Absorb BVS
(N = 335)
XIENCE
(N = 166)
Difference
(95% CI)
p-value
ID-NTVR
1.5%
2.4%
-0.91%
[-4.65%, 1.56%]
0.49
ID-revascularization
2.7%
5.5%
-2.73%
[-7.49%, 0.76%]
0.13
All TLR
1.2%
1.8%
-0.61%
[-4.08%, 1.61%]
0.69
All TVR, nonTLR
1.8%
3.6%
-1.82%
[-6.28%, 0.67%]
0.23
All NTVR
1.8%
3.6%
-1.82%
[-6.00%, 1.05%]
0.23
All Revascularization
3.6%
7.3%
-3.64%
[-8.88%, 0.39%]
0.076
Composite Safety and Effectiveness (Hierarchical)
TLF (cardiac death, TVMI,
ID-TLR)
4.8%
3.0%
1.82%
[-2.46%, 5.18%]
0.34
TVF (cardiac death, all
MI, ID-TVR)
5.5%
4.8%
0.61%
[-4.24%, 4.43%]
0.78
MACE (cardiac death, all
MI, ID-TLR)
5.1%
3.0%
2.12%
[-2.19%, 5.53%]
0.28
PoCE (all death, all MI, all
revascularization)*
7.3%
9.1%
0.8%
[0.43%, 1.48%]
0.47
* PoCE – Patient Oriented Composite Endpoint
8.7
Benefit of the Absorb Bioresorbable Scaffold Technology
In the ABSORB Cohort A clinical investigation, Absorb BVS showed excellent long-term
clinical outcomes with low MACE rates out to 5 years with absence of any cardiac death,
ID-TLR, Q-wave MI, and scaffold thrombosis. The ABSORB Cohort B clinical investigation
confirms these findings out to 3 years, including patency comparable to XIENCE V.
Additionally, one-year ABSORB II RCT and ABSORB EXTEND clinical outcome data again
demonstrated and confirmed the safety and performance of the Absorb BVS with comparable
MACE, TLF, revascularization (ID-TLR), and stent / scaffold thrombosis rates as the
commercially available XIENCE.
Absorb BVS thus performs all the functions of a drug-eluting stent while offering future
potential benefits resulting from the absence of a permanent metallic implant. The gradual
disappearance of the scaffold allows for the possibility of vascular healing and restoration of
vessel function as discussed in the Vasomotor Function Results at 2 Years (sections
8.2.4
Vasomotor Function Results at 2 years – 8.2.5 Discussion
). The absence of a permanent
metallic implant in the vascular tissue may facilitate any required re-interventions on the
target vessel / lesion or side branches either by percutaneous or surgical means, thus
enabling a broader range of treatment options after bioresorption of the scaffold. Finally,
unlike permanent metal implants, polymeric implants do not cause imaging artifacts during
non-invasive CT or MR evaluation. This provides the additional benefit that a polymeric
bioresorbable scaffold may be more compatible with the growing usage of non-invasive
follow-up imaging than is the case with metallic stents, potentially facilitating patient
management and providing economic benefits.
9.0
PATIENT SELECTION AND TREATMENT
9.1 Individualization of Treatment
The risks and benefits described above should be considered for each patient before using
the Absorb GT1 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 GT1 BVS per ACC / AHA
and ESC guidelines. Physicians should use the information from the SPIRIT Clinical trials
and the ABSORB Clinical trials, 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 six months' duration is recommended.
It is very important that the patient comply with the post-procedural antiplatelet
recommendations. Premature discontinuation of prescribed antiplatelet medication could
result in a higher risk of thrombosis, MI, or death. Prior to 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
Inspection Prior to Use
Prior to using the Absorb GT1 BVS System, carefully remove the system from the package
and inspect for bends, kinks, and other damage. Verify that the scaffold does not extend
beyond the radiopaque balloon markers and that it is still well-crimped onto the balloon
catheter. Do not use if any defects are noted.
10.2
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 µ/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
10.3
Vessel and Lesion Selection
•
Quantitative imaging is strongly recommended
for the assessment of target vessel
diameter at baseline for appropriate Absorb GT1 BVS size selection.
• The target vessel diameter ranges to be treated in the procedure are indicated in
Table
13
along with the Absorb GT1 BVS diameter to be used.
Table 13: Target Vessel Diameter Ranges and Absorb GT1 BVS Diameter to be Used
(Quantitative Imaging)
Target Vessel Diameter Distal and Proximal
Absorb GT1 BVS Diameter to be Used
≥ 2.0 mm and ≤ 3.0 mm
2.5 mm
≥ 2.5 mm and ≤ 3.3 mm
3.0 mm
≥ 3.0 mm and ≤ 3.8 mm
3.5 mm
•
If visual estimation is used:
°
Use the predilatation balloon, when inflated, to assist in sizing the vessel.
°
Plan to upsize the scaffold for in-between diameters to ensure appropriate
expansion.
• 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.
10.4 Preparation
10.4.1 Packaging Removal
Note: The foil pouch is the sterile barrier. Sterile product is contained within this one
pouch—there is no secondary pouch.
1. Peel the pouch open from the top corner.
2. Carefully remove the delivery system from its protective tubing for preparation of
the delivery system.
3. Do not bend or kink the hypotube during removal.
10.4.2 Dual Layer Sheath Removal
1. While holding the distal catheter shaft with one hand, grasp only the yellow outer
sheath with the other hand and gently slide the sheath distally.
2. A longitudinal split on the inner sheath will open up and be visible.
3. The stylet and dual layer sheath are removed simultaneously from the delivery
system by continuing to slide the yellow sheath distally until the inner and outer
layers of the dual layer sheath as well as the stylet are free from the catheter
system. See section
6.1 Scaffold Handling – Precautions.
Do not use the device if
the sheath cannot be removed as indicated.
4. 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.
10.4.3 Guide Wire Lumen Flush
Flush the guide wire lumen with HepNS until fluid exits the guide wire exit notch.
Note:
Avoid manipulation of the scaffold while flushing the guide wire lumen, as this may
disrupt the placement of the scaffold on the balloon.
10.4.4 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 of
the product. Do not bend the product hypotube when connecting to the inflation
device / syringe.
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.
5. Close the stopcock to the delivery system; purge the inflation device / syringe of
all air.
6. Repeat steps 3 through 5 until all air is expelled. If bubbles persist, do not use the
product.
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.
10.5
Delivery Procedure
1. Prepare the vascular access site according to standard practice.
2.
Predilate the lesion to match the reference vessel diameter with a percutaneous
transluminal coronary angioplasty catheter.
Predilatation is strongly recommended
and can also be utilized to properly size the vessel.
Note:
Limit the length of the predilatation by the PTCA balloon to avoid creating a
region of vessel injury that is outside the boundaries of the Absorb GT1 scaffold.
3. Administer a standard dose of intracoronary nitroglycerine prior to finalizing the RVD
within the target zone.
4. Maintain neutral pressure on the inflation device. Open the rotating hemostatic valve
as widely as possible.
5. Backload the delivery system onto the proximal portion of the guide wire, while
maintaining guide wire position across the target lesion.
6. 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:
If removal of a scaffold system is required prior to deployment, ensure that
the guide catheter is coaxially positioned relative to the scaffold delivery
system and cautiously withdraw the scaffold delivery system into the guiding
catheter. Should
unusual resistance
be felt
at any time
when withdrawing the
scaffold into the guide catheter, the scaffold delivery system and the guide
catheter should be
removed as a single unit.
This should be done under
direct visualization with fluoroscopy.
7. Tighten the rotating hemostatic valve. The scaffold is now ready to be deployed.
10.6
Deployment Procedure
1.
CAUTION: Refer to product label for
in vitro
scaffold inner diameter, nominal
pressure and RBP.
2. Prior to deployment, reconfirm the correct position of the scaffold relative to the
target lesion using the radiopaque balloon markers.
3. 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. Fully expand the scaffold by inflating to nominal pressure at a minimum;
accepted practice generally targets an initial deployment pressure that would achieve
a scaffold inner ratio of about 1.1 times the reference vessel diameter.
CAUTION: Do not exceed the labeled rated burst pressure RBP of 16 atm
(1621 kPa) or maximum deployment diameter of the scaffold.
4. Fluoroscopic visualization during scaffold expansion should be used in order to
properly judge the optimum scaffold diameter as compared to the proximal and
distal native coronary artery diameters (reference vessel diameters). Optimal scaffold
expansion and proper apposition require that the scaffold be in full contact with the
arterial wall.
5. If necessary, the delivery system can be repressurized or further pressurized to
ensure complete apposition of the scaffold to the artery wall. Fully cover the entire
lesion and balloon-treated area (including dissections) with the Absorb GT1 scaffold,
allowing for adequate scaffold coverage into healthy tissue proximal and distal to
the lesion.
6. Deflate the balloon by pulling negative on the inflation device for 30 seconds.
Confirm complete balloon deflation before attempting to move the delivery system.
If unusual resistance is felt during scaffold delivery system withdrawal, pay particular
attention to the guiding catheter position.
Note:
See section
10.8 Removal Procedure
for instruction on withdrawal of scaffold
delivery system.
7. Confirm scaffold position and deployment using standard angiographic techniques.
For optimal results, the entire stenosed arterial segment should be covered by the
scaffold. Fluoroscopic visualization during scaffold expansion should be used in
order to properly judge the optimum expanded scaffold diameter as compared to
the proximal and distal coronary artery diameter(s). Optimal expansion requires that
the scaffold be in full contact with the artery wall, which can be facilitated with the
use of routine angiography, intravascular ultrasound (IVUS), or optical coherence
tomography (OCT).
8.
Postdilatation with a noncompliant balloon is recommended
following instructions
in section
10.7 Further Expansion of the Deployed Scaffold,
as long as the
postdilated segment is within the allowable expansion limits of the scaffold.
10.7
Further Expansion of the Deployed Scaffold
1.
DEPLOyED SCAFFOLDS SHOULD NOT BE LEFT UNDERDILATED.
Deployed scaffolds should be well-apposed to the vessel wall. To achieve optimal
scaffold apposition, postdilatation is recommended with a low profile, high pressure,
noncompliant balloon that is up to +0.5 mm larger than the nominal scaffold
diameter as long as the postdilated segment is within the allowable expansion
limits of the scaffold. The scaffolded segment should be carefully recrossed with
a prolapsed guide wire to avoid disrupting the scaffold geometry. Postdilatation
must only be done with balloons sized to fit within the boundaries of the scaffold.
The compliance chart of the noncompliant balloon selected must be carefully
reviewed prior to dilatation and an appropriate maximum pressure used to ensure
that the scaffold is not over-dilated.
The scaffold dilatation limit is 0.5 mm above
the nominal diameter for all scaffold sizes.
CAUTION: Do not dilate the scaffold beyond the dilatation limit which is 0.5 mm
above the nominal diameter. Over-dilatation may result in scaffold damage.
Nominal Scaffold Diameter
Dilatation Limit
2.5 mm
3.00 mm
Maximum postdilatation diameter
3.00 mm
3.50 mm
Maximum postdilatation diameter
3.5 mm
4.00 mm
Maximum postdilatation diameter
2. If more than one Absorb GT1 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
GT1 BVS should be positioned inside the deployed scaffold prior to expansion. It is
recommended not to use more than two Absorb GT1 BVS to treat one lesion.
3. Ensure the final scaffold diameter matches the reference vessel diameter to
ENSURE
GOOD SCAFFOLD APPOSITION.
Reconfirm scaffold position and angiographic
results. Repeat inflations until achieved.
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Printed on : 04/29/2015
