Aims This multicentre prospective randomised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)eguided/implantable cardioverter defibrillator (ICD) strategy in patients at high risk of sudden death (SD) early after myocardial infarction (MI). Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI. Methods and results We enrolled 143 survivors of acute MI (!1 month) with left ventricular ejection fraction5% and either frequent (R10/h) premature ventricular complexes (PVCs), or depressed heart rate variability (SDNN!70 ms) or abnormal signal-averaged ECG, who were able to tolerate optimised beta-blocker therapy (68G40 mg/day of metoprolol). Of these, 138 were randomised, in a 2:3 ratio, to two therapeutic strategies: conventional (CONV) strategy (nZ59) or EPSguided/ ICD strategy (nZ79). The latter resulted in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55. During a mean follow-up of 540G378 days, 26 patients (19%) died: nine (6.5%) SD, nine (6.5%) non-SD, and four (3%) non-cardiac death; in four patients (3%) the cause of death was unknown. The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18% vs 14% after 1 year and 29.5% vs 20% after 2 years, respectively (PZ0.3 and 0.2). Conclusions Despite optimal therapy, mortality remains significant in high-risk patients following MI. Although there is a trend in favour of EPS-guided/ICD, our data are insufficient to demonstrate a survival benefit of this strategy early after MI.
Early EPS/ICD strategy in survivors of acute myocardial infarction with severe left ventricular dysfunction on optimal beta-blocker treatment. The Beta-bloker Strategy plus ICD trial
CALVI V.
2005-01-01
Abstract
Aims This multicentre prospective randomised trial was undertaken to evaluate the usefulness of an electrophysiological study (EPS)eguided/implantable cardioverter defibrillator (ICD) strategy in patients at high risk of sudden death (SD) early after myocardial infarction (MI). Previous studies have shown the benefits of such a strategy only in high-risk patients late after MI. Methods and results We enrolled 143 survivors of acute MI (!1 month) with left ventricular ejection fraction5% and either frequent (R10/h) premature ventricular complexes (PVCs), or depressed heart rate variability (SDNN!70 ms) or abnormal signal-averaged ECG, who were able to tolerate optimised beta-blocker therapy (68G40 mg/day of metoprolol). Of these, 138 were randomised, in a 2:3 ratio, to two therapeutic strategies: conventional (CONV) strategy (nZ59) or EPSguided/ ICD strategy (nZ79). The latter resulted in ICD implantation in 24 inducible patients and in CONV therapy in the remaining 55. During a mean follow-up of 540G378 days, 26 patients (19%) died: nine (6.5%) SD, nine (6.5%) non-SD, and four (3%) non-cardiac death; in four patients (3%) the cause of death was unknown. The actuarial overall mortality for the CONV and EPS-guided/ICD arms was 18% vs 14% after 1 year and 29.5% vs 20% after 2 years, respectively (PZ0.3 and 0.2). Conclusions Despite optimal therapy, mortality remains significant in high-risk patients following MI. Although there is a trend in favour of EPS-guided/ICD, our data are insufficient to demonstrate a survival benefit of this strategy early after MI.File | Dimensione | Formato | |
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