User Manual Part 2

C-20
CLINICAL STUDY - MADIT II
Table C-11 . Follow- up co mpliance (continued)
Follow-up Sequence Month % Compl iant
ICD Group
% Compliant
Conventional Therapy Group
43–51 months 96 100
Total Average 96 94
Subgroup Analysis of MADIT II Patient Population
Figure C-5 on page C-20 provides the hazard ratios and 95 percent confidence
intervals for death from any cause in the ICD group as compared to the
conventional therapy group according to selected clinical characteristics.
The hazard ratios in the various subgroups w ere similar, with no statistically
significant interactions. The dotted vertical line represents the results for the
entire study (nominal hazard ratio, 0.66, without adjustment for the stopping
rule). The horizontal lines indicate nominal 95 percent confidence intervals.
0.4 0.6 0.8 1.0 1.41.2
ICD Better Conventional Better
Hazard Ratio
A
ll patients 1232
Age
< 65 yr 573
≥ 65 yr 659
Sex
Male 1040
Female 192
LVEF
≤ 0.25 831
> 0.25 401
NYHA Class
≤ II 861
> II 351
QRS
< 0.12 s 597
0.12 - 0.15 s 352
> 0.15 s 262
Beta-blockers
Yes 844
No 388
Variable Number of patients
Figure C-5. Hazard ratios and 95 percent co nfidence intervals
Analysis of Inducibility as a R isk Factor
There were 583 patients enrolled in MADIT II who had EP testing performed
either prior to or during ICD implant. The definitio n for inducib ility was the
same one used for the MADIT I study. Of these 583 patients, 373 (63 percent)
were not inducible and the remaining 210 (36 percent) were inducible. Of the
210 patients who were inducible, 180 (88 percent) had EP testing performed
- DRAFT -