BACKGROUND: It has been shown that an implantable cardioverter defibrillator (ICD) may be beneficial when added to optimal drug treatment in patients with reduced left ventricular function who survive a myocardial infarction (MI). However, it is not known whether patients with increased risk of death after primary percutaneous coronary intervention (PCI) for ST-elevation MI also have benefit of prophylactic ICD therapy to reduce sudden cardiac death. METHODS AND STUDY DESIGN: The DAPA trial is designed to evaluate the efficacy and safety of ICD in high-risk patients after primary PCI for ST-elevation MI. In this randomized multicenter controlled study, a total of 700 patients will be included. Enrolment started in October 2004. Inclusion criteria are thrombolysis in myocardial infarction flow less than 3 after primary PCI or left ventricular ejection fraction lower than 30% as measured short after admission for the index MI. Patients will be randomized between 30 and 60 days after their MI. The primary end point will be total death during the follow-up period of at least 3 years for each patient. CONCLUSIONS: This multicenter trial of patients at high risk of death after primary angioplasty for ST-elevation MI will evaluate prophylactic ICD therapy in addition to the current standard of care.
RCT Entities:
BACKGROUND: It has been shown that an implantable cardioverter defibrillator (ICD) may be beneficial when added to optimal drug treatment in patients with reduced left ventricular function who survive a myocardial infarction (MI). However, it is not known whether patients with increased risk of death after primary percutaneous coronary intervention (PCI) for ST-elevation MI also have benefit of prophylactic ICD therapy to reduce sudden cardiac death. METHODS AND STUDY DESIGN: The DAPA trial is designed to evaluate the efficacy and safety of ICD in high-risk patients after primary PCI for ST-elevation MI. In this randomized multicenter controlled study, a total of 700 patients will be included. Enrolment started in October 2004. Inclusion criteria are thrombolysis in myocardial infarction flow less than 3 after primary PCI or left ventricular ejection fraction lower than 30% as measured short after admission for the index MI. Patients will be randomized between 30 and 60 days after their MI. The primary end point will be total death during the follow-up period of at least 3 years for each patient. CONCLUSIONS: This multicenter trial of patients at high risk of death after primary angioplasty for ST-elevation MI will evaluate prophylactic ICD therapy in addition to the current standard of care.