Evaluating Recent Clinical Trial Data in the Secondary Prevention of ACS

Disclosures

The Good News! We now have simpler and perhaps safer oral anticoagulants

Study Design Phase 2 Clinical Trials of New Anticoagulants Post-ACS

Study Designs Largely similar but a few important differences

ESTEEM – Ximelagatran, Bleeding

ESTEEM – Ximelagatran, Efficacy

Study Design

ISTH Major or CRNM Bleeding

Bleeding by Clopidogrel Status

Ischemic Outcomes

Ischemic Events by Clopidogrel Status

Primary Safety Endpoint Clinically Significant Bleeding

PRIMARY EFFICACY ENDPOINT Death / MI / Stroke / Severe Ischemia Requiring Revascularization

SECONDARY EFFICACY ENDPOINT Death / MI / Stroke

Primary Safety Endpoint Major and CRNM Bleeding at 6 Months

Main Secondary Endpoint Composite of all cause mortality, non-fatal MI, non-fatal stroke, and severe recurrent ischemia at 6 months

Phase 2 Conclusions

Trial Stopped Prematurely

Baseline Characteristics

Index ACS Event

Primary Outcome CV Death, MI, Ischemic Stroke

Other Efficacy Outcomes

Primary Outcome CV Death, MI, Stroke — Subgroups

TIMI Major Bleeding

TIMI Major Bleeding Subgroups

Conclusions