Antiplatelets and elderly patients

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Importance of the antiplatelets in reducing the incidence of cardiovascular events and in reducing cardiovascular mortality , but data about usage of these agents in the elderly patients

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Antiplatelets And Elderly: It Is a Grey Zone ?:

By Dr.Abdelsalam Sherif MD Cardiology Venue: Holiday Inn, Ar-riyad , KSA Date : 14/ 11/ 2012 Antiplatelets And Elderly: It Is a Grey Zone ?

Introduction:

Introduction

Manifestations of Atherothrombosis Atherothrombosis is a generalized and progressive process with an inflammatory component, it is the most common cause of ischemic events. :

Manifestations of Atherothrombosis Atherothrombosis is a generalized and progressive process with an inflammatory component, it is the most common cause of ischemic events . Stroke TIA ANGINA PECTORIS Unstable angina Non STE MI, STEMI PAD © Teri J M c Dermott CMI 2003

CVD , including heart attack and stroke is the leading cause of death worldwide. :

Heart Disease and Strokes are Leading Killers in the U.S. where * Cause 1 of every 3 deaths * Over 2 million heart attacks and strokes each year -800,000 deaths -Leading cause of preventable death in people < 65 yrs -$444 billion in health care costs, lost productivity -Treatment accounts for ~ $1 of every $6 spent * Greatest expression of racial disparities in life expectancy CVD , including heart attack and stroke is the leading cause of death worldwide.

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Platelets activation, adhesion and aggregation in the final stage of atherothrombosis are responsible for arterial occlusion and consequent ischemia . So, antiplatelets therapy is an effective treatment choice for secondary prevention of ischemic events, where antiplatelets significantly reduced the risk of vascular events in patients with CVA, TIA, PAD and CAD.

Benefit Impact Of Antiplatelets:

Benefit Impact Of Antiplatelets

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Selected outcomes in secondary prevention trials of aspirin by sex.33 Reprinted with permission from Elsevier Fuster V , Sweeny J M Circulation 2011;123:768-778

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Proportional effects of antiplatelet therapy (145 trials) on vascular events (myocardial infarction, stroke, or vascular death) in four main high risk categories of trial and in low risk (primary prevention ) Antiplatelet Trialists' Collaboration BMJ 1994;308:81-106 ©1994 by British Medical Journal Publishing Group

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Effects of aspirin with clopidogrel therapy on risk of major cardiovascular events Zhou Y-H, Wei X, Lu J, Ye X-F, et al. (2012) Effects of Combined Aspirin and Clopidogrel Therapy on Cardiovascular Outcomes: A Systematic Review and Meta-Analysis. PLoS ONE 7(2): e31642. doi:10.1371/journal.pone.0031642 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0031642

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* PCI-CURE is a sub-study of the CURE study Published ( Lancet, 1996) Published ( JAMA, 2002) Published ( N Engl J Med, 2001) Published ( Lancet, 2001) 19,185 2,116 12,562 2,658 36 months 12 months 12 months 12 months Ischemic stroke, MI or PAD PCI Unstable angina or NQWMI CURE patients undergoing PCI CAPRIE 2 CREDO 4 CURE 5 PCI-CURE* 6 Published ( NEJM 2006) Published (Lancet 2005) Published ( NEJM 2005) Published (Lancet 2004) ~ 15,200 ~ 45,000 3,000 7,601 42 months 4 weeks 4 weeks 18 months Coronary, cerebrovascular, PAD, or major risk factors Acute MI Acute MI TIA or ischemic stroke CHARISMA COMMIT (CCS-2) CLARITY MATCH Status of study (data expected) Number of patients Maximum follow-up Patients Study 1) Bhatt D, Topol E. Nature Rev (Drug Dis) 2003; 3: 15 –28 2) CAPRIE Steering Committee. Lancet 1996; 348: 1329–1339 3) Bertrand NE et al. Circulation 2000; 102 : 624–629 4) Steinhubl S et al. JAMA 2002; 288(19): 2411–242 5) The CURE Trial Investigators. N Engl J Med 2001; 345: 494 – 502 6) Mehta SR et al. Lancet 2001; 358: 527 –533 One of the Largest Clinical Trial Programs Ever Developed More than 100,000 patients in studies with clopidogrel 1

CAPRIE: Higher Long-Term Efficacy of Clopidogrel vs Aspirin in Reducing Ishemic Events:

CAPRIE: Higher Long-Term Efficacy of Clopidogrel vs Aspirin in Reducing Ishemic Events Cumulative Event Rate (MI, Ischemic Stroke, or Vascular Death) Months of Follow-up 8.7%* Overall relative risk reduction 0 4 8 12 16 0 3 6 9 12 15 18 21 24 27 30 33 36 Cumulative Event Rate (%) P = 0.043 Clopidogrel (n = 9,599) *Intention to treat analysis ASA (n = 9,586) 1 . CAPRIE Steering Committee. Lancet 1996; 348: 1329–1339. 2. Antiplatelet Trialists' Collaboration. BMJ 2002; 324: 71–86 20 This improvement was observed over and above the effect of ASA (25% odds reduction reported previously for ASA using a similar outcome cluster of all-cause stroke, MI and vascular death).

CAPRIE: Benefit of Clopidogrel over ASA in the Reduction of Myocardial Infarction1:

CAPRIE: Benefit of Clopidogrel over ASA in the Reduction of Myocardial Infarction 1 1. Gent M. Circulation 1997; 96(suppl 8): I - 467. Months of follow-up 0 1 2 3 4 5 0 3 6 9 12 15 18 21 24 27 30 33 36 Cumulative event rate (%) p = 0.008 Clopidogrel ASA 19.2% * Relative risk reduction n = 19,185

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CURE Trial C lopidogrel in U nstable angina to prevent R ecurrent E vents 1. The CURE Trial Investigators. N Engl J Med 2001; 345: 494 – 502.

CURE: Results :

P < 0.001 Cumulative events (myocardial infarction, stroke, or cardiovascular death) Months of Follow-up 20% Relative Risk Reduction Placebo * (n = 6,303) Clopidogrel * (n = 6,259) 0.00 0.02 0.04 0.06 0.08 0.10 0.12 0.14 0 3 6 9 12 Cumulative Hazard Rate CURE: Results *On top of standard therapy (including acetylsalicylic acid) 1. The CURE Trial Investigators. N Engl J Med 2001; 345: 494 – 502 A significant RRR of approximately 20% was noted during the first 30 days

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PCI-CURE Trial a sub-study of the CURE study 1. The CURE Trial Investigators. N Engl J Med 2001; 345: 494 – 502.

PCI-CURE: 31% Relative Risk Reduction at Long-Term1:

* On top of standard therapy (including ASA) PCI-CURE: 31% Relative Risk Reduction at Long-Term 1 1. Mehta SR et al. Lancet 2001; 358: 527–33. 0.00 0.05 0.10 0.15 0 100 200 300 400 Days of follow-up Cumulative hazard rate Placebo * (n = 1,345) 31% RRR p < 0.002 Clopidogrel * (n = 1,313) Median time to PCI 10 Endpoint: Myocardial Infarction or Vascular Death 8.8% 12.6% This endpoint included events that were prevented prior to PCI as well as those following the procedure

CLARITY trial CLopidogrel as Adjunctive ReperfusIon TherapY TIMI 28 Trial :

CLARITY trial CL opidogrel as A djunctive R eperfus I on T herap Y TIMI 28 Trial Sabatine M et al. New Eng J Med 2005; 352: 1179 – 1189.

Clopidogrel Reduced Clinical Events by 20% at 30 Days1:

Clopidogrel Reduced Clinical Events by 20% at 30 Days 1 *Odds Ratio (OR) in CV death, MI or recurrent ischemia leading to urgent revascularization Time (days) Incidence of clinical endpoints (%) 0 5 10 15 0 5 10 15 20 25 30 Placebo Clopidogrel 20%* p=0.03 1. Sabatine MS et al. New Engl J Med 2005; 352 (available at www.nejm.org)

CHARISMA Study Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance :

CHARISMA Study C lopidogrel for H igh A therothrombotic R isk and I schemic S tabilization, M anagement and A voidance

Conclusions:

Conclusions CHARISMA tested the efficacy and safety of long-term dual AP therapy with Clopidogrel and ASA in a broad population including patients who had a past history of disease and those with risk factors. Data from CHARISMA suggest a clinical benefit of Clopidogrel with aspirin over aspirin alone in patients with established atherothrombotic disease . CHARISMA suggests that in patients with multiple risk factors, without clearly established disease, dual AP therapy is not appropriate.

CAPRIE – MATCH: Summary:

CAPRIE – MATCH: Summary CAPRIE : Demonstrates that clopidogrel is more efficacious than ASA to reduce long- term ischemic events in a large population of atherothrombotic patients, including stroke patients. Clopidogrel offers a favorable safety as compared to ASA in this population. MATCH : Demonstrates that ASA did not show additional clinical value (benefit / risk ratio) in specific high-risk cerebrovascular patients when added to clopidogrel and other standard therapies : The MATCH Trial results show a non-significant trend for the reduction in major vascular events in favor of adding ASA to clopidogrel over clopidogrel alone in specific high-risk cerebrovascular patients The results are consistent across all components of the primary endpoint, and regardless of patient baseline characteristics. There was a significant increase in life-threatening bleeding. 1. CAPRIE Steering Committee. Lancet 1996; 348: 1329–39 2. Diener H-C, et al . Lancet 2004; 364: 331–337 3. Circulation . 2005 May 3;111(17):2233-40

PowerPoint Presentation:

Date of download: 10/22/2012 Copyright © The American College of Physicians. All rights reserved. From: Aspirin for the Prevention of Cardiovascular Disease: U.S. Preventive Services Task Force Recommendation Statement Ann Intern Med. 2009;150(6):396-404. doi:10.7326/0003-4819-150-6-200903170-00008 Aspirin for the prevention of cardiovascular disease: clinical summary of a U.S. Preventive Services Task Force recommendation statement.CHD = coronary heart disease; CVD = cardiovascular disease; GI = gastrointestinal; HDL = high-density lipoprotein; MI = myocardial infarction; NSAID = nonsteroidal anti-inflammatory drug; USPSTF = U.S. Preventive Services Task Force. Figure Legend:

Aging And Antiplatelets:

Aging And Antiplatelets

Strategies to prevent bleeding complications in elderly patients:

Established strategies • Adjust dose of GPI, enoxaparin for patients with renal insufficiency. • Consider bivalirudin use for PCI. • Consider lower-dose aspirin (81 mg) for chronic antiplatelet therapy. • Avoid triple anticoagulant therapy (aspirin, clopidogrel,warfarin). • when possible, including preferential use of bare metal stents to avoid long-term dual therapy during warfarin treatment Strategies to prevent bleeding complications in elderly patients

Strategies to prevent bleeding complications in elderly patients:

Potential strategies • Reduce dose of chronic prasugrel or preferential use of clopidogrel. • Adjust doses of aspirin and clopidogrel based upon point-of-care platelet function assays. • PCI: use radial artery routinely versus femoral artery Strategies to prevent bleeding complications in elderly patients

Conclusions:

• Elderly patients are underrepresented in clinical research. • When making antiplatelet treatment decisions, it is important to balance risk versus benefit, taking into account age related changes, particularly risk of bleeding and potential drug interactions Conclusions

Conclusions:

• Physicians must pay particular attention to antiplatelet drug choice and dose—being mindful of metabolism, clearance route, and comorbidities that add risk for complications such as bleeding. Conclusions

Thank You:

Thank You

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