National Institute for Health and Care Excellence
1090 – Bioresorbable stent implantation for treating coronary artery disease
Consultation Comments table
IPAC date: Thursday 13th March 2014
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Consultee name and
organisation
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no.
Comments
Response
Please respond to all comments
1
Consultee 1
NHS Professional (on
behalf of British
Cardiovascular
Intervention Society)
1
BCIS suggests that special clinical governance arrangements
are not required as data to date indicate at least equivalent
outcomes to metallic drug eluting stents.
We also suggest that written information provided for patients
being offered bioresorbable stents should be specific for the
bioresorbable stent planned for use.
2
Consultee 2
NHS Professional
1
Thank you for your comment.
IPAC considered you comment but
chose not to change guidance.
Published evidence that fits the
search criteria for the title of the
guidance has been considered.
Information on specific stents cannot
be incorporated in Information For
Patients document for this procedure.
However, information about whether
the stents are drug-eluting or not will
be provided to individual patients by
the clinician.
The currently available data suggest that bioresorbable stents
Thank you for your comment.
performance in terms of clinical outcomes is similar to second
Section 1.2 recommends those
generation DES. However, there remain unanswered questions providing the intervention ‘enter
regarding long-term clinical outcomes from prospective
details about all patients undergoing
comparative studies. Therefore it would be recommended that
bioresorbable stent implantation for
patient treated with bioresorbable stents should be within clinical treating coronary artery disease onto
studies or entered into clinical registries where possible.
the UK Central Cardiac Audit
Database and review local clinical
outcomes’.
Section 1.3 recommends further
research on this procedure.
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Comments
Response
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3
Consultee 3
Manufacturer
1.1
• The Absorb scaffold, with the current amount of evidence
available, has a similar safety and efficacy profile as the best in
class DES Xience. The evidence documented in the
Interventional Procedure Overview document looks at different
bioresorbable scaffolds but these cannot be compared one to
another. There are devices which are drug eluting whilst others
are not. The absorption profiles vary and also the manner in
which the devices are deployed acutely. There are no trials
comparing bioresorbable scaffolds head to head so data from
one device cannot be used to gauge any safety or efficacy
measure of another.
• So far, the evidence collected on the Abbott Absorb product is
mostly on simpler lesions and has been reported in multiple
scientific publications and during international congresses whilst
a comprehensive international Clinical trial programme is
underway which plans to include over 9,500 patients. At the
time of this public consultation, 4,000 patients have been
enrolled.
• Later this year in September 2014, the 1 year results from the
first RCT (Randomised Controlled Trial) comparing Absorb to
DES (XIENCE) will be presented at the TCT congress
(Transcatheter Cardiovascular Therapeutics – the biggest
congress in international cardiology), along with 3 year data on
250 patients from a single arm study. There are also over
12,000 patients to be studied internationally in Investigator
Sponsored trials, both registries and RCTs. Additional
publications in more complex and all-comer patients have been
published since September 25 2013, they are listed under
section 4.
Thank you for your comments.
The IP Programme uses published
evidence that fits the search criteria
for the title of the guidance.
Column 1 of Table 2 presents details
of the device used in the procedure
description.
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The efficacy section of the guidance
has been developed to include details
of whether the stent used is drugeluting or not.
Current ongoing studies have been
listed in the IP overview.
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4
Consultee 3
Manufacturer
1.2
• Bioresorbable stents represent a new class of stent used in an
existing procedure.
• Longer term data (4 year cohort B) have been presented at the
TCT Congress in November 2013 (presentation by Dr Chevalier
and are available upon request). Detailed clinical and imaging
follow up of these patients has also been published: Serruys et
al. Dynamics of vessel wall changes following the implantation
of the Absorb everolimus eluting bioresorbable vascular
scaffold: A multi-imaging modality study at 6,12,24 and 36
months. Eurointervention e pub ahread of print |2013:9-on line
ahead of print, December 2013
• Based on the above, we do not believe that there is a need to
include all patients treated by Absorb in a registry given the
extent of the data collection, both in the UK and internationally.
Absorb will be an option in the CCA database as a device used
during PCI procedure.
• A single arm post-market study with 1,000 patients has now
started, it is called “Absorb UK Registry” – and will be rolled out
in 21 selected sites spread across the country. The aim is to
capture patients’ outcomes data over a year period. In addition,
the registry will collect additional information (e.g. acute
success) to evaluate handling and implantation of Absorb BVS
by physicians under routine clinical practice. • This is an “allcomers” registry that will document safety and clinical outcome
of the Absorb device in daily PCI practice, as per the IFU.
Alongside the registry there are a select number of additional
hospitals with Absorb trained/ certified physicians wishing to
implant the device as they have strong belief in the patient
benefits of the product for certain patient types. Outcomes
measured will be: - Acute success - Clinical outcomes at 1 and
3 years on all patients (death, MI, TLR, ID-TLR, TVR, ID-TVR,
all coronary revascularizations, composites outcomes and
scaffold/stent thrombosis) - Additional analysis will be performed
(access site, lesions preparation, treatment parameters and
post-treatment of lesion)
Thank you for your comments.
The study by Serruys (2013) is a 3
year follow-up of study 2 (ABSORB
B) in table 2 in the IP overview. This
has been updated.
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Absorb UK registry referred by the
Consultee is a manufacturer funded
ongoing study which has been listed
in the IP overview.
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5
Consultee 3
Manufacturer
1.3
Thank you for your comment.
Current ongoing studies have been
listed in the IP overview.
The IP programme process enables
the committee to access published
evidence only for efficacy.
6
Consultee 2
NHS Professional
2
There is an ongoing comprehensive trial program both designed
and implemented by Abbott and also the physician community
internationally. Currently over 22,500 patients will be studied. It
should be pointed out that some of them are RCT comparing
Absorb to best in class DES. As an example, the AIDA trial will
compare Absorb to the XIENCE family in 2,690 all-comers
patients (Woudstra et al. Am Heart J 2014; 167: 133-40).
These statements are generic NICE guidance on treatment of
coronary artery disease. The bioresorbable scaffolds may also
be considered in patients with a history of metal allergies where
standard stents cannot be used. This is novel indication and
reported in case studies only. Bioresorbable stents have only
been tested in patients with relatively simple coronary lesions,
Patients with anatomically complex disease, have not been
studied in great depth and therefore bioresorbable stents may
not be applicable in this subset of patients
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Thank you for your comment.
There is evidence from clinical trials
on the use of bioresorbable stents in
simple coronary lesions but not in
depth in other groups mentioned by
the consultee.
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7
Consultee 3
Manufacturer
2
• The international clinical expert experience indicates certain
patient types may benefit from Absorb – these include those
patients with long diffuse disease, young patients, diabetics,
those likely to have repeated PCIs and those potentially needing
surgery in the future, this has been published and here are the 2
recent published references:
o Latib et al, Which patients could benefit the most from
bioresorbable vascular scaffold implant: from clinical trials to
clinical practice. MINERVA CARDIOANGIOL 2013;61:255-62
o R Campante Teles et al, Position statement on bioresorbable
vascular scaffolds in Portugal. Rev Port Cardiol.
2013;32(12):1013---1018. Article in Portuguese with summary in
English
• Per Absorb IFU (Instructions For Use), indications are as
follows: The Absorb Bioresorbable Vascular Scaffold is a
temporary scaffold indicated for improving coronary luminal
diameter that will eventually resorb and potentially facilitate
normalization of vessel function in patients with ischemic heart
disease due to de novo native coronary artery lesions. The
treated lesion length should be less than the nominal scaffolding
length (12 mm, 18 mm, 28 mm) with reference vessel diameters
> 2.0 mm and < 3.8 mm.
• Per Absorb IFU, it is recommended to have a minimum of 6
month DAPT treatment.
BCIS suggest that operators planning to use bioresorbable
stents should be experienced in the use of metallic coronary
stents and performing at least 75 PCI procedures per year as
per BCIS guidelines. Operators should ensure that they have
undergone appropriate education and preparation for the safe
use of these stents. Proctoring arrangements are advised for
the first use. Operators should also have facilities for and be
capable of ensuring adequate bioresorbable stent deployment
using intra-vascular imaging such as ultra-sound or OCT.
Thank you for your comment.
There is evidence from clinical trials
on the use of bioresorbable stents in
simple coronary lesions but not in
depth in other groups mentioned by
the consultee.
The study by Latib et al (2013) has
been added to appendix A as the
clinical outcomes are not reported.
The study by Campante Teles et al
(2013) is not published in English and
will not be included.
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Consultee 1
NHS Professional (on
behalf of British
Cardiovascular
Intervention Society)
3
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Section 3.3 in the guidance states
that ‘dual antiplatelet agents are
usually prescribed for at least 6
months following the procedure’.
Thank you for your comment.
IPAC considered whether to add a
recommendation about training for
the procedure but decided that
training requirements are well
established.
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9
Consultee 2
NHS Professional
3
Thank you for your comment.
10
Consultee 3
Manufacturer
3.1
11
Consultee 1
NHS Professional (on
behalf of British
Cardiovascular
Intervention Society)
4.7
These are generic comments. No changes are required. Current
recommendation is for 6 month dual anti-platelet treatment.
There is no definitive data to support a reduction in duration of
anti-platelet use in patients who have had bioresorbable stents
implanted in comparison with metal stents.
• Absorb is designed to fully resorb through natural metabolic
process. Absorb may offer benefits to certain patient
populations, by broadening future treatment options, and
minimising the potential for late inflammation and thrombosis.
Some PCI patients may require DAPT longer term than the
recommended European Society of Cardiology (ESC) drug
eluting stent guidelines which the Absorb IFU is aligned to. Due
to the unique benefit of the resorption of Absorb, versus a
permanent metallic stent, potentially Absorb could be more
appropriate for this type of patient as the need for DAPT would
be eliminated.
BCIS suggest that further key efficacy measures are the rates of
stent thrombosis and target vessel revascularisation (compared
to metallic drug eluting stents) at intervals of greater than 12
months.
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Thank you for your comment.
IPAC considered your comments and
decided not to amend paragraph 3.1.
To note in paragraph 1.3 the
committee highlight the need for more
evidence development.
Thank you for your comment.
Additional outcomes listed by BCIS
have been added to paragraph 4.7
(efficacy) in the guidance.
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Comments
Response
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12
Consultee 2
NHS Professional
4
The clinical studies presented here include data on stent
platforms not in clinical use. There applicability to the current
bioresorbable stents is questionable. They are of historical
interest in terms of evolution of this stent technology. There is
no randomised data comparing bioresorbable stents and current
generation drug eluting stents/bare metal stents. However,
propensity matched cohorts of bioresorbable stent vs second
generation DES suggest that bioresorbable stents performance
is similar to current DES in terms of MACE and TVF at 2 year
follow up. Further studies are planned and further data will be
available in the next 12-18 months. Until randomised and
blinded data is available, it is impossible to be certain that
bioresorbable stents are as efficacious or more efficacious than
the current gold standard of DES.
Thank you for your comment.
The IP Programme uses published
evidence that fits the search criteria
for the title of the guidance.
Column 1 of Table 2 presents details
of the device used in the procedure
description.
The efficacy section of the guidance
has been developed to include details
of whether the stent used is drugeluting or not.
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Com
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Consultee name and
organisation
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no.
Comments
Response
Please respond to all comments
13
Consultee 3
Manufacturer
4
• The Absorb scaffold, with the current amount of evidence
available, has a similar safety and efficacy profile as the best in
class DES Xience. The evidence documented in the
Interventional Procedure Overview document looks at different
bioresorbable scaffolds but these cannot be compared one to
another. There are devices which are drug eluting whilst others
are not. The absorption profiles vary and also the manner in
which the devices are deployed acutely. There are no trials
comparing bioresorbable scaffolds head to head so data from
one device cannot be used to gauge any safety or efficacy
measure of another.
• Additional publications on Absorb clinical outcomes became
available, mainly on line, from September 25 2013 presenting
short term efficacy and safety results in more complex patients
such as patients suffering from Acute Coronary Syndromes,
STEMI and NSTEMI.
o Wiebe et al, Short-term outcome of patients with ST-segment
elevation myocardial infarction (STEMI) treated with an
everolimus-eluting bioresorbable vascular scaffold. Clin Res
Cardiol, Published on line 18 October 2013
o Diletti et al, Everolimus-eluting bioresorbable vascular
scaffolds for treatment of patients presenting with ST-segment
elevation myocardial infarction: BVS STEMI first study.
European Heart Journal, Advanced access published 6 January
2014
o Gori et al, Early outcome after implantation of Absorb
bioresorbable drug-eluting scaffolds in patients with acute
coronary syndromes. EuroIntervention 2013 9-on line published
ahead of print, September 2013
o Kocka et al, Bioresorbable vascular scaffolds in acute STsegment elevation myocardial infarction: a prospective
multicenter study ‘Prague 19’ European Heart Journal,
Advanced access published 12 January 2014
Thank you for your comment.
The IP Programme uses published
evidence that fits the search criteria
for the title of the guidance.
Column 1 of Table 2 presents details
of the device used in the procedure
description.
The efficacy section of the guidance
has been developed to include details
of whether the stent used is drugeluting or not.
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Of the 4 studies listed by the
Consultee,
Gori 2013, Kocka 2014 will be added
to table 2 and;
Wiebe 2013, Diletti 2014 will be
added to appendix A of the guidance
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Comments
Response
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14
Consultee 3
Manufacturer
4.7
• we would recommend changing the last part of the sentence
to: “and potential reduced need for DAPT on the long term”.
Thank you for your comment.
Paragraph 4.7 includes specialist
advisers’ comments on efficacy as
direct quotations and therefore
cannot be amended.
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15
Consultee 2
NHS Professional
5
The currently published studies show no increase in the rates of
stent thrombosis among patients treated with bioresorbable
stents. However, these observations are based on propensity
matched cohorts or post hoc analysis with historical second
generation DES data. Recently, published network metaanalysis has suggested possible increased rate of stent
thrombosis among patient treated with bioresorbable stents
when compared to second generation DES. However, this data
should be interpreted with caution given the study methods.
Therefore further data will be needed from prospective studies,
before any definitive conclusions can be made regarding the
safety of bioresorbable stents.
Thank you for your comment.
The meta-analysis referred by the
Consultee compares the efficacy and
safety of biodegradable polymer drug
eluting stents with those of bare metal
stents and durable polymer drug
eluting stents but not bioresorbable
stents.
Section 1.1 in the guidance states
that ‘evidence on the safety and
efficacy of the procedure in the long
term is inadequate’.
In 1.3 it recommended further
research on this procedure as
follows:
‘NICE encourages further research
into bioresorbable stent implantation
for treating coronary artery disease
and may review the procedure on
publication of further evidence Details
of subsequent antiplatelet therapy
should be reported and outcomes
should include major adverse cardiac
events, (MACE) particularly in the
long term (at least 2–3 years).
Studies on the safety and efficacy of
the procedure compared with other
types of coronary stent implantation
would be useful’.
In section 6 the Committee noted that
there are several ongoing trials.
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Consultee 3
Healthcare Other
(manufacturer)
5.3
Absorb is designed to fully resorb through natural metabolic
process between 2 to 3 years. That complete resorption that
differentiates Absorb from metallic DES should minimise the
potential for late inflammation and thrombosis. As mentioned
previously, Abbott clinical trial is collecting safety endpoints in all
single arm and randomized clinical trials and more data will
become available in the coming years. We do not agree with
the last sentence because of the total resorption of the
Bioresorbable stent over time, at least for Absorb. We believe
this sentence should be deleted.
17
Consultee 1
NHS Professional
(on behalf of British
Cardiovascular
Intervention Society)
6.1
18
Consultee 2
NHS Professional
6.1
Thank you for your comment.
In paragraph 3.3 the sentence ‘time
of stent absorption’ has been
amended.
Paragraph 5.3 includes specialist
advisers’ comments on safety,
particularly relating to theoretical or
anecdotal adverse events as direct
quotations and therefore cannot be
amended.
BCIS agree with these comments and suggest that outcomes
Thank you for your comment.
with bioresorbable stents are likley to vary between devices so The IP Programme uses published
that data should be considered in a device specific manner
evidence that fits the search criteria
rather than grouped for all bioresorbable stents.
for the title of the guidance.
Column 1 of Table 2 in the IP
overview presents details of the
device used in the procedure
description.
The efficacy section of the guidance
has been developed to include details
of whether the stent used is drugeluting or not.
Although there are number of bioresorbable stents in
Thank you for your comment.
development, the only stent platform in clinical use is the
The IP Programme uses published
ABSORB stent (Abbott Vascular). Other bioresorbable stent
evidence that fits the search criteria
technologies are likely to be available in the future, and their
for the title of the guidance.
efficacy and safety will need to be proven by way of prospective,
The Committee have noted in section
randomised, blinded trials.
6 of the guidance states that ‘the
technology is evolving’ and there are
‘several ongoing studies’.
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19
Consultee 3
Healthcare Other
(manufacturer)
6.1
We recommend that this sentence is positioned at the beginning Thank you for your comment.
of the document plus the various sections should reflect which
Section 1 is for the guidance
stent is considered when reporting results.
recommendations. The guidance
relates to the procedure and is not
device specific.
"Comments received in the course of consultations carried out by NICE are published in the interests of openness and transparency, and to promote
understanding of how recommendations are developed. The comments are published as a record of the submissions that NICE has received, and are
not endorsed by NICE, its officers or advisory committees."
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