DAVID
Trial question
What is the role of dual-chamber pacing in patients with an indication for ICD?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
25.0% female
75.0% male
N = 506
506 patients (125 female, 381 male).
Inclusion criteria: patients with an indication for ICD.
Key exclusion criteria: permanent pacemaker, preexisting endocardial pacing leads, symptomatic bradycardia or second- or third-degree AV block, frequent or uncontrolled atrial tachyarrhythmia, or awaiting cardiac transplantation.
Interventions
N=250 DDDR-70 pacing (dual-chamber rate-responsive pacing at 70/min).
N=256 VVI-40 pacing (implantable cardioverter defibrillators programmed to ventricular backup pacing at 40/min).
Primary outcome
Survival free of death or hospitalization for new or worsened congestive heart failure at 1 year
73.3%
83.9%
83.9 %
62.9 %
42.0 %
21.0 %
0.0 %
DDDR-70
pacing
VVI-40
pacing
Significant
increase ▲
NNT = 9
Significant increase in survival free of death or hospitalization for new or worsened congestive HF at 1 year (73.3% vs. 83.9%; RH 1.61, 95% CI 1.06 to 2.44).
Secondary outcomes
No significant difference in hospitalization for new or worsened congestive HF (22.6% vs. 13.3%; RH 1.54, 95% CI 0.97 to 2.46).
No significant difference in death at 1 year (10.1% vs. 6.5%; RH 1.61, 95% CI 0.84 to 3.09).
Safety outcomes
No significant difference in severe adverse events within 30 days.
Significant difference in early death (2.2% vs. 0.8%).
Conclusion
In patients with an indication for ICD, DDDR-70 pacing was inferior to VVI-40 pacing with respect to survival free of death or hospitalization for new or worsened congestive HF at 1 year.
Reference
Wilkoff BL, Cook JR, Epstein AE et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA. 2002 Dec 25;288(24):3115-23.
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