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Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 2) Trial

ISAR-REACT 2 Trial. Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 2) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Adnan Kastrati. ISAR-REACT 2 Trial: Background.

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Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 2) Trial

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  1. ISAR-REACT 2 Trial Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT 2) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Adnan Kastrati

  2. ISAR-REACT 2 Trial: Background • The previous ISAR-REACT and ISAR SWEET trials showed that the glycoprotein IIb/IIIa inhibitor abciximab may not be necessary in low-risk elective PCI patients who are pretreated with 600 mg clopidogrel • The benefit of GP IIb/IIIa inhibition on top of 600 mg of clopidogrel have not yet been studied in high-risk ACS patients undergoing PCI • The ISAR-REACT 2 trial evaluates the efficacy of treatment with abciximab compared with placebo among patients undergoing PCI for acute coronary syndrome who were treated with high dose clopidogrel (600 mg) Presented at ACC 2006

  3. ISAR-REACT 2 Trial: Study Design 2022 patients with an episode of angina within the preceding 48 hours and an elevated troponin T level or new ST-segment depression of ≥0.1 mV or transient (<20 minutes) ST-segment elevation of ≥0.1 mV or new or presumed new bundle-branch block; significant angiographic lesions in a native coronary vessel or venous bypass graft amenable to and requiring a PCI Placebo Controlled. Randomized. Blinded. 24% female, mean age 66 years, mean follow-up 30 days Pre-treatment with high dose (600mg) clopidogrel at least 2 hours pre-procedure Placebo n=1010 Abciximab (usual bolus or infusion dose) n=1012 • Primary Endpoint: Composite of death, MI, and urgent target vessel revascularization (TVR) due to myocardial ischemia within 30 days • Secondary Endpoint: In-hospital major and minor bleeding Presented at ACC 2006

  4. ISAR-REACT 2 Trial: Primary Composite Endpoint Composite of death, MI, or urgent TVR due to Myocardial Ischemia within 30 days (%) p=0.03 • The primary composite endpoint occurred less frequently in the abciximab group compared to placebo (8.9% vs 11.9%; relative risk [RR] 0.75 p=0.03) Presented at ACC 2006

  5. ISAR-REACT 2 Trial: Death or MI Composite of death or MI (%) p<0.05 • The composite endpoint of death or MI was also significantly reduced in the abciximab group compared to placebo (8.6% vs 11.5%; RR 0.75; p<0.05) Presented at ACC 2006

  6. ISAR-REACT 2 Trial: Individual Endpoints Components of Primary Composite Endpoint (%) • The components of the primary composite endpoint were directionally lower in the abciximab group: • Death (1.1% vs 1.6%; RR 0.69) • MI (8.1% vs 10.5%; RR 0.77) • Urgent TVR (1.0% vs 1.2%; RR 0.83) Presented at ACC 2006

  7. ISAR-REACT 2 Trial: Primary Endpoint (subgroup) Primary endpoint in troponin positive patients (defined as >0.03 µg/L, n=1049) • Abciximab therapy was associated with reductions in the primary endpoint among patients who were troponin positive at baseline (13.1% vs 18.3%; RR 0.71; p=0.02) p=0.02 % Presented at ACC 2006

  8. ISAR-REACT 2 Trial: Primary Endpoint (subgroup) Primary endpoint in troponin negative patients (defined as <0.03µg/L, n=973) • There was no difference seen in patients who were troponin negative at baseline (4.6% each; RR 0.99; p=0.98; interaction p=0.07) p=0.98 % Presented at ACC 2006

  9. ISAR-REACT 2 Trial: Secondary Endpoint In-hospital Major and Minor Bleeding (%) p=NS • There was no difference between the abciximab and placebo groups in in-hospital major and minor bleeding (p=NS for both). • There was one intracranial bleed in each group. • 2.5% of patients received transfusions in the abciximab group compared with 2.0% in the placebo group (RR 1.25) Presented at ACC 2006

  10. ISAR-REACT 2 Trial: Summary • For patients undergoing PCI for a non ST-segment elevation ACS who were treated with high dose clopidogrel (600 mg) at least 2 hours before the procedure, treatment with abciximab was associated with a reduction in death, MI, or urgent target vessel revascularization within 30 days. • A subgroup analysis showed that the benefit of abciximab therapy was largely confined to patients with an elevated troponin level as there was no significant difference in the incidence of the primary endpoint among patients without an elevated troponin level. • There were no significant differences in in-hospital TIMI major bleeding (1.4% in each group, p=NS) or TIMI minor bleeding (4.2% abciximab vs 3.3% placebo, p=NS) Presented at ACC 2006

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