Lipid Management Among Coronary Artery Disease Patients With Diabetes Mellitus or Advanced Age Mark W. Massing, MD, MPH, Carla A. Sueta, MD, PhD, Mridul Chowdhury, David P. Biggs, BS, and Ross J. Simpson, Jr., MD, PhD his study evaluates lipid management among persons with a history of coronary artery disease T (CAD) seen in the outpatient setting. It uses data recently made available from the Merck and Co., Inc. Quality Assurance Program (QAP) consisting of abstracted medical records from ambulatory practices throughout the United States. We extend earlier QAP studies1,2 by examining pharmacologic lipid management and its association with age and diabetes among patients with CAD in a newly released phase of data collection. Our objectives were to confirm the previously observed undertreatment of older patients with CAD1,3,4 and to determine whether CAD patients with diabetes were aggressively treated as recommended by established guidelines.5,6 •••
Data were obtained from a national database of abstracted medical records created as part of QAP, which was initiated and funded by Merck & Co., Inc. QAP was conducted in consecutive phases of data collection. Data collection methods and the study population in the first phase (QAP-I) have been described elsewhere.1,2 The present study focuses only on data collected during the second phase of the program (QAPII), which was derived from a separate study population during a later time period than were QAP-I. A sample of ambulatory medical practices in the United States was identified based on high-volume prescription rates of lipid-lowering medications and angiotensin-converting enzyme inhibitors. Within each participating practice, a random sample of medical records for patients with CAD and/or congestive heart failure was selected for chart review. Medical record abstractions were performed by ACCESS Medical, Ltd. (Arlington Heights, Illinois) under contract with Merck & Co, Inc. Abstracted data elements included demographics, medical history, lipid assay results, and medications often prescribed to patients with heart disease. ACCESS Medical provided for patient, physician, and practice confidentiality by removing identifying information before the release of the data for analysis. Patients included in the final QAP-II database were ⱖ21 years of age with CAD and/or congestive heart failure, and seen at the practice by the physician at least twice within 2 years. Patients who were excluded From Medical Review of North Carolina, Cary; and School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. This report was supported by an unrestricted grant from Merck & Co., Inc., Whitehouse Station, New Jersey. Dr. Massing’s address is: Medical Review of North Carolina, 5625 Dillard Drive, Cary, North Carolina 27511-9227. E-mail: mmassing@mrnc. org. Manuscript received May 22, 2000; revised manuscript received and accepted September 12, 2000.
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PhD,
had evidence of terminal illness, a history of transplant or on a transplant waiting list, or patients who had died before the review. Patients excluded during the analysis were those without CAD (i.e., patients with no documented evidence of CAD and those with congestive heart failure only). Thus, only patients with CAD with or without congestive heart failure are considered in this report. Data analysis was performed by Medical Review of North Carolina, Inc. Patients with CAD were identified by diagnosis codes (410 – 414), medical history, and cardiac procedures (i.e., percutaneous transluminal coronary angioplasty, coronary artery bypass graft, stent, or rotoblation). Patients with diabetes mellitus were identified by diagnosis codes (250.0-250.9), medical history, and prescribed medications (i.e., insulin or oral hypoglycemics). Other comorbidities were determined from documented diagnosis codes, medical history, and medical procedures. Diagnosis codes were consistent with the Ninth Revision of the International Classification of Diseases.7 Daily doses were determined for 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitors, subsequently referred to as statins. The proportion of statin users taking above the starting dose was considered a surrogate measure of dose titration in this study. The daily starting doses for statins were identified in earlier QAP analyses1 based on manufacturer recommendations for the minimum doses to be given when the medications started. Although these recommendations may change over time, for consistency with earlier studies, the daily starting doses for statins used in QAP-II were defined as follows: lovastatin 20 mg, pravastatin 20 mg, simvastatin 10 mg, fluvastatin 20 mg, and atorvastatin 10 mg. Stratified and regression analyses examining the relations of lipid medication use and dose titration with age and diabetes status were performed. A total of 56,320 medical records from 296 medical practices throughout the United States were reviewed from April 1997 through March 1998. Patients excluded from the study were those (n ⫽ 6,069) without documented evidence of CAD and those (n ⫽ 530) with invalid age or visit date values. The remaining 49,721 patients were most recently seen by physicians from 1995 through 1998, and most (78%) were most recently seen in 1997. Medical practice specialties included cardiology (56%), multiple specialty (22%), internal medicine (12%), family medicine (4%), and other (5%). The number of completed chart reviews per practice after exclusions ranged from 2 to 750 (mean 168, median 117). Chart reviewers identified the physician seen most frequently at each practice for each patient in the study. These 1,544 physi0002-9149/01/$–see front matter PII S0002-9149(00)01447-8
FIGURE 1. Percentage of medications given for dyslipidemia, and mean LDL cholesterol levels in coronary artery disease patients with and without diabetes by age.
tery bypass graft, and/or congestive heart failure were more common in CAD With Diabetes* CAD Without Diabetes* diabetic than nondiabetic patients. In (n ⫽ 11,270) (n ⫽ 38,451) contrast, percutaneous transluminal coronary angioplasty was slightly Age (yrs) 68.1 ⫾ 0.1† 68.7 ⫾ 0.06 Women 41%‡ 36% more common among those without Region diabetes, and myocardial infarction Northeast 26% 27% rates were similar in the 2 groups. Midwest 34% 33% Patients with diabetes were not South 21% 18% West 16% 18% more likely to have recorded total Systemic hypertension 64%† 51% cholesterol or triglyceride values and Myocardial infarction 43% 44% were less likely to have recorded † Coronary bypass 41% 34% low-density lipoprotein (LDL) choCoronary angioplasty/stent 26%† 28% lesterol and high-density lipoprotein Congestive heart failure 43%† 31% Lipid levels cholesterol values (Table 1). For Total cholesterol recorded 83% 83% those with recorded values, mean LDL Mean total cholesterol (mg/dl) 198.8 ⫾ 0.5 199.0 ⫾ 0.2 cholesterol and high-density lipopro† HDL cholesterol recorded 64% 67% tein cholesterol were slightly lower, Mean HDL cholesterol (mg/dl) 39.6 ⫾ 0.2† 43.7 ⫾ 0.1 LDL cholesterol recorded 57%† 63% and mean triglyceride levels were Mean LDL cholesterol (mg/dl) 117.1 ⫾ 0.4† 121.1 ⫾ 0.2 markedly higher among patients with Triglycerides recorded 77% 77% than without diabetes. The proportion † Mean triglycerides (mg/dl) 223.5 ⫾ 1.8 173.7 ⫾ 0.7 of patients in compliance with recomPharmacologic therapy for 44%† 45% mended guidelines5,6,8,9 was far from dyslipidemia‡ ideal (not shown in the table). LDL *Percent values are percentage of column total; other values are mean ⫾ SE. † cholesterol concentrations were optiPatients with diabetes significantly different from those without diabetes (p ⬍0.01). ‡ mal (i.e., ⱕ100 mg/dl) for only 29%. Medical record documented use of at least 1 statin or nonstatin lipid-lowering drug. HDL ⫽ high-density lipoprotein. About 35% exceeded the pharmacologic threshold for patients with CAD (i.e, ⱖ130 mg/dl).8 Even among patients prescribed statins, only 33% cians cared for a minimum of 1 to a maximum of 378 were at optimal levels for LDL cholesterol. Among patients not prescribed any lipid medication, 24% study patients (mean 32, median 35). Patients with diabetes were slightly younger and were at optimal LDL cholesterol levels and 41% were more likely to be female than those without diabetes above the pharmacologic threshold. Pharmacologic therapy for dyslipidemia was doc(Table 1). Overall, about 66% of patients were aged ⱖ65 years (not shown). Systemic hypertension, coronary ar- umented in less than half of all patients at rates that TABLE 1 Characteristics of CAD Patients With and Without Diabetes
BRIEF REPORTS
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FIGURE 2. Percentage of patients given statin drugs at doses greater than the recommended starting dose, and mean LDL cholesterol levels in coronary artery disease patients with and without diabetes by age (statin users only).
TABLE 2 Odds ratios (OR) and 95% Confidence Intervals (CI) for the Association of Age With Medical Record Documentation of Lipid-Lowering Medication Use and Dose Titration*
Age (yrs) 21–44 45–54 55–64 65–74 75–84 ⱖ85†
Lipid Medication Use (n ⫽ 30,056) OR (95% CI) 4.5 4.9 4.7 3.7 2.3
(3.7–5.5) (4.2–5.7) (4.1–5.4) (3.2–4.2) (2.0–2.6) 1.0
Greater than Starting Dose Statin Users Only (n ⫽ 15,758) OR (95% CI) 3.2 2.4 2.2 1.7 1.3
(2.3–4.3) (1.9–3.1) (1.7–2.8) (1.3–2.1) (1.0–1.7) 1.0
*Based on logistic regression models controlling for: age, diabetes history, sex, geographic region, medical practice type, history of hypertension, myocardial infarction, coronary bypass, coronary angioplasty/stent, and congestive heart failure; serum concentration of LDL cholesterol, high-density lipoprotein cholesterol, and triglycerides; excluding patients with missing values. † Referent group.
were similar for patients with and without diabetes (Table 1). Almost all patients taking lipid medications were given statins (not shown). Patients without diabetes were somewhat more likely to be prescribed statins (41.8%) than those with diabetes (38.5%). In contrast, diabetic patients were slightly more likely to be using a nonstatin lipid drug (8.5%) than those without diabetes (7.0%). Lipid medication rates declined with advancing age from a peak of almost 60% in patients almost 50 years of age to ⬍15% in those at age ⱖ85 (Figure 1). About 57% of patients aged ⬍65 years and 39% of patients aged ⱖ65 were prescribed lipid medications. Lipid medication rates were slightly lower for diabetic versus nondiabetic patients, except for the 2 oldest age 648 THE AMERICAN JOURNAL OF CARDIOLOGY姞
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groups. Mean LDL cholesterol levels ranged from 116 to 128 mg/dl across these age strata and declined slightly with age, reaching a minimal value between 60 and 70 years. Mean LDL cholesterol increased slightly in the oldest age groups. Patients with diabetes had lower LDL cholesterol on average than those without diabetes. Among patients prescribed statins, dose titration was inversely related to age (Figure 2). The percentage of patients given statins at doses greater than the recommended starting doses declined steadily from about 60% at ages 21 to 44 years to about 35% by age ⱖ85. Patients with and without diabetes were similar with respect to dose titration. Mean LDL cholesterol levels for these patients ranged from 112 to 131 mg/dl, declining with age up to 60 to 70 years, and increasing slightly thereafter. LDL cholesterol levels were slightly lower among patients with diabetes, but the relation between LDL cholesterol and age was similar regardless of diabetes status. Patients given and not given lipid medications were similar, on average, with respect to the quantity of nonlipid medications recorded during chart review. Those not given lipid medications experienced slightly more nonlipid comorbidities (mean 4.0) than those given lipid medications (mean 3.6). Medical practice specialties differed little with respect to goal attainment. Only 30%, 28%, and 27% of patients seen at practices specializing in cardiology, internal medicine, and family medicine, respectively, were at LDL cholesterol goal (ⱕ100 mg/dl). The inverse relation of age with lipid-lowering medication use and dose titration, as shown in the figures, was corroborated by logistic regression analyses controlling for diabetes, sex, geographic region, medical practice type, medical history, and serum lipid concentrations. Diabetic patients were about MARCH 1, 2001
20% less likely to be prescribed a lipid-lowering medication than those without diabetes. In contrast, diabetes status was not associated with dose titration. Patients in the 45- to 54-year-old age group were almost 5 times more likely to be given a lipid medication than those aged ⱖ85 (Table 2). Patients 21 to 44 years of age given statins were over 3 times more likely to be taking doses above the recommended starting doses than those aged ⱖ85 years. Patients ⬍65 years of age were 1.7 (95% confidence interval 1.6 to 1.8) times more likely to be prescribed lipid medications than older persons (not shown). •••
Our findings are consistent with previous studies showing that lipid management among patients with CAD continues to be less than optimal. CAD patients with advanced age were strikingly undertreated for reasons apparently not related to LDL cholesterol levels. Likewise, CAD patients with diabetes were not more aggressively treated than those without diabetes despite their elevated CAD risks.10 –12 1. Sueta CA, Chowdhury M, Boccuzzi SJ, Smith SC Jr, Alexander CM, Londhe
A, Lulla A, Simpson RJ Jr. Analysis of the degree of undertreatment of hyper-
lipidemia and congestive heart failure secondary to coronary artery disease. Am J Cardiol 1999;83:1303–1307. 2. Simpson RJ Jr, Sueta CA, Boccuzzi SJ, Lulla A, Biggs D, Londhe A, Smith SC Jr. Performance assessment model for guideline-recommended pharmacotherapy in the secondary prevention of coronary artery disease and treatment of left ventricular dysfunction. Am J Cardiol 1997;80:53H-56H. 3. Aronow WS. Underutilization of lipid-lowering drugs in older persons with prior myocardial infarction and a serum low-density lipoprotein cholesterol ⬎125 mg/dl. Am J Cardiol 1998;82:668 – 669. 4. Grundy SM. The role of cholesterol management in coronary disease risk reduction in elderly patients. Endocrinol Metab Clin North Am 2000;27:655– 675. 5. American Diabetes Association. Management of dyslipidemia in adults with diabetes. Diabetes Care 1998;21:179 –182. 6. Haffner SM. Management of dyslipidemia in adults with diabetes. Diabetes Care 1998;21:160 –178. 7. St. Anthony’s ICD-9-CM Code Book. Reston, VA: St. Anthony Publishing, 1998. 8. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA 1993;269:3015–3023. 9. Grundy SM, Cleeman JI, Rifkind BM, Kuller LH. Cholesterol lowering in the elderly population. Coordinating Committee of the National Cholesterol Education Program Arch Intern Med 1999;159:1670 –1678. 10. Abbott RD, Donahue RP, Kannel WB, Wilson PW. The impact of diabetes on survival following myocardial infarction in men vs women. The Framingham Study.JAMA 1988;260:3456 –3460. 11. Gu K, Cowie CC, Harris MI. Mortality in adults with and without diabetes in a national cohort of the U. S. population, 1971–1993. Diabetes Care 1998:21: 1138 –1145. 12. Miettinen H, Lehto S, Salomaa V, Mahonen M, Niemela M, Haffner SM, Pyorala K, Tuomilehto J. Impact of diabetes on mortality after the first myocardial infarction. The FINMONICA Myocardial Infarction Register Study Group. Diabetes Care 1998;21:69 –75.
Complete Atrioventricular Block After Valvular Heart Surgery and the Timing of Pacemaker Implantation Michael H. Kim, MD, G. Michael Deeb, MD, Kim A. Eagle, MD, David Bruckman, MS, Frank Pelosi, MD, Hakan Oral, MD, Christian Sticherling, MD, Robert L. Baker, MD, Steven P. Chough, MD, Kristina Wasmer, MD, Gregory F. Michaud, MD, Bradley P. Knight, MD, S. Adam Strickberger, MD, and Fred Morady, MD he natural history of complete atrioventricular block (AVB) after valvular heart surgery is not T well defined. Thus, patients who develop complete AVB and require a permanent pacemaker have this procedure performed with wide variations in timing. Prior reports have recommended 3 to 21 days after the onset of high-degree AVB as a reasonable waiting period before pacemaker implantation.1– 4 The goals of this investigation were to determine the prevalence and natural history of complete AVB after valvular heart surgery and to assess the optimal timing of pacemaker implantation.
From the Divisions of Cardiology and Cardiac Surgery, University of Michigan Health System in Ann Arbor, Ann Arbor; and Consortium for Health Outcomes, Innovations, and Cost Effectiveness Studies, Ann Arbor, Michigan. This report was supported in part by a grant from Hoechst Marion Roussel for outcomes research (ACCORD) to Michael H. Kim and Kim A. Eagle. Dr. Morady’s address is: B1F245 University Hospital, Cardiovascular Division, University of Michigan Health System, 1500 East Medical Center Drive, Ann Arbor, Michigan 48109. E-mail:
[email protected]. Manuscript received June 20, 2000; revised manuscript received and accepted September 7, 2000. ©2001 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 87 March 1, 2001
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A cardiac surgery database used to investigate postoperative atrial fibrillation after cardiac surgery was queried for all patients who underwent valvular heart surgery and had postoperative complete AVB. The database consisted of all patients who had cardiac surgery (n ⫽ 467) over a 13-month period (January to May 1995 and November 1996 to June 1997) with preoperative sinus rhythm, no prior history of atrial fibrillation, and no chronic antiarrhythmic therapy. The query produced 155 patients who had a cardiac surgical procedure consisting of either isolated valvular surgery or valvular surgery as part of the overall procedure. Among these, 17 (11%) patients were noted to have complete AVB in the postoperative period. These charts, including documentation of complete AVB, were reviewed by the investigators. The onset or first documentation of complete AVB was noted as was the time of resolution of AVB or pacemaker implantation. Postoperative length of stay and date of discharge were also recorded. Clinical follow-up data were obtained for up to 1 year in the 9 patients who received a permanent pacemaker. Stan0002-9149/01/$–see front matter PII S0002-9149(00)01448-X
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