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Coronary Artery Disease (CAD): The Diagnosis Often Comes Too Late (Adapted from Levy et al.) Levy D et al in Textbook of Cardiovascular Medicine, 1998.

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Presentation on theme: "Coronary Artery Disease (CAD): The Diagnosis Often Comes Too Late (Adapted from Levy et al.) Levy D et al in Textbook of Cardiovascular Medicine, 1998."— Presentation transcript:

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2 Coronary Artery Disease (CAD): The Diagnosis Often Comes Too Late (Adapted from Levy et al.) Levy D et al in Textbook of Cardiovascular Medicine, 1998.

3 American Heart Association , 2000 Heart and Stroke Statistical Update, 1999; Braunwald E, N Engl J Med, 1997; Kannel WB in Atherosclerosis and Coronary Artery Disease, 1996. Vascular Disease: Scope of the Problem Vascular disease—and CAD in particular— is the leading cause of death in the US and other Western nations Vascular disease—and CAD in particular— is the leading cause of death in the US and other Western nations By 2020, cardiovascular disease will become the most common cause of death worldwide By 2020, cardiovascular disease will become the most common cause of death worldwide Due to the high initial mortality of vascular disease, the target of clinical practice must be aggressive risk factor management Due to the high initial mortality of vascular disease, the target of clinical practice must be aggressive risk factor management Vascular disease—and CAD in particular— is the leading cause of death in the US and other Western nations Vascular disease—and CAD in particular— is the leading cause of death in the US and other Western nations By 2020, cardiovascular disease will become the most common cause of death worldwide By 2020, cardiovascular disease will become the most common cause of death worldwide Due to the high initial mortality of vascular disease, the target of clinical practice must be aggressive risk factor management Due to the high initial mortality of vascular disease, the target of clinical practice must be aggressive risk factor management

4 Atherosclerosis: A Systemic Disease Aronow WS et al, Am J Cardiol, 1994. From a prospective analysis of 1886 patients aged  62 years, 810 patients were diagnosed with CAD as defined by a documented clinical history of MI, ECG evidence of Q-wave MI, or typical angina without previous MI. (Adapted from Aronow et al.)

5 (Adapted from Salonen.) Salonen R in Risk Factors for Ultrasonographically Assessed Common Carotid Atherosclerosis, 1991. Carotid IMT Predicts Coronary Events

6 Major Risk Factors for CAD Grundy SM et al, Circulation, 1998; Grundy SM, Circulation, 1999.

7 CAD Risk Is Incremental (Adapted from Neaton et al.) Neaton JD et al, Arch Intern Med, 1992.

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10 Most Myocardial Infarctions Are Caused by Low-Grade Stenoses Pooled data from 4 studies: Ambrose et al, 1988; Little et al, 1988; Nobuyoshi et al, 1991; and Giroud et al, 1992. (Adapted from Falk et al.) Falk E et al, Circulation, 1995.

11 Lesion Severity: A Poor Predictor of Survival From the Coronary Artery Surgery Study (CASS) as reported by Little et al. Little WC et al, Clin Cardiol, 1991.

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16 Angiography: Significant Limitations in Atheroma Assessment Angiography reflects a planar, 2-dimensional silhouette of the lumen Angiography reflects a planar, 2-dimensional silhouette of the lumen Remodeling Remodeling –Because angiography does not visualize the vessel wall, it cannot account for positive or negative remodeling Composition Composition –Because angiography does not assess plaque composition, it cannot differentiate lipid-rich, more vulnerable plaques Postprocedure Postprocedure –Due to plaque fissuring, angiography overestimates the degree of postintervention lumen expansion Angiography reflects a planar, 2-dimensional silhouette of the lumen Angiography reflects a planar, 2-dimensional silhouette of the lumen Remodeling Remodeling –Because angiography does not visualize the vessel wall, it cannot account for positive or negative remodeling Composition Composition –Because angiography does not assess plaque composition, it cannot differentiate lipid-rich, more vulnerable plaques Postprocedure Postprocedure –Due to plaque fissuring, angiography overestimates the degree of postintervention lumen expansion Nissen SE et al in Restenosis After Intervention With New Mechanical Devices, 1992; Yamashita T et al, Progress in Cardiovascular Diseases, 1999; Topol EJ et al, Circulation, 1995.

17 (Adapted from Glagov et al.) Coronary Remodeling NormalvesselMinimalCAD Progression Compensatory expansion maintains constant lumen Expansion overcome: lumen narrows SevereCADModerateCAD Glagov et al, N Engl J Med, 1987.

18 3.1 mm Angiography Cannot Account for Coronary Remodeling

19 Atheroma Morphology by Ultrasound “Soft” Lipid-Laden Plaque “Hard” Fibrous Plaque

20 LAORAO Angiography Masks Complicated Lesions

21 Angiography Underestimates Diffuse Disease

22 What Is the Culprit Lesion? 58-year-old male with chronic stable angina Positive stress test with small reversible ischemic defect on nuclear scintigraphy Medical Rx, but 6 weeks later… 3-day history of unstable angina, including 30 minutes of rest pain Medically “cooled off” followed by angiography 58-year-old male with chronic stable angina Positive stress test with small reversible ischemic defect on nuclear scintigraphy Medical Rx, but 6 weeks later… 3-day history of unstable angina, including 30 minutes of rest pain Medically “cooled off” followed by angiography Case provided by the McLaren Heart and Vascular Center, Flint, Michigan; used with permission.

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24 Absence of Correlation Between Angiographic Results and Clinical Outcomes (Adapted from Brown et al.) (Adapted from Brown et al.) Brown BG et al, Circulation, 1993.

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27 Thin Cap With Lipid Core Thick Stable Fibrotic Cap Same Lumen Size: Different Atheromas

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29 Assessing Volumetric Atheroma Changes Trial performed at Kobe General Hospital (Kobe, Japan) Trial performed at Kobe General Hospital (Kobe, Japan) Hypothesis: patients with angiographically normal arteries receiving statin therapy will show reduced progression of coronary plaque as measured by IVUS Hypothesis: patients with angiographically normal arteries receiving statin therapy will show reduced progression of coronary plaque as measured by IVUS Trial performed at Kobe General Hospital (Kobe, Japan) Trial performed at Kobe General Hospital (Kobe, Japan) Hypothesis: patients with angiographically normal arteries receiving statin therapy will show reduced progression of coronary plaque as measured by IVUS Hypothesis: patients with angiographically normal arteries receiving statin therapy will show reduced progression of coronary plaque as measured by IVUS Takagi T et al, Am J Cardiol, 1997.

30 IVUS: Changes in Atheroma Volume Results for 25 patients (13 in the pravastatin group, 12 in the control group) who completed the study. These patients were similar at baseline with regard to dyslipidemia (LDL-C 200-260 mg/dL) and IVUS. Mean plaque index at baseline was 41.2%. Qualifying arteries had not undergone a procedure and were angiographically normal (<25% lumen reduction). (Adapted from Takagi et al.) Statin reduced TC and LDL-C; no change in HDL-C or TG Statin reduced TC and LDL-C; no change in HDL-C or TG Takagi T et al, Am J Cardiol, 1997.

31 Ongoing Statin Trials Utilizing IVUS: REVERSAL Primary hypothesis A large (vs moderate) reduction in LDL-C will cause a greater decrease in the total atherosclerotic burden in patients with established CAD measured by IVUS A large (vs moderate) reduction in LDL-C will cause a greater decrease in the total atherosclerotic burden in patients with established CAD measured by IVUS Secondary hypothesis The reduction in plaque burden as assessed by IVUS will be evident despite the absence of any angiographically apparent improvement The reduction in plaque burden as assessed by IVUS will be evident despite the absence of any angiographically apparent improvement Primary hypothesis A large (vs moderate) reduction in LDL-C will cause a greater decrease in the total atherosclerotic burden in patients with established CAD measured by IVUS A large (vs moderate) reduction in LDL-C will cause a greater decrease in the total atherosclerotic burden in patients with established CAD measured by IVUS Secondary hypothesis The reduction in plaque burden as assessed by IVUS will be evident despite the absence of any angiographically apparent improvement The reduction in plaque burden as assessed by IVUS will be evident despite the absence of any angiographically apparent improvement Data on file, Pfizer Inc., New York, NY.

32 REVERSAL: Study Design International, prospective, randomized, multicenter, double-blind International, prospective, randomized, multicenter, double-blind Projected completion: 2002 Projected completion: 2002 International, prospective, randomized, multicenter, double-blind International, prospective, randomized, multicenter, double-blind Projected completion: 2002 Projected completion: 2002 Data on file, Pfizer Inc., New York, NY.

33 Interventions Beyond Lipid Reduction Lichtlen PR et al, Lancet, 1990; Waters D et al, Circulation, 1990; Borhani NO et al, JAMA, 1996.

34 CCB Imaging Trials: Results INTACT–CCB showed significantly lower rate of new lesions; neutral effect on existing lesions INTACT–CCB showed significantly lower rate of new lesions; neutral effect on existing lesions Montreal Heart Study–CCB showed significantly less progression of early lesions; neutral effect on existing lesions overall Montreal Heart Study–CCB showed significantly less progression of early lesions; neutral effect on existing lesions overall MIDAS–CCB showed initial effect on IMT; but there was no subsequent difference MIDAS–CCB showed initial effect on IMT; but there was no subsequent difference Although these trials were not powered for clinical end points, the shorter-acting CCBs exerted neutral effects overall; nonsignificant trends suggested poorer outcomes in at least one study Although these trials were not powered for clinical end points, the shorter-acting CCBs exerted neutral effects overall; nonsignificant trends suggested poorer outcomes in at least one study INTACT–CCB showed significantly lower rate of new lesions; neutral effect on existing lesions INTACT–CCB showed significantly lower rate of new lesions; neutral effect on existing lesions Montreal Heart Study–CCB showed significantly less progression of early lesions; neutral effect on existing lesions overall Montreal Heart Study–CCB showed significantly less progression of early lesions; neutral effect on existing lesions overall MIDAS–CCB showed initial effect on IMT; but there was no subsequent difference MIDAS–CCB showed initial effect on IMT; but there was no subsequent difference Although these trials were not powered for clinical end points, the shorter-acting CCBs exerted neutral effects overall; nonsignificant trends suggested poorer outcomes in at least one study Although these trials were not powered for clinical end points, the shorter-acting CCBs exerted neutral effects overall; nonsignificant trends suggested poorer outcomes in at least one study Lichtlen PR et al, Lancet, 1990; Waters D et al, Circulation, 1990; Borhani NO et al, JAMA, 1996.

35 Ongoing IVUS/Calcium Channel Blocker Trial: CAMELOT/NORMALISE CAMELOT hypothesis Whether amlodipine will reduce major cardiac end points in patients with CAD compared with enalapril and placebo Whether amlodipine will reduce major cardiac end points in patients with CAD compared with enalapril and placebo NORMALISE (substudy) hypothesis Whether amlodipine will reduce the progression of coronary atherosclerosis as measured by IVUS (vs QCA) Whether amlodipine will reduce the progression of coronary atherosclerosis as measured by IVUS (vs QCA) CAMELOT hypothesis Whether amlodipine will reduce major cardiac end points in patients with CAD compared with enalapril and placebo Whether amlodipine will reduce major cardiac end points in patients with CAD compared with enalapril and placebo NORMALISE (substudy) hypothesis Whether amlodipine will reduce the progression of coronary atherosclerosis as measured by IVUS (vs QCA) Whether amlodipine will reduce the progression of coronary atherosclerosis as measured by IVUS (vs QCA) Data on file, Pfizer Inc., New York, NY.

36 CAMELOT/NORMALISE: Study Design International, prospective, randomized, multicenter, double-blind International, prospective, randomized, multicenter, double-blind Projected completion: 2003 Projected completion: 2003 International, prospective, randomized, multicenter, double-blind International, prospective, randomized, multicenter, double-blind Projected completion: 2003 Projected completion: 2003 Data on file, Pfizer Inc., New York, NY.

37 IVUS: An Invaluable Research Tool Correlates more closely with clinical end points than angiography, which is insensitive until lesions are relatively advanced Correlates more closely with clinical end points than angiography, which is insensitive until lesions are relatively advanced Reveals direct effects on plaque of treatments for atherosclerosis as well as modifications of its predisposing risks Reveals direct effects on plaque of treatments for atherosclerosis as well as modifications of its predisposing risks Used in conjunction with angiography, IVUS is uncovering new data about vascular response and atherogenesis Used in conjunction with angiography, IVUS is uncovering new data about vascular response and atherogenesis Correlates more closely with clinical end points than angiography, which is insensitive until lesions are relatively advanced Correlates more closely with clinical end points than angiography, which is insensitive until lesions are relatively advanced Reveals direct effects on plaque of treatments for atherosclerosis as well as modifications of its predisposing risks Reveals direct effects on plaque of treatments for atherosclerosis as well as modifications of its predisposing risks Used in conjunction with angiography, IVUS is uncovering new data about vascular response and atherogenesis Used in conjunction with angiography, IVUS is uncovering new data about vascular response and atherogenesis Nissen SE et al in Textbook of Cardiovascular Medicine, 1998; Yamashita T et al, Progress in Cardiovascular Diseases, 1999; Topol EJ et al, Circulation, 1995.

38 Atherosclerosis Begins in Childhood (Adapted from Berenson et al.) Berenson GS et al, N Engl J Med, 1998.

39 Tuzcu EM et al, in press. One in Six Teenagers Has Atheromas (Adapted from Tuzcu et al.)

40 Consistent Evidence of Early Atherosclerosis (Adapted from Berenson et al and Tuzcu et al.) Berenson GS et al, N Engl J Med, 1998; Tuzcu EM et al, in press.

41 CAD: Silent Disease Necessitates Aggressive Risk Factor Management IVUS corroborates necroscopy studies, proving that atherosclerosis begins in youth IVUS corroborates necroscopy studies, proving that atherosclerosis begins in youth CAD progresses silently; the initial presentation is usually MI or sudden death CAD progresses silently; the initial presentation is usually MI or sudden death Most atheromas are extraluminal, rendering them angiographically silent Most atheromas are extraluminal, rendering them angiographically silent The only reasonable approach is early and aggressive risk factor management The only reasonable approach is early and aggressive risk factor management IVUS corroborates necroscopy studies, proving that atherosclerosis begins in youth IVUS corroborates necroscopy studies, proving that atherosclerosis begins in youth CAD progresses silently; the initial presentation is usually MI or sudden death CAD progresses silently; the initial presentation is usually MI or sudden death Most atheromas are extraluminal, rendering them angiographically silent Most atheromas are extraluminal, rendering them angiographically silent The only reasonable approach is early and aggressive risk factor management The only reasonable approach is early and aggressive risk factor management Berenson GS et al, N Engl J Med, 1998; Tuzcu EM et al, in press; Levy D et al in Textbook of Cardiovascular Medicine, 1998 ; Yamashita T et al, Progress in Cardiovascular Diseases, 1999; Topol EJ et al, Circulation, 1995. Kannel WB in Atherosclerosis and Coronary Artery Disease, 1996.

42 The Correlation Between Atherosclerosis and Risk Factors Begins Early (Adapted from Berenson et al.) Berenson GS et al, N Engl J Med, 1998.

43 Small Increases in Cholesterol Lead to Dramatic Increases in CAD Death (Adapted from Neaton et al.) Neaton JD et al, Arch Intern Med, 1992.

44 CAD: Not Just a Lipid Disease Half of all MIs occur in normolipidemic patients Half of all MIs occur in normolipidemic patients Smoking Accounts for 200,000 cardiovascular deaths annually Smoking Accounts for 200,000 cardiovascular deaths annually Diabetes Affects 16 million Americans—and is growing Diabetes Affects 16 million Americans—and is growing Hypertension Confers as much risk for MI as smoking or dyslipidemia Hypertension Confers as much risk for MI as smoking or dyslipidemia –Systolic hypertension is an even greater indicator of CAD risk than diastolic hypertension Half of all MIs occur in normolipidemic patients Half of all MIs occur in normolipidemic patients Smoking Accounts for 200,000 cardiovascular deaths annually Smoking Accounts for 200,000 cardiovascular deaths annually Diabetes Affects 16 million Americans—and is growing Diabetes Affects 16 million Americans—and is growing Hypertension Confers as much risk for MI as smoking or dyslipidemia Hypertension Confers as much risk for MI as smoking or dyslipidemia –Systolic hypertension is an even greater indicator of CAD risk than diastolic hypertension Braunwald E, N Engl J Med, 1997; Grundy SM et al, Circulation, 1998; The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the National High Blood Pressure Education Program Coordinating Committee, Arch Intern Med, 1997.

45 Systolic BP Confers Incremental Risk Even Within “Normal” Levels (Adapted from Neaton et al.) Neaton JD et al, Arch Intern Med, 1992.

46 CAD Risk Factors: Minimal and Optimal Grundy SM, Circulation, 1999; American Heart Association Consensus Panel, Circulation, 1995; The Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure and the National High Blood Pressure Education Program Coordinating Committee, Arch Intern Med, 1997.

47 Conclusions: Critical Lessons in Understanding Atherogenesis CAD is a ubiquitous, systemic disease that requires a systemic solution CAD is a ubiquitous, systemic disease that requires a systemic solution Most patients progress to MI or sudden death before a diagnosis of CAD is ever considered Most patients progress to MI or sudden death before a diagnosis of CAD is ever considered IVUS demonstrates that remodeling causes angiography to underestimate the extent of disease IVUS demonstrates that remodeling causes angiography to underestimate the extent of disease Extraluminal, angiographically silent atheromas are responsible for most acute coronary events, including sudden death Extraluminal, angiographically silent atheromas are responsible for most acute coronary events, including sudden death CAD is a ubiquitous, systemic disease that requires a systemic solution CAD is a ubiquitous, systemic disease that requires a systemic solution Most patients progress to MI or sudden death before a diagnosis of CAD is ever considered Most patients progress to MI or sudden death before a diagnosis of CAD is ever considered IVUS demonstrates that remodeling causes angiography to underestimate the extent of disease IVUS demonstrates that remodeling causes angiography to underestimate the extent of disease Extraluminal, angiographically silent atheromas are responsible for most acute coronary events, including sudden death Extraluminal, angiographically silent atheromas are responsible for most acute coronary events, including sudden death Aronow WS et al, Am J Cardiol, 1994; Levy D et al in Textbook of Cardiovascular Medicine, 1998; Nissen SE et al in Textbook of Cardiovascular Medicine, 1998; Falk E et al, Circulation, 1995.

48 Conclusions: Risk Factor Management Atherosclerosis begins in childhood and is strongly associated with major CAD risk factors from the youngest ages Atherosclerosis begins in childhood and is strongly associated with major CAD risk factors from the youngest ages Hypertension (particularly systolic), diabetes, and smoking—in addition to dyslipidemia—confer comparable risks Hypertension (particularly systolic), diabetes, and smoking—in addition to dyslipidemia—confer comparable risks The effect of these risk factors is continuous, extending even into the “normal” range The effect of these risk factors is continuous, extending even into the “normal” range Therefore, aggressive risk factor modification is the most effective strategy for reducing the consequences of CAD Therefore, aggressive risk factor modification is the most effective strategy for reducing the consequences of CAD Atherosclerosis begins in childhood and is strongly associated with major CAD risk factors from the youngest ages Atherosclerosis begins in childhood and is strongly associated with major CAD risk factors from the youngest ages Hypertension (particularly systolic), diabetes, and smoking—in addition to dyslipidemia—confer comparable risks Hypertension (particularly systolic), diabetes, and smoking—in addition to dyslipidemia—confer comparable risks The effect of these risk factors is continuous, extending even into the “normal” range The effect of these risk factors is continuous, extending even into the “normal” range Therefore, aggressive risk factor modification is the most effective strategy for reducing the consequences of CAD Therefore, aggressive risk factor modification is the most effective strategy for reducing the consequences of CAD Berenson GS et al, N Engl J Med, 1998; Braunwald E, N Engl J Med, 1997; Neaton JD et al, Arch Intern Med, 1992; Kannel WB in Atherosclerosis and Coronary Artery Disease, 1996.

49 “Awaiting overt signs and symptoms of coronary disease before treatment is no longer justified.” “In some respects, the occurrence of symptoms may be regarded more properly as a medical failure than as the initial indication for treatment.” —William B. Kannel, MD Department of Medicine Boston University Medical Center “Awaiting overt signs and symptoms of coronary disease before treatment is no longer justified.” “In some respects, the occurrence of symptoms may be regarded more properly as a medical failure than as the initial indication for treatment.” —William B. Kannel, MD Department of Medicine Boston University Medical Center Kannel WB in Atherosclerosis and Coronary Artery Disease, 1996.

50 Supplemental Slides

51 Carotid Disease: A Reliable Predictor of Coronary Risk Carotid atherosclerosis, even when very mild, is associated with MI and sudden cardiac death Carotid atherosclerosis, even when very mild, is associated with MI and sudden cardiac death Ultrasound-derived carotid intimal-medial thickness (IMT) has been shown to predict the risk of MI Ultrasound-derived carotid intimal-medial thickness (IMT) has been shown to predict the risk of MI The same risk factors predispose patients to atherosclerosis in both the coronary and carotid arterial systems The same risk factors predispose patients to atherosclerosis in both the coronary and carotid arterial systems Carotid atherosclerosis, even when very mild, is associated with MI and sudden cardiac death Carotid atherosclerosis, even when very mild, is associated with MI and sudden cardiac death Ultrasound-derived carotid intimal-medial thickness (IMT) has been shown to predict the risk of MI Ultrasound-derived carotid intimal-medial thickness (IMT) has been shown to predict the risk of MI The same risk factors predispose patients to atherosclerosis in both the coronary and carotid arterial systems The same risk factors predispose patients to atherosclerosis in both the coronary and carotid arterial systems Salonen R in Risk Factors for Ultrasonographically Assessed Common Carotid Atherosclerosis, 1991; O’Leary DH et al, N Engl J Med, 1999; Androulakis AE et al, Eur Heart J, 2000.

52 Emerging Risk Factors Increased serum homocysteine Increased serum homocysteine Increased lipoprotein (a) (Lp[a]) Increased lipoprotein (a) (Lp[a]) Increased C-reactive protein (CRP) Increased C-reactive protein (CRP) Chlamydia pneumoniae infection Chlamydia pneumoniae infection Estrogen deficiency Estrogen deficiency Coagulation factor abnormalities Coagulation factor abnormalities –Plasma fibrinogen –Factor VII –Endogenous tissue plasminogen activator –Plasminogen-activator inhibitor type I –D -Dimer Increased serum homocysteine Increased serum homocysteine Increased lipoprotein (a) (Lp[a]) Increased lipoprotein (a) (Lp[a]) Increased C-reactive protein (CRP) Increased C-reactive protein (CRP) Chlamydia pneumoniae infection Chlamydia pneumoniae infection Estrogen deficiency Estrogen deficiency Coagulation factor abnormalities Coagulation factor abnormalities –Plasma fibrinogen –Factor VII –Endogenous tissue plasminogen activator –Plasminogen-activator inhibitor type I –D -Dimer Braunwald E, N Engl J Med, 1997.

53 Multiple Risk Factors: Additive Risk Grundy SM et al, J Am Coll Cardiol, 1999; Data on file, Pfizer Inc., New York, NY. Risk of developing CAD over 10 years according to specified BP levels and other risk factors. Calculations are based on a Framingham Heart Study computer program, which includes variables for systolic BP, diastolic BP, TC, HDL-C, LVH by ECG, cigarette smoking, and glucose intolerance. The following remained constant unless otherwise indicated: male, age 45 years, TC 180 mg/dL, HDL 45, and nonsmoker. Elevated LDL-C estimated based on TC 250 mg/dL with triglycerides 200 mg/dL. (Data on file, Pfizer Inc.)

54 Angiography Underestimates Diffuse Disease Nissen SE et al in Textbook of Cardiovascular Medicine, 1998; Topol EJ et al, Circulation, 1995.

55 An Apparently Successful Angioplasty PreinterventionPreintervention PostinterventionPostintervention

56 AA CC B D

57 Angiography Has Major Limitations in Assessing Complicated Lesions Nissen SE et al in Textbook of Cardiovascular Medicine, 1998; Topol EJ et al, Circulation, 1995.

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59 Precision Cross-Sectional Planimetry Lumen 5.51 mm 2 Direct and Calculated Atheroma Measurements EEM — 15.47 mm 2 Atheroma Area — 9.96 mm 2 Area Reduction — 64.4%

60 Atheroma Morphology by Ultrasound Moderate Calcification Severe Calcification

61 Morphology of Ruptured Atheroma Fibrous Cap Fracture With “Escape” of Lipid Core Fracture Site “Missing” Lipid Core

62 ENCORE: A CCB/Statin IVUS Trial Lüscher TF et al, Eur Heart J Supplements, 2000. ENCORE I hypothesis: CCB and/or statin therapy will improve coronary endothelial function in CAD patients ENCORE I hypothesis: CCB and/or statin therapy will improve coronary endothelial function in CAD patients Prospective, randomized, double-blind (completed 2/00; results TBA) Prospective, randomized, double-blind (completed 2/00; results TBA) ENCORE I hypothesis: CCB and/or statin therapy will improve coronary endothelial function in CAD patients ENCORE I hypothesis: CCB and/or statin therapy will improve coronary endothelial function in CAD patients Prospective, randomized, double-blind (completed 2/00; results TBA) Prospective, randomized, double-blind (completed 2/00; results TBA)

63 Hypothesis: endothelial function improved by statin therapy ±CCB will correlate with atheroma regression as measured by IVUS Hypothesis: endothelial function improved by statin therapy ±CCB will correlate with atheroma regression as measured by IVUS Prospective, randomized, double-blind Prospective, randomized, double-blind Projected completion: 2002 Projected completion: 2002 Hypothesis: endothelial function improved by statin therapy ±CCB will correlate with atheroma regression as measured by IVUS Hypothesis: endothelial function improved by statin therapy ±CCB will correlate with atheroma regression as measured by IVUS Prospective, randomized, double-blind Prospective, randomized, double-blind Projected completion: 2002 Projected completion: 2002 Lüscher TF et al, Eur Heart J Supplements, 2000. ENCORE II: IVUS and Endothelial Function

64 Limitations of IVUS Visualizes only one artery at a time Visualizes only one artery at a time Only arteries capable of accommodating the IVUS catheter may be examined Only arteries capable of accommodating the IVUS catheter may be examined May be distorted May be distorted Delineates thickness and echogenicity but not actual histology Delineates thickness and echogenicity but not actual histology More costly than angiography (although its benefits may be cost-effective) More costly than angiography (although its benefits may be cost-effective) Visualizes only one artery at a time Visualizes only one artery at a time Only arteries capable of accommodating the IVUS catheter may be examined Only arteries capable of accommodating the IVUS catheter may be examined May be distorted May be distorted Delineates thickness and echogenicity but not actual histology Delineates thickness and echogenicity but not actual histology More costly than angiography (although its benefits may be cost-effective) More costly than angiography (although its benefits may be cost-effective) Yamashita T et al, Progress in Cardiovascular Diseases, 1999; Topol EJ et al, Circulation, 1995; Nissen SE et al, Circulation, in press.

65 Other Emerging Imaging Modalities Angioscopy uses visible light via fiberoptic filaments Angioscopy uses visible light via fiberoptic filaments –Allows direct examination of surface characteristics and intraluminal morphology Doppler uses a catheter device to measure the velocity of red blood cells and identify flow patterns Doppler uses a catheter device to measure the velocity of red blood cells and identify flow patterns FFR (fractional flow reserve) uses a nonobstructive catheter to measure flow after maximum vasodilation FFR (fractional flow reserve) uses a nonobstructive catheter to measure flow after maximum vasodilation –Compares the maximum flow of a stenotic vessel with the same vessel without stenosis MRI (magnetic resonance imaging) allows noninvasive imaging of the cardiovascular system MRI (magnetic resonance imaging) allows noninvasive imaging of the cardiovascular system –MRI may be used to investigate coronary blood flow but the direct analysis of atheroma remains unlikely Angioscopy uses visible light via fiberoptic filaments Angioscopy uses visible light via fiberoptic filaments –Allows direct examination of surface characteristics and intraluminal morphology Doppler uses a catheter device to measure the velocity of red blood cells and identify flow patterns Doppler uses a catheter device to measure the velocity of red blood cells and identify flow patterns FFR (fractional flow reserve) uses a nonobstructive catheter to measure flow after maximum vasodilation FFR (fractional flow reserve) uses a nonobstructive catheter to measure flow after maximum vasodilation –Compares the maximum flow of a stenotic vessel with the same vessel without stenosis MRI (magnetic resonance imaging) allows noninvasive imaging of the cardiovascular system MRI (magnetic resonance imaging) allows noninvasive imaging of the cardiovascular system –MRI may be used to investigate coronary blood flow but the direct analysis of atheroma remains unlikely Nissen SE et al in Textbook of Cardiovascular Medicine, 1998; White RD in Textbook of Cardiovascular Medicine, 1998.

66 Diabetes: Half of All Patients Are Unaware of Their Condition CAD is the leading cause of hospitalization and death among patients with type 2 diabetes (NIDDM) CAD is the leading cause of hospitalization and death among patients with type 2 diabetes (NIDDM) Patients with both type 1 and type 2 diabetes are at a high short-term risk of CAD-related end points Patients with both type 1 and type 2 diabetes are at a high short-term risk of CAD-related end points Insulin resistance increases risk and may exist for 25 years or more before diabetes is diagnosed Insulin resistance increases risk and may exist for 25 years or more before diabetes is diagnosed Patients with diabetes tend to cluster other risk factors (such as hypertension and dyslipidemia) while diabetes confers risk unto itself Patients with diabetes tend to cluster other risk factors (such as hypertension and dyslipidemia) while diabetes confers risk unto itself CAD is the leading cause of hospitalization and death among patients with type 2 diabetes (NIDDM) CAD is the leading cause of hospitalization and death among patients with type 2 diabetes (NIDDM) Patients with both type 1 and type 2 diabetes are at a high short-term risk of CAD-related end points Patients with both type 1 and type 2 diabetes are at a high short-term risk of CAD-related end points Insulin resistance increases risk and may exist for 25 years or more before diabetes is diagnosed Insulin resistance increases risk and may exist for 25 years or more before diabetes is diagnosed Patients with diabetes tend to cluster other risk factors (such as hypertension and dyslipidemia) while diabetes confers risk unto itself Patients with diabetes tend to cluster other risk factors (such as hypertension and dyslipidemia) while diabetes confers risk unto itself Aronson D et al in Atherosclerosis and Coronary Artery Disease, 1996; Grundy SM et al, J Am Coll Cardiol, 1999.

67 UK Prospective Diabetes Study Group, BMJ, 1998. *UK Prospective Diabetes Study Group. *UK Prospective Diabetes Study Group. UKPDS*: The Case for Aggressive Blood Pressure Control Mean final BP: More-aggressive control, 144/82 mm Hg Less-aggressive control, 154/87 mm Hg Mean final BP: More-aggressive control, 144/82 mm Hg Less-aggressive control, 154/87 mm Hg


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