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DESERT ( D rug- E luting S tent E vent R egistry of T hrombosis)

DESERT ( D rug- E luting S tent E vent R egistry of T hrombosis). The International FDA approved DES Thrombosis Registry. Ron Waksman, MD and Martin Leon, MD On Behalf of the DESERT Investigators. Grant/Research Support Consulting Fees/Honoraria. Volcano Medtronic Vascular

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DESERT ( D rug- E luting S tent E vent R egistry of T hrombosis)

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  1. DESERT(Drug-Eluting Stent Event Registry of Thrombosis) The International FDA approved DESThrombosis Registry Ron Waksman, MD and Martin Leon, MD On Behalf of the DESERT Investigators

  2. Grant/Research Support Consulting Fees/Honoraria Volcano Medtronic Vascular Abbott Vascular Boston Scientific Biotronik Medtronic Abbott Vascular Boston Scientific Lilly Daiichi Astra Zeneca Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company This is an investigator initiated trial sponsored in part by Medtronic Vascular

  3. Acute and subacute DES thrombosis are the most devastating complication of coronary stent implantation Late DES thrombosis is a relatively new and poorly studied phenomenon Cohort-based analyses require years of follow-up, and very large numbers of patients Background DES Thrombosis

  4. Most have not included angiographic and procedural data Limited number of stent thrombosis events (frequency of 2% or less): Ability to assess only very strong correlates Wide confidence intervals around risk estimates A study of 5000 patients would only have approximately 100 events, with ability to reliably assess 5-10 predictors Background Limitations of Prior Analyses

  5. DESERT: Study Objectives • To describe the correlates (clinical, procedural, and angiographic) of late (FDA approved) DES thrombosis (>30 days from stent implantation) using an adequately sized and powered case-control study design • 500 total late Stent thrombosis events • To describe the outcomes of patients with stent thrombosis in the DES era

  6. DESERT Investigator Sponsored Study Organization

  7. DESERT Study Investigative Sites

  8. Trial Design • Case Inclusion Criteria: • Subject >18 yo • Definite late/very late ST per ARC definition • Implanted with DES since 4/2003 Consecutive prospective enrollment Multicenter Case-Control 1:1 Study Limited Matching for the Site and ± 3 days to thrombosis event Case Control DES Implant(s) DES Implant(s) > 30 days from implant; no acute or subacute thombosis ST Event • Control Inclusion Criteria: • Subject >18 yo • No known ST per ARC definition • Implanted with DES since 4/2003 Follow-Up Subset of Pts • 30 days • 180 days • 365 days NCT00812552 Data Lock 26 OCT 2011

  9. DES Implant Baseline Demographics

  10. DES Implantation Clinical Presentation

  11. DES Implantation Lesion Characteristics

  12. DES Implantation Characteristics Continued

  13. Stent Details

  14. Time to ST Event Presentation 1 year 75% of ST after 1 yr

  15. ST Event Clinical Presentation

  16. ST Event: Antiplatelet Therapy Intake

  17. ST Event Lesion Characteristics

  18. ST Lesion PCI Details

  19. ST Events In Hospital

  20. Available Follow up Post Discharge from ST event to 12 months %

  21. Available Follow up Post Discharge from ST event MACE KM Curve

  22. Correlates of Late DES Stent Thrombosis

  23. Independent Correlates of Late DES Stent Thrombosis

  24. Limitations • Prevalence of Late and Very Late DES ST cannot be assessed • In DESERT 90% of the patients in both groups had first generation DES • This analysis only identifies patients who survived the acute event of ST and presented for an angiogram • Angiographic data is currently being analyzed

  25. Summary • DESERT is the largest case-control registry of late and very late DES Stent Thrombosis • In DESERT, the majority of the Late ST occurred after one year (~75%) and continued to occur up to 7.3 years • The clinical presentation of late ST was mainly MI (66.9% STEMI and 22% NSTEMI) • Nearly 30% of the patients with L ate ST were on DAPT at the time of the event • In hospital mortality of patients who presented with late ST was 3.8% and 1.67% at one year

  26. Conclusions • Patients who had first generation DES continue to be at risk for late stent thrombosis up to 7 years • Younger patients, smokers, black ethnicity, patients with multi vessel disease, STEMI, or SVG lesions are at higher risk of developing late ST and should be reconsider for DES, or for a potent or longer DAPT regimen • Mortality with late ST is lower when compared with historically reported acute and subacute ST. This suggest a different pathological mechanism for late ST: (late restenosis and/or neo-atherosclerosis)

  27. Thank You for your attention

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