User Manual Part 2

C-10
CLINICAL STUDY - MADIT II
PATIENT STATUS
There were a total of 1,232 patients with a prior myocardial infarction and a
left ventricular e jection fraction of ≤ 0.30 enrolled in the MADIT II trial. A total
of 742 patients were randomized to receive an ICD and 490 patients were
randomized to conventional therapy. Figure C-1 on page C-10 provides an
overview of the patient enrollment.
Patients Enrolled
n = 1232*
ICD
(device)
n = 742
Dead
n = 105
Alive
n = 625
Dead
n = 97
Alive
n = 381
Conventional Therapy
(Control)
n = 490
Unknown
n = 12
Unknown
n = 12
* Includes crossovers
(32 in Device arm, 22
in Control arm)
Figure C-1. Patient enrollmen t cascade primary endpoint
PRIMARY ENDPOINT
The primary endpoint for MADIT II was death from any cause. Analysis was
performed according to the intention-to-treat principle. The trial was designed
to have 95 percent power to detect a 38 percent reduction in the two-year
mortality rate among the patients in the ICD group, given a postulated two-year
mortality ra te o f 19 percent among patients assigned to conve n tional therapy,
with a two-sided significance level of 5 percent. For proportional-hazards
modeling, power was maintained for a true hazard ratio of 0.63, after allowance
for crossovers. A triangular sequential design was used, which was modified
for two-sided alte rnatives. The d at a was c orrected to account for an y lag in
obtaining data accrued (during weekly m onitoring), but not reported before
the termination of the trial with preset boundaries to permit termination of the
trial if the ICD therapy was found to be superior to, inferior to, or equal to
conventional medical therapy.
Secondary analyses were performed with use of the Cox proportional hazards
regression m od el. Survival curves were determine d according to the Kap la n
and Meier method, with comparisons of cumulative mortality based on
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