Specifications
Diamondback360®CoronaryOrbitalAtherectomySystem
13
Table 4. Primary Safety Endpoint (30-day MACE)
Primary Safety Endpoint % [95% CI]
1
Hypothesis
2
Freedom from MACE within 30 days post-
procedure
3
89.6% [86.7%-
92.5%]
4
H
O
: π
s
≤ 83%
H
A
: π
s
> 83%
1
Kaplan-Meier method used to obtain estimate of freedom from MACE. Peto’s
method used to obtain the 95% confidence interval for the estimate.
2
π
s
is the probability of freedom from MACE within 30 days of the procedure of
OAS device treatment.
3
Freedom from MACE within 30 days post-procedure includes all subjects where
the guide wire crossed the lesion.
4
Study conclusions do not change for the worst-case analysis in which all subjects
with missing primary safety endpoint data, and those without post-procedural CK-
MB and troponin data, are treated as having 30-day MACE events.
A time to event analysis of the cumulative MACE rate (along with each component that
comprises MACE) and the thrombosis rate at 30 days and annually are presented in
Table 5.
Table 5. Cumulative Thrombosis and MACE Rates through 2-Year Follow-up
Number of days post index
procedure
30 365 730
Number of Subjects with Completed Visits 430 215 47
Thrombosis Event Rate 0.2% 0.2% 0.2%
MACE Event Rate 10.4% 18.3% 23.8%
Cardiac Death Event Rate 0.2% 4.4% 4.4%
TVR/TLR Event Rate 1.4% 6.3% 10.2%
MI Event Rate 9.5% 11.6% 11.6%
Procedural success was measured by the success in facilitating stent delivery, to the
target lesion, with <50% residual stenosis and without in-hospital MACE. Final percent
stenosis, as well as other procedural parameters, were evaluated by an independent
Angiographic Core Laboratory. Procedural success occurred in 391 of 440 evaluable
patients (i.e., patients in whom the study guide wire crossed the lesion and treatment with
the OAD was inserted). The observed rate of procedural success was 88.9%. Table 6
summarizes the Primary Effectiveness Endpoint.