Tachycardia: Implantable cardioverter defibrillators clearly decreased mortality.

Clinical bottom line (level 1b)

  1. Patients who were survivors of sudden cardiac arrest who were given propafenone, had greater total mortality to those given implantable cardioverter defibrillators. (NNH = 7 at 24 months)
  2. Patients given propafenone were more likely to suffer sudden death than those given a defibrillator (NNH = 6 at 24 months) .
Siebels et al: American Heart Journal 1994; 127: 1139-1144
Expires August 2004

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting: 7 general hospitals, Germany

115 patients (aged range 19 to 78 years; mean 57, 80% male) survivors of sudden cardiac death caused by documented ventricular tachycardia, fibrillation or both
Control Group: (n = 59, 59 analysed): implantable cardioverter defibrillator (Cardiac Pacemakers Inc devices) with no concomitant antiarrhythmic treatment.
Experimental Group: (n = 56, 56 analysed): propafenone starting at a low initial dose of 450 mg per day; if tolerated the dose was advanced during 8 to 14 days up to the maximum tolerated dose or 900 mg per day
The cut off rate for the implantable cardioverter defibrillator was 170-200 beats per minute. Coronary revascularisation was performed in 14 patients at implantation of the defibrillator and in 11 patients before propafenone treatment.
100% followed for 24 months

The evidence

Outcome Time to outcome CEREERRRR
(95% CI)		ARR
(95% CI)		NNH
(95% CI)
total mortality 24 months 8
(13.6%)		 9
(28.6%)		 -111%
(-353% to 2%)		 -15.0%
(-25.7% to -0.3%)		 7
(3 to 328)
sudden death 24 months 0
(0.00%)		 10
(17.8%)		 -100%
(% to %)		 -17.8%
(-27.9% to -7.8%)		 6
(4 to 13)

Comments

  1. The propafenone arm of the trial was stopped in March 1992 due to the excess mortality compared with the implantable defibrillator group. As well as the 6 incidents of sudden death in the propafenone group, 5 more had a recurrence of cardiac arrest during follow-up and were successfully resuscitated and the drug was discontinued in 12 more patients.

Citation

  1. Siebels J, Kuck K-H, the CASH Investigators : Implantable cardioverter defibrillator compared with antiarrhythmic drug treatment in cardiac arrest survivors (the Cardiac Arrest Study Hamburg). American Heart Journal 1994; 127: 1139-1144
Contributor: Clare Wotton and Bob Phillips, August 1999
Reviewer:

Clinical Question.
Patient survivors of sudden cardiac death
Intervention or Exposure propafenone
Comparison implantable cardioverter defibrillator
Outcome total mortality