Spectranetics AngioSculpt X Mode D'emploi page 6

The primary e cacy objective was to demonstrate reduced in-segment
late lumen loss (LLL) in the coated-balloon group compared to the
bare group at 6 months per QCA analysis.
included procedural success, major adverse cardiac events (MACE)
through 6 months, and the individual clinical endpoints of death,
stent thrombosis, myocardial infarction and coronary revascularization
through 6 months. Additionally, patients were followed for the same
individual clinical endpoints of death, stent thrombosis, myocardial
infarction and coronary revascularization through 12 months for the
purpose of assessing long-term safety.
Results were analyzed on an intent-to-treat (ITT) and per-protocol (PP)
basis. The ITT population was comprised of patient grouping according
to randomization assignment regardless of actual treatment received.
The PP population was comprised of the patient grouping according
to the actual treatment received. All 28 patients (and 30 lesions)
randomized to the bare group were successfully treated with a bare
AngioSculpt device, and were eligible for inclusion in the ITT and PP
analyses. As 3 patients in the coated group did not receive treatment with
a coated AngioSculpt, 3 of the 33 patients and lesions in the coated ITT
population were excluded from the PP population, leaving 30 patients/
lesions in the PP population.
PRIMARY EFFICACY ENDPOINT
Late Lumen Loss at 6 Months
The PATENT-C Trial met the primary endpoint of the study of in-segment
LLL (calculated as di erence between the angiographic in-segment
minimum lumen diameter [MLD] post procedure and at 6 month
follow-up) evaluated by QCA. LLL at 6 months in the bare balloon was
0.48±0.51 for both the ITT and PP analysis compared to 0.17±0.40
(p = 0.01) and 0.12±0.26 (p= 0.009) in the coated ITT and PP groups
respectively (Table 1).
Table 1: LLL at 6 Month Follow-up by QCA (ITT and PP Population)
Lesions
Population available
for analysis for analysis for analysis for analysis
In-segment 27 bare/
ITT
LLL, mm 27 coated
In-segment 27 bare/
PP
LLL, mm LLL, mm 24 coated
* Values are mean±SD
SECONDARY ENPOINTS AND ONGOING SAFETY SURVEILLANCE
Procedural Success
In accordance with the protocol, which de ned procedural success
as < 50% diameter stenosis (by Core Lab analysis) and absence of
in-hospital MACE, the three patients in whom an AngioSculpt could
not be crossed/advanced to the lesion were considered device failures,
but not procedural failures. Furthermore, as the protocol stated that
procedural success rate is calculated as the number of patients achieving
procedural success divided by the total number of patients treated
with the drug-coated AngioSculpt device, the 3 patients who were not
treated with an AngioSculpt device were removed from the calculation
of procedural success rate. Success rate was therefore 100% in the
drug-coated group and 92.6% in the bare balloon group. The source of
failure in the bare group included one patient who experienced an in
hospital MACE and another patient with > 50% nal residual diameter
stenosis by QCA. The success rates are shown in Table 2.
Table 2: Procedural Success Rate
Procedural Success Rate
Success rate, success/
total patients treated with 25/27† (92.6%)* 30/30 (100%)*
AngioSculpt device (%) AngioSculpt device (%)
Values are n (%), * Angiogram unavailable for one patient in the
bare group, so cannot be certain of procedural success; therefore
N = 27 patients.
MACE up to 6 Months
Adjudicated MACE was de ned as cardiac death, target vessel MI, or
clinically driven target lesion revascularization (TLR) through 6 months.
MACE rates were calculated by counting one event type per patient: once
a patient met an endpoint, subsequent events of the same endpoint
were not counted for that patient. Within 6 months after the index
procedure the cumulative MACE rate was 32.1% in the bare group and
P009923-D 22NOV19 (2019-11-22)
Secondary endpoints
Paclitaxel-
Bare
coated
Balloon
Balloon
0.48± 0.17±
0.51* 0.40*
0.48± 0.12±
0.51* 0.26*
Paclitaxel-
Bare Balloon
coated Balloon
6.1% in the coated group. The rate of target vessel MI (TV-MI) was 7.1% in
the bare group and zero in the coated group. The rate of clinically driven
TLR was 32.1% in the bare group compared to 3% in the coated group.
No patients died of cardiac causes in the bare group and 1 patient (3%)
in the coated group experienced cardiac death. The cardiac death in the
coated patient was determined to be secondary to non-target vessel MI
resulting from non-TVR performed the day prior to death. Table 3 and
Table 4 summarize the MACE rates up to 6 months post procedure in the
ITT and PP populations.
Table 3: Secondary endpoint of MACE at 6 months of follow-up,
ITT Population
Secondary Endpoint
Occurrence
Any MACE
Cardiac Death
Target Vessel MI
Clinically driven TLR Clinically driven TLR
Values are n (%), * One patient in the bare group experienced two TV-MIs
and one TLR, but is counted as having reached the endpoints once per
usual convention.
Table 4: Secondary endpoint of MACE at 6 months of follow-up,
PP population
Secondary Endpoint
Occurrence
Any MACE
Cardiac Death
Target Vessel MI
Clinically driven TLR
Values are n (%),
p-value
and one TLR, but is counted as having reached the endpoints once per
usual convention.
0.01
Individual Clinical Endpoints up to 6 Months
All patients were followed for the individual clinical endpoints of stent
0.009
thrombosis (occurrence and timing), death (cardiac/non-cardiac),
MI (target vessel or any infarction), and repeat revascularization
(clinically driven TLR, clinically driven TVR, any revascularization) through
6 months. Individual clinical endpoint rates were calculated by counting
one event of each type per patient; once. There were no cases of stent
thrombosis in either group. In addition to the cardiac death noted in the
preceding section (MACE through 6 months), one patient in the bare
group experienced non-cardiac death (ITT and PP analyses). The rates
of MI were similar in both groups. The rate of clinically driven TVR was
35.7% in the bare group, including 9 patients (32.1%) that also met the
endpoint of clinically driven TLR (ITT and PP). In the bare group, one
patient experienced clinically driven TLR (and therefore also TVR) in the
ITT analysis. As this patient was not included in the PP population for
reason of not receiving a drug-coated AngioSculpt, no patients in the
coated group PP population experienced clinically driven TVR or TLR.
The individual clinical endpoint rates through 6 months are shown in
tables 5 and 6, which summarize events up to 12 months.
Any Death, Any Myocardial Infarction, Coronary Revascularization,
and Stent Thrombosis up to 24 months
Although not part of the formal secondary endpoint analysis, all patients
p-value
were also followed for death, MI, coronary revascularization and stent
thrombosis through 24 months as part of ongoing safety surveillance.
Between 6 and 12 months of follow up one patient in the coated group
0.2
died, secondary to TV-MI and possible very late stent thrombosis (ST).
The cardiac death in this patient was classi ed as not related to the
study device or procedure per investigator assessment and this was
con rmed by the CEC. The CEC made the additional determination of
possible very late ST and TV-MI as a conservative measure on the basis
that there was not su cient source documentation to exclude these
events. As the possible stent thrombosis occurred > 1 year after the
index procedure (1 year and 3 days after), it was classi ed as very late
per the ARC consensus document; however, as it was within the 1 year
follow-up window of 12±2 months, it was included in the calculation of
12 month event rates. Table 5 (ITT) and 6 (PP) summarize the event rates
up to 24 months of follow up.
Paclitaxel-Coated
Bare Balloon,
N= 28 patients
N = 33 patients
9 (32.1%)
0
2* (7.1%)
9* (32.1%)
Paclitaxel-Coated
Bare Balloon,
N= 28 patients
N = 30 patients
9 (32.1%)
0
2* (7.1%)
9* (32.1%)
* One patient in the bare group experienced two TV-MIs
Balloon, p-value
2 (6.1%) 0.016
1 (3.0%) 1.0
0 0.21
1 (3.0%) 0.004
Balloon, p-value
1 (3.3%) 0.005
1 (3.3%) 1.0
0 0.23
0 0.0006
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