Research Project: What are the anti-platelet strategies for ...


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Research Project: What are the anti-platelet strategies for ...

  1. 1. Research Project: What are the anti-platelet strategies for patients with DES in non-cardiac surgeries Washington Hospital Center Georgetown University Hospital Vikram Raya August 10, 2006
  2. 2. Investigators <ul><li>Principal Investigators </li></ul><ul><ul><li>Vikram Raya (humble resident) </li></ul></ul><ul><ul><li>Probal Roy (interventional cardiology fellow) </li></ul></ul><ul><li>Co-Investigator </li></ul><ul><ul><li>Ron Waksman (interventional cardiology attdg) </li></ul></ul>
  3. 3. Clinical Question <ul><li>We all at some point will take care of pt’s with DES (drug eluting stents) </li></ul><ul><li>However what happens to these guys when they go surgery while they are still on ASA and clopidogrel </li></ul><ul><li>Do you stop the anti-platelet agents and risk the vessel closing up and causing an MI ? </li></ul><ul><li>Or </li></ul><ul><li>Do you keep them on both agents and risk major bleeding? </li></ul>
  4. 4. Clinical Question <ul><li>What is the incidence of non cardiac surgery in patients within 6 months of receiving DES? </li></ul><ul><li>What are the management strategies for clopidogrel use in pt’s going to non-cardiac surgery </li></ul><ul><li>What are the outcomes of these surgeries </li></ul><ul><ul><li>bleeding complications and rate of sub-acute stent thrombosis </li></ul></ul>
  5. 5. Background <ul><li>FDA approved 1 st DES in 2003 for the purpose of reducing in-stent restenosis compared to BMS (bare metal stents) </li></ul><ul><li>DES are initially thrombogenic and until the stent has time for endothelialisation anti-platelet agents are needed </li></ul><ul><li>Clopidogrel is used along with ASA as an anti-platelet strategy to prevent thrombosis </li></ul>
  6. 6. Background <ul><li>Clopidogrel binds irreversibly to platelet receptors inhibiting platelet activation </li></ul><ul><li>Based on pivotal trials that led to approval of DES, dual anti-platelet therapy recommended for 6 months then lifelong aspirin </li></ul><ul><li>Many patients with stents have significant co-morbidities, and require non cardiac surgeries within this 6 month period </li></ul><ul><li>There is very little literature on the percentage of patients going on to non-cardiac surgeries after having a DES placed </li></ul>
  7. 7. Background <ul><li>We know going into a surgery or procedure with a patient on clopidogrel brings the risk of bleeding and other surgical complications </li></ul><ul><li>Also the literature states by stopping clopidogrel, the pt is put at high risk for a thrombotic event, specifically sub-acute stent thrombosis </li></ul><ul><li>However, there is no RCT or guidelines to dictate what the best strategy to manage pt’s on anti-platelet agents undergoing non-cardiac surgery </li></ul>
  8. 8. Hypothesis <ul><li>Pt’s who are kept on clopidogrel will have minor bleeding events but will have a lower rate of thrombosis </li></ul><ul><li>Interrupted anti-platelet therapy will result in increased cases of sub acute thrombosis </li></ul>
  9. 9. Study Design <ul><li>6000 total pt’s since 2003 who have received DES at WHC </li></ul><ul><li>3000 have received followup </li></ul><ul><ul><li>Screened database and selected all patients with </li></ul></ul><ul><li>Approx 250 have non-cardiac surgery within 6 months of DES (9%) </li></ul><ul><ul><li>Major surgery 166 </li></ul></ul><ul><ul><li>Minor surgery 87 </li></ul></ul>
  10. 10. ***Still have to further delineate based on literature what is major vs minor surgery     8.50% Percentage of Pt’s with DES who required non-cardiac surgery 2984 Total Patients who have received DES 253 Total Non cardiac Surgery Patients 276 Total Surgery Patients 103 Death: from all causes 44 Miscellaneous : not sure if surgery occurred, Not sure how to classify, pacemaker or AICD without date of placement 23 Cardiac Surgery: Valve Repair, CABG, Heart Transplant 166 Major Surgery: Hip Replacement, Knee Replacement, Hernia surgery, Appendectomy, Cholecystectomy, C- Spine Surgery, Back Surgery, Gastric Bypass, Sinus Surgery, Thyroidectomy, AAA repair, Nephrectomy, Breast Surgery, Prostate Surgery, Fem Bypass, Polypectomy, Foot Surgery, Amputation, Carpal Tunnel Surgery, Basal Cancer Removal, Liver Transplant, Liver Bx, CEA, Eye/Cataract Surgery 87 Minor Surgery: Dental Surgery, AICD, Pacemaker, Skin cancer/lesion removal, EGD, Colonoscopy, Urological stent, Cystoscopy Total count# Types of classifications:
  11. 11. Protocol 253 Pt’s non-cardiac surgery Major Surgery 166 Minor Surgery 87 Clopidogrel continued Clopidogrel held Clopidogrel continued Clopidogrel held
  12. 12. Outcomes <ul><li>Primary End Point </li></ul><ul><ul><li>Bleeding </li></ul></ul><ul><ul><ul><li>TIMI bleeding assessment </li></ul></ul></ul><ul><ul><ul><li>Transfusions? </li></ul></ul></ul><ul><ul><li>Stent Thrombosis </li></ul></ul><ul><ul><ul><li>Early and Late stent thrombosis </li></ul></ul></ul><ul><ul><ul><li>Revascularized? </li></ul></ul></ul>
  13. 13. What needs to be done… <ul><li>Get medical records for these patients and identify (request from various hospitals, call pt’s, call surgeons, physicians) </li></ul><ul><ul><li>When was DES placed  Cath database </li></ul></ul><ul><ul><li>When surgery occurred </li></ul></ul><ul><ul><li>Status of clopidogrel: compliance etc. </li></ul></ul><ul><ul><li>Anti-platelet strategy </li></ul></ul><ul><ul><ul><li>Keep it on or hold clopidogrel </li></ul></ul></ul><ul><ul><li>Complications </li></ul></ul><ul><ul><ul><li>Bleeding </li></ul></ul></ul><ul><ul><ul><li>Stent Thrombosis </li></ul></ul></ul><ul><ul><ul><li>Death </li></ul></ul></ul><ul><ul><ul><li>Hospitalization </li></ul></ul></ul>
  14. 14. What needs to be done… <ul><li>Once all the results are gathered, have to get statistical analysis done </li></ul><ul><li>Based on this we can decide </li></ul><ul><ul><li>How many patients go to non-cardiac surgery after receiving DES </li></ul></ul><ul><ul><li>What is the best strategy for clopidogrel usage </li></ul></ul><ul><ul><li>What is bleeding risks on clopidogrel </li></ul></ul><ul><ul><li>What is re-stenosis risk off clopidogrel </li></ul></ul>