BIOTRONIK Evia DR, Technical Manual

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48 Evia Technical Manual
** Number of patients that have contributed at least 1 follow-up
Analysis
The comparison of the number of 3, 6, 9, and 12 month and
unscheduled office follow-up visits in Group 1 versus Group 2
showed that there was an average number of 1.9 office follow-up
visits on a per year basis in Group 1 (HM) and an average
number of 3.4 office follow-up visits on a per year basis in Group
2 (Control). Therefore, the null hypothesis (HØ) can be rejected,
indicating that the average number of office visits per year is
statistical significantly less in the HM group than in the Control
group (p < 0.001). The primary effectiveness endpoint was met.
6.4.3.2 Primary Endpoint 2: Safety Event Rate
The purpose of the primary endpoint 2 was to compare the
Safety Event Rate (SER), which includes death, incidence of
strokes and events requiring surgical interventions (e.g. device
explants or lead revision) between the two groups.
Table 11
summarizes the Safety Event Rate for the study
patients for 12 months post-enrollment.
Figure 6
shows these
data in a Kaplan-Meier analysis.
Table 11: Safety Event Rate Comparison
Safety Event Rate* Group 1 Group 2 p value**
Type of Event
Death
Stroke
Surgical
intervention
36 / 608 (5.9%)
2 / 574 (0.3%)
57 / 605 (9.4%)
18 / 245 (7.3%)
3 / 227(1.3%)
22 / 239 (9.2%)
0.440
0.141
1.000
Any Event
95 / 643 (14.8%) 42 / 256 (16.4%) 0.539
* Only includes events occurring within 12 months of enrollment
** 2-sided Fisher Exact test