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STEMI, Bleeding & Outcomes in Seniors: What Are the Issues?

This article explores the challenges of treating STEMI in elderly patients, including increased bleeding risk, delayed diagnosis and treatment, and lower success rates in PCI. It also discusses the impact of bleeding on mortality and long-term outcomes.

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STEMI, Bleeding & Outcomes in Seniors: What Are the Issues?

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  1. Trans –Radial Education and Therapeutics (TREAT IV STEMI, Bleeding & Outcomes in Seniors: What Are the Issues? Ron Waksman, MD Joshua P, Loh, MD July 29, 2013

  2. Overview • Challenges of treating STEMI in elderly • PPCI in the elderly • Increased bleeding risk in STEMI • Increased bleeding risk in the elderly • Bleeding avoidance strategies

  3. STEMI in the elderly: Challenges • Eligibility for reperfusion decreases in the elderly (contraindications, cognition, comorbidities). Elderly STEMI patients less likely to receive reperfusion (PCI or fibrinolysis) even if eligible. • Many elderly present with atypical symptoms, abnormal baseline ECGs, or comorbidities that contribute to clinical uncertainty, delayed diagnosis and delayed treatment. • PCI success rates lower, with higher complication rates in the elderly. • Higher mortality after STEMI. • Limited data from clinical trials Alexander et al. Acute coronary care in the elderly, part II: ST-segment-elevation myocardial infarction: a scientific statement for healthcare professionals from the American Heart Association Council on Clinical Cardiology: in collaboration with the Society of Geriatric Cardiology. Circulation. 2007;115:2570-89.

  4. Primary PCI vs. Fibrinolysis in the Elderly • Few trials enrolled adequate numbers of older patients

  5. Primary PCI vs. Fibrinolysis in the Elderly:Absolute mortality advantage of PCI increases with age Boersma E; Primary Coronary Angioplasty vs. Thrombolysis Group. Eur Heart J. 2006;27:779-788.

  6. Challenges of Primary PCI in the Elderly:High-risk subset More peri-procedural complications Less ST resolution Mechanical Electrical Bleeding (3% in <65 yrs, 9% in >75 yrs) More comorbidities HTN, COPD, stroke, CHF, CKD, prior revasc, higher KILLIP class on presentation ELDERLY ≥ 75 yrs Lower procedural success

  7. Challenges of Primary PCI in the Elderly:outcomes according to age APEX-AMI On multivariable adjustment, age was the strongest independent predictor of 90-day mortality (HR 2.07 per 10-year increase; 95% CI 1.84-2.33). CADILLAC Guagliumi G, et al. Outcome in elderly patients undergoing primary coronary intervention for acute myocardial infarction: CADILLAC. Circulation 2004;110:1598-604.

  8. Primary PCI in the very elderly

  9. Bleeding after PCI Elderly Increased Risk Comorbidities e.g. renal failure STEMI

  10. Post PCI bleeding increases mortality: NCDR • CathPCI registry: analyzed 3 million PCIs in the US between 2004 and 2011 • Bleeding events occurred in 1.7% • In-hospital deaths occurred in 0.65% Chhatriwalla et al; NCDR. Association between bleeding events and in-hospital mortality after percutaneous coronary intervention. JAMA 2013;309:1022-9.

  11. Bleeding after Primary PCI: Sustained effect of bleeding on mortality and MACE up to 3 years Suh JW, et al. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI trial. J Am CollCardiol. 2011;58:1750-6.

  12. Bleeding after PCI in ≥65 yrs old: NCDR/Medicare/MedicaidIncreased risks of MACE, mortality and future bleeding events Rao SV et al. Association between periprocedural bleeding and long-term outcomes following percutaneous coronary intervention in older patients. JACC CardiovascInterv 2012;5:958-65.

  13. Bleeding increases mortality: proposed mechanisms Doyle BJ, et al. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am CollCardiol 2009;53:2019-2027.

  14. Access vs. non-access site bleed Non-access site bleed confers higher mortality compared with access site bleed Chhatriwalla et al; NCDR. Association between bleeding events and in-hospital mortality after percutaneous coronary intervention. JAMA. 2013;309:1022-9. Verheugt et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC CardiovascInterv 2011;:191-7.

  15. Bleeding across clinical presentations Loh, Waksman. Impact Of Clinical Presentation On In-Hospital Bleeding Outcomes In Percutaneous Coronary Intervention. TCT 2013

  16. Patients at highest bleeding risk (NCDR): pre-procedural factors Many risk factors co-exist in the elderly patient Mehta SK, et al; NCDR. Bleeding in patients undergoing percutaneous coronary intervention: the development of a clinical risk algorithm from the NCDR. Circ CardiovascInterv. 2009;2:222-229.

  17. Patients at highest bleeding risk: HORIZONS-AMI Suh JW, et al. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI trial. J Am CollCardiol. 2011;58:1750-6.

  18. Elderly patients at increased bleeding risk: NCDR/Medicare/Medicaid PCI in 461311 patients ≥ 65 yrs old Post PCI bleeding in 3.1% Of patients who bled, access site bleed = 48.6% Predominantly femoral access Rao SV et al. JACC CardiovascInterv 2012;5:958-65.

  19. Reduction in overall PCI bleeding complications: NCDR 2005-2009 (n=599524) Overall 20% reduction in post-PCI bleeding Reduction in annual bleeding risk (n=836103) Reduction in in annual bleeding risk (n=267632) No change in annual bleeding risk Subherwal S, et al. Temporal trends in and factors associated with bleeding complications among patients undergoing percutaneous coronary intervention: a report from the NCDR. J Am CollCardiol. 2012;59:1861-9.

  20. Reduction in overall PCI bleeding complications: NCDR 2005-2009 (n=599524) Temporal decrease in heparin + GPI Increase in bivalirudin (n=836103) (n=267632) No change in anticoagulation/ thrombolytic use IABP use 10%

  21. Reduction in overall PCI bleeding complications: NCDR 2005-2009 (n=599524) Only slight temporal increase in radial access and vascular closure device use (n=836103) (n=267632)

  22. Bleeding avoidance strategies Dauerman et al. Bleeding avoidance strategies. Consensus and controversy. J Am CollCardiol 2011;58:1-10.

  23. Bleeding avoidance strategies:Consensus and Controversy Dauerman et al. Bleeding avoidance strategies. Consensus and controversy. J Am CollCardiol 2011;58:1-10.

  24. Pharmacology: Bivalirudin Stone GW, et al; HORIZONS-AMI Trial Investigators. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med 2008;358:2218-30.

  25. Pharmacology: Bivalirudin Reduction in both access and nonaccess site bleeding compared to Hep + GPI Verheugt FW, et al. Incidence, prognostic impact, and influence of antithrombotic therapy on access and nonaccess site bleeding in percutaneous coronary intervention. JACC CardiovascInterv 2011;4:191-7.

  26. Pharmacology: Bivalirudin Does not reduce bleeding when used in conjunction with GPI Time to event curve of major bleeding Stone GW, et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the ACUITY trial. Lancet 2007;369:907-19.

  27. Bivalirudin vs. Heparin monotherapy Bleeding outcomes Transfemoral Decrease in major bleeding Similar MACE Bertrand OF, et al. Meta-analysis comparing bivalirudin versus heparin monotherapy on ischemic and bleeding outcomes after percutaneous coronary intervention. Am J Cardiol 2012;110:599-606.

  28. Effect of radial access on bleeding: Clinical trials • Crossover rates 4-6%, age 60-65 yrs old • RIVAL (STEMI, n=1958): no difference in bleeding (0.84% vs. 0.61%) • RIFLE-STEACS (n=1001): reduced bleeding (7.8% vs. 12.2%) • STEMI-RADIAL (n=707):

  29. Growth of transradial access in the US: NCDR 2007-2012 Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the NCDR (2007-2012). Circulation 2013;127:2295-306.

  30. Reduced bleeding and vascular complications in key subgroups with transradial access Bleeding complications (unadjusted rates) Vascular complications (unadjusted rates)

  31. New generation antiplatelet therapy: efficacy PLATO TRITON TIMI-38 Wiviott et al. N Engl J Med 2007 15;357:2001-2015 Wallentin et al. N Engl J Med 2009;361(11):1045-57 Newer generation antiplatelet agents significantly reduce adverse outcomes compared to clopidogrel up to 1-year in patients with ACS.

  32. Balance of efficacy and safety: Ticagrelor Overall no difference in major bleeding as defined by the study criteria More fatal intracranial bleed, non-CABG related bleed Although no recommendation to dose-adjust in elderly, should take into consideration potential bleeding risks

  33. Balance of efficacy and safety: Prasugrel Less clinical efficacy Greater absolute levels of bleeding

  34. Dose adjust in the very elderly? Prasugrel 5mg suggested based on population pharmacokinetic substudy modeling in TRITON-TIMI 38. Prasugrel 5mg resulted in fewer very elderly poor responders compared to clopidogrel 75mg Prasugrel 5mg in very elderly met non-inferiority criterion by MPA vs. Prasugrel 10mg in non-elderly Erlinge D, et al. Prasugrel 5-mg in the very elderly attenuates platelet inhibition but maintains non-inferiority to prasugrel 10-mg in non-elderly patients: The GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable CAD patients. J Am CollCardiol 2013 Jun 6. [Epub ahead of print]

  35. Prasugrel: Summary of Boxed Warning • Contraindications: Clinical hx of stroke/TIA • Generally not recommended for age ≥ 75 yrs, except in high risk situations (prior MI, DM) where the ischemic benefit appears to be greater • Greater risk of bleeding in patients weighing <60kg, can consider MD adjustment (5mg)

  36. Summary • The elderly STEMI patient presents an extremely challenging subset to treat due to presence of co-morbidities, high periprocedural mortality and significant morbidity. • The elderly STEMI patients are at high risk of bleeding post PCI, and bleeding avoidance strategies should be employed as much as possible. • There is still controversy towards certain strategies to reduce post-PCI bleed. • The overall impact of transradial access on reduction of bleeding appears favorable,. However the greatest impact appears to be in the proper selection of antithrombotic therapy, especially in this high risk subpopulation.

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