Antiplatelet Therapy in Primary CVD Prevention and Stable Coronary Artery Disease. Καρακώστας Γεώργιος Διευθυντής Καρδιολογικής Κλινικής, Γ.Ν.

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1 Antiplatelet Therapy in Primary CVD Prevention and Stable Coronary Artery Disease Καρακώστας Γεώργιος Διευθυντής Καρδιολογικής Κλινικής, Γ.Ν.Κιλκίς

2 Primary CVD Prevention A co-ordinated set of actions, at public and individual level, aimed at eradicating, eliminating or minimizing the impacts of CVDs and their related disability.

3 Why is prevention of CVD needed? Atherosclerotic CVD, especially CHD, remains the leading cause of premature death worldwide. Of all deaths that occur in Europe before the age of 75 years, 42% are due to CVD in women and 38% in men. Prevention works: >50% of the reduction seen in CVD mortality relates to changes in risk factors, and 40% to improved treatments. There is still room for improvements in risk factor control, even in individuals at very high risk.

4 The targets for primary CVD prevention Smoking cessation Healthy eating habits Adequate physical activity, at least 30 min 5 times a week Weight reduction in overweight and obese individuals Avoiding excessive stress and management of psychological factors Target HbA1c <7% in diabetic patients Blood pressure lowering treatment to 140/90mmHg in all hypertensive patients LDL-cholesterol levels <115mg/dl IA IB IA IA IA IA IIα, Α IIα, A

5 European Heart Journal (2012) 33,

6 European Heart Journal (2012) 33,

7 The absolute risk of vascular complications is the major determinant of the absolute benefit of antiplatelet prophylaxis. Chest 2001 ; 119 :39S 63S

8 A systematic review of six trials (N=95000) by the Antithrombotic Trialists Collaboration Primary End Point (Non-fatal MI, Non-fatal stroke, Vascular death) placebo Aspirin Risk reduction Proportional Risk reduction % Lancet 2009 ; 373 :

9 Aspirin use in men Aspirin use in women 32% relative risk reduction for MI 17% relative risk reduction for strokes No effect on stroke or all-cause mortality No effect on MI or all-cause mortality USPSTF, March 2009

10 GUSTO Bleeding Classification Severe or life-threatening Either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. Moderate Mild Bleeding that requires blood transfusion but does not result in hemodynamic compromise. Bleeding that does not meet criteria for either severe or moderate bleeding.

11

12 Absolute benefit and bleeding risk of aspirin in primary prevention

13 The use of antiplatelet drugs should be considered in patients for whom the benefits of antiplatelet therapy clearly outweigh the risk of bleeding complications.

14

15 Estimates of Benefits and Harms of Aspirin Therapy Given for 5 Years to 1,000 Individuals with Various Levels of Baseline Risk for Coronary Heart Disease Baseline risk for coronary heart disease over 5 years : 1% Total mortality: No effect CHD events: 1-4 avoided Hemorrhagic strokes: 0-2 caused Major gastrointestinal bleeding events: 2-4 caused Baseline risk for coronary heart disease over 5 years : 3% Total mortality: No effect CHD events: 4-12 avoided Hemorrhagic strokes: 0-2 caused Major gastrointestinal bleeding events: 2-4 caused Baseline risk for coronary heart disease over 5 years : 5% Total mortality: No effect CHD events: 6-20 avoided Hemorrhagic strokes: 0-2 caused Major gastrointestinal bleeding events: 2-4 caused Guide to Clinical Preventive Services 2007: Recommendations of the U.S.

16 Estimated myocardial infarctions (MIs) prevented and estimated harms of using aspirin for 10 years in a hypothetical cohort of 1000 men

17 Estimated number of strokes prevented and estimated harms of using aspirin for 10 years in a hypothetical cohort of 1000 women on the basis of age and 10-year stroke risk

18 Men 10-year CHD risk Women 10-year stroke risk Age years 4% Age years 3% Age years 9% Age years 8% Age years 12% Age years 11% U.S. Preventive Services Task Force (USPSTF) 2009

19

20 Aspirin European Heart Journal (2004) 25,

21 Clopidogrel European Heart Journal (2004) 25,

22 Main features of aspirin and clopidogrel Chest 2001;119:39S 63S.

23 Aspirin dose An association between increases in aspirin dose and risk of adverse events has been confirmed in multiple studies, whereas no such dose relationship has been identified efficacy. This suggests that every far effort should be made to minimize the long-term dosage. Currently available clinical data are most supportive of a 75 or 81 mg daily dose. JAMA 2007 ; 297(18) :

24 Aspirin should be recommended in very high risk patients: A calculated SCORE 10% Diabetes mellitus (type 1 or type 2) with one or more CV risk factors and/or target organ damage (such as microalbuminuria: mg/24 h). Severe chronic kidney disease (CKD) (GFR<30 ml/min/1.73 m2). Aspirin should not be considered in low and moderate risk patients. Aspirin may be considered in high risk patients (SCORE: 5-9%), especially in younger individuals, where the possibility of bleeding is quite low. However, more studies are required to elucidate the issue.

25 CHARISMA Trial Design Patients age 45 years at high risk of atherothrombotic events R (n=15603) Low dose ASA mg/day Double-blind treatment up to 1040 primary efficacy events* Clopidogrel 75 mg/day (n=7802) 1-month visit Low dose ASA mg/day 3-month visit Visits every 6 months Final visit (Fixed study end date) Placebo 1 tablet/day (n=7801) * MI (fatal or non-fatal), stroke (fatal or non-fatal), or cardiovascular death; event-driven trial Bhatt DL et al. Am Heart J 2004; 148:

26 Inclusion Criteria Patients aged 45 years with at least one of the following: 1A) Documented coronary disease and/or 1B) Documented cerebrovascular disease and/or 1C) Documented symptomatic PAD and/or 2) Two major or one major and two minor or three minor risk factors Bhatt DL et al. Am Heart J 2004; 148: With written informed consent Without exclusion criteria

27 Inclusion Criteria: Patients with Multiple Risk Factors For the risk factor only population, two major or one major and two minor or three minor atherothrombotic risk factors must be present ABI= Ankle Brachial Index Major risk factors Type 1 or 2 diabetes (treated with medications) Diabetic nephropathy ABI <0.9 Asymptomatic carotid stenosis 70% Presence of at least one carotid plaque Minor risk factors SBP 150 mm Hg (despite therapy) Primary hypercholesterolemia Currently smoking (>15 cigarettes per day) Male aged 65 years or female aged 70 years Bhatt DL et al. Am Heart J 2004; 148:

28 Primary outcome event rate (%) Multiple Risk Factor Subgroup: Primary Efficacy Outcome (MI/Stroke/CV Death) Clopidogrel + ASA* 6.6% Placebo + ASA* 5.5% RRR: -20% [95% CI: -58.8%, 9.3%] p= Months since randomization *All patients received ASA mg/day Bhatt DL. Presented at ACC 2006.

29 Multiple Risk Factor Population: Primary and Secondary Efficacy Results (MI/Stroke/CV Death/ Hospitalization) Clopidogrel Placebo + ASA + ASA Endpoint* N (%) (n=1659) (n=1625) RR (95% CI) p value Primary Efficacy Endpoint 109 (6.6) 89 (5.5) 1.20 (0.91, 1.59) 0.20 All Cause Mortality 89 (5.4) 62 (3.8) 1.41 (1.02, 1.95) 0.04 Cardiovascular Mortality 64 (3.9) 36 (2.2) 1.74 (1.16, 2.62) 0.01 Myocardial Infarction (nonfatal) 25 (1.5) 26 (1.6) 0.95 (0.55, 1.64) 0.84 Ischemic Stroke (nonfatal) 16 (1.0) 23 (1.4) 0.68 (0.36, 1.29) 0.24 Stroke (nonfatal) 20 (1.2) 27 (1.7) 0.73 (0.41, 1.29) 0.27 Principal Secondary Endpoint 224 (13.5) 216 (13.3) 1.01 (0.84, 1.22) 0.88 Hospitalization 140 (8.4) 147 (9.0) 0.93 (0.74, 1.18) 0.55 First occurrence of MI (fatal or not), stroke (fatal or not), cardiovascular death (including hemorrhagic death), or hospitalization for UA, TIA, or revascularization *Intention to treat analysis Components of the primary efficacy endpoint. Patients that did not die from CV causes, are counted for the first non-fatal event of MI or stroke. For UA, TIA, or revascularization Bhatt DL, Fox KA, Hacke W, et al. NEJM 2006.

30 Stable Coronary Artery Disease (SCAD) SCAD is characterized by episodes of reversible myocardial demand/supply mismatch, related to ischemia or hypoxia, which are reproducible and usually inducible by exercise, emotion or other stress. These episodes are commonly associated with transient chest discomfort (angina pectoris).

31 Mechanisms of myocardial ischemia Fixed or dynamic stenoses of epicardial coronary arteries Microvascular dysfunction Focal or diffuse epicardial coronary spasm The above mechanisms may overlap in the same patient and change over time. European Heart Journal (2013) 34,

32 Clinical Presentations Effort induced angina Rest angina caused by Vasospasm Silent ischemia Ischemic Cardiomyopathy European Heart Journal (2013) 34,

33 Classification of Angina severity according to Canadian Cardiovascular Society European Heart Journal (2013) 34,

34 Definition of Risk for various test modalities European Heart Journal (2013) 34,

35 THE SAPAT STUDY

36 Pharmacological treatments in SCAD patients European Heart Journal (2013) 34,

37 Medical management of patients with SCAD European Heart Journal (2013) 34,

38 Antiplatelet agents in patients with SCAD Low-dose aspirin (75-150mg/day) remains the cornerstone of pharmacological prevention in SCAD. The P2Y12 inhibitors (clopidogrel) should be proposed as a second line treatment, especially for aspirin-intolerant patients. The new P2Y12 inhibitors (prasugrel & ticagrelor) are both associated with a significant reduction of CV outcomes as compared with clopidogrel in ACS patients (THE TRITON TRIAL, THE PLATO TRIAL), but no clinical studies have evaluated the benefit of these drugs in SCAD patients.

39 Patients with Qualifying CV Disease (CAD, CVD or PAD): Primary Efficacy Outcome (MI/Stroke/CV Death) Primary outcome event rate (%) N=12,153 Placebo + ASA* 7.9% Clopidogrel +ASA* 6.9% 4 2 RRR: 12.5% [95% CI: 0.2%, 23.2%] p= Months since randomization *All patients received ASA mg/day Bhatt DL. Presented at ACC 2006.

40 Patients with Qualifying CV Disease (CAD, CVD, PAD): Primary and Secondary Efficacy Results (MI/Stroke/CV Death/ Hospitalization) Clopidogrel Placebo + ASA + ASA Endpoint* - N (%) (n=7802) (n=7801) RR (95% CI) p value Primary Efficacy Endpoint 420 (6.9) 480 (7.9) 0.88 (0.77, 0.998) All Cause Mortality 278 (4.6) 306 (5.0) 0.91 (0.78, 1.07) 0.27 Cardiovascular Mortality 172 (2.8) 191 (3.1) 0.90 (0.74, 1.11) 0.34 Myocardial Infarction (nonfatal) 120 (2.0) 127 (2.1) 0.95 (0.74, 1.22) 0.67 Ischemic Stroke (nonfatal) 114 (1.9) 140 (2.3) 0.82 (0.64, 1.05) 0.11 Stroke (nonfatal) 128 (2.1) 162 (2.7) 0.79 (0.63, 0.999) Principal Secondary Endpoint 1066 (17.6) 1169 (19.2) 0.91 (0.83, 0.98) 0.02 Hospitalization 720 (11.9) 803 (13.2) 0.89 (0.81, 0.99) 0.03 First occurrence of MI (fatal or not), stroke (fatal or not), cardiovascular death (including hemorrhagic death), or hospitalization for UA, TIA, or revascularization *Intention to treat analysis Components of the primary efficacy endpoint. Patients that did not die from CV causes, are counted for the first non-fatal event of MI or stroke. For UA, TIA, or revascularization Bhatt DL, Fox KA, Hacke W, et al. NEJM 2006.

41 The dual antiplatelet therapy, combining aspirin and clopidogrel, did not confer benefit in patients with SCAD (THE CHARISMA TRIAL).

42 Low-dose Aspirin should be used in all patients with SCAD. Dual antiplatelet therapy should be considered in high risk patients with chronic stable angina and: Prior MI Prior multi-vessel PTCA Prior multi-vessel CABG Patients with Class III and IV according to the CCS High risk patients for various test modalities

43 European Heart Journal (2013) 34,

44 Follow-up of revascularized SCAD patients European Heart Journal (2013) 34,

45

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