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Device-Related
1
System Organ Class /
Subjects
Events
Preferred Term
% (n/N)
N
Renal and urinary
0.0% (0/384)
0
disorders
Renal failure
0.0% (0/384)
0
Respiratory, thoracic and
0.0% (0/384)
0
mediastinal disorders
Respiratory failure
0.0% (0/384)
0
Vascular disorders
0.3% (1/384)
1
Hypertension
0.0% (0/384)
0
Hypotension
0.3% (1/384)
1
Shock
0.0% (0/384)
0
Embolism
0.0% (0/384)
0
Peripheral ischaemia
0.0% (0/384)
0
Note: A subject experiencing multiple occurrences of an adverse event was counted,
at most, once per system organ class and preferred term. Adverse events are coded
using MedDRA version 21.1.
1. Includes events reported with device relatedness as possible, probable or
definite.
2. Includes events reported with procedure relatedness as possible, probable
or definite.
The angiographic complications as identified by core
laboratory assessment for pivotal subjects are provided in
Table 9 below.
Table 9. Angiographic Complications (Core Lab)
(Pivotal Analysis Set)
After Final
Pre-Dil
Post-
Post-IVL
Before
Stent
Stent
Any Serious
2.6%
1.6%
0.8%
Angiographic
(9/341)
(1/64)
(3/357)
Complication
2
Dissection
3
A
0.3%
0.0%
0.0%
(1/341)
(0/64)
(0/357)
B
10.6%
3.1%
2.2%
(36/341)
(2/64)
(8/357)
C
4.7%
1.6%
0.0%
(16/341)
(1/64)
(0/357)
Severe Dissection
(Type D to F)
D
1.5%
0.0%
0.0%
(5/341)
(0/64)
(0/357)
E
0.6%
0.0%
0.0%
(2/341)
(0/64)
(0/357)
F
0.0%
1.6%
0.0%
(0/341)
(1/64)
(0/357)
Perforation
4
Any
0.0%
0.0%
0.6%
(0/341)
(0/64)
(2/357)
I
0.0%
0.0%
0.0%
(0/341)
(0/64)
(0/357)
II
0.0%
0.0%
0.3%
(0/341)
(0/64)
(1/357)
III
0.0%
0.0%
0.3%
(0/341)
(0/64)
(1/357)
Abrupt Closure
0.0%
1.6%
0.0%
(0/341)
(1/64)
(0/357)
Slow Flow
0.6%
0.0%
0.3%
(2/341)
(0/64)
(1/357)
No Reflow
0.0%
0.0%
0.0%
(0/341)
(0/64)
(0/357)
LBL 64191 Rev D, Instructions for Use ( June 2023)
Procedure-Related
2
Subjects
Events
% (n/N)
N
0.3% (1/384)
1
1. The final image is the one chosen by the core lab analyst based on optimal
projection, image quality, etc. from the post-procedural images obtained after
0.3% (1/384)
1
all devices have been removed and the procedure has been completed.
0.3% (1/384)
1
2. Serious angiographic complications include severe dissection (Type D to F),
perforation, abrupt closure, persistent slow flow and no flow.
0.3% (1/384)
1
3. Dissections were categorized per the NHLBI classification system.
4. Perforations were categorized per the Ellis classification for coronary perforation.
1.3% (5/384)
5
0.0% (0/384)
0
Supplemental Clinical Information
0.5% (2/384)
2
An analysis of long-term MACE (through 24 months) was
0.3% (1/384)
1
conducted for pivotal subjects on the complete data set.
0.3% (1/384)
1
0.3% (1/384)
1
All MACE were adjudicated by the CEC, and of the events
that occurred beyond 30 days, none were adjudicated by
the CEC as being definitely or probably device-related.
Table 10. MACE through 24 Months (Pivotal Analysis Set)
Number of Subjects with Completed
Follow-up Visits
MACE
1,2
Cardiac Death
Non-Q-wave Myocardial Infarction
Q-wave Myocardial Infarction
Target Vessel Revascularization
Note: MACE rates were calculated as Kaplan-Meier estimates event rates with the
Post
number of events.
Final
1
OCT-IVUS
1. All MACE were adjudicated by an independent CEC.
2. Some subjects failed >1 component of the MACE criteria; therefore, the
categories are not mutually exclusive.
0.0%
0.5%
(0/122)
(2/384)
3. Myocardial Infarction (MI) is defined as CK-MB level > 3 times the upper limit
of lab normal (ULN) value with or without new pathologic Q wave at discharge
(periprocedural MI) and using the Fourth Universal Definition of Myocardial
Infarction beyond discharge (spontaneous MI).
0.0%
0.3%
(0/122)
(1/384)
Target Lesion Revascularization (TLR) Kaplan-Meier (K-M)
0.0%
1.6%
estimates at 6, 12, and 24 months are 2.4%, 4.3%, and
(0/122)
(6/384)
6.4%, respectively.
0.0%
0.3%
(0/122)
(1/384)
The effect of IVL on hemodynamics during the index
procedure was assessed.
0.0%
0.0%
(0/122)
(0/384)
Table 11 summarizes the hemodynamic data for those
0.0%
0.0%
subjects with IVL-induced capture (n=171) and those
(0/122)
(0/384)
without (n=245). There were no instances of sustained
0.0%
0.3%
(0/122)
(1/384)
ventricular arrhythmias in the group with IVL-induced
capture, and there was no difference in the magnitude
0.0%
0.3%
of BP drop between the two groups.
(0/122)
(1/384)
0.0%
0.0%
(0/122)
(0/384)
0.0%
0.3%
(0/122)
(1/384)
0.0%
0.0%
(0/122)
(0/384)
0.0%
0.3%
(0/122)
(1/384)
0.0%
0.0%
(0/122)
(0/384)
0.0%
0.0%
(0/122)
(0/384)
After Final
Pre-Dil
Post-
Post
Post-IVL
Final
Before
Stent
OCT-IVUS
Stent
6 Months
12 Months
24 Months
373
367
346
10.2%
13.6%
18.9%
0.8%
1.1%
2.7%
7.8%
9.2%
11.3%
3
1.6%
1.6%
1.6%
2.9%
5.8%
8.5%
EN
Table 11. Hemodynamic Effects of IVL-Induced Capture
During Index Procedure (Safety Set)
1
Subjects
without
Parameter
IVL-induced
capture
(n=245)
Pre-Procedure Heart Rate (bpm)
69.0 ± 11.9
Heart Rate ≤ 60 bpm
20.8% (51/245)
Drop in Systolic BP during
24.5% (58/237)
IVL Procedure
Clinically Significant Drop in
3.4% (2/58)
Systolic BP
1
Magnitude of Systolic BP Drop
23.5 ± 15.0
Sustained Ventricular Arrhythmia
0.4% (1/245)
During or After IVL Procedure
1. Clinical significance determined by the investigator.
2. One subject experienced a drop in BP (23 mmHg) secondary to ventricular
tachycardia which occurred during pre-dilatation prior to IVL and the procedure
continued without further complication.
3. One subject experienced a drop in BP (50 mmHg) following two unsuccessful
attempts to deliver a stent post-IVL, loss of guidewire position, difficulty placing
a new guidewire, and subsequent PTCA.
4. One subject experienced a drop in BP (36 mmHg) after becoming transiently
bradycardic and hypotensive following IVL; after treatment, the procedure
continued without further complication.
An additional analysis by pooling individual patient-level
data from the Disrupt CAD studies (CAD I-IV) based on
uniform study inclusion/exclusion criteria and endpoint
definitions, as well as the use of an independent
angiographic core lab and Clinical Events Committee
adjudication, was conducted. Across the four studies,
a total of 683 subjects were enrolled from December 2015
to April 2020 at 72 sites from 12 countries including
Australia, Europe, U.S. and Japan. The Safety Set population
from CAD III and IV was used for this analysis.
A total of 42 subjects in the pooled safety set (6.1%, 42/683)
had a prior PPM/ICD. Table 12 summarizes relevant adverse
events in this subset including PPM/ICD-related adverse
events (e.g., inappropriate shock, transient pacing inhibition),
arrhythmias and hemodynamic events (including
hypotension, cardiogenic shock and hemodynamic
instability). In the pooled safety set, there were no
PPM/ICD-related events and no hemodynamic adverse
events. Three (3) subjects (7.1%, 3/42) with a PPM/ICD
experienced an arrhythmia > 30 days following the index
procedure; however, none were related to the study device
(IVL) or the index procedure. All three subjects were
enrolled in the Disrupt CAD III study; all had a medical
history of arrhythmia; and all arrhythmia-related AEs
occurred > 30 days following the index procedure.
In conclusion, the pooled safety analysis demonstrates
there is no association between PPM/ICD adverse events
and coronary IVL and support the conclusion that coronary
IVL is safe in patients with an implanted PPM/ICD device.
Subjects with
IVL-induced
p-value
capture
(n=171)
65.9 ± 11.4
0.0094
37.4% (64/171)
0.0002
40.5% (66/163)
0.0007
1.5% (1/66)
0.5988
2,3
4
18.9 ± 14.2
0.0670
0% (0/171)
1.0000
2
5/18
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