Secondary Endpoints Including Safety Summary; Adverse Events - Boston Scientific Contour Mode D'emploi

The mean hospital stay for the UFE subjects was 23.8 hours (SD 11.02, range 5 to 60 hours)
which was less then the mean hospital stay for the myomectomy cohort of 61.6 hours (SD
32.89, range 6 to 196 hours).
Primary Effectiveness Endpoint
Based on the 149 UFE ITT subjects, 130/149 (87.2%) UFE subjects completed up to 6-months
of follow-up. Of the 130 subjects, 121/149 (81.2%, 95% CI (74.00%, 87.13%)) achieved
success based on a ≥ 5 point improvement on the Overall Fibroid Symptom component of
the UFQoL. There were 28 (18.8%) subjects not considered a success at 6-months; 8/149
(5.4%) did not achieve a ≥ 5 point increase on the Overall Fibroid Symptom component of
a validated uterine fibroid quality of life questionnaire, 2/149 (1.3%) were never treated
with embolic on the day of the UFE procedure and were considered technical failures,
10/149 (6.7%) were lost to follow-up, 4/149 (2.7%) withdrew consent, 1/149 (0.7%) had a
post procedure myomectomy, 2/149 (1.3%) had a post procedure hysterectomy, and 1/149
(0.7%) were excluded from the analysis due to a significant inclusion criteria protocol
deviation that may have confounded her data. Table # 2 presents the improvement in
Overall Fibroid Symptom Score Success.
Table 2. Primary Effectiveness Success Endpoint: Improvement in Overall fibroid
Symptom Score Success rates
Change in Overall fibroid Symptom Score
Considered Success
≥ 5 point increase
not Considered Success
< 5 point increase
Technical Procedure Failure
(never treated with embolic)
Lost to Follow-up
re
Withdrew Consent
Post-procedure Myomectomy
on
Post-procedure Hysterectomy
h.
Significant protocol deviation that may have
as
confounded outcomes
ny

SECOnDary EnDPOInTS InClUDInG SafETy SUMMary

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81.2% (121/149) UFE subjects through 6-months experienced an increase ≥ 5 points from
a,
baseline up to 6-months post procedure on the Overall Fibroid Symptom component of
he
the UFQoL, while 75.0% (45/60) myomectomy subjects through 6-months experienced an
he
increase ≥ 5 points from baseline up to 6-months post procedure on the Overall Fibroid
a.
Symptom component of the UFQoL. (p=0.315).
ia
Overall, the UFE cohort returned to normal activities after their procedures in a
significantly shorter amount of time when compared to myomectomy cohort. The
4,
median number of days for the UFE cohort to return to normal activities was 9.5 days;
he
however, the median number of days for the myomectomy cohort to return to normal
activities was 39.5 days. However, when restricting this comparison to ages 36-40, to
remove the confounding with age, there was no significant difference between the UFE
(median = 17.5) and myomectomy (median 26.5) cohorts.
Due to the significant non-Normality of dominant fibroid sizes at each of baseline,
3 months, and 6 months (p < 0.05), the median change in fibroid size from baseline
to 3 or 6 months was assessed using Wilcoxon Signed – Rank Test. The median size
of the dominant fibroid in UFE subjects significantly reduced from baseline to 3 and
6-months post-procedure (p < 0.05). The median fibroid size of the dominant fibroid
was 116.9 cm
6-months). This represents a 39.2% decrease in fibroid size from baseline to 3-months
and a 52.4% decrease in fibroid size from baseline to 6-months.
The total uterine volume for the UFE patients significantly reduced from baseline to
3 and 6-months post-procedure with p-values < 0.001. In the UFE cohort, there was a
mean 30.0% reduction in uterine volume from baseline to 3-months and a mean 38.6%
reduction from baseline to 6-months.
The menorrhagia bleeding scores for both the UFE and myomectomy patients significantly
reduced from baseline to 3 and 6 months post-procedure with p-values < 0.001. In the UFE
cohort, there was a 49.2% reduction in the menorrhagia bleeding score at 3-months and a
55.2% reduction in the menorrhagia bleeding score from baseline up to 6-months.
The UFE cohort missed a significantly shorter amount of days of work when compared
6 Month Success rates n/149 (%)
to myomectomy cohort. The mean number of work days for the UFE cohort missed was
9.9 days; however, the mean number of missed work days for the myomectomy cohort
was 37.0 days (p < 0.001).
121 (81.2%)

aDVErSE EVEnTS

There were no deaths reported during the course of the study.
8 (5.4%)
There were no reports of unanticipated adverse device effects occurring during the study.
2 (1.3%)
There was a significantly higher adverse event rate in the myomectomy cohort
when compared to the UFE cohort for number of subjects with at least one adverse
10 (6.7%)
event (p < 0.05). Thirty seven out of 149 UFE subjects (24.8%) experienced at least
4 (2.7%)
one adverse event, whereas 24/60 (40.0%) myomectomy subjects experienced at
least one adverse event.
1 (0.7%)
Twenty four out of the 53 adverse events (45.3%) of the in the UFE cohort were related
2 (1.3%)
to the procedure, while 22/43 (51.2%) of the adverse events in the myomectomy cohort
1 (0.7%) were related to the procedure. There were no reports of device-related adverse events
in the UFE cohort occurring during the study.
There were 6/149 (4.0%) subjects with major adverse events for the UFE cohort and 1/60
(1.7%) for the myomectomy cohort (p > 0.05). Of the 6 major adverse events in the UFE
cohort, 3/6 were classified as related to the procedure, 1/6 was classified as not related
to the procedure, and 2/6 were classified as prior condition/new onset. The one major
adverse event in the myomectomy cohort was classified as procedure-related.
There were no UFE subjects enrolled with normal FSH values and regular menstrual
cycles who post-procedure experienced both signs and symptoms of the ovarian failure
(e.g., elevated FHS [sign], ammenorhea or hot flashes [symptoms]).
9
(at baseline) compared to 61.5 cm (at 3-months) and 49.1 cm
3 3
(at
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