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Active Lipid Management In Coronary Artery Disease (ALMICAD) Study

      Abstract

      Purpose

      Many providers have implemented specialized lipid clinics to more effectively identify, monitor, and treat hyperlipidemia in patients with coronary artery disease. The effectiveness of such a strategy is not known. We sought to investigate whether a specialized clinic achieves better lipid results and clinical outcomes than standard care.

      Subjects and Methods

      A total of 1233 patients who had coronary disease documented by coronary angiography were randomized to lipid clinic or standard care groups by their providers and followed for 2 years. The primary end point was a composite of death, myocardial infarction, repeat revascularization, and stroke.

      Results

      Lipid clinic (n=617) and standard care (n=616) groups had no significant baseline differences. After 2 years, the lipid clinic group had similar total cholesterol (166±42 mg/dL vs 166±41 mg/dL, P=.83), low-density lipoprotein cholesterol levels (84±32 vs 85±32, P=.28), and percentage of patients with low-density lipoprotein cholesterol less than 100 mg/dL (77.5% vs 77.6%, P=.97). There were no significant differences in the primary end point (12.3% vs 11.4%, P=.60) and mortality (7.6% vs 7.3%, P=.80) between the lipid clinic and standard care groups.

      Conclusions

      In patients identified by diagnostic coronary angiography and managed within a single health care system, implementation of a specialized lipid clinic did not achieve greater attainment of hyperlipidemia treatment goals or improved cardiac outcomes.

      Keywords

      Treatment of hyperlipidemia in patients with risk factors for cardiovascular disease or established atherosclerosis reduces adverse cardiovascular outcomes.
      Heart Protection Study Collaborative Group
      MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial.
      • Shepherd J.
      • Cobbe S.M.
      • Ford I.
      • et al.
      West of Scotland Coronary Prevention Study Group
      Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
      • Downs J.R.
      • Clearfield M.
      • Weis S.
      • et al.
      AFCAPS/TexCAPS Research Group
      Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS.
      Scandinavian Simvastatin Survival Study Group
      Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S).
      • Sacks F.M.
      • Pfeffer M.A.
      • Moye L.
      • et al.
      The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels.
      The Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group
      Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels.
      • Cannon C.P.
      • Braumwald E.
      • McCabe C.H.
      • et al.
      Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction-22 Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
      Secondary prevention of coronary artery disease with 3-hydroxy-3-methylglutaryl-CoA reductase inhibitors (statins) is both efficacious and cost-effective.
      • Yusuf S.
      • Anand S.
      Cost of prevention: the case of lipid lowering.
      Although statins have revolutionized lipid-lowering therapy and have been a major advance in primary and secondary coronary artery disease prevention, there is still controversy concerning target lipid levels, risk-stratified dose adjustment, and optimal systems of patient management and monitoring.
      Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults
      Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III).
      Often the highest risk patients are not treated to the recommended target levels according to randomized clinical trials.
      • Pearson T.A.
      • Laurora I.
      • Chu H.
      • Kafonek S.
      The lipid treatment assessment project- a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals.
      • Marcello J.J.
      • Feingold K.
      Inadequate treatment with HMG-CoA reductase inhibitors by health care providers.
      Some health care systems and providers use specialized lipid clinics in an attempt to more effectively identify, monitor, and treat patients with hyperlipidemia, often at significant expense. There are no data whether patients with coronary artery disease treated for hyperlipidemia by specialized lipid clinics have better outcomes than conventional treatment and follow-up. We therefore conducted the Active Lipid Management In Coronary Artery Disease (ALMICAD) trial to test whether a specialized lipid clinic achieves better results and clinical outcomes than standard care in patients with angiographically documented coronary artery disease.
      • Follow-up in a specialized lipid clinic resulted in similar long-term achievement of target lipid goals and clinical outcomes compared with standard care by patient care providers.
      • Educating providers about lipid management and emphasis on universal high-dose statin use in patients with established coronary artery disease may be equally appropriate uses of resources compared with managing patients in specialized lipid clinics.

      Methods

      Patient Population

      Between April 2002 and February 2004, 1233 patients were enrolled in the study from a single center (Figure 1). Written informed consent was obtained from all patients. Patients who were more than 18 years of age and had angiographic coronary artery disease during diagnostic coronary angiography were randomized to either the lipid clinic or standard care. Coronary artery disease was defined as any luminal diameter stenosis of 20% or more in an epicardial coronary artery with a diameter of 2 mm or more. Patients were excluded if they had participated in any other investigational study within 30 days, were pregnant or breastfeeding, or were already being followed by a lipid clinic at the time of enrollment. Patients were not excluded on the basis of current lipid levels or statin use at the time of enrollment. The study enrollment was stopped in October of 2004 when it was determined by a monitoring committee that there was little likelihood of showing a clinical difference between the 2 treatment groups. Clinical follow-up was obtained for 24 months in all enrolled patients. Some 6% of patients (79/1233) were lost to follow-up at 24 months (Figure 1). Mortality was confirmed in all enrolled patients using the national death registries. Only 13 patients had less than a 6-month clinical follow-up, and 4 patients had no clinical follow-up since enrollment. All analyses were done on an intention-to-treat basis.
      Figure thumbnail gr1
      Figure 1Screening, enrollment, and follow-up.

      Study Design and Protocol

      This was a single-center, prospective, open-label, outpatient, randomized study to compare active lipid management in the lipid clinic versus usual care by the patients’ care providers. Patients presenting to the cardiac catheterization laboratory were asked to participate in the study, sign informed consent form, and provide fasting blood samples. Patients were randomly assigned in a 1:1 ratio to the lipid clinic or their usual caregivers (standard therapy) for lipid management. All patients had assigned primary care providers within the health system, and nearly all patients had precatheterization evaluation by a cardiologist. Patient demographics and clinical, angiographic, and fasting lipid profiles were collected at the time of enrollment. Primary care and cardiology providers of both patient groups were notified of the angiography results and had electronic medical record access to baseline and all subsequent lipid testing results. Patients randomized to the lipid clinic were managed in a specialized telephone-based computerized clinic staffed by trained nonphysician health care professionals using a proprietary lipid workflow program. The lipid clinic followed a standard lipid management algorithm based on patients’ lipid levels and response to therapy (Figure 2). Delegated physician authority was given to the lipid clinic staff to optimize drug therapy by escalating doses of statins to achieve target lipid levels, provide lifestyle counseling, manage medication side effects, monitor laboratory results, and ensure patient medication and laboratory compliance by mail or telephone. The aim was to maximize statin therapy and achieve a low-density lipoprotein (LDL) cholesterol level less than 100 mg/dL (Figure 2). All changes in treatment were electronically communicated to their physician. All patients enrolled in the study were scheduled to have a fasting serum lipid profile and alanine aminotransferase (ALT) measured at 6 months and 2 years. Clinical data were also collected at the same intervals through telephone interviews and chart reviews.
      Figure thumbnail gr2
      Figure 2Lipid clinic algorithm. FLPP=fasting lipid profile; ALT=alanine aminotransferase; D/C=discontinue; LDL=LDL cholesterol. %Statins: May substitute simvastatin with atorvastatin or pravastatin at equivalent doses. #Niacin (long acting): Start with 500 mg/d and increase as tolerated to 3 g/d. +Fibrates: fenofibrate 67 mg/d to maximum 200 mg/d; may substitute gemfibrozil 600 mg twice daily. ∧Bile acids: colesevelam 625 mg, 3 tablets twice per day with meals; may substitute cholestyramine or colestipol 2 to 6 scoops twice daily with meals.

      End Points

      The primary end point of this study was to compare the incidence of major adverse cardiac events (MACE), defined as the composite of death, nonfatal myocardial infarction, stroke, percutaneous coronary intervention, and coronary artery bypass surgery at 2 years follow-up between the lipid clinic group and the standard care group. Secondary end points included individual components of the primary end point and target LDL cholesterol level of less than 100 mg/dL at 6 months and 2 years. Death was defined as death due to any cause. Myocardial infarction was defined as the presence of either 2 of the 3 following criteria: chest pain of anginal character lasting more than 30 minutes, biochemical marker of myocardial damage (troponin or creatine phosphokinase MB-fraction), or new Q-waves in a standard 12-lead electrocardiogram in 2 or more contiguous leads. Stroke was defined as any permanent, documented (clinically and/or by neurologic imaging) neurologic impairment. Percutaneous coronary intervention was defined as any coronary balloon angioplasty, stent implantation, and atherectomy or thrombus removal other than in the index enrollment period. Coronary artery bypass surgery included any coronary bypass procedure in the follow-up period. Rehospitalization was defined as admission to the hospital with cardiac symptoms requiring 1 day or more in the hospital. All analysis was done as intention to treat.

      Statistical Analysis

      All data were maintained, monitored, and analyzed by a central data-coordinating center. Statistical analyses were done using SAS (SAS Institute Inc, Cary, NC) or SPSS (SPSS Inc, Chicago, Ill) statistical software. Continuous variables were reported as means and standard deviations and compared with a 2-sample t test. The categoric variables were reported as proportions and compared with chi-square and Fisher exact tests. The primary end point was calculated as the percentage of enrolled patients between the groups and compared with the chi-square test. The difference in event-free survival was also evaluated with survival curves using the Kaplan-Meier method and compared with the log-rank test. A P value of less than .05 was considered significant. The Henry Ford Hospital Institutional Review Board approved the study protocol.
      On the basis of an initial pilot 100-patient data collection, we anticipated a 60% rate of statin use and a 27% MACE incidence over 2 years of follow-up in the control group. Thus, after accounting for a 5% expected dropout rate, we intended to enroll 2260 patients in the trial to provide 80% or greater power to detect a 20% primary end point reduction in the lipid clinic group using a 2-sided alpha=0.05. Study conduct, enrollment, and data collection were reviewed throughout by a Steering Committee blinded to group assignment. The Steering Committee recommended early termination of patient enrollment in October of 2004 after randomization of 1233 patients because of apparent inadequate group differences in lipid results. All enrolled patients were followed for at least 24±6 months for lipid results and clinical end points.

      Results

      Patients in the 2 groups were demographically and clinically well matched at baseline (Table 1). Sixty percent of 617 patients in the lipid clinic group and 63% of the 616 patients in the standard care group were receiving statin therapy at the time of enrollment (P=.59). The percentages of patients with LDL cholesterol less than 100 mg/dL at study entry were 45% and 48% (P=.59) in the lipid clinic and standard care groups, respectively (Table 2).
      Table 1Baseline Characteristics of Patients
      VariableLipid Clinic N=617Standard Care N=616P value
      Demographics and history
      Age, y (mean±SD)64±1165±11.74
      Male sex, No. (%)381 (62)386 (63).91
      White race, No. (%)407 (66)386 (63).60
      Hypertension, No. (%)490 (79)505 (82).74
      Diabetes, No. (%)202 (33)221 (36).45
      Family history of CAD, No. (%)209 (34)207 (34).99
      Current smoker, No. (%)102 (17)119 (19).32
      History of hyperlipidemia, No. (%)488 (79)475 (77).80
      Prior myocardial infarction, No. (%)118 (19)127 (21).64
      Prior percutaneous coronary intervention, No. (%)134 (22)124 (20).63
      Prior coronary bypass surgery, No. (%)98 (16)86 (14).46
      Prior stroke, No. (%)46 (7)39 (6).54
      Peripheral vascular disease, No. (%)81 (13)66 (11).28
      Medications at enrollment
      Aspirin, No. (%)501 (81)500 (81).99
      Beta-blocker, No. (%)408 (66)442 (72).38
      ACE inhibitor, No. (%)296 (48)294 (48).99
      Statin, No. (%)369 (60)389 (63).59
      Indications for angiography and findings
      Unstable angina, No. (%)172 (28)176 (29).88
      ST-elevation MI, No. (%)18 (3)21 (3).75
      Non ST-elevation MI, No. (%)96 (16)86 (14).55
      Abnormal stress test, No. (%)241 (39)255 (41).62
      Left ventricular ejection fraction (mean±SD)50±1450±12.95
      Severe (>70% diameter) coronary stenosis, No. (%)425 (69)438 (71).75
      1-vessel disease, No. (%)201 (47)220 (52).45
      2-vessel disease, No. (%)127 (30)91 (21).03
      3-vessel disease, No. (%)70 (16)94 (21).09
      Left main disease, No. (%)27 (6)24 (5).79
      SD=standard deviation; CAD=coronary artery disease; ACE=angiotensin-converting enzyme; MI=myocardial infarction.
      Table 2Baseline Lipid Profiles of Patients
      VariableLipid Clinic N=617Standard Care N=616P value
      Total cholesterol mg/dL±SD180±47181±47.86
      LDL cholesterol mg/dL±SD107±38106±37.72
      Triglycerides mg/dL±SD153±125162±188.36
      HDL cholesterol mg/dL±SD44±1343±12.32
      ALT Units/L±SD28±8223±16.23
      % with LDL <100 mg/dL4548.33
      SD=standard deviation; LDL=low-density lipoprotein; HDL=high-density lipoprotein; ALT=alanine aminotransferase.

      Primary End Point

      There was no difference in the composite primary end point of major cardiovascular events between the 2 groups (12.3% vs 11.4%, P=.62) (Figure 3). Time-to-event analysis using event-free Kaplan-Meier survival curves did not show a difference in outcomes between the groups (Figure 4).
      Figure thumbnail gr3
      Figure 3Comparison of clinical outcomes at 2 years (%) between the groups. MACE=major adverse cardiac events, MI=myocardial infarction, PCI=percutaneous coronary intervention, CABG=coronary bypass surgery.
      Figure thumbnail gr4
      Figure 4Kaplan-Meier major cardiovascular event-free survival curves. MACE=major adverse cardiac events.

      Secondary Lipid End Points

      There were no differences in the proportion of patients with LDL concentrations less than 100 mg/dL at 6 months (63.4% vs 58.3%, P=.10) or 2 years (77.5% vs 77.6%, P=.96) between the lipid clinic and standard care groups, respectively. At 6 months, the lipid clinic group had lower total cholesterol (170±39 mg/dL vs 177±40 mg/dL, P=.04) and LDL cholesterol (94±33 mg/dL vs 98±33 mg/dL, P=.03) (Table 3). There was no difference in total cholesterol (166±42 mg/dL vs 166±41 mg/dL , P=.83) and LDL cholesterol (84±32 mg/dL vs 85±32 mg/dL, P=.28) at the 2-year follow-up (Table 3). The lipid clinic group had marginally higher high-density lipoprotein cholesterol (53±16 mg/dL vs 51±15 mg/dL, P=.017). More patients in the lipid clinic group were receiving statins at 6 months (84% vs 79%, P=.02) and 2 years (94% vs 88%, P<.001). The mean ALT was similar between the groups at 6 months and the end of the study. Four patients in the lipid clinic group and 1 patient in the standard care group had an ALT level 3 times greater than normal values. One patient in the lipid clinic group developed reversible hepatic insufficiency, which was later confirmed to be caused by viral hepatitis. There were no cases of rhabdomyolysis clinically reported in the study population.
      Table 3Comparison of Lipid Profiles at Six Months and Study Completion
      VariableLipid ClinicStandard CareP Value
      6 mo
      Total cholesterol mg/dL170±39177±40.004
      LDL cholesterol mg/dL94±3398±33.03
      Triglycerides mg/dL157±105168±116.15
      HDL cholesterol mg/dL45±1346±13.56
      2 y
      Total cholesterol mg/dL166±42166±41.83
      LDL cholesterol mg/dL84±3285±32.28
      Triglycerides mg/dL145±94147±95.47
      HDL cholesterol mg/dL53±1651±15.02
      ALT Units/L±SD24±1823±14.26
      LDL=low-density lipoprotein; HDL=high-density lipoprotein; ALT=alanine aminotransferase; SD=standard deviation.

      Discussion

      In a US tertiary care setting, we showed that implementation of a lipid clinic does not improve long-term hyperlipidemia management or clinical outcomes among patients with angiographically documented coronary artery disease.
      Many studies have demonstrated that secondary prevention with statins in patients with established coronary artery disease results in improved cardiovascular outcome.
      Heart Protection Study Collaborative Group
      MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial.
      • Shepherd J.
      • Cobbe S.M.
      • Ford I.
      • et al.
      West of Scotland Coronary Prevention Study Group
      Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
      • Downs J.R.
      • Clearfield M.
      • Weis S.
      • et al.
      AFCAPS/TexCAPS Research Group
      Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS.
      Scandinavian Simvastatin Survival Study Group
      Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S).
      • Sacks F.M.
      • Pfeffer M.A.
      • Moye L.
      • et al.
      The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels.
      The Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group
      Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels.
      More recent studies have demonstrated that statins reduce cardiovascular events regardless of the pretreatment LDL cholesterol level in higher risk patients.
      Heart Protection Study Collaborative Group
      MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial.
      • Cannon C.P.
      • Braumwald E.
      • McCabe C.H.
      • et al.
      Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction-22 Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
      Therefore, revised guidelines have recommended even more aggressive LDL reduction in such patients, advocating LDL cholesterol target concentrations of less than 70 mg/dL in patients with acute coronary syndromes or ongoing risk factors.
      • Grundy S.M.
      • Cleeman J.I.
      • Merz N.B.
      • et al.
      Coordinating Committee of the National Cholesterol Education Program
      Implications of the recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines.
      Most positive randomized studies using statins for secondary therapy have generated differences of 20 to 40 mg/dL between treatment and control groups, leading to significant difference in clinical outcome.
      Heart Protection Study Collaborative Group
      MRC/BHF heart protection study of cholesterol lowering with simvastatin in 20536 high-risk individuals: a randomised placebo-controlled trial.
      • Shepherd J.
      • Cobbe S.M.
      • Ford I.
      • et al.
      West of Scotland Coronary Prevention Study Group
      Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia.
      • Downs J.R.
      • Clearfield M.
      • Weis S.
      • et al.
      AFCAPS/TexCAPS Research Group
      Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS.
      Scandinavian Simvastatin Survival Study Group
      Randomized trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S).
      • Sacks F.M.
      • Pfeffer M.A.
      • Moye L.
      • et al.
      The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels.
      The Long-term Intervention with Pravastatin in Ischemic Disease (LIPID) Study Group
      Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels.
      • Cannon C.P.
      • Braumwald E.
      • McCabe C.H.
      • et al.
      Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction-22 Intensive versus moderate lipid lowering with statins after acute coronary syndromes.
      The standard care group in the ALMICAD trial had a baseline LDL concentration of 106 mg/dL, a 63% rate of statin use at study entry, and an 88% rate of statin use at study end. Therefore, only a modest difference of 4 mg/dL was achieved in LDL cholesterol at 6 months, which entirely resolved at 2 years in the lipid clinic group versus standard care group. In this patient cohort, a specialized lipid clinic intervention had no clinical benefit because the majority of the patients in the control group were receiving high doses of effective statin therapy throughout the study. Because a majority of patients were already receiving statin therapy and had relatively low LDL cholesterol enrollment, the resultant low major cardiovascular event rate made it harder to show a difference between the treatment groups.
      Small sample size, a short follow-up duration, and significantly lower than expected rates of MACE also diminished the opportunity for demonstrating lipid clinic benefit. This current study enrolled only half the calculated sample size and terminated early, limiting its ability to statistically evaluate differences in clinical outcomes. However, it is unlikely that the minimal initial difference in cholesterol levels would have resulted in significant differences in clinical outcome if sample size or follow-up duration was increased. The rate of primary end point was significantly lower than expected because of case selection and high rates of coronary artery disease secondary prevention efforts. It is possible that enrollment in the study may have sensitized or persuaded patients and providers toward more aggressive lipid management in this nonblinded study. It is more likely that the high rates of effective coronary artery disease secondary prevention in both groups were due to access and exposure to cardiologists before and after coronary angiography, and to our health care system’s emphasis on modifying coronary artery disease prognosis using aspirin, beta-blocker, angiotensin-converting enzyme inhibitor, revascularization, and high-dose statin therapy in all eligible patients. It is not clear whether a stricter treatment algorithm (aim for LDL cholesterol<70 mg/dL), upfront treatment with potent high-dose statins, or treatment of only patients with hyperlipidemia would have resulted in a different outcome.
      Despite robust data about secondary prevention and national guidelines, hyperlipidemia is not adequately treated in clinical practice.
      Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults
      Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III).
      The highest risk patients with established coronary artery disease, who benefit the most from lipid-lowering therapy, historically achieve LDL cholesterol targets at low rates in practice.
      • Pearson T.A.
      • Laurora I.
      • Chu H.
      • Kafonek S.
      The lipid treatment assessment project- a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals.
      • Marcello J.J.
      • Feingold K.
      Inadequate treatment with HMG-CoA reductase inhibitors by health care providers.
      Treatment of these patients in some specialized clinics has demonstrated better lipid control, but clinical efficacy studies are lacking.
      • Bloome M.
      • Saier R.
      • Bronken T.
      • Zarowitz B.
      Tele health attainment of lipid goals through automated workflow technology.
      • Harris D.E.
      • Record N.B.
      • Gipson G.W.
      • Pearson T.A.
      Lipid lowering in a multidisciplinary clinic compared with primary physician management.
      Therefore, resources required to implement such clinics have to be balanced with the potential benefits. A recent study reported that an aggressive atorvastatin treatment of patients with coronary artery disease in lipid-lowering disease-managed clinics resulted in better clinical outcome than usual care.
      • Koren M.J.
      • Hunninghake D.B.
      ALLIANCE Study investigators
      Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics.
      These patients, however, were treated with the aim to achieve LDL cholesterol less than 80 mg/dL with high-dose statins and followed for an average of 51.5 months.
      In our health care system, implementation of a lipid clinic failed to improve clinical outcomes largely because patients in the control group received similar aggressive lipid-lowering therapy. Study patients were dispersed throughout a large metropolitan area, and the lipid clinic employed midlevel providers to manage patients’ lipids through telephone and mail encounters. Medication status, lipid levels, and other laboratory safety parameters were monitored through proprietary computer software. Other health care systems with less cardiologist access or coronary artery disease prevention emphasis might generate more robust differences in lipid and clinical outcomes using a specialized lipid clinic or a more aggressive lipid management algorithm. However, experience from this study shows that it is likely that educating care providers about lipid management and emphasis on universal high-dose statin use in patients with established coronary artery disease may be equally appropriate uses of resources compared with managing patients in specialized lipid clinics.

      Conclusions

      This study demonstrates that follow-up in a specialized lipid clinic results in similar long-term achievement of target lipid goals and clinical outcomes compared with standard care by patient care providers. In a health care system with ready access to cardiovascular specialists and emphasis on aggressive coronary artery disease prevention, implementation of a lipid clinic does not improve clinical outcomes.

      Acknowledgments

      We acknowledge the Henry Ford Coordinating Center, Cardiac Catheterization Laboratory of Henry Ford Hospital, and study coordinators Lori Douthat, Diana Sydlowski, and Debra Hochberg for study support.

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