Abizaid, Alexandre

Costa, J. Ribamar

Gibson, C. Michael

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J O U R N A L O F T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y VO L . 6 5 , N O . 8 , 2 0 1 5
ª 2 0 1 5 B Y T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N I S S N 0 7 3 5 - 1 0 9 7 / $ 3 6 . 0 0
P U B L I S H E D B Y E L S E V I E R I N C . h t t p : / / d x . d o i . o r g / 1 0 . 1 0 1 6 / j . j a c c . 2 0 1 4 . 1 2 . 0 1 6EDITORIAL COMMENTBioresorbable Vascular Scaffolds
in Daily Clinical Practice
Is the Essential Really Invisible to the Eyes?*Alexandre Abizaid, MD, PHD,y J. Ribamar Costa, JR, MD, PHD,y C. Michael Gibson, MDzSEE PAGE 791B ioresorbable vascular scaffolds (BVS) boastthe unique ability to satisfy the temporaryneed for mechanical support during initial
arterial healing following percutaneous coronary
revascularization, obviating the long-term disadvan-
tages of permanent metallic prostheses.
Based on the results of the ABSORB trial cohort A
(n ¼ 30) (1) and cohort B (n ¼ 101) (2), the Absorb BVS
(Abbott Vascular, Santa Clara, California) was the ﬁrst
such device to obtain CE mark approval and become
available for clinical use in Europe. Registry data
have demonstrated sustained efﬁcacy of the BVS
during 5-year follow-up (3–5), based on multimodality
imaging, as well as the presence of unique ﬁndings
such as restoration of nitrate-induced vasomotion (6)
and vessel enlargement (positive remodeling) in the
treated segment after 2 to 5 years of scaffold
deployment (3).
Notably, more than 60,000 patients have been
treated worldwide with Absorb in the past 3 years,
despite the absence of a single randomized trial
comparing these devices with contemporary metallic
drug-eluting stents (DES). Recently, the results of 2
randomized trials comparing the Absorb BVS with
metallic DES were released.
In ABSORB II, Serruys et al. (7) compared the BVS
with the everolimus-eluting cobalt-chromium Xience
stent. This study had a 2:1 single-masked design and
coprimary endpoints of nitrate-induced vasomotion*Editorials published in the Journal of the American College of Cardiology
reﬂect the views of the authors and do not necessarily represent the
views of JACC or the American College of Cardiology.
From the yInstituto Dante Pazzanese de Cardiologia, São Paulo, Brazil;
and the zHarvard Medical School, Boston, Massachusetts. Dr. Abizaid has
received research grants from Abbott Vascular and Elixir Medical. All
other authors have reported that they have no relationships relevant to
the contents of this paper to disclose.(a novel endpoint) and changes in minimum lumen
diameter (in-stent late loss) at 3 years (a traditional
endpoint). However, the Lancet publication only
contained the results for secondary endpoints, such
as acute (peri-procedural) performance, and the
composite clinical endpoints of death, myocardial
infarction, coronary revascularization, and angina
status at 6 and 12 months. Despite superior acute
performance of the metallic stent over the polymeric
scaffold (i.e., higher in-stent acute gain and less
residual stenosis), both devices showed excellent
midterm clinical performance, with low and compa-
rable rates of clinical adverse events. Although these
preliminary results might reassure enthusiasts of this
novel technology, including us, it is important to note
that the trial was not powered to speciﬁcally address
any of the secondary endpoints; therefore, the results
should be interpreted cautiously.In this issue of the Journal, Puricel et al. (8) pre-
sented the acute and 9-month angiographic results
of the single-center, randomized (1:1:1) EVERBIO II
(Comparison of Everolimus- and Biolimus-Eluting
Stents With Everolimus-Eluting Bioresorbable Vas-
cular Scaffold Stents II) trial (NCT01711931), comparing
the Absorb BVS and 2 of the most-used contemporary
DES, the everolimus-eluting platinum-chromium
stent (EES) and Biolimus-eluting stainless steel stent
(BES) (8). Interestingly, the trial was designed to show
superiority of themetallic DES at themidterm invasive
follow-up.
The investigators should be congratulated on
carrying out the ﬁrst “real-world” randomized com-
parison of the best-in-class metallic DES and the
ﬁrst market-approved BVS. For a 1-year period,
they enrolled 240 consecutive patients, including
those with acute coronary syndrome (39%), chronic
J A C C V O L . 6 5 , N O . 8 , 2 0 1 5 Abizaid et al.
M A R C H 3 , 2 0 1 5 : 8 0 2 – 4 BVS in Clinical Practice
803total occlusions (1.5%), and lesions involving vein
grafts (4%).
Despite marked differences in composition, thick-
ness, crossing proﬁle, and radial strength, the Absorb
BVS was associated with reasonable acute perfor-
mance, with comparable in-stent acute gain (1.97 
0.66 mm vs. 2.13  0.5 mm; p ¼ 0.31) and residual ste-
nosis (9.0  5.3% vs. 7.7  5.2%; p ¼ 0.08), although
acute recoil, as expected, was higher with the BVS (9.3
 6.5% vs. 6.7  4.8%; p < 0.01). Contrary to the re-
searchers’ a priori hypothesis, at the 9-month angio-
graphic evaluation, the Absorb BVS was associated
with a low and equivalent in-stent late luminal loss
versus DES (0.30  0.39 mm vs. 0.23  0.36 mm; p ¼
0.19). However, the in-segment analysis showed a
discrete but signiﬁcantly higher lumen loss at the
edges of the BVS (0.31  0.45 mm vs. 0.18  0.47;
p ¼ 0.04), which did not translate into a higher rate
of binary in-segment restenosis (12% with Absorb vs.
14% with the combined metallic DES; p ¼ 0.83).
Encouragingly, there was only a single case of BVS
thrombosis.
Although the EVERBIO II data are reassuring, a
few points require scrutiny. First, despite being the
ﬁrst randomized angiographic comparison between
metallic DES and BVS, the sample size remains
modest. Furthermore, it is unclear why the investi-
gators included 2 groups of metallic DES as compara-
tors because their primary endpoint was based on
9-month angiographic parameters and there is no ev-
idence of differences in EES and BES at this time point.
Second, although the enrolled population reﬂects
the daily practice and patient composition of
Sweden’s Fribourg University Hospital, it may not
represent patients in routine clinical practice else-
where. Although patient characteristics, including
vessel size and lesion length, are comparable with
published “all-comer” patient populations, the
mean number of stents/scaffold per patient (1.2) is
rather low, suggesting that only 1 lesion may have
been treated in most patients (9,10). Also, the in-
vestigators did not report the percentage of treated
bifurcation, ostial, and calciﬁed lesions or procedure
and device success rates. Differences in lesion com-
plexity might confound angiographic and clinicaloutcomes and are therefore important to fully under-
stand this novel device’s performance and limitations.
Third, to explain the slight increase in late lumen
in-segment loss, the researchers mentioned a possible
“transient constrictive effect found at scaffold
edges,” as previously described by Gogas et al. (11) in
a retrospective evaluation of the ABSORB cohort B
population. Other explanations might also be related
to “geographic miss,” especially at the time of post-
dilation because the operators relied only upon the
proximal and distal markers to identify scaffold
boundaries. Core laboratory difﬁculties in accurately
ascertaining the in-scaffold and in-segment regions,
especially in calciﬁed vessels treated with non-
radiopaque BVS, as well as “play of chance,” alter-
natively explain the in-segment differences observed.
Finally, as Puricel et al. (8) highlighted, metallic
stents and the current BVS devices are deployed
differently. With BVS, careful vessel sizing, “aggres-
sive” pre-dilation, and particular attention to the
balloon used for post-dilation help minimize risk of
scaffold damage (12). This may account for the dif-
ferences in pre-dilation rates and deployment pres-
sure observed in the EVERBIO II trial. Overall, the
rates of post-dilation were very low (31% with EES,
30% with BES, and 34% with BVS) and smaller than
usually reported in clinical registries, even with BVS
(13–15). Whether this reﬂected the researchers’ daily
practice or their particular concern with scaffold
rupture, we believe that post-dilation is an essential
“step” in either stent or scaffold implantation and
should be more often performed.
Although considered a children’s book, The Little
Prince by Antoine de Saint-Exupéry is also an adult
philosophical fable, with several observations about
life and human nature, such as “One sees clearly only
with the heart. What is essential is invisible to the
eyes.” The results of the present study are reassuring
that the radiolucent BVS technology may be a step in
the right direction to fulﬁll this premise.
REPRINT REQUESTS AND CORRESPONDENCE: Dr.
Alexandre Abizaid, Av. Dr. Dante Pazzanese, 500 –
Vila Mariana, São Paulo 04012-180, Brazil. E-mail:
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KEY WORDS ABSORB, bioresorbable vascular
scaffold, drug-eluting stents(s), randomized trial


Bioresorbable Vascular Scaffolds in Daily Clinical Practice Is the Essential Really Invisible to the Eyes?∗

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Bioresorbable Vascular Scaffolds in Daily Clinical Practice Is the Essential Really Invisible to the Eyes?∗

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