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IRIS Post-hoc Analysis

IRIS Post-hoc Analysis. Background IRIS compared the safety and efficacy of early ICD implantation with medical treatment alone in 898 patients at high risk for SCD after MI

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IRIS Post-hoc Analysis

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  1. IRISPost-hoc Analysis Background • IRIS compared the safety and efficacy of early ICD implantation with medical treatment alone in 898 patients at high risk for SCD after MI • Primary analysis showed significantly fewer deaths due to SCD in the ICD group compared with medical therapy alone; this was offset by an increase in non-SCD, resulting in a neutral effect on total mortality after 72 months Objective of Post-hoc Analysis • Elucidate predictors and mechanisms that contributed to the observed increase in non-sudden cardiac death (SCD) in the implantable cardiac defibrillator (ICD) group

  2. IRISPost-hoc Analysis Key Post-hoc Findings • Mortality risk patterns were consistent across 30 subgroups, with early ICD associated with decreased risk of SCD and increased risk of non-SCD in each subgroup (except for 91 patients with STEMI who did not undergo reperfusion) • Independent of ICD use, five factors predicted total mortality: older age, left main or three-vessel disease, QRS ≥120 ms, NYHA class 3 or 4 heart failure, and ejection fraction <35% • Use of an ACE inhibitor or ARB and administration of clopidogrel were associated with lower mortality risk • Right ventricular pacing was associated with increased total mortality due to an elevated risk of non-SCD • Periods of appropriate or inappropriate shocks were associated with a particularly high risk of total mortality due to increased non-SCD

  3. IRISPost-hoc Analysis Summary • SCD is reduced by the ICD in the first 2 years • The risk of non–SCD is higher in the ICD group than in controls throughout the study, the difference being most prominent at 3 years of follow up • In multivariate analysis, the IRIS overall result is identical in 30 interaction tests for subgroup effects, except the one without reperfusion • ICD intervention is associated with an increased risk of death due to elevated non-SCD: identified periods at risk are those with both appropriate and inappropriate shocks, and those with increased right ventricular pacing

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