Transcript Trial Overview - Clinical Trial Results

Inhibition of Unnecessary RV Pacing with
AV Search Hysteresis in ICDs Trial
INTRINSIC RV Trial
Presented at
The Heart Rhythm Society Meeting
May 2006
Presented by Dr. Brian Olshansky
INTRINSIC RV Trial: Background
• The goal of the trial was to evaluate dual vs. single
chamber pacing among patients implanted with an
internal cardioverter defibrillator (ICD) for standard
indications.
www. Clinical trial results.org
Presented at HRS 2006
INTRINSINC RV Trial: Study Design
988 patients, standard indications for ICD implantation, implanted with a VITALITY AVT
ICD programmed to dual chamber rate adaptive pacemaker (DDDR) mode
Randomized.
22% female, mean age 63 years, mean follow-up 1 year
67% of patients had coronary artery disease, 78% received beta-blockers,
64% received ACE-inhibitors and 50% received diuretics
Patients with RV pacing ≤20% were randomized
Continued programming of
DDDR AV search hysteresis
(AVSH) 60-130
n=502

Reprogramming to VVI-40
n=486
Primary Endpoint: All-cause mortality or hear failure hospitalization through one
year, evaluated for non-inferiority
www. Clinical trial results.org
Presented at HRS 2006
INTRINSIC RV Trial: Primary Endpoint
Primary endpoint of death or heart failure
hospitalization
9.5%
10%
8%
6.4%
6%
4%
2%
• The primary endpoint
of death or heart
failure hospitalization
occurred in 6.4% of
the DDDR AVSH
group and 9.5% of
VVI-40 group,
meeting the threshold
for non-inferiority.
• For superiority of
DDDR AVSH, p=0.072
and the risk ratio was
0.67.
0%
DDDR AVSH
www. Clinical trial results.org
VVI-40
Presented at HRS 2006
INTRINSIC RV Trial: All – Cause Mortality
Primary endpoint of all-cause mortality
p<0.001
6%
4%
5.1%
3.6%
2%
0%
DDDR AVSH
www. Clinical trial results.org
• All-cause mortality
also met the criteria
for non-inferiority
(3.6% for DDDR
AVSH vs. 5.1% for
VVI-40 group,
p<0.001 for noninferiority, p=0.23
for superiority).
• During follow-up,
RV pacing in the
DDDR AVSH group
averaged 10%.
VVI-40
Presented at HRS 2006
INTRINSIC RV Trial: Summary
• Among patients implanted with an ICD for standard indications, use
of dual chamber DDDR AVSH pacing was non-inferior to single
chamber VVI-40 pacing for death or heart failure hospitalization at one
year.
• Results of the present trial differ from those of the DAVID trial, which
showed treatment with dual-chamber pacing was associated with an
increase in mortality or CHF hospitalizations by 1 year compared with
ventricular backup pacing in patients with LV dysfunction and
standard indications for ICD therapy but not for pacing.
• There are several major differences between the trials, including
pacing at a lower threshold in the present trial (60 bpm vs. 70bpm in
DAVID) and the patient population, which in INTRINSIC RV excluded
patients with >20% pacing in the first week
www. Clinical trial results.org
Presented at HRS 2006