puri R, Virani SS, Blumenthal RS, Martin SS, Jones SR, Michos ED. Total cholesterol/HDL-cholesterol ratio discordance with LDL-cholesterol and non-HDL-cholesterol and incidence of atherosclerotic cardiovascular disease in primary prevention: The ARIC study. European journal of preventive cardiology. 2019 Jul 10; 2047487319862401.
  21. Santo K, Isiguzo GC, Atkins E, Mishra SR, Panda R, Mbau L, Fayomi SB, Ugwu C, Odili A, Virani S. Adapting a club-based medication delivery strategy to a hypertension context: the CLUBMEDS Study in Nigeria. BMJ open. 2019 Jul 9; 9(7):e029824.
  22. Dixon DL, Virani SS. Mortality reduction with PCSK9 inhibition: A case of cautious optimism. Journal of clinical lipidology. 2019 Sep 1; 13(5):712-713.
  23. Sardana M, Tang Y, Magnani JW, Ockene IS, Allison JJ, Arnold SV, Jones PG, Maddox TM, Virani SS, McManus DD. Provider-Level Variation in Smoking Cessation Assistance Provided in the Cardiology Clinics: Insights From the NCDR PINNACLE Registry. Journal of the American Heart Association. 2019 Jul 2; 8(13):e011412.
  24. Nanna MG, Navar AM, Wang TY, Li S, Virani SS, Li Z, Robinson JG, Roger VL, Wilson PWF, Goldberg AC, Koren A, Louie MJ, Peterson ED. Practice-level variation in statin use and low-density lipoprotein cholesterol control in the United States: Results from the Patient and Provider Assessment of Lipid Management (PALM) registry. American heart journal. 2019 Aug 1; 214:113-124.
  25. Jia X, Al Rifai M, Ramsey DJ, Ahmed ST, Akeroyd JM, Nambi V, Ballantyne CM, Petersen LA, Stone NJ, Virani SS. Association Between Lipid Testing and Statin Adherence in the Veterans Affairs Health System. The American journal of medicine. 2019 Sep 1; 132(9):e693-e700.
  26. Pokharel Y, Mouhanna F, Nambi V, Virani SS, Hoogeveen R, Alonso A, Heiss G, Coresh J, Mosley T, Gottesman RF, Ballantyne CM, Power MC. ApoB, small-dense LDL-C, Lp(a), LpPLA activity, and cognitive change. Neurology. 2019 May 28; 92(22):e2580-e2593.
  27. Trang A, Kampangkaew J, Fernandes R, Tiwana J, Misra A, Hamzeh I, Blaustein A, Aguilar D, Shah T, Ballantyne C, Quinones M, Nagueh SF, Dokanish H, Virani SS, Deswal A, Kirkpatrick JN, Nambi V. Understanding by General Providers of the Echocardiogram Report. The American journal of cardiology. 2019 Jul 15; 124(2):296-302.
  28. Mahtta D, Virani S, Bavry AA. Emerging Lipid-Lowering Therapies in Secondary Prevention. Current cardiovascular risk reports. 2019 Apr 17; 13(11):
  29. Shah NR, Ahmed ST, Winchester DE, Ramsey DJ, Akeroyd JM, Wu WC, Waldo SW, Schofield RS, Ballantyne CM, Petersen LA, Virani SS. Facility-Level Variation in Stress Test Utilization in Veterans With Ischemic Heart Disease. JACC. Cardiovascular imaging. 2019 Jul 1; 12(7 Pt 1):1292-1293.
  30. Merchant AT, Virani SS. Childhood Oral Infections and Subclinical Atherosclerosis in Adulthood: Should We Wait for Causality or Just Treat?. JAMA Network Open. 2019 Apr 5; 2(4):e192489.
  31. Bradley CK, Wang TY, Li S, Robinson JG, Roger VL, Goldberg AC, Virani SS, Louie MJ, Lee LV, Peterson ED, Navar AM. Patient-Reported Reasons for Declining or Discontinuing Statin Therapy: Insights From the PALM Registry. Journal of the American Heart Association. 2019 Apr 2; 8(7):e011765.
  32. Jia X, Al Rifai M, Birnbaum Y, Smith SC, Virani SS. The 2018 Cholesterol Management Guidelines: Topics in Secondary ASCVD Prevention Clinicians Need to Know. Current Atherosclerosis Reports. 2019 Apr 2; 21(6):20.
  33. Jia X, Virani SS. CLEAR Serenity Trial: More Clarity for the Future of Bempedoic Acid in Patients Unable to Take Statins?. Journal of the American Heart Association. 2019 Apr 2; 8(7):e012352.
  34. Sandesara PB, Virani SS, Fazio S, Shapiro MD. The Forgotten Lipids: Triglycerides, Remnant Cholesterol, and Atherosclerotic Cardiovascular Disease Risk. Endocrine reviews. 2019 Apr 1; 40(2):537-557.
  35. Jia X, Akeroyd JM, Nasir K, Nambi V, Ballantyne CM, Petersen LA, Virani SS. Eligibility and Cost for Icosapent Ethyl Based on the REDUCE-IT Trial. Circulation. 2019 Mar 5; 139(10):1341-1343.
  36. Okunrintemi V, Khera R, Spatz ES, Salami JA, Valero-Elizondo J, Warraich HJ, Virani SS, Blankstein R, Blaha MJ, Pawlik TM, Dharmarajan K, Krumholz HM, Nasir K. Association of Income Disparities with Patient-Reported Healthcare Experience. Journal of general internal medicine. 2019 Jun 1; 34(6):884-892.
  37. Valero-Elizondo J, Khera R, Saxena A, Grandhi GR, Virani SS, Butler J, Samad Z, Desai NR, Krumholz HM, Nasir K. Financial Hardship From Medical Bills Among Nonelderly U.S. Adults With Atherosclerotic Cardiovascular Disease. Journal of the American College of Cardiology. 2019 Feb 19; 73(6):727-732.
  38. Hyman DA, Siebert V, Jia X, Alam M, Levine GN, Virani SS, Birnbaum Y. Risk Assessment of Stroke in Patients with Atrial Fibrillation: Current Shortcomings and Future Directions. Cardiovascular drugs and therapy. 2019 Feb 1; 33(1):105-117.
  39. Kamal AK, Khalid W, Zulfiqar M, Muqeet A, Zaidi F, Gowani A, Virani SS. The potential of m-Health-based interventions to improve medication literacy and adherence in non-communicable diseases in Pakistan. International journal of stroke : official journal of the International Stroke Society. 2019 Apr 1; 14(3):NP8-NP10.
  40. Mishra SR, Ghimire S, Shrestha N, Shrestha A, Virani SS. Socio-economic inequalities in hypertension burden and cascade of services: nationwide cross-sectional study in Nepal. Journal of Human Hypertension. 2019 Aug 1; 33(8):613-625.
  41. Virani SS, Akeroyd JM, Nambi V, Michos ED, Morris PB, Nasir K, Smith SC, Stone NJ, Petersen LA, Ballantyne CM. Applicability and Cost Implications for Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors Based on the ODYSSEY Outcomes Trial. Circulation. 2019 Jan 15; 139(3):410-412.
  42. Lowenstern A, Navar AM, Li S, Virani SS, Goldberg AC, Louie MJ, Lee LV, Peterson ED, Wang TY. Association of Clinician Knowledge and Statin Beliefs With Statin Therapy Use and Lipid Levels (A Survey of US Practice in the PALM Registry). The American journal of cardiology. 2019 Apr 1; 123(7):1011-1018.
  43. Hira RS, Kataruka A, Akeroyd JM, Ramsey DJ, Pokharel Y, Gurm HS, Nasir K, Deswal A, Jneid H, Alam M, Ballantyne CM, Petersen LA, Virani SS. Association of Body Mass Index With Risk Factor Optimization and Guideline-Directed Medical Therapy in US Veterans With Cardiovascular Disease. Circulation. Cardiovascular quality and outcomes. 2019 Jan 1; 12(1):e004817.
  44. Saeed A, Sun W, Agarwala A, Virani SS, Nambi V, Coresh J, Selvin E, Boerwinkle E, Jones PH, Ballantyne CM, Hoogeveen RC. Lipoprotein(a) levels and risk of cardiovascular disease events in individuals with diabetes mellitus or prediabetes: The Atherosclerosis Risk in Communities study. Atherosclerosis. 2019 Mar 1; 282:52-56.
  45. Kamal AK, Khalid W, Muqeet A, Jamil A, Farhat K, Gillani SRA, Zulfiqar M, Saif M, Muhammad AA, Zaidi F, Mustafa M, Gowani A, Sharif S, Bokhari SS, Tai J, Rahman N, Sultan FAT, Sayani S, Virani SS. Making prescriptions "talk" to stroke and heart attack survivors to improve adherence: Results of a randomized clinical trial (The Talking Rx Study). PLoS ONE. 2018 Dec 20; 13(12):e0197671.
  46. Virani SS, Ballantyne CM. Low-Density Lipoprotein Cholesterol: Is 160 the New 190? Circulation. 2018 Nov 20; 138(21):2326-2329.
  47. Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. Circulation. 2019 Jun 18; 139(25):e1162-e1177.
  48. Lloyd-Jones DM, Braun LT, Ndumele CE, Smith SC, Sperling LS, Virani SS, Blumenthal RS. Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology. Journal of the American College of Cardiology. 2019 Jun 25; 73(24):3153-3167.
  49. Rodwin BA, Salami JA, Spatz ES, Valero-Elizondo J, Virani SS, Blankstein R, Blaha MJ, Nasir K, Desai NR. Variation in the Use of Warfarin and Direct Oral Anticoagulants in Atrial Fibrillation and Associated Cost Implications. The American journal of medicine. 2019 Jan 1; 132(1):61-70.e1.
  50. Saeed A, Virani SS, Jones PH, Ballantyne CM, Nambi V. Case reports of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibition nonresponse. Journal of clinical lipidology. 2018 Sep 1; 12(5):1141-1145.

DRA: Cardiovascular Disease
DRE: Treatment - Implementation, Prevention, Prognosis
Keywords: none
MeSH Terms: none

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