Deutsch - Abbott ABSORB BVS Manual De Usuario

Cohort B, Group 1
(N = 45)
30 ±7 180 ±14 270 ±14
Days Days Days
Ischemia-driven
MACE, (cardiac
2.2% (1) 4.4% (2) 4.4% (2)
death, MI or
ischemia-driven
TLR, %)
Scaffold thrombosis
0% 0%
(%)
For the 45 patients in Group 1, up to 6 months, there was only one non-Q-wave myocardial
infarction that occurred during hospitalization following bail out treatment of a dissection during
the procedure and one ischemia-driven target lesion revascularization by PCI that occurred at 168
days follow-up coronary angiography (critical stenosis (≥ 50 and < 70%, FFR of 0.72). During
the baseline procedure a dissection had occurred during an attempt to cross the device with an
IVUS catheter. It was left untreated. At 168 days a stenosis was treated with a XIENCE V EECS in
the proximal segment of the target lesion. No further clinical events were reported from 6 months
to 9 months.
For the full Cohort B (101 patients), up to 6 months, there were three non-Q-wave myocardial
infarction that occurred, 2 during hospitalization, and 1 at 43 days post-procedure. Two ID-TLR
(ischemia-driven target lesion revascularization) by PCI were reported, one at 168 days and the
other at day 89 post-procedure. No cases of cardiac death or scaffold thrombosis per protocol or
per Academic Research Consortium definitions have been reported in both groups.
The 9-month Cohort B, Group 1 (45 patients) outcomes are consistent with the Cohort A
outcomes at 9 months. The clinical outcomes at 9 months reveal a low MACE rate of 3.3% and
4.4% in the ABSORB Cohort A and Cohort B (Group 1) groups, respectively. Furthermore, there
were no cases of cardiac death or scaffold thrombosis in either group. Therefore, based on these
results, the performance and safety established in the Cohort A investigation have been confirmed
by the clinical outcomes from Cohort B (Group 1).
8.3.3 Angiographic and IVUS Outcomes at 180 days
The 6-month angiographic results from Cohort B demonstrated a late loss of 0.19 mm which
compares well to the 0.10 mm late loss of the 3.0 x 18 mm XIENCE V Everolimus Eluting
Coronary Stent System (XIENCE V EECSS) observed in the SPIRIT FIRST First-In-Man trial and
compares favorably with the 0.43 mm late loss from Cohort A. At 180 days, the IVUS results from
Cohort B showed limited intra-scaffold neointimal hyperplasia, the volume obstruction (VO) was
1.2% and the neointimal hyperplasia area was 0.08 mm 2 . These results compare favorably with
XIENCE V EECSS in SPIRIT FIRST (VO of 8.0% and NIH area of 0.56 mm
of 5.3% and NIH area of 0.29 mm ). As observed in Cohort A, the 6-month IVUS results showed a
2
significant reduction in the average lumen area (6.60 ±1.22 mm
6.37 ±1.12 mm at 180-day, p = 0.0048). The vessel area remained comparable between
2
baseline and 180-day follow-up (14.22 ±3.75 mm vs. 14.49 ±3.67 mm
2
absence of significant expansive or constrictive remodeling.
8.3.4 Discussion
A total of 101 patients were enrolled with clinical data available out to 6 months for the full
Cohort. In addition, imaging data at 6 months are available for the 45 patients in Group 1. Overall,
the ABSORB BVS System has demonstrated acute success (98% procedure success and 100%
device success) and safety up to 9 months after implantation. The clinical outcomes at 6 months
reveal a low MACE rate of 4.4%. At 9 months, the MACE rate remained low at 3.3% and 5.0%
in the ABSORB Cohort A and Cohort B (Group 1) groups, respectively. Furthermore, there were
no cases of cardiac death or scaffold thrombosis in either group. Based on these results, the
performance and safety established in the Cohort A investigation have been confirmed by the
clinical outcomes from Cohort B.
9.0 INDIVIDUALIZATION OF TREATMENT
The risks and benefits described above should be considered for each patient before using the
ABSORB BVS System. Patient selection factors to be assessed should include judgment regarding
risk of antiplatelet therapy. Special consideration should be given to those patients with recently
active gastritis or peptic ulcer disease.
Antiplatelet drugs should be used in combination with the ABSORB BVS. Physicians should use
the information from the SPIRIT Clinical trials and the ABSORB trial, coupled with the current
literature on drug-eluting stents / scaffolds and the specific needs of individual patients, to
determine the specific antiplatelet / anticoagulation dose and duration to be used for their patients
in general practice. A minimum of 6 months duration is recommended.
It is very important that the patient comply with the postprocedural antiplatelet recommendations.
Premature discontinuation of prescribed antiplatelet medication could result in a higher risk
of thrombosis, myocardial infarction, or death. Prior to percutaneous coronary intervention
(PCI), if a surgical or dental procedure is anticipated that requires early discontinuation or
temporary interruption of antiplatelet therapy, the interventionalist and patient should carefully
consider whether an everolimus-eluting scaffold and its associated recommended antiplatelet
therapy are the appropriate PCI choice. Following PCI, should a surgical or dental procedure be
recommended, the risks and benefits of the procedure should be weighed against the possible risk
associated with premature or temporary discontinuation of antiplatelet therapy.
Patients who require premature discontinuation of antiplatelet therapy secondary to significant
active bleeding, should be monitored carefully for cardiac events and, once stabilized, have their
antiplatelet therapy restarted as soon as possible per the discretion of their treating physicians.
10.0 CLINICIAN USE INFORMATION
10.1 Vessel and Lesion Selection
• Quantitative imaging is recommended for the assessment of target vessel diameter
at baseline for appropriate ABSORB BVS size selection.
• The target vessel diameter ranges allowed to be treated in the index procedure are
indicated in the table below, along with the ABSORB BVS diameter to be used.
Target Vessel Diameter Distal and
ABSORB BVS Diameter to Be Used
Proximal
≥ 2.0 mm and ≤ 3.0 mm
≥ 2.5 mm and ≤ 3.3 mm
• For cases where the combination of target vessel diameter and target lesion length
is appropriate to be treated by more than one scaffold size, the selection of scaffold
size can be made per the judgment of the physician.
6
10.2 Inspection Prior to Use
Full Cohort B
Prior to using the ABSORB BVS System, carefully remove the system from the package and
(N = 101)
inspect for bends, kinks, and other damage. Verify that the scaffold does not extend beyond the
30 ±7 180 ±14
radiopaque balloon markers, and that it is still well-crimped onto the balloon catheter. Do not use
Days Days
if any defects are noted.
10.3 Peel-away Sheath Removal
2.0% (2) 5.0% (5)
1. Prior to removal of the packaging mandrel (inserted into the distal tip of the
catheter), carefully separate the ends of the peel-away, protective scaffold sheath.
2. Peel away sheath, by separating and pulling ends from distal to proximal, exposing
the scaffold. Special care should be taken to avoid handling the scaffold. See
0% 0% 0%
Section 6.1 Scaffold Handling – Precautions. Do not use if sheath cannot be
removed as indicated.
3. Verify that the scaffold does not extend beyond the radiopaque balloon markers and
no scaffold struts are lifted. Do not use if any defects are noted.
10.4 Materials Required
• 6F/0.070"/1.8 mm minimum inner diameter guiding catheter(s) of appropriate
shape for the target vessel
• 2 – 3 syringes (10 – 20 cc)
• 1,000 u/500 cc heparinized normal saline (HepNS)
• 0.014 inch (0.36 mm) x 175 cm (minimum length) guide wire
• Rotating hemostatic valve with 0.096 inch (2.44 mm) minimum inner diameter
• Contrast diluted 1:1 with normal saline
• Inflation device
• Three-way stopcock
• Torque device
• Guide wire introducer
10.5 Device Preparation
10.5.1 Guide Wire Lumen Flush
1. Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch.
10.5.2 Delivery System Preparation
1. Prepare an inflation device / syringe with diluted contrast medium.
2. Attach an inflation device / syringe to stopcock; attach it to the inflation port.
3. With the tip down, orient the delivery system vertically.
4. Open the stopcock to delivery system; pull negative for 30 seconds; release to
neutral for contrast fill.
) and with Cohort A (VO
2
5. Close the stopcock to the delivery system; purge the inflation
device / syringe of all air.
after procedure vs.
2
6. Repeat steps 3 through 5 until all air is expelled.
) demonstrating the Note: If air is seen in the shaft, repeat Delivery System Preparation, steps 3
2
through 5, to prevent uneven scaffold expansion.
7. If a syringe was used, attach a prepared inflation device to the stopcock.
8. Open the stopcock to the delivery system.
9. Leave on neutral.
Note: The labeled scaffold diameter refers to expanded scaffold inner diameter.
10.6 Delivery Procedure
1. Prepare the vascular access site according to standard practice.
2. Predilate the lesion with a percutaneous transluminal coronary angioplasty
catheter.
3. Maintain neutral pressure on the inflation device. Open the rotating hemostatic valve
as wide as possible
4. Backload the delivery system onto the proximal portion of the guide wire, while
maintaining guide wire position across the target lesion.
5. Advance the delivery system over the guide wire to the target lesion. Utilize
radiopaque balloon markers to position the scaffold across the lesion; perform
angiography to confirm scaffold position.
Note: Should any resistance be felt at any time during either lesion access or
removal of the delivery system post scaffold implantation, remove the entire
system as a single unit. See Scaffold / System Removal – Precautions for
specific delivery system removal instructions.
6. Tighten the rotating hemostatic valve. The scaffold is now ready to be deployed.
10.7 Deployment Procedure
1. CAUTION: Refer to product label for
Deploy the scaffold slowly, by pressurizing delivery system in 2 atm increments,
every 5 seconds, until scaffold is completely expanded. Maintain pressure for
30 seconds. If necessary, the delivery system can be repressurized or further
pressurized to ensure complete apposition of the scaffold to the artery wall. Do not
exceed RBP of the balloon or maximum deployment diameter of the scaffold..
FURTHER EXPANSION OF THE DEPLOYED SCAFFOLD:
If the deployed scaffold size is still inadequate with respect to reference vessel
diameter, a larger balloon may be used to further expand the scaffold. If the initial
angiographic appearance is suboptimal, the scaffold may be further expanded using
a low profile, high-pressure, noncompliant balloon dilatation catheter. For the 3.0 mm
diameter, the maximum diameter of the noncompliant balloon should be 3.25 mm
to avoid postdilatation beyond 3.50 mm. For the 2.5 mm diameter, the maximum
diameter of the noncompliant balloon should be 2.75 mm to avoid postdilatation
beyond 3.0 mm. Postdilatation must only be done with balloons sized to fit within
the boundaries of the scaffold. If this is required, the treated segment should be
carefully recrossed with a prolapsed guide wire to avoid disrupting the scaffold
geometry. Deployed scaffolds should be well-apposed to the vessel wall.
2.5 mm
CAUTION: Do not dilate the scaffold beyond the dilatation limit. Expansion
beyond 3.00 mm for 2.5 mm size scaffold, and beyond 3.50 mm for 3.0 mm size
3.0 mm
scaffold, may result in scaffold damage.
2.
3.
10.8
1.
2.
3.
4.
5.
11.0 TRADEMARKS
ABSORB and XIENCE V are trademarks of the Abbott Group of Companies.
CYPHER is a registered trademark of Cordis Corporation in the U.S.
ABSORB
Bioresorbierbares vaskuläres Gerüstsystem
(BVS)
VERSCHREIBUNGSINFORMATIONEN
Inhaltsverzeichnis
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
in vitro scaffold inner diameter and RBP.
9.0
10.0 ANLEITUNG ZUM KLINISCHEN GEBRAUCH
Nominal Scaffold Diameter Dilatation Limit
2.5 mm 3.00 mm
Maximum postdilatation diameter
3.0 mm 3.50 mm
Maximum postdilatation diameter
If more than one ABSORB BVS is needed to cover the lesion and balloon-treated
area, it is suggested that, to avoid the potential for gap restenosis, the scaffolds be
overlapped by a minimum of 1 mm and a maximum of 4 mm. To ensure that there
are no gaps between scaffolds, the balloon marker bands of the second ABSORB
BVS should be positioned inside the deployed scaffold prior to expansion. It is
recommended not to use more than two ABSORB BVS to treat one lesion.
Deflate the balloon by pulling negative on the inflation device for 30 seconds.
Removal Procedure
Ensure the delivery system is fully deflated.
Fully open the rotating hemostatic valve.
While maintaining guide wire position and negative pressure on the inflation device,
withdraw the delivery system.
Note: Should any resistance be felt at any time during either lesion access or
removal of delivery system post scaffold implantation, remove the entire system
as a single unit. See Scaffold / System Removal – Precautions for specific
delivery system removal instructions.
Tighten the rotating hemostatic valve.
Repeat angiography to assess the treated area.
If postdilatation is necessary, ensure the final scaffold diameter matches the
reference vessel diameter to ENSURE GOOD SCAFFOLD APPOSITION.
PRODUKTBESCHREIBUNG
Tabelle 1: Wirkstoffgehalt im ABSORB BVS
Tabelle 2: In-vitro-Produktspezifikationen
LIEFERUNG
INDIKATIONEN
KONTRAINDIKATIONEN
WARNHINWEISE
VORSICHTSMASSNAHMEN
6.1 Vorsichtsmaßnahmen bei der Handhabung des Gerüsts
6.2 Vorsichtsmaßnahmen bei der Gerüstplatzierung
6.3 Vorsichtsmaßnahmen bei Verwendung in anderen Verfahren
6.4 Vorsichtsmaßnahmen bei der Gerüst-/Systementfernung
6.5 Vorsichtsmaßnahmen nach der Implantation
6.6 Hinweis zur MR-Sicherheit
6.7 Wechselwirkungen mit anderen Medikamenten
6.8 Schwangerschaft
KOMPLIKATIONEN
7.1 Beobachtete Komplikationen
7.2 Potenzielle Komplikationen
KLINISCHE STUDIEN DES ABSORB BVS-SYSTEMS
8.1 Klinische Erprobung von ABSORB
8.2 ABSORB-Kohorte A
8.2.1 Methodologie und derzeitiger Stand
8.2.2 Klinisches Ergebnis nach 3 Jahren
Tabelle 3: Klinisches Ergebnis nach 3 Jahren
8.2.3 Angiographische, IVUS- und OCT-Ergebnisse nach 180 Tagen und
2 Jahren
8.2.4 Ergebnisse bei der vasomotorischen Funktion nach 2 Jahren
Abbildung 1: Ergebnisse der Prüfungen mit Acetylcholin und
Methergin in den proximalen, gerüstgestützten und distalen Segmenten
8.2.5 Diskussion
8.3 ABSORB-Kohorte B
8.3.1 Methodologie und derzeitiger Stand
8.3.2 Klinische Ergebnisse für Gruppe 1 der Kohorte B und für die gesamte
Kohorte B
Tabelle 4: Hierarchisch geordnete klinische Ergebnisse für Kohorte B
(ITT-Population)
8.3.3 Angiographie- und IVUS-Ergebnisse nach 180 Tagen
8.3.4 Diskussion
INDIVIDUELLE ANPASSUNG DER BEHANDLUNG
10.1 Auswahl des Gefäßes und der Läsion
10.2 Inspektion vor dem Gebrauch
10.3 Entfernen der Peel-Away-Hülle
Deutsch / German