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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(Drug-Eluting Stent Event Registry of Thrombosis)

The International FDA approved

DES Thrombosis Registry

Ron Waksman, MD and Martin Leon, MD

On Behalf of the DESERT Investigators

disclosure statement of financial interest
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

background
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

background4
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

desert study objectives
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
trial design
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

time to st event presentation
Time to ST Event Presentation

1 year

75% of ST after 1 yr

limitations
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
summary
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
conclusions
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)