Copyright © 2003 by the European Society of Cardiology.
Survival after withdrawal of dofetilide in patients with congestive heart failure and a short baseline QTc interval
A follow-up on the DiamondCHF QT substudy
a Department of Cardiology, Copenhagen University Hospital, Gentofte, Denmark
b Department of Cardiology, Copenhagen University Hospital, Rigshospitalet, Denmark
Received May 13, 2002;
accepted June 26, 2002
* Corresponding author. Skippermosen 11, 3400 Hillerød, Denmark. Tel.: +45-482-68623; fax: +45-397-51803
bb{at}heart.dk
Background We have previously observed dofetilide to be associated with improved survival when the pre-treatment baseline QTc interval was below 429ms. In this study we tested the natural extension of this observationthat the same group of patients should have a loss of survival benefit after withdrawal of dofetilide.
Methods Patients with congestive heart failure (CHF) and reduced left ventricular function enrolled in the DiamondCHF (Danish Investigations of Arrhythmia and Mortality on DofetilideCHF) study were eligible for our QT substudy provided they were in sinus rhythm and had a measurable QTc interval from a 12-lead standard ECG taken before randomization to placebo or dofetilide. An extended follow-up was performed from study closure, December 1996 until August 2001.
Results Of the 418 patients entering the extended follow-up, 215 (51%) patients died during this 4.5 years of additional observation time. The baseline QTc interval made no prognostic difference to mortality in placebo treated patients. For dofetilide treated patients with a baseline QTc interval <7429ms, increased mortality was observed during the extended follow-up compared to placebo (risk ratio 1.5, 95% confidence interval 1.12.8).
Conclusions This follow-up study shows significant loss of survival benefit upon withdrawal of dofetilide in patients with CHF and a pre-treatment QTc interval below 429ms. An independent randomized trial is warranted to validate these results.
Key Words: QT interval Heart failure Prognosis Antiarrhythmic agents
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